Monday report

Uncategorized

Monday report

David Ermer–Uncategorized–

Simplicity is a virture.

From Washington, DC,

  • The American Hospital Association News reports
    • “The Senate’s budget resolution to set up a third reconciliation bill was released Aug. 7 by Sen. Ron Johnson, R-Wis., chairman of the Senate Budget Committee. It instructs 11 Senate committees to provide up to $150 billion in funding by Sept. 11. No healthcare committees received instructions. The House passed its budget resolution July 21. That version instructs the House committees on Administration, Agriculture, Armed Services and Intelligence to draft legislation that provides up to $95 billion in funding by Sept. 11.
    • “Legislators continue to focus their efforts on a reconciliation bill that would narrowly provide additional funding for defense, farm aid and election-related provisions. The House and Senate must pass an identical budget resolution before moving forward with a reconciliation bill. Additional legislative activity is expected in September when Congress returns to session.” 
  • The Wall Street Journal relates,
    • “President Trump signed a new executive order Monday calling for most children to receive fewer vaccines and made some of his most extensive comments yet linking childhood shots and autism—a connection that scientists have said is unfounded.
    • “The document Trump signed Monday is similar to a previous executive order to decrease the number of vaccines children receive. It also urges parents to spread out vaccines in more visits to pediatricians’ offices and encourages states to mandate fewer vaccines for school attendance. It calls for the measles, mumps and rubella vaccination to be given in separate shots rather than the combination shot commonly given in the U.S.
    • “The new executive order goes further than the prior effort by grouping vaccines into three buckets: those recommended for all children, those recommended only for high-risk children and those that are subject to “shared-decision making,” in which parents and doctors discuss risks and benefits for each child. Included in the final category are vaccines for Covid-19, the flu, hepatitis B and more.
    • “The order doesn’t explicitly link vaccines to autism, but the president did so in his remarks Monday at an Oval Office event.” * * *
    • “The order calls on Kennedy and a newly revived vaccine task force to, in the next 90 days, come up with new recommendations for the timing and sequencing of childhood vaccines and find alternatives to a common vaccine ingredient, aluminum. A study of more than one million children in Denmark last year found no link between aluminum in vaccines and childhood chronic diseases, but Kennedy denounced the study. Scientists have said children are exposed to more aluminum from daily life than they receive in vaccines.”
  • and
    • “The Trump administration took a partial step Monday toward Health Secretary Robert F. Kennedy Jr. promised food-system overhaul.
    • “Here’s what to know:
      • “Kennedy’s health department is asking food companies for more information about the substances they are putting into the U.S. food supply.” * * *
      • “The new proposed rule falls short of what some food-safety advocates have hoped for. Acting Food and Drug Administration Commissioner Kyle Diamantas said the notifications for new substances are mandatory, but it was unclear how the government will enforce the requirement. Food suppliers can still put new ingredients on the market before they notify regulators, Diamantas said.” * * *
      • “Health officials said stronger regulation—such as blocking companies from going to market before the FDA signs off on the safety of their ingredients—would require congressional action.” * * *
      • “Kennedy blames ultraprocessed food for many of America’s health woes, and in February promised to release a definition of ultraprocessed food by April. Such a move would allow the FDA to craft labeling rules based on the definition, he said. 
      • “The health department was widely expected to release the definition on Monday, but health officials said the draft was still being reviewed by other agencies.” 
  • Govexec tells us,
    • “The largely self-funded Postal Service is asking for “modest” annual funding from Congress, at least in the short term, to help the agency pay its bills. 
    • “USPS told lawmakers that it would run out of cash in early 2027, if it kept meeting all of its financial obligations. But the agency now expects to avoid a cash crisis for another few years by suspending its contributions to one of its employee retirement plans. 
    • “Agency leaders warn these extraordinary measures are just buying USPS more time to deal with what they consider a broken business model. 
    • “Postmaster General David Steiner said last Friday that USPS will seek a “relatively modest appropriation” from Congress, adding that those funds would “create a large return for the American economy.” 

From the U.S. Office of Personnel Management front,

  • An OPM news release offers a transcript of (OPM Director Scott Kupor[‘s conversation during] Greg Kelly Reports on Newsmax to discuss the Trump Administration’s efforts to restore merit-based hiring and strengthen accountability across the federal workforce.

From the Food and Drug Administration front,

  • The New York Times reports,
    • “Taylor Farms, which has been linked to a large outbreak of cyclosporiasis associated with iceberg lettuce in the United States, said on Sunday that it was voluntarily recalling several of its products made with fresh jalapeños that have been tied to a multistate salmonella outbreak.
    • “The recalled products include spicy guacamole, mango pico de gallo, taco dip and more than a dozen other Taylor Farms branded and unbranded products, the company said in a statement on its website. They were distributed across 26 states to major retailers — including Whole Foods, Trader Joe’s, Hannaford and Kroger’s — and have a “Best If Used By” date up to and including Aug. 16, 2026.”
  • STAT News relates,
    • “The Food and Drug Administration has rejected a radiopharmaceutical therapy because of manufacturing issues, halting what would have been a competitor for Novartis. 
    • “The drug, ITM-11, had been developed by ITM Isotope Technologies Munich SE, a long-standing player in the field. Radiopharmaceuticals are an emerging type of treatment designed to shoot radioactive isotopes directly at tumor cells.” * * *
    • “ITM has more than a dozen drugs lined up behind ITM-11, for glioblastomas, renal cell carcinoma, as well as prostate and ovarian cancers.
    • “The company plans to resubmit the ITM-11 application. “Our confidence in ITM-11’s therapeutic potential has not wavered, and we are committed to working closely with the FDA and our partners to address the items outlined in the CRL,” CEO Andrew Cavey said in a statement.” 
  • and
    • “Sanofi is experiencing shortages of two medicines used to treat Pompe disease, and the problem emerged shortly after the Food and Drug Administration warned the company over manufacturing issues at the Irish facility where the drugs are made.
    • “In recent days, the drugmaker has alerted patient groups and physicians in both the U.S. and Europe that supplies of Myozyme, an older standard of care, and Nexviazyme, a newer treatment, are dwindling due to what has been described as a bottleneck in the final manufacturing phase, as well as quality control issues at its Waterford plant.” * * *
    • “For now, it is not clear when normal supplies will return because Sanofi has indicated it could take months before production has sufficiently resumed and stabilized. But the shortage will continue to reverberate after that occurs, because it will likely take time for normal inventories to be rebuilt, according to a statement on the IPA website.”

From the judicial front,

  • Beckers Hospital Review reports,
    • “A federal judge has dismissed an antitrust lawsuit brought by compounding pharmacy Strive Specialties against Eli Lilly and Novo Nordisk.
    • “The ruling, filed Aug. 3 in the U.S. District Court for the Western District of Texas, found the company failed to plausibly allege a legally cognizable product market or a cognizable antitrust injury.
    • “Strive filed the lawsuit in January, accusing the drugmakers of using exclusive-dealing agreements with telehealth providers and public statements questioning compounded drugs’ safety to unlawfully restrict competition and limit patient access to compounded GLP-1 medications.
    • “The court found Strive’s compounded products cannot be considered reasonably interchangeable with Lilly and Novo Nordisk’s branded GLP-1 medications, because compounded versions are legally available only when a prescriber determines a branded drug is medically unsuitable for a specific patient. That determination is driven by necessity rather than ordinary consumer preference, the court ruled, undercutting Strive’s proposed cash-pay submarket and its broader GLP-1 market theory alike. Without a viable relevant market, the court found Strive’s Sherman Act and Clayton Act claims, including its challenge to Lilly and Novo Nordisk’s exclusivity arrangements with telehealth platforms, also failed.”
  • Health Exec relates,
    • “A newspaper reporter just got an exclusive peek inside a law-enforcement operation that most Americans—including the well-informed among us—know next to nothing about. He took notes and is sharing what he can. 
    • “The operation is the National Training Operations Center—NTOC, called “Noc” for short—of HHS’s Office of Inspector General (HHS-OIG). It’s largely hidden in plain sight for obvious reasons, but it’s a prime mover in the Trump administration’s ongoing crackdown on healthcare fraud. 
    • “The reporter is Chadwick Moore of the New York Post.” * * *
    • “Here are six telling observations the newshawk offers in his article, posted by the Post on Aug. 6. 
      • “More than a few agents are healthcare professionals who feel passionate about stopping healthcare fraud.” * * *
      • “The stealthy suburban facility features highly realistic mockups of medical offices—physical as well as virtual.” * * *
      • “Often the HHS-OIG anti-fraud team is not catching someone red-handed—they’re proving a negative.” * * *
      •  “A Faraday box is essential equipment for the team.” * * *
      • “HHS-OIG is exempt from HIPAA. * * *
      • “In cities where fraud is rampant, real patients are often part of the problem.” * * * 

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “Department of Health and Human Services Secretary Robert F. Kennedy Jr. Aug. 7 declared a public health emergency for Washington state to address the impacts of ongoing wildfires. This follows an emergency declaration approved by President Trump Aug. 4. Because of both a presidential declaration and a PHE, the loosening of certain regulatory requirements for Medicare, Medicaid and the Children’s Health Insurance Program is permitted under the Section 1135 waiver process. 
    • “The Administration for Strategic Preparedness and Response said it has sent regional staff to support Washington state officials and partners with the public health and medical response. The Washington State Hospital Association has also provided a series of resources to assist with response efforts.”
  • The American Medical Association News lets us know “what doctors want patients to know about tickborne illnesses.”
    • “Tickborne illnesses can start with a single bite. Know the signs, prevention steps and when to call a doctor to protect your health.”
  • ALS News Today relates,
    • “Traumatic brain injuries are often linked to a higher short-term mortality risk in patients with ALS [Lou Gehrig’s Disease].”
    • “The connection could suggest reverse causation, where early, undiagnosed ALS leads to falls and resulting head injuries.
    • “Further research is required to evaluate diagnostic timing and clarify the relationship between traumatic brain injury and ALS.”
  • Health Day tells us,
    • “Yoga may help relieve symptoms of irritable bowel syndrome 
    • “People with irritable bowel syndrome who practice yoga experience fewer digestive symptoms, as well as reduced anxiety and depression
    • “Researchers think yoga’s combination of movement, breathing and mindfulness activates the body’s ‘rest and digest’ response.”
  • MedPage Today points out,
    • “In 2024, the national incidence rate of type I diabetes was 24.0 per 100,000 persons under age 20, but state-level rates ranged from 17.0 to 27.8.
    • :The ratio of board-certified pediatric endocrinologists to patients with type 1 diabetes also varied widely.
    • :Three states had fewer than five pediatric endocrinologists per 1,000 patients under age 18; in contrast, Washington, D.C. had 46.4.”
  • Genetic Engineering and Biotechnology News informs us,
    • “Targeted protein degradation is a therapeutic strategy that leverages the ubiquitin–proteasome system to eliminate disease-associated proteins—including those that have traditionally been considered undruggable.
    • “Protein degraders remove unwanted proteins from inside a cell by disposing of them using the cell’s built-in recycling system. Specifically, a molecular glue degrader binds an E3 ligase and redirects it to tag a disease-related protein for disposal.
    • “Now, investigators at Dana-Farber Cancer Institute have developed a platform for systematically discovering molecular glues that could become protein degradation drug candidates. The platform could help drug developers expand the range of disease-related proteins that can be therapeutically targeted for elimination via protein degradation. The platform also enabled their discovery of the first molecular glue degrader that is metabolically activated, suggesting that molecular glues could be more context dependent and potentially tunable than previously thought.
    • “The study was published in Nature in the paper, “DCAF11-dependent molecular glue degrader activated by glutathionylation.”
    • “This novel platform is an exciting scalable approach to the discovery of molecular glues that could help drive the significant expansion of molecular glue applications for the treatment of cancer and other diseases,” says Eric Fischer, PhD, professor of Biological Chemistry and Molecular Pharmacology at Harvard Medical School.”
  • STAT News notes,
    • “Tenax Therapeutics on Monday reported negative results from a late-stage clinical trial evaluating an experimental treatment for a type of heart failure associated with high blood pressure in the lungs.” * * *
    • “Despite the failed study, Tenax does not appear ready to give up on oral levosimendan. The company believes the drug may have a benefit for PH-HFpEF patients with more severe disease, based on pre-specified and post-hoc analyses of the LEVEL study. 
    • “Having reviewed the available trial results, I am encouraged we have a clear path forward,” said Tenax Chief Medical Officer Stuart Rich, in a statement.
    • “The company said it will meet with the Food and Drug Administration to discuss the LEVEL study results and potentially make changes to a second Phase 3 study already underway.”
  •  and
    • “Sionna Therapeutics said Monday that its experimental pill for cystic fibrosis did not show any benefit when added onto Vertex Pharmaceuticals’ Trikafta in a Phase 2 trial. 
    • “The company will no longer try to advance the drug, called SION-719, as an add-on therapy for CF patients. And it hinted at potential layoffs, saying it will “take actions to preserve capital while evaluating next steps.”

From the U.S. healthcare business and artificial intelligence front,

  • Fierce Pharma reports,
    • “Everything is bigger in Texas. And so it is with Bristol Myers Squibb’s $2.3 billion investment in a manufacturing campus in Houston, which comes in at more than twice the price the company estimated in a government application earlier this year.
    • “In May, the New Jersey pharma filed documents with the state of Texas to build a $1 billion, 600,000-square-foot complex, with an option to expand, in the Generation Park Management District in northeast Houston. It was one of several U.S. sites BMS was considering, the company said at the time.
    • “On Monday, BMS made it official in a statement saying it intends to employ nearly 500 at the facility, which will be built to “grow in scale, capability and workforce for decades to come.” It will support drug product and finished manufacturing from late development through launch, the company added, with plans to finish construction in 2030.” 
  • BioPharma Dive adds,
    • “Jazz Pharmaceuticals has agreed to buy a San Diego-based biotechnology company developing treatments for genetic epilepsies, through a deal that could be worth just over $1.3 billion.
    • “Terms hold that privately held Actio Biosciences will receive $820 million up front and be eligible for $500 million in additional payments if its research programs hit certain regulatory and sales milestones. The company’s most advanced drug is being tested against a rare form of epilepsy caused by mutations in a gene known as KCNT1.
    • “The companies expect to close their deal sometime in the final three months of the year. Concurrent with the closing, Actio will spin out a new private entity funded by existing investors and headlined by one of its other programs, an ion channel inhibitor in early-stage testing for a form of “Charcot-Marie-Tooth,” an uncommon neurological disease. Jazz said it will hold a minority stake in the spinout — an investment that, by focusing on rare diseases, “represents a strong strategic fit” for its long-term strategy.”
  • and
    • “The race to build pharma’s most powerful supercomputer gained a new entrant last month, when Bristol Myers Squibb said a newly expanded partnership with Nvidia would give it “the most powerful and energy-efficient single-owned Nvidia infrastructure in life sciences.”
    • “Bristol Myers is the latest large pharmaceutical company to stake an AI-computing superlative claim along those lines. Eli Lilly said in October it would work with Nvidia to build “the most powerful supercomputer owned and operated by a pharmaceutical company.” In March, Roche said an expanded Nvidia collaboration gave it “the pharmaceutical industry’s largest announced hybrid-cloud AI factory,” with more than 3,500 GPUs, or graphics processing units.”
  • Beckers Payer Issues identifies the ten insurers exiting the Affordable Care Act market next year (updated as of today).
  • Beckers Hospital Review points out the 17 health systems with credit rating upgrades and tells us,
    • “A July 21 Center for Healthcare Quality and Payment Reform analysis found 700 rural hospitals are at risk of closing across the U.S. In almost every state, at least some rural hospitals are at risk of closing, with the exception of four. 
    • “The report did not classify a single rural hospital in Delaware, Maryland, New Jersey or Utah as “at risk of closing” or “at immediate risk.”
    • “Becker’s connected with hospital association and state agency leaders in each of those states to discuss what they credit for this stability. Their responses point to geography, a mix of specific state payment policy and long-standing regional partnerships.” 
  • MedTech Dive informs us,
    • “IRhythm said Thursday it has struck a deal to buy VitalConnect for $287.5 million to add mobile cardiac telemetry capabilities. 
    • “VitalConnect sells a wearable device, VitalPatch, that monitors for 21 cardiac arrhythmias and several vital signs. The device lasts seven days, after which users can apply a new patch.
    • “IRhythm sells its own cardiac monitor and is working to secure clearance of a second device, but it has identified VitalPatch as a product that can unlock another part of the market.”  
  • Beckers Clinical Leadership notes,
    • “This year, CMS has implemented eight changes to the HCAHPS survey and scoring.
    • “The changes are part of CMS’ HCAHPS 2.0 launch, which began in 2025. Last year, CMS began allowing patients to fill out the HCAHPS survey online; sunset two survey administration options; added three submeasures for care coordination, restfulness and information about symptoms; extended the data-collection period from 42 to 49 days; ended regulation that prohibits patients’ loved ones from filling out the survey on their behalf; limited the number of supplemental items; and required hospitals to collect information about the language patients speak.
    • “The first results of the HCAHPS 2.0 rollout are due to be published any day, Rick Evans, strategic advisor at New York City-based NewYork-Presbyterian, said in an Aug. 6 column.”
  • Per Fierce Healthcare,
    • “Women’s health companies drew a record $1.55 billion in disclosed equity investment in 2025, up 41% from $1.1 billion in 2024, according to a recent report from W Group.
    • “The report, the organization’s first global women’s health investment report, was built on proprietary tracking of more than 500 funding stories and around 164 equity rounds, and it reveals a sector at its largest-ever scale, with capital reaching more companies, categories and countries than at any point on record, according to W Group, a data-first intelligence platform.
    • “Eighty-five companies raised equity in 2025, the highest single-year count ever recorded, and 10 rounds reached $50 million or more, double the number in 2024.” * * *
    • But the report’s central finding is not the headline number. It is that the money has stopped concentrating at the top. In 2024, the three largest rounds accounted for 41% of all disclosed capital; in 2025 that share fell to 32%, as funding to companies outside the top three grew 56% year over year. 
  • and
    • “Doximity is boosting artificial intelligence spending, viewing it as a significant catalyst for growth, and CEO Jeff Tangney is bullish that hospital adoption of enterprise AI platforms will ramp up.
    • :Doximity is a digital platform for U.S. medical professionals that offers workflow tools such as a telehealth solution, a clinician-to-patient dialer tool and digital faxing capabilities. Its paying customers include pharmaceutical manufacturers, health systems and medical recruiting firms.
    • “The company aims to become a leading AI platform for doctors with plans to scale its clinical AI suite, including its ambient notetaking tool Scribe and clinical AI assistant and medical search engine Ask. A year ago, Doximity acquired clinical AI company Pathway and then integrated Pathway’s datasets and its AI into its free Doximity GPT product to offer DoxGPT (now Ask).
    • “Healthcare AI will increasingly be purchased by hospitals rather than individual physicians, with companies winning on accuracy and trust of the AI, Doximity executives assert.”

Notable Deaths

  • The New York Times reports
    • “Maura Gillison once told an interviewer that she had wanted to be a doctor and a scientist since childhood. She trained in ballet, but as she grew, reaching a height of 6-foot-2, dance became an unlikely career path because she felt that it would draw too much attention to her height.
    • “Instead, she forged a trailblazing career as a medical oncologist and molecular epidemiologist, studying head and neck cancers. In the early 2000s, she was credited as the first researcher to show definitively that the human papillomavirus, or HPV — the most common sexually transmitted infection — caused the so-called oropharyngeal cancers of the throat, tonsils and base of the tongue.
    • “No head and neck medical oncologist has had a bigger impact on patients than Maura Gillison,” Dr. John V. Heymach, the chair of thoracic/head and neck oncology at MD Anderson Cancer Center in Houston, where Dr. Gillison conducted research beginning in 2017, said in an interview.
    • “Dr. Gillison died on June 21 at her childhood family home in Willoughby, Ohio, northeast of Cleveland. She was 61. The cause was a rare cancer of the small intestine, her husband Dr. David E. Symer, an oncologist, said.”
  • Beckers ASC relates,
    • “American College of Cardiology Past President Robert Frye, MD, has died at age 94 after a career spanning more than 70 years in medicine, the ACC announced Aug. 7. 
    • “Dr. Frye served as ACC president from 1991 to 1992 and spent more than 60 years practicing and teaching cardiology at Mayo Clinic in Rochester, Minn.
    • “Dr. Frye earned his medical degree from Vanderbilt University School of Medicine in 1956 and trained in residency at Johns Hopkins Hospital in Baltimore. He went on to become the first physician research fellow and clinical associate at the National Institutes of Health, recruited by Eugene Braunwald, MD, MACC.” * * *
    • Valentin Fuster, MD, PhD, MACC, who worked alongside Dr. Frye as the first Braunwald fellow at the NIH, said Dr. Frye “helped lay the foundation for a generation of clinical discovery that transformed” cardiovascular medicine.
  • RIP. The FEHBlog also encourages his readers to listen to Russ Roberts’ Econtalk discussion with former U.S. Senator Ben Sasse.
    • From the transcript
      • Ben Sasse: “So, to be pushing seven months when you had 90 days to live is pretty great. And, that’s because of the really wonderful experience of being on daraxonrasib, this new miracle drug at UCSF [UCSF] and a few other places, that’s a RAS [renin-angiotensin system] inhibitor. If you’re 80-something, pancreatic cancer might be environmental. If you’re 50 something, like I am, it’s almost always a genetic mutation. 89% of people have a RAS mutation. So, this new drug–there hadn’t been good news in pancreatic cancer in 40 years–this new drug essentially tries to inhibit the RAS mutation’s ability to toggle the on-off switches the wrong way.
      • “The great news is my tumors are down over 80% right now. The bad news is, it’s probably not going to be a cure for me because I presented so far along and so metastasized, but this drug is going to be super-interesting over the next two to ten years.
      • “My two rough byproducts right now of a really aggressive dose of chemo are a real hard time growing skin and hair, so my root follicles on my head are all kind of tingly and falling out and bleeding all the time. So, my scalp is real a bloody mess, but I have an amazing dermatological oncology team at MD Anderson>

Cybersecurity Saturday

David Ermer–Agentic & Generative AI, Cybersecurity, Uncategorized–

“We are in the Singularity.” Elon Musk

From the Project Glasswing front,

  • The Wall Street Journal reports,
    • OpenAI is pausing some activities involving an upcoming artificial-intelligence model, Astra, after internal evaluations led the company to conclude it “cannot rule out critical cyber capabilities,” the company said in a blog post on Friday [August 7, 2026]. 
    • The announcement of the slowdown, which represents one of the first times an AI developer has publicly held back model development due to security concerns, follows a series of loss-of-control incidents that have raised alarm among cyber defense professionals and AI-safety researchers. 
  • and
    • “Meta Platforms META  said that one of its artificial-intelligence models went rogue during cybersecurity testing, slipped onto the internet and hacked a third-party service, the latest in a drumbeat of disclosures that suggest such incidents are becoming widespread.
    • “The Instagram and Facebook owner said that one of its AI models was able to access the internet because of a “misconfiguration” in a hacking test conducted by a third-party AI testing company. 
    • “The same benchmark test, which aims to explore a model’s hacking capabilities, was behind some of several earlier autonomous AI hacking incidents involving Anthropic and OpenAI, according to a person familiar with the matter. * * *
    • “Irregular, the company that conducted tests for the three companies, said the incidents didn’t involve a sophisticated cyber action and said it had “no current open issues” related to its test environment. The San Francisco-based company said it is working on a white paper on best practices for containing AI models when running tests—dubbed evals—of their cybersecurity capabilities.
    • “The new case [reported August 6, 2026] is the latest proof that AI loss-of-control scenarios, once confined to science fiction and AI-safety experiments, are now a real-world issue.”
  • Cybersecurity Dive relates,
    • “An alliance of more than 100 tech companies and other organizations is proposing a safety reporting system for AI agents that the group says will help prevent rogue models from wreaking havoc on society.
    • “The Shared AI Findings Exchange (SAFE), crafted by a working group of the Open Secure AI Alliance, would establish mechanisms for collecting information about AI-related security incidents, sharing that information with affected organizations, identifying commonalities across incidents and publishing recommendations based on those lessons.”
  • Tech Times adds,
    • “ByteDance is pre-training an artificial intelligence model with up to 10 trillion total parameters — a scale that would make it the largest AI model ever built by a Chinese company and place it within striking distance of Anthropic’s Mythos system, the Financial Times reported Friday, citing people familiar with the matter. The headline figure is real and remarkable. What it does not tell you — what ByteDance has not disclosed and no outlet has yet asked — is how many of those parameters actually activate during any given query. At a scale like this, that distinction changes everything.”
  • FEHBlog observation; Ruh-roh.
  • Cyberscoop notes,
    • “As AI-generated code continues to be injected into all corners of the internet, concerns have risen about an expanding attack surface for malicious hackers to exploit.
    • “Some have argued that the enhanced cybersecurity capabilities of large language models could serve as a check, finding and fixing vulnerabilities nearly as fast as they’re created.
    • “But new research that tested the patching capabilities of two popular commercial models, OpenAI’s ChatGPT 5.5 and Anthropic’s Claude Opus 4.8, found that generative AI is more likely to create an exploitable patch or introduce entirely new bugs than close off a vulnerability.
    • “Researchers at 1Password tested the models ability to patch six “high-impact, high-complexity” CVEs, including the “Copy Fail” vulnerability, a kernel flaw that can give an attacker root access to Linux cloud environments. The overall success rate (or fully patching the vulnerability without introducing new problems), was less than a coin flip at 47%.
    • “Our research findings show that, in aggregate across a variety of scenarios, both Claude and ChatGPT had a low rate of successful patch generation, which we define as full remediation of all known exploit paths with no erroneous changes to application behavior,” wrote John Hoodlet, Axel Mierczuk and Spencer Michaels.

From the cybersecurity policy and law enforcement front,

  • Roll Call reports,
    • “The Senate easily passed a bipartisan continuing resolution early Saturday morning [August 8, 2026] likely easing the traditional September rush to head off a partial government shutdown in October.
    • “On a lopsided vote of 90-6, the Senate passed a measure that would extend current funding through Dec. 11, giving lawmakers about 10 extra weeks to complete full-year appropriations bills for fiscal 2027.
    • “But the bill still requires a vote in the House, which won’t be back in session until the first week of September. The House had passed a more bare-bones funding extension last month without many of the “anomalies,” or deviations in current spending, requested by the Trump administration.”
  • Federal News Network adds,
    • “The Senate’s bill to keep the government funded past the midterm elections would extend critical cybersecurity authorities and allow the Technology Modernization Fund to continue investing in agency tech projects. * * *
    • The Senate CR, unlike the House bill, would extend two cybersecurity authorities for the duration of the stopgap: the Cybersecurity Information Sharing Act of 2015 and the Federal Cybersecurity Enhancement Act of 2015. Both laws are set to expire after Sept. 30.
    • CISA 2015 provides privacy and liability protections to encourage companies to share data about cyber vulnerabilities and threats with government and each other. Cybersecurity leaders say those protections provide a critical underpinning to facilitate collaboration across government and industry. * * *
    • “Meanwhile, the Federal Cybersecurity Enhancement Act authorizes the Department of Homeland Security to deploy intrusion detection tools, like the long-running “EINSTEIN” service, across federal agencies.”
  • Cybersecurity Dive relates,
    • “National Cyber Director Sean Cairncross on Tuesday [August 4, 2026] said the Trump administration is working to strike a balance between responsible, secure development practices, while promoting growth and allowing the private sector to innovate. 
    • Cairncross, the opening keynote at the Black Hat USA 2026 cybersecurity conference, said the White House understands the growing safety concerns about AI, but recognizes the need to work collaboratively with the private sector. 
    • He warned that due to the current pace of innovation, an overly prescriptive regulatory regime could be obsolete within 48 hours of being implemented.  
    • “So what needs to be built is a flexible, adaptable structure that enables information sharing between industry and government,” Cairncross said. “So we can guarantee that this technology benefits everyone that it’s going to benefit but is used responsibly and securely.”
  • and
    • “Policymakers and business executives need to focus on basic cybersecurity resilience instead of getting distracted by flashy claims about AI-fueled hacking nightmares, a group of senior U.S. and allied government officials said on Wednesday.
    • “The immediate challenge is not runaway AI,” Jonathon Ellison, director for national resilience at the UK’s National Cyber Security Centre, said during a panel at the Black Hat 2026 cybersecurity conference here. “The immediate challenge is being resilient enough for the faster-paced environment that we are entering into, given the legacy issues that we are carrying.”
    • “Michael Duffy, the acting U.S. federal chief information security officer, said organizations needed to shift from a prevention-focused mindset to one that prioritizes continuity of services.
    • “Things will go down,” he said, and organizations need to prioritize their most important systems so they can continue delivering on their mission.
    • “The cybersecurity community, he added, needs “a new risk calculus for what it means to operate in a contested environment.”
  • The Wall Street Journal tells us,
    • “An outbreak of digital attacks on U.S. water plants is stoking fears across party lines that budget cuts at the federal government’s primary cybersecurity agency could leave the nation ill-equipped to thwart global hackers.
    • “We need a skilled cyber workforce at CISA,” Rep. Andrew Garbarino, a New York Republican, said about the Cybersecurity and Infrastructure Security Agency. Garbarino, who chairs the House homeland security committee, said Congress and the White House need to work together to ensure the agency has the staff and resources to protect critical infrastructure.” * * *
    • “In April, CISA’s annual budget was cut by $300 million, to $2.6 billion from $2.9 billion, reversing an annual growth rate of roughly 9% since the agency was launched in 2018. The shortfall has both Republican and Democratic lawmakers seeking ways to recharge the agency—for a start, by confirming a permanent director, a role vacant since January 2025. 
    • “Rep. Bennie Thompson (D., Miss.), ranking member on the Homeland Security committee, said he plans to propose legislation aimed at guiding the process of restaffing CISA. Thompson didn’t provide a timeline, saying he will also work with appropriations to restore the agency’s funding. Staff and budget cuts, he said, have “damaged our national security and set critical capabilities back years as the security environment is shifting under our feet.”
    • “An agency spokesperson said CISA is “constantly assessing our operational needs as the threat landscape evolves” and that Homeland Security recently approved new hiring in several mission critical positions.”
  • Cyberscoop informs us,
    • “A Canadian man pleaded guilty to playing a central role in one of the most far-reaching cyberattacks of 2024 — the widespread compromise of more than 165 Snowflake customer environments, resulting in massive data theft for extortion, the Justice Department said Wednesday [August 5, 2026]. 
    • Connor Moucka earned $495,000 by extorting his victims, offering stolen data for sale online, and in one case re-extorted a victim with stolen data of a government official and members of a then-former government official’s immediate family, authorities said.
    • Moucka and his alleged co-conspirators John Binns and Cameron Wagenius stole billions of sensitive records and received more than $2.5 million in extortion payments combined, according to prosecutors. Victims of the attack spree included AT&T, Ticketmaster, Advance Auto Parts and Santander.
  • and
    • “A longtime cybercriminal was sentenced to 16 years in prison for creating and running Ransom Cartel, a ransomware strain linked to attacks on at least 18 companies between 2021 and 2023, the Justice Department said Wednesday [August 5, 2026]. 
    • “Maksim Silnikau, a Belarusian national, actively participated in Russian-speaking cybercrime forums since at least 2005, and was a member of the cybercrime site Direct Connection from 2011 to 2016, officials said. The 40-year-old created Ransom Cartel and began recruiting participants from cybercrime forums in 2021. 
    • “Silnikau and his co-conspirators attempted to extort at least $5.2 million from victims during the multi-year scheme. 
    • “Victims included a group of law firms, medium-sized businesses, a small medical technology startup, educational institutions and large multinational corporations based in California, New York, Nebraska and elsewhere. Some of the victims’ operations were disrupted for several months, officials said.
  • HIPAA Journal points out,
    • “Over the past 18 months, many healthcare providers have settled class action lawsuits over their use of website tracking and analytics tools. The list continues to grow with a further five settlements recently announced [and discussed in the article]; however, class action lawsuits stemming from the use of tracking and analytics tools do not always result in settlements.
    • “A proposed class action lawsuit against CRH Healthcare, doing business as Peachtree Immediate Care in Georgia, that alleged violations of the federal Electronic Communications Privacy Act and asserted claims for negligence/negligence per se, breach of implied contract, breach of express contract, breach of fiduciary duty, and unjust enrichment, has been dismissed with prejudice.
    • “The judge ruled that the complaint was speculative, as the plaintiff failed to explain what damages had been suffered as a result of the defendant’s actions. The plaintiff has been given 14 days to file an amended complaint, or the lawsuit will be permanently dismissed. The decision shows that while tracking and analytics tools may result in disclosures of sensitive data to third parties, the plaintiff(s) must demonstrate that the disclosures resulted in a compensable injury.”

From the cybersecurity breaches and vulnerabilities front,

  • Healthcare Dive continues to track healthcare data breaches here.
  • For example, Bleeping Computer notes,
    • “Healthcare software company Unlimited Technology Systems reported that more than 3.8 million people were impacted by a data breach incident that occurred in October 2025.
    • ‘The organization submitted data breach notification samples to the authorities this year on July 1st without revealing the exact number of impacted individuals.
    • “An entry on the breach notification portal of the U.S. Dept. of Health and Human Services now shows that a company server was breached and data of 3,803,750 people was exposed to an unauthorized party.
    • “Unlimited Technology Systems is a software company specializing in providing financial and revenue cycle technology for specialty healthcare providers. According to its website, the firm serves 4,500 clinics and 6,500 specialty healthcare providers across the United States, and processes more than $70 billion in net healthcare charges annually.”
  • The Wall Street Journal reports,
    • “Federal agencies are investigating cyberattacks that targeted more than 30 water systems in Minnesota and utilities in several other states.
    • “Former national security officials say the attacks are consistent with Iran-linked activity, but President Trump rejected that idea.
    • “Small water utilities are vulnerable to hackers because they rely on internet-connected automation but often lack the funding to secure it.”
  • Cyberscoop adds,
    • “The U.S. Coast Guard said it is monitoring the aftermath of a cyberattack that disrupted gate operations at all three of North Carolina’s port facilities this week, though it offered few details as the investigation into the breach continues.
    • “A Coast Guard spokesperson told CyberScoop that the branch’s IT unit was coordinating with partner agencies while conducting the investigation. A spokesperson for CISA did not respond to CyberScoop’s inquiry by press time [on August 7, 2026]. 
  • Security Week points out,
    • “Thousands of data centers are at risk of compromise due to a 22-year-old vulnerability in Baseboard Management Controller (BMC) management processors, data center security firm Lava reports.
    • “Found in most server platforms, BMCs enable server management operations even without a working operating system and typically represent some of the most privileged control points in a data center.
    • “Through a BMC, administrators can power-cycle the host, perform firmware updates, make low-level platform configuration changes, read hardware sensors, and more, using several management surfaces, including the IPMI out-of-band protocol, the Redfish HTTPS-based management API, and a web-based administrative interface.
    • “In many implementations, these interfaces share the same user database. A credential that works for IPMI may also work for the web interface or Redfish API. This matters because the IPMI authentication process can expose information that enables offline password recovery,” Lava notes.”
  • To sum up, Cybersecurity Dive lets us know,
    • “Cyberattacks on operational technology have shifted in recent years from extortion and espionage to destruction, a trend that should alarm those tasked with defending outdated industrial equipment, experts said on Thursday.
    • “The panel discussion at the Black Hat USA cybersecurity conference here highlighted the plethora of risks facing U.S. critical infrastructure operators — many of them poorly staffed and funded — at a time of heightened geopolitical conflict.
    • “OT attacks are increasingly moving from targeting not just data but physical operations,” said Cheri Benedict, a cybersecurity and supply chain adviser at the White House’s Office of the Federal Chief Information Officer.
    • “There is a real desire and willingness to cause this impact at scale,” said Matthew Rogers, the operational technology cybersecurity lead at the Cybersecurity and Infrastructure Security Agency (CISA).”
  • and
    • “Cyberattacks on the healthcare industry have brought hospitals, clinics and other providers to a breaking point, researchers said on Friday.
    • “These are patient safety issues, and yet these types of attacks continue to increase,” Christian Dameff, the co-director of the University of California San Diego’s Center for Healthcare Cybersecurity, said during a presentation at the DEF CON conference here.
    • “The healthcare sector consistently ranks as one of hackers’ top targetsbecause of the sector’s financial constraints, supply-chain opacity and low tolerance for downtime. Cybercriminals have repeatedly broken into hospital chains and healthcare vendors, sometimes causing widespread disruptions and even jeopardizing patient safety.”
  • Cyberscoop adds,
    • “In less than four hours early Tuesday [August 4, 2026], an attacker compromised a GitHub maintainer account and unleashed a self-replicating piece of malware which injected malicious code into more than 440 distinct npm packages, according to multiple security firms. 
    • “The worm, built on the open-source Mini Shai-Hulud repository that TeamPCPpublished in May, was initially let loose in keyv, a data management interface software package with more than 600 million monthly downloads. The attacker spent the next 30 minutes compromising additional packages controlled by the same maintainer, including cacheable, flat-cache, file-entry-cache.
    • “The attack spread to other maintainers, eventually compromising more than 860 packages with a “combined total of over 2 billion monthly installs,” Ilyas Makari, malware researcher at Aikido Security, wrote in a blog post. 
    • “Wiz researchers told CyberScoop it hasn’t observed any new malicious packages since the initial wave moved through a massive footpoint of cloud and code environments in those first four hours.” 
  • Cybersecurity Dive tells us,
    • “Researchers have found fifteen previously unknown vulnerabilities that affect zero-touch provisioning in TP-Link Omada, which is widely used to provision network devices from a central location, according to a report by Forescout Research – Vedere Labs. 
    • “Small to medium-sized companies use the technology to rapidly set up routers and firewalls, which in some cases involves thousands of devices. The technology helps companies save considerable costs when deploying network devices, but it also offers attackers wide access to a lot of systems. 
    • “The research, presented Wednesday [August 5, 2026,] at the Black Hat USA conference in Las Vegas, shows that attackers can chain together vulnerabilities with previously disclosed flaws and infiltrate networks.”
  • and
    • “The malicious use of AI has rapidly accelerated to the point where some threat groups have embedded the technology across their cyber operations, according to a report released Monday [August 3, 2026,]by CrowdStrike. 
    • “China-nexus actors Vault Panda and Genesis Panda have used AI to exploit critical vulnerabilities within 24 hours after a proof-of-concept was disclosed. 
    • “Meanwhile a North Korea-nexus group tracked as Stardust Chollima was able to inject a malicious npm package into 131 trusted Mastra AI frameworks in a supply-chain attack, according to CrowdStrike researchers.” 
  • Per Bleeping Computer,
    • “The Greatness phishing-as-a-service (PhaaS) platform has expanded from credential phishing to adversary-in-the-middle attacks and device-code phishing targeting Microsoft 365 accounts.
    • “The platform has been active since at least mid-2022, targeting Microsoft 365 users in the United States, Canada, the UK, Australia, and South Africa.
    • “It evolved over the years and now targets multiple platforms, including Microsoft 365, iCloud, Yahoo, and Google Workspace.
    • “Currently, it is sold for $289 per month to cybercriminals over a Telegram channel with thousands of subscribers.”

From the ransomware front,

  • Cybersecurity Dive reports,
    • “Ransomware extortion caused roughly three-quarters of business losses in the first half of 2026, the cyber insurance firm Resilience said in a recent report.
    • “At the same time, ransomware accounted for less than 6% of the incidents for which Resilience customers submitted claims, which the company said highlighted how “disproportionately costly” they are.
    • “Other data in the report highlight the importance of proper employee training and vigilant adherence to protocols such as regular backups.”
  • The Register adds,
    • “Ransomware attacks jumped nearly 20 percent in July, with UK firm Comparitech counting 799 incidents, up from 668 in June.
    • “Of those, 51 had been confirmed by victims. The tally makes July the second-busiest month of the year for ransomware, behind March, albeit just barely, when the firm recorded 805 attacks.
    • “The most interesting data after this surging month of attacks is the targets: While news of widespread cyberattacks targeting water infrastructure in the United States may be dominating security headlines lately, those attacks aren’t ransomware, and ransomware attacks on utility companies were actually down 44 percent last month.
    • “In addition to a decline in attacks on utilities, legal firms and government agencies also became less attractive targets, with attacks on those sectors down 31 percent and 11 percent, respectively, Comparitech said.
    • “On the other hand, ransomware attacks increased most heavily in July against finance companies, tech firms, pharmaceutical companies and medical billers, and the education sector, with rates up 71 percent, 62 percent, 46 percent and 44 percent, respectively. 
    • “Those numbers should come as no surprise given what pentesting firm DeepStrike reported about the most frequent payers of ransomware: Manufacturing, education, healthcare, and financial sector firms are the most likely to pay out a ransom, the firm says, with even the least likely (finance) still paying ransoms 51 percent of the time. Ripe targets, in other words.” 
  • Cyberscoop relates,
    • “Researchers said INC ransomware, one of the most active ransomware groups globally, has been the main attacker exploiting a pair of SonicWall zero-days soon after they were disclosed last month.
    • “The prolific ransomware-as-a-service operation wasn’t the first group to exploit the flaws, which were actively exploited for three weeks before the vendor disclosed and patched the defects July 14, but it has been the most assertive and concerning group to target and chain both vulnerabilities together for full access.
    • “Since public disclosure, INC ransomware has emerged as the most commonly named threat actor actively weaponizing this vulnerability chain,” Brett Deroche, director of incident response at Rapid7, told CyberScoop. “While Inc is the name driving the post-disclosure wave, we can’t attribute the full body of exploitation to INC specifically.” * * *
    • “The SonicWall vulnerabilities — CVE-2026-15409 and CVE-2026-15410 — are the latest in a series of security issues confronting the vendor’s customers, including actively exploited zero-days, previously disclosed defects, and an attack last year that allowed a state-sponsored threat group to steal the firewall configurations of every SonicWall customer.” 

From the cybersecurity business and defenses front,

  • The Wall Street Journal reports,
    • “Hasbro CFO Gina Goetter was abroad when a cyberattack hit the company this spring. The day started as planned, but her schedule was wiped clean a few hours later.  
    • “The team “knew something was wrong in the morning,” said Goetter, who is also the company’s COO. “By afternoon, they were aware that it was a breach.” 
    • “The toy and game maker discovered the intrusion in late March. Executives quickly pulled its entire SAP system, which tracks everything from financial to human-resource matters, offline to assess the damage. For three or four days, employees relied on manual workarounds to keep operations moving, forcing Hasbro to delay its first-quarter earnings. 
    • “Company leadership, however, refused to derail certain business operations. * * *Systems were restored faster than anticipated following the cyberattack, keeping costs lower than expected. Hasbro lost roughly $25 million in revenue because of the breach in the three months ended June 28, below the projected $40 million to $60 million hit. The swift recovery allowed the company to quickly terminate third-party legal and accounting support, often a significant part of the costs, according to Goetter.  “We came up faster, which helped,” she said.”
  • SC Media adds,
    • “No, 60% of small businesses don’t fail within six months of suffering a data breach.
    • “That widely circulated figure has been bouncing around for 15 years, but it’s dead wrong, security researcher Adrian Sanabria said Tuesday (Aug. 4) at the BSides Las Vegas hacker conference.” * * *
    • “Sanabria didn’t have any suggestions for companies that are short of cash when an attack or breach happens, other than to have a line of credit at the ready. But he pointed out that transparency and honesty go a long way toward restoring trust after a breach.
    • “Especially in healthcare, he said, “the more transparent you are, the less you’ll get sued for.”
      An audience member cited CrowdStrike as handling its devastating July 2024 bad-update incident very well, with the company leader’s same-day online mea culpa and subsequent apology tour to visit affected clients.
    • “Unfortunately, Sanabria said, many companies of every size still think it’s wiser to not disclose data breaches. That’s mainly out of fear of legal exposure, even though it’s clear that timely and full disclosure is the better policy.
      “Most of the reasons we have for keeping breaches quiet are not good reasons,” Sanabria said. “The model is there, and we know how to do it, but the lawyers won’t let us.”
  • Here’s a link to Dark Reading’s CISO Corner.

Friday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC,

  • The Senate remains in session this evening while it considers Senator Susan Collins substitute amendment #6732 to H.R.6500, the Senate’s legislative vehicle for a Continuing Resolution to fund the federal goverment from October 1, 2026, through December 11, 2026.
  • Roll Call adds,
    • “Sen. Bill Cassidy of Louisiana said Friday he intended to vote to confirm Todd Blanche to be attorney general, ending a weekslong back-and-forth with the White House to win over GOP holdouts.
    • “All eyes were on Cassidy’s Friday morning floor speech after his fellow Republican Sens. Susan Collins of Maine and Lisa Murkowski of Alaska announced they would vote against Blanche, citing myriad concerns such as the Epstein files, the so-called “anti-weaponization” fund and questions of his independence.
    • “With Sen. Mitch McConnell, R-Ky., still absent after a hospitalization, Senate Republicans could afford to lose only two votes in their ranks if all Democrats vote against Blanche. Had Cassidy not supported Blanche, Majority Leader John Thune, R-S.D., would lack the votes to confirm him before the August recess. Now he can move ahead and hold a final vote on the Senate floor.”
  • and
    • “A bipartisan bill aimed at combating hepatitis C is stalled in the Senate due to a high score from the Congressional Budget Office, the bill’s lead sponsor Bill Cassidy, R-La., said on Thursday.
    • “The bill, co-sponsored by Sen Chris Van Hollen, D-Md., proposes a national strategy to reduce hepatitis C infections by providing free medications and expanding testing for high-risk and vulnerable groups.
    • “Cassidy, chairman of the Senate Health, Education, Labor and Pensions Committee, is a former liver doctor who spent much of his career treating the disease and has said getting this bill across the finish line is a priority before he leaves Congress in January. But the measure has not advanced since its introduction in June 2025, despite bipartisan interest.
    • “There was a score on it that was a disappointing score, but there’s at least some conversations taking place by some with the CBO to get that re-scored,” Cassidy said Thursday afternoon.
    • “Cassidy’s office would not provide the exact figure for the bill’s estimated cost but did say it was higher than a related CBO estimate last Congress.”
  • Govexec points out, “The Senate on Friday confirmed in a 51-47 party-line vote multiple executive branch nominees, including several involved in government oversight and federal employee matters.” 
  • Per an August 5, 2026, AHIMA news release,
    • “AHIMA, a founding member of the Patient ID Now coalition, applauds the Senate introduction of the Patient Matching and Transparency in Certified Health IT (MATCH IT) Act of 2026 by Senators Mark Warner (D-VA) and Jim Banks (R-IN), a companion bill to H.R.2002 introduced in the US House of Representatives by Representatives Mike Kelly (R-PA) and Bill Foster (D-IL).
    • “The MATCH IT Act addresses the problem of patient misidentification within the healthcare ecosystem. The bill would create an industry standard definition for how patient match rates are measured and would improve standardization of patients’ demographic elements entered into certified health IT products to ensure patients are accurately matched with the correct medical record.”
  • FEHBlog observation: Congress should pass this bill.
  • Per an August 6, 2026, White House news release,
    • President Donald J. Trump and Vice President JD Vance are waging war on the fraudsters and scammers who have looted hardworking Americans for far too long.
    • Today, that war becomes fully transparent at fraud.gov — a new website where Americans can track every action, every takedown, and every dollar recovered as part of the unrelenting effort.
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services Aug. 7 released a procedural notice on its new pathway to expedite access to certain Food and Drug Administration-designated Class II and Class III devices for Medicare beneficiaries. The Regulatory Alignment for Predictable and Immediate Device coverage pathway, or RAPID, is designed to reduce delays between FDA market authorization and Medicare national coverage determinations. CMS is accepting comments on the procedural notice for 60 days following publication in the Federal Register.”
  • Beckers Hospital Review reports,
    • “The U.S. economy lost 23,000 jobs in July, but healthcare kept adding positions, according to the Aug. 7 jobs report from the U.S. Bureau of Labor Statistics.
    • “Here are [three] things to know from the July jobs report:
      • 1. Healthcare employment continued its upward trend in July, adding 22,000 jobs, though that marked a slower pace than the average monthly gain of 36,000 over the prior 12 months.
      • 2. Hospitals were essentially flat in July, dipping by about 400 jobs after adding roughly 9,500 in June. 
      • 3. Ambulatory healthcare services drove most of the sector’s gains, adding 18,100 jobs, including 4,200 in offices of physicians and 4,600 in home health care services. Nursing and residential care facilities added 4,300 jobs. 
  • Per an August 7, 2026, U.S. Postal Service news release,
    • “The U.S. Postal Service today announced its financial results for the third quarter of fiscal year 2026 (Apr. 1, 2026 – Jun. 30, 2026). Controllable loss, which excludes certain expenses that are not controllable by management, was $1.0 billion for the quarter, compared to controllable loss of $1.6 billion for the same quarter last year.
    • “Net loss for the quarter under generally accepted accounting principles (GAAP) totaled $2.5 billion, compared to $3.1 billion for the same quarter last year. This $562 million decrease is attributed to an operating revenue increase of $1.1 billion along with a decrease in workers’ compensation of $416 million. These are partially offset by increases in retirement benefits of $324 million, retiree health benefits of $195 million, and compensation and benefits of $129 million.
    • “Our results this quarter reflect some progress relative to those areas of the business where we can exercise control, namely with revenue generation, cost control and service improvement,” said Postmaster General David Steiner. “Nevertheless, the Postal Service is today continuing to face a severe liquidity crisis, and our financial losses this quarter reflect systemic challenges inherent in our Congressionally established business model and regulatory framework. We are taking responsible steps to conserve cash to extend our operating window, but we require thoughtful legislative and other actions to establish a financially sustainable Postal Service capable of serving the American public far into the future.”

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “A Food and Drug Administration advisory committee meeting is scheduled for September to evaluate data for Grail’s Galleri multicancer early detection blood test.
    • “Grail launched Galleri as a laboratory developed test in 2021. Designed to detect signals from multiple cancers using a single blood sample, the MCED test hit a setback in February when a clinical trial missed its primary endpoint.
    • “CEO Josh Ofman told analysts on an earnings call this week that Grail continues to expect Galleri to receive FDA approval in the first part of 2027.”
  • Targeted Oncology tells us,
    • “The FDA has granted fast track designation to BI-1808, a first-in-class anti-TNFR2 antibody, for the treatment of advanced platinum-resistant ovarian cancer in combination with pembrolizumab (Keytruda), according to a news release from BioInvent International AB.”
  • Fierce Pharma informs us,
    • “Fresenius Kabi voluntarily recalled one lot of morphine sulfate injection due to a labeling mix-up with prefilled syringes of the opioid dilaudid that could trigger an overdose resulting in severe respiratory distress or death.
    • “The recall, issued in a letter dated Aug. 4 and posted to the FDA website, is for a single lot of morphine sulfate marketed as Simplist 2 mg/1 ml that was mislabeled and could contain a prefilled syringe of dilaudid 0.5 mg/0.5 ml.”

No Surprises Act News,

  • The American Hospital Association News reports,
    • “Guidance on the implementation timeline for the No Surprises Act independent dispute resolution operations final rule was released Aug. 7 by the Departments of Labor, Health and Human Services, and the Treasury, along with the Office of Personnel Management. The final rule, issued May 28, was designed to streamline communication between group health plans and health insurance issuers, providers and certified IDR entities, while clarifying timelines and processes. The guidance includes details on applicability dates of certain provisions associated with the final rule, including the stand-alone claim adjustment reason codes and remittance advice remark codes guidance.” 

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of August 7, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “Based on multiple data sources, COVID-19 activity is low in many regions but is increasing in the West and South.
    • “RSV activity is very low in most areas of the country. Emergency department visits and hospitalizations for RSV are low but remain highest among infants and children younger than 4 years old.
    • “Seasonal influenza activity is low.
    • “Parainfluenza (PIV) and respiratory adenovirus are elevated nationally. Whooping cough (pertussis) continues to circulate at lower levels compared to post-pandemic peaks.”
  • The American Hospital Association reports,
    • “A study published Aug. 5 by Nature found that COVID-19 infection can reactivate dormant, chronic viruses such as Epstein-Barr and cytomegalovirus. The study found that reactivation is correlated with the severity of the COVID-19 infection. The study included data from more than 1,100 hospitalized patients with COVID-19 and found reactivation of various Herpesviridae and Anelloviridae viruses. Researchers said that reactivation occurred frequently in “immunocompetent” individuals during severe illness.”
  • The University of Minnesota CIDRAP relates,
    • “Working-age adults living with long COVID feel less satisfied with life, experience less happiness, and have less hope, according to a study published this week in BMC Public Health. The paper highlights the association between having long COVID and poorer wellbeing. 
    • “The findings underscore that the burden of long COVID extends beyond clinical health outcomes to encompass how individuals evaluate and experience their lives,” wrote the authors, from Syracuse University in New York.
    • “Long COVID symptoms were significantly associated with lower levels of subjective wellbeing in a dose-dependent manner.”  
    • “The World Health Organization defines long COVID “as the continuation or development of new symptoms 3 months after the initial SARS-CoV-2 infection, with these symptoms lasting for at least 2 months with no other explanation.”
  • and
    • “The Centers for Disease Control and Prevention (CDC) today confirmed 94 new measles infections—most of them in Pennsylvania—bringing the US total for the year to 2,465, the agency said in its weekly update.
    • “The numbers likely provide additional data to move the United States toward losing its measles elimination status this year. The nation gained that distinction in 2000, but  has now logged consecutive years of more than 2,200 measles cases (2,289 for all of last year). This year’s total is the highest since 1991.”
  • The Washington Post tells us,
    • “Michigan health officials say new cases of cyclosporiasis are declining in the state hit hardest by an outbreak that has sickened more than 12,000 people and left two dead in the state since June. 
    • “The state’s health department said new case reports are slowing and diarrhea-related emergency department visits are trending downward. The drop in cases prompted officials to lift their broad recommendation to avoid bagged salad mixes. But Michigan continues to recommend avoiding recalled lettuce from Taylor Farms de Mexico sourced from central Mexico.
    • “Michigan officials said they believe most of their exposures took place in late June to early July and that most contaminated produce is probably no longer available for consumption.
    • “Cyclospora infections typically cause symptoms about seven days after exposure, although symptoms can take up to 14 days to appear. The health department said residents can now return to routine food-safety guidance for handling and consuming produce, including lettuce and salad greens.”
  • The AP informs us,
    • “In the past year, the U.S. has seen a jump in frequent marijuana users going to the hospital with a nausea and vomiting condition, according to a report released Thursday.
    • “The abruptness and sustained magnitude of the increase” is largely due to the condition getting its own diagnosis code last fall, which is providing a more accurate picture of what was an underrecognized problem, the authors of the U.S. Centers for Disease Control and Prevention report wrote.
    • “Hospital emergency room diagnoses of the condition, cannabis hyperemesis syndrome, rose 16% from last October to May of this year, federal researchers found.
    • “The syndrome — seen in people who frequently use marijuana, especially smokers — is characterized by recurring nausea, uncontrollable vomiting and excruciating abdominal pain.
    • “Past research has suggested that an estimated 2.75 million Americans suffer from it each year, and that hospital emergency room visits have been rising as daily recreational marijuana use has increased.”
  • MedPage Today points out,
    • “Maintaining three key health factors during midlife — normal blood pressure, no diabetes, and not smoking — was associated with nearly 13 additional dementia-free years, a study of 12,000 people in the U.S. showed.
    • “Individuals who met these criteria at age 55 lived an average 30.1 more years dementia-free, reported Josef Coresh, MD, PhD, of NYU Langone Health in New York City, and co-authors.
    • “Conversely, those who smoked, had hypertension, and had diabetes at age 55 had dementia-free survival of only 17.5 years, Coresh and colleagues wrote in Neurology Open Accessopens in a new tab or window.”
  • and
    • “Low-fat vegan diets can help aid in weight loss, but the mechanisms behind this have been unclear.
    • “Adults on a low-fat vegan diet reduced dietary energy density by 30% compared with controls in a secondary analysis of a randomized trial.
    • “Reductions in dietary energy density were significantly associated with greater weight loss after adjusting for overall energy intake.”
  • Medscape adds,
    • “Adding coronary artery calcium (CAC) scoring to risk estimates helped better identify adults at lower and higher risk for atherosclerotic cardiovascular disease (ASCVD) events. People with no detectable CAC had lower observed risk, while those with CAC had higher observed risk, especially when the decision about starting a statin was uncertain.”
  • Healio notes,
    • “Adults with type 2 diabetes and established CVD had lower risk for CV events with tirzepatide [a/k/a Zepbound] compared with sitagliptin [a/k/a Januvia].
    • “Tirzepatide decreased risk for infections leading to hospital admission.
  • Per Genetic Engineering and Biotechnology News,
    • “For people with severe food allergies, avoiding a trigger food like peanuts or tree nuts can mean constant vigilance. Approximately 8% of children and 10.8% of adults in the United States experience some type of food allergy. Even trace exposures can provoke reactions, and while oral immunotherapy can raise the threshold for some patients, the protection often depends on continued treatment and is associated with disease relapse in many patients. A new study suggests that another route to food tolerance may run through the gut microbiome.
    • “In a small Phase I open-label trial (NCT02960074), researchers at Boston Children’s Hospital tested whether oral encapsulated fecal microbiome transplantation (FMT) could safely increase peanut tolerance in adults with peanut allergy. The work, published in Science Translational Medicine, also used mouse models to probe how donor gut microbes might help restore oral tolerance. The study is titled, “Fecal microbiome transplant in food allergy in humans and mice identifies a role for bile acid metabolites in oral tolerance.”
  • The Wall Street Journal adds,
    • “Artificial-intelligence systems have been displaying some eye-opening new abilities in recent weeks: breaking out of their enclosures, hacking other companies, lying to people. 
    • “And now, for the first time, an AI model has created a new virus. A whole family of them, in fact. 
    • “In a study published in the journal Science, researchers at Stanford University and elsewhere said they successfully directed an AI model to create a collection of simple viruses that only infect bacteria and pose no threat to humans.
    • “In an interview, two of the authors said their research could help develop designer viruses that could be used to eliminate drug-resistant bacteria, which according to the World Health Organization kill millions of people every year.
    • “If we develop responsibly, I think it can lead to tremendous benefits in human health,” said Brian Hie, a computational biologist at Stanford and an author of the study.”

From the U.S. healthcare business and artificial intelligence front,

  • Fierce Healthcare reports, “Insurers see positive results in managing health costs in Q2.”
    • “The health insurance industry weathered a rough 2025, and the turnaround for some companies through the midpoint has surprised even Wall Street analysts.”
  • Beckers Payer Issues adds,
    • “Clover Health posted a $28 million profit for the second quarter of 2026, according to a recent earnings filing.
    • “During the same period last year, Clover logged a $10.6 million loss. The company had its first profitable quarter in 2024.
    • “Total revenue for the second quarter of 2026 was $743.2 million, up nearly 56% year over year. The company attributed the improved results to membership growth and a disciplined approach to administrative spend.
    • “On June 30, Clover had 157,309 members. The company’s benefit-expense ratio dipped to 87.6% this past quarter from 88.4% during the same time in 2025.”
  • and
    • “CVS Health’s pharmacy benefit manager, CVS Caremark, is bringing on Keith Reynolds as chief growth officer.
    • “Chief Sales Officer Jim Fowler will transition into retirement, according to an Aug. 7 LinkedIn post from Mr. Reynolds.” 
  • Beckers Hospital Review relates,
    • “A number of healthcare organizations have recently closed medical departments or ended services at facilities to shore up finances, focus on more in-demand services or address staffing shortages.
    • [The article identifies] 52 department closures or services that are ending or have been announced, advanced or finalized that Becker’s reported since Jan. 1
  • Health Exec adds,
    • “When a nursing home closes down, the local population and press often perceive the move as a simple exit from the market due to failing fiscal health. But in about half the cases, additional forces are in play—and “closures” may be, in truth, do-overs of one kind or another. 
    • “Researchers at the University of Massachusetts fill out the picture with facts in a study published July 31 by JAMA Health Forum.
    • “Joohyun Chung, PhD, RN, and colleagues suggest understanding the dynamics behind nursing-home closings is important because such events can disrupt continuity of care, place additional burdens on remaining facilities and disproportionately affect vulnerable populations.” 
  • Fierce Pharma tells us,
    • “Injected weight loss drugs remain favored over newer oral treatments by a significant margin, with Eli Lilly’s Zepbound leading the pack, according to a survey of healthcare specialists by Spherix Global Insights.
    • “In the poll, which includes input from 185 specialists in the United States, 80% were highly satisfied with Zepbound, compared with 59% for Novo Nordisk’s rival injectable, Wegovy. Though it remains early in the launches of Novo’s oral version of Wegovy and Lilly’s GLP-1 pill Foundayo, 48% and 47% of those surveyed were highly satisfied with the newer products, respectively.”
  • and 
    • “Prescriptions for Eli Lilly’s Foundayo continue to build, jumping 16% sequentially to 34,219 the previous week, according to IQVIA data cited by Citi. The oral GLP-1 med has been on a roll lately as it appears to celebrate four weeks of consecutive growth in total scripts. However, as Citi noted, there’s still a potential gap in IQVIA’s capture of telehealth data, and it’s not clear how much of the scripts growth was from IQVIA getting better at including those data, or, if the actual growth was much faster in telehealth channels.
    • “This week, Lilly’s reported Foundayo sales for the second quarter—$98 million in total, including $67 million in the U.S.—disappointed many. As CEO David Ricks noted on an earnings call, Lilly began broad direct-to-consumer marketing to raise consumer awareness after securing commercial access across the three major pharmacy benefit managers in June. Besides, The Medicare GLP-1 Bridge program went live on July 1, offering coverage for certain weight-loss medications, including Foundayo, for a $50 copayment per month. Ilya Yuffa, president of Lilly USA and global customer capabilities, said the company is “starting to see an inflection point on Foundayo now.”
    • “As for Novo Nordisk’s Wegovy pill, total scripts recorded by IQVIA have been largely flat with small upticks in the past two weeks, having reached roughly 172K in the previous week. The oral version of semaglutide now makes up 35% of total Wegovy scripts, which take up about 40.6% of the U.S. obesity market share, as Lilly’s Zepbound remains the leader.” 
  • Fierce Healthcare informs us,
    • “Despite the rapid implementation of artificial intelligence solutions across the healthcare industry, many organizations are still working on establishing necessary infrastructures and governance foundations, a new report from UPMC’s Center for Connected Medicine and KLAS Research found.
    • “Ninety-three percent of respondents report that their organizations deploy third-party AI solutions, though only 44% have a dedicated data platform or environment for tool testing. But 92% of respondents report testing third-party tools prior to deployment.
    • “What’s emerging from this research is a clear recognition that implementation is only the first step,” said Rob Bart, M.D., UPMC chief medical officer, in a statement. “Health systems are now focused on building the governance structures, testing capabilities and organizational strategies necessary to ensure AI delivers meaningful and measurable value.”
    • “The “Validation and Trust: The Governance of AI Solutions at Health Systems” report drew insights from 27 healthcare leaders, including those from health systems and ambulatory care organizations.” 
  • Healio adds,
    • “Many patients report high comfort with health systems using AI-written portal messages, noting it gets them information quickly and reduces clinician workload.
    • “Their comfort comes with caveats, though. Patients want both clinician oversight and transparency that AI is being used.”

Friday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, Obesity, OPM, Rx coverage, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC,

  • Roll Call reports,
    • “The timeline is slipping for senators to strike a bipartisan deal on a short-term funding patch before their August recess as leadership struggles to work out the finer details.
    • “Senior appropriators had been hopeful of unveiling text before the weekend for a stopgap measure expected to keep the government funded into early December. But sources say leaders are now more likely to release text later this weekend or early next week amid snags over a federal grant rule and other add-ons.
    • “The Trump administration’s proposed rule would give senior political appointees greater influence over the grant approval process and has drawn pushback from appropriators on both sides of the aisle.
    • “Senate Appropriations Chair Susan Collins, R-Maine, noted Thursday that the rule has drawn considerable criticism from “a wide range of groups.”
    • “So, I hope we’ll take advantage of this opportunity to delay it,” she said. “But that’s up to the leadership. It’s obviously not a funding issue.”
    • “The grants dispute is among the last-minute hitches and “anomalies” that negotiators have said leadership is sorting through as senators aim for floor consideration next week.
    • “The Senate is currently scheduled to take a procedural vote Monday on the legislative vehicle for the continuing resolution that is needed to stave off a partial government shutdown on Oct. 1, when the new fiscal year begins.
    • “The House has already passed a Republican-crafted stopgap bill to extend current funding through Dec. 4. But senators say further “anomalies,” or deviations from current spending, are needed, noting the gap between add-ons requested by the White House and the House GOP’s bare-bones funding patch.”
  • Bloomberg Law relates,
    • “The Trump administration will increase Medicare payments for hospital services by 2.3%, or $2.1 billion in fiscal year 2027, according to a final rule released Friday.
    • “The final rule (RIN 0938-AV79) from the Centers for Medicare & Medicaid Services also includes a 2.2% reimbursement bump of $54 million for long-term care hospitals, along with several new hospital quality reporting measures.
    • “These include the adoption of quality measures for diabetes, deep vein thrombosis/pulmonary embolisms, quality care planning, and mortality rates. 
    • “The final rule also expands the agency’s Comprehensive Care for Joint Replacement (CJR) Model, which holds hospitals financially accountable for the quality and cost of hip, knee, and ankle replacements, through incentive payments
    • “The agency says the program has produced strong evidence of cost savings while maintaining quality of care. 
    • “The mandatory model will now be expanded nationwide beginning Jan. 1, 2028.”
  • Beckers Hospital Review points out nine things to know about today’s rule.
  • Here’s a link to CMS’s Fact Sheet on today’s rule.
  • The American Hospital Association News adds.
    • “The Centers for Medicare & Medicaid Services today finalized a 2.3% payment update for long-term care hospitals for fiscal year 2027 relative to FY 2026. This includes a 3.2% market basket update, reduced by a 0.9 percentage point productivity adjustment. In addition, CMS finalized its decision to freeze the outlier threshold at $78,936, the same level as FY 2026. For the LTCH Quality Reporting Program, CMS finalized the removal of two measures related to COVID-19 vaccination and a shortened data reporting timeline.
    • :In a statement shared with media today, Joanna Hiatt Kim, AHA’s vice president of payment policy, said, “[W]e remain concerned about continued inadequacies in the LTCH payment system that have contributed to declining patient volumes and the closure of facilities across the country, threatening access to care for medically complex patients. Although the AHA appreciates that CMS did not further raise the outlier threshold in this final rule, broader reforms are needed to support the LTCH field. We remain committed to working with the Administration and Congress to advance the AHA’s LTCH reform principles and promote a more sustainable payment framework that preserves patient access to LTCH services.”
  • The American Hospital Association News further informs us,
    • “The Department of Health and Human Services today issued a notice announcing a revised 340B Rebate Model Pilot Program, allowing qualifying drug manufacturers to use rebates rather than upfront discounts to effectuate the 340B ceiling price for certain drugs purchased by 340B covered entities. 
    • “In a statement shared with the media, AHA President and CEO Rick Pollack said, “The AHA is deeply concerned that HHS has chosen to move forward with a 340B Rebate Model Program despite the overwhelming evidence that it will impose massive new administrative and financial burdens on hospitals that serve America’s most vulnerable patients. The agency’s analysis dramatically understates the true costs of this program, ignoring the hundreds of millions of dollars in compliance expenses, cash-flow disruptions, and operational burdens that will inevitably divert scarce resources away from patient care. At a time when many hospitals are already under severe financial strain, this policy will force hospitals in rural and other underserved communities to spend more on bureaucracy and less on the services and care that patients depend on every day. As we continue to review today’s notice, the AHA is considering all available options to prevent this flawed program from going into effect.” 
    • “HHS’ Health Resources and Services Administration said the pilot is designed to test a rebate-based approach for a set of drugs while gathering information on program integrity, operational impacts and the interaction between the 340B program and Medicare’s Drug Price Negotiation Program. The pilot is limited to drugs included on the Centers for Medicare & Medicaid Services Medicare Drug Price Negotiation Selected Drug Lists for initial price applicability years 2026 and 2027. 
    • “Under the notice, manufacturers that wish to participate must submit plans to HRSA by Aug. 24. HRSA said it will make approval decisions by Sept. 24, and approved rebate models will take effect Jan. 1, 2027. Participating manufacturers must commit to the pilot for at least one year. “
  • Per an HHS news release,
    • ‘The Substance Abuse and Mental Health Services Administration (SAMHSA), a division within the U.S. Department of Health and Human Services (HHS), announced today that it has awarded $73.2 million in grants to strengthen children’s mental health services, suicide prevention programs, and to expand assisted outpatient treatment (AOT) to those with serious mental illness.”
  • OPM posted in the Federal Register today direct final rules (previously known as interim final rules with opportunity for public comment)
    • FLSA Claims and Compliance
      • to update the provisions concerning Fair Labor Standards Act (FLSA) claims submissions to OPM.
      • DATES: This direct final rule (DFR) is effective September 29, 2026 unless significant adverse comment is submitted by August 31, 2026. If OPM receives significant adverse comment, OPM will publish a timely withdrawal in the Federal Register.
  • and
    • Procedures for settling claims
      • to update the provisions concerning administrative claims submissions to OPM.
      • DATES: This direct final rule (DFR) is effective September 29, 2026 unless significant adverse comment is submitted by August 31, 2026. If OPM receives significant adverse comment, OPM will publish a timely withdrawal in the Federal Register.
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) today issued governmentwide guidance to departments and agencies on preparing Fiscal Year 2027 Annual Staffing Plans, advancing the Trump Administration’s efforts to modernize federal workforce planning, strengthen merit-based hiring, and ensure agencies are strategically positioned to deliver efficient, high-quality services to the American people.
    • “The guidance implements Executive Order 14356, Ensuring Continued Accountability in Federal Hiring, and provides agencies with a framework for conducting rigorous, bottom-up workforce planning that prioritizes mission-critical positions, modern technology talent, and early career hiring while improving governmentwide visibility into staffing needs.
    • “Annual Staffing Plans will require agencies to identify workforce needs based on mission requirements—not historical staffing levels—and reserve budget and positions for critical hiring priorities, including artificial intelligence, cybersecurity, software engineering, and other technology roles. The guidance also directs agencies to leverage governmentwide hiring initiatives such as US Tech Force and the Early Career Talent Network to improve hiring quality, reduce duplication, and accelerate recruitment across the federal government.”
  • Kevin Moss, writing in Federal News Network, explains “How a household with two federal employees can save on their FEHB premiums by enrolling self-only.”

From the Food and Drug Administration front,

  • Cure reports,
    • “The Food and Drug Administration (FDA) has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with androgen receptor pathway inhibitor (ARPI) therapy for adults with PSMA-positive metastatic androgen pathway modulation-naïve or -sensitive prostate cancer, a disease previously known as metastatic hormone-sensitive prostate cancer.
    • “The July 31 approval expands the use of Pluvicto to patients whose prostate cancer has spread but has not yet become resistant to hormone therapy. The treatment is intended for patients whose tumors express prostate-specific membrane antigen (PSMA), a protein found on many prostate cancer cells.”
  • MedTech Dive relates,
    • “Surgical robotics company MMI has received the Food and Drug Administration’s approval to expand an early feasibility study of microsurgery for Alzheimer’s disease.
    • “The REMIND study is evaluating the safety and feasibility of using MMI’s Symani robotic system in microsurgery procedures to re-establish drainage pathways in the deep cervical lymph nodes of patients with neurodegenerative disease. Patients in the trial also have confirmed lymphatic abnormalities.
    • “The FDA gave MMI the go-ahead to expand the number of people who can enroll in the study to 15, from up to five in the initial group, the company said Thursday.”
  • The American Journal of Managed Care lets us know,
    • “Late last week] six peptides received narrow advisory support for potential 503A Bulks List inclusion, an atypical outcome given FDA staff recommendations against all seven under review. 
    • “Legal compounding remains prohibited absent FDA acceptance and completion of proposed and final rulemaking; none of the substances is FDA-approved. 
    • “FDA reviewers cited short, underpowered studies insufficient for safety/efficacy across proposed indications, including limited BPC-157 trial data. 
    • “Committee reconstitution drew conflict-of-interest scrutiny, with increased representation from clinicians and businesses involved in prescribing, producing, or promoting peptides. 
    • “Payers should expect persistent cash-pay utilization and unregulated online procurement, necessitating rigorous medication reconciliation and adverse-event monitoring given sparse human safety data.”

From the judicial front,

  • Per a Justice Department news release,
    • “New York ophthalmology practices Mark D. Fromer, P.C. doing business as Fromer Eye Centers and Floral Park Ophthalmology P.C. have agreed to pay a total of $2.3 million to resolve alleged violations of the False Claims Act arising from their billing for trans-cranial doppler ultrasounds (TCDs) through a kickback arrangement with a third-party testing company. The Estate of Mark Fromer, the former owner of Fromer Eye Centers, also joined in the settlement with the practice. Both practices have agreed to cooperate with the Justice Department’s ongoing investigations of other participants in the alleged scheme.” * * *
    • “The claims resolved by the settlements are allegations only and there has been no determination of liability.“

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of July 31, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “Considering multiple data sources, COVID-19 activity is low and stable nationally but is beginning to show early signs of an increase in the West and South.
    • “RSV activity is very low in most areas of the country. Emergency department visits and hospitalizations for RSV are low but remain highest among infants and children younger than 4 years old.
    • “Seasonal influenza activity is low.
    • “Parainfluenza (PIV) and respiratory adenovirus are elevated nationally. Whooping cough (pertussis) continues to circulate at lower levels compared to post-pandemic peaks.”
  • The University of Minnesota CIDRAP reports,
    • “The Centers for Disease Control and Prevention (CDC) confirmed 53 new US measles cases this week, bringing the total for the year to 2,371 cases.
    • “All but 16 of the cases were locally acquired in 45 US jurisdictions, with the rest tied to international travel, the CDC said in its weekly update. There have been 37 new measles outbreaks reported this year, with 94% of cases associated with outbreaks (defined as three or more cases).” * * *
    • “Among the current measles hotspots is Pennsylvania, which has reported 31 new cases over the past seven days and now has 167 cases for the year, according to the Pennsylvania Department of Health. Officials in neighboring Ohio yesterday confirmed four new cases in unvaccinated individuals in Ashtabula and Tuscarawas counties. It’s Ohio’s third measles outbreak this year.”
  • The American Journal of Managed Care gives us “FAQs: Cyclospora Recovery, Treatment, and Outbreak Prevention Strategies.”
    • “Epidemiologic and traceback evidence implicates shredded iceberg lettuce from Taylor Farms de Mexico as the exposure source, despite a disclosed false-positive border test not changing investigation conclusions. 
    • “Symptom onset typically occurs about one week post-exposure and includes profuse watery diarrhea, anorexia, nausea, bloating, weight loss, and fatigue, while some infections remain asymptomatic. 
    • “Higher-risk groups include immunocompromised patients, older adults, and those with limited care access, who may need longer antibiotic courses and closer monitoring for dehydration and prolonged illness. 
    • “TMP-SMX is the treatment of choice but requires individualized risk–benefit assessment given adverse reactions and a clinically meaningful, though comparatively lower, association with C difficile. 
    • “Public health control relies on clinician/lab case reporting, standardized exposure questionnaires, and FDA traceback; absent whole-genome sequencing for Cyclospora, marker-based genotyping supports source identification.”
  • The Wall Street Journal adds,
    • “In the verdant fields of California’s Salinas Valley, Larry Cox is watching his lettuce wilt.
    • “Cox and his two sons run Coastline Family Farms, which supplies leafy greens to some of the country’s biggest restaurant chains and grocery stores. But this week, in the region known as America’s Salad Bowl, around 300,000 pounds of his romaine hearts were chopped and plowed back into the soil.
    • “There is no evidence that his, or any of the nation’s homegrown lettuce, was infected with the parasite behind an illness outbreak that has sickened thousands of people so far. Even so, that hasn’t stopped Cox’s dependable restaurant and grocery customers from cutting back on orders.
    • “Many growers are destroying the crops they can’t find buyers for. Since lettuce has about a 30-day growing cycle, farmers that are plowing their crops back into the ground are weighing whether to replant or dial back. 
    • “It is incredibly demoralizing,” Cox said. “I would’ve been better off taking a vacation in the South of France than planting the crop.”
  • USA Today relates,
    • “As electric bikes and scooters become an increasingly common way for young people to get around, injuries tied to the devices are climbing at an alarming rate.
    • “New research from Truveta, a health data and analytics firm supported by a coalition of 30 U.S. health systems, analyzed over 12,000 emergency room visits nationwide. The findings revealed that injury rates associated with e-bikes and e-scooters among children and adolescents surged 7.5-fold between January 2023 and May 2026, an increase compared to the rates seen in adults.
    • “ER visits related to e-bikes and e-scooters have increased by 671% for children and adolescents, said Karen Gilbert Farrar, PhD, lead researcher at Truveta. “Just to put that in context, that’s if one patient is was being seen in 2023, that’s now nearly eight patients in 2026.”
    • “The findings also highlight the severity of many crashes: more than one-third of injured patients suffered head or neck injuries. And nearly 7% of child and adolescent visits that were related to e-bike and e-scooter use involved traumatic brain injury, Farrar said.”
  • Health Day lets us know,
    • “E-cigarettes could be reshaping the future of cancer in the United States, by offering people a less-toxic option than smoking, a new study argues.
    • :Smokers are increasingly switching to vaping and other forms of nicotine use, researchers reported July 27 in the journal JNCI Cancer Spectrum.
    • :They’re also sticking with their vapes, rather than swapping back and forth with tobacco cigarettes, researchers found.
    • “Our results show that exclusive cigarette use is being replaced by exclusive use of other combustible products, mainly e-cigarettes, especially among young adults,” said lead researcher Kenneth Michael Cummings, in a news release.”
  • and
    • “Work stress could be eating away at the sleep of most middle-aged working folks, undermining their health, a new study says.
    • “Nearly 70% of a small group of people ages 50 to 66 experienced persistent sleepproblems, even though they had no history of sleep disorders, researchers reported July 28 in the journal Scientific Reports.
    • “Even more concerning, more than 9 out of 10 (92%) of the participants met the clinical threshold for a sleep disorder at least once during the yearlong study, researchers said.
    • “I was genuinely surprised by the sheer scale of sleep problems we uncovered in this otherwise undiagnosed group,” lead researcher Athanasios Tsanas said in a news release. He is a professor of digital health and data science at the University of Edinburgh in the U.K.”
  • BioPharma Dive tells us,
    • “A Novo Nordisk heart drug missed the main goal of a Phase 3 trial, failing to show it prevented heart attacks, strokes or cardiovascular death in people with hardened arteries or chronic kidney disease, the company said Friday.
    • “Called ziltivekimab, the drug is part of a sprawling clinical program involving three late-stage trials that have collectively enrolled more than 20,000 people. Two others, in people with heart failure or who’ve had an acute heart attack, are ongoing. Results are expected next year. They all aim to show lowering levels of an inflammatory protein called IL-6 can can reduce the risk of heart-related complications and death.
    • “Novo gained control of ziltivekimab through a 2020 acquisition of Corvidia Therapeutics, for which it paid $725 million up front and promised up to $2.1 billion in total payouts. Novo said it will take a “non-cash impairment charge” in the third quarter but will not need to change its operating profit forecasts.” 

From the U.S. healthcare business and artificial intelligence front,

  • Fierce Healthcare reports,
    • “Cigna executives offered investors a look at the progress the company has made in the rollout of its new Signature pharmacy benefits model, which moves away from traditional drug rebates.
    • “CEO Brian Evanko said during the company’s earnings call that the team is “making strong progress in the build-out” of the model. It will roll out to Cigna Healthcare’s fully insured plans in 2027, before a wider launch in 2028.
    • ‘In particular, the model is designed around the affordability of brand-name drug products, and the company projects that it could save members 30% per month on branded medications. Through Signature, tech platforms will surface the lowest price to the member at the pharmacy counter, even if that’s a cash-pay option or provided by a manufacturer’s direct-to-consumer programs.
    • “We see significant early interest from health plans and employers as we prepare for our broader market launch in 2028,” Evanko said. “At the same time, we’re adding value and winning business today, with 2027 representing one of our strongest selling seasons in recent years.”
  • and
    • “Alignment Healthcare delivered a strong second quarter, in what CEO John Kao said was supported by the deployment of its new artificial intelligence-powered stratification model.
    • “This advancement improved our ability to predict which members are going to be hospitalized,” Kao said. “Our model now accurately and dynamically predicts the 10% of members who will account for nearly 70% of hospital admissions over the next 30 days.” 
    • “Kao said the on the company’s Thursday earnings call it plans to “reinvest a portion” of savings to areas that produce “tangible, measurable returns,” including market expansions, branding and “deepening AI capabilities.
    • “Beyond its potential to unlock efficiencies in our cost structure, AI represents a meaningful opportunity to further enhance our care model and support providers,” Kao said. “Most importantly, our approach to AI is grounded in decades of clinical expertise and reinforces our commitment to high-quality care. This is further supported by a governance framework to ensure responsible use, human accountability, and equitable treatment of our members.” 
  • Healthcare Dive relates,
    • “Siemens Healthineers has struck a 10-year deal to support diagnostic imaging, cardiology and radiation oncology at Cleveland Clinic, the company said Thursday.
    • “Building on its 35-year relationship with the academic medical center, Siemens Healthineers will provide diagnostic imaging and therapeutic technologies, including magnetic resonance imaging, computed tomography, radiation oncology, interventional radiology and X-ray.
    • “Siemens Healthineers is expanding an existing team dedicated to Cleveland Clinic, adding on-site technicians and training personnel to its current group of more than 30 people.”
  • Beckers Hospital Review points out,
    • “A total of 438 urban hospitals closed across the U.S. between 2000 and June 2026, according to data shared with Becker’s from New Haven, Conn.-based Yale University’s Health Care Affordability Lab.
    • “Between 2001 and 2023, the period for which both openings and closures are fully tracked, urban hospitals posted a net gain of 11 nationally, with 396 openings and 385 closures. However, there were significant losses in individual states. New York lost a net 33 urban hospitals over that period, California lost 29 and Pennsylvania lost 24.
    • “The data covers general, short-term acute-care hospitals and excludes specialty facilities such as psychiatric, rehabilitation, children’s and VA hospitals. Urban and rural classifications follow the census-tract-level definition from the Health Resources & Services Administration’s Federal Office of Rural Health Policy.
    • “The tables [found in the article] show urban hospital net change by state from 2001 to 2023 and total urban closures by state from 2000 through June 2026. States with no urban hospital activity in the Yale dataset are not listed.
  • Fierce Pharma informs us,
    • “The small inflection point we noticed two weeks ago regarding Eli Lilly’s Foundayo does not appear to be a flash in the pan. Weekly total prescriptions for the small molecule reached 29,388, a new high for the oral GLP-1 receptor agonist after three weeks of consecutive growth, according to IQVIA data cited by Citi. 
    • “As IQVIA may be missing some scripts from telehealth channels, we will get a clearer picture of Foundayo’s launch progress when Lilly reports its second-quarter earnings on Wednesday, Aug. 5. Analysts at Jefferies have been modeling $71 million in U.S. sales for the quarter based on IQVIA data.
    • “Meanwhile, Novo Nordisk’s Wegovy pill remains far ahead in the oral GLP-1 race with total scripts also hitting a new record of about 171,700, according to Citi. The number represents 1.1% growth from its previous best recorded during the prior week.
    • “Coincidentally, the entire GLP-1 class also saw its total scripts grow 1.1% sequentially across diabetes and obesity uses. Lilly’s Zepbound regained some lost ground with total scripts up 1.9% week over week. That’s compared to Wegovy, which now makes up 40.6% of the obesity market after a 0.2% sequential decline in total scripts.” 
  • Per Fierce Healthcare,
    • “WellSpan Health inked an expanded multi-year partnership with artificial intelligence company Hippocratic AI, which expands AI-powered capacity across the network.
    • “Through the update, Hippocratic AI’s generative AI agent—Ana—will expand from handling inbound calls and primary care appointment scheduling to post-discharge follow-up and chronic disease check-ins.
    • “Initial workflows will focus on closing care gaps through outreach to patients with missed imaging appointments, executives say. Every new use of the AI agent will follow governance, safety and implementation structures in coordination with WellSpan teams.
    • “WellSpan Health CEO Roxanna Gapstur, Ph.D, said in a statement the future of the industry will “be shaped by the organizations that build the culture, governance and clinical capabilities” to utilize AI responsibly at scale.
    • “At WellSpan, we’ve been intentional about creating this foundation, so innovation advances safely, strengthens clinical excellence and earns trust,” Gapstur said. “Our expanded partnership with Hippocratic AI is an investment in the future of care — one that expands access, supports our care teams and creates a more personalized experience for every patient we serve.”

Thursday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, No Surprises Act, Rx coverage, Telehealth, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC,

  • The New York Times reports,
    • “The Senate health ​committee on Thursday advanced the nomination of Dr. Erica Schwartz, President Trump’s pick for director of the Centers for Disease Control and Prevention, for a full Senate vote.
    • “The committee’s Republican members and Senator Tim Kaine, Democrat of Virginia, all voted in favor of her candidacy, with the remaining Democrats opposed.” * * *
    • “The committee on Thursday also voted to ​advance ⁠the nomination of Sean Kaufman for assistant secretary for preparedness and response, a role that includes oversight of emergency measures during public health crises.”
  • The American Hospital Association News relates,
    • “The Centers for Medicare & Medicaid Services [(CMS)] July 30 released the fiscal year 2027 final rule for inpatient rehabilitation facilities. The rule will increase payments by 2.3% overall, which includes a 3.2% market basket update reduced by a 0.9 percentage point productivity adjustment. In addition, CMS updated the outlier threshold, which it says will increase overall payments by 0.4% in FY 2027.
    • “CMS also finalized two changes to the IRF coverage requirements. This includes a requirement that therapies be initiated within 36 hours of admission to the IRF and an initial interdisciplinary team meeting be held within four days of admission to the IRF. CMS did not finalize a third proposal that would have required the patient’s current functional status be documented on the preadmission screening. For the IRF Quality Reporting Program, CMS finalized a shortened timeframe for submitting program data.
    • “Changes are generally effective Oct. 1, 2026.”
  • Per a CMS fact sheet,
    • “On July 30, 2026, the Centers for Medicare & Medicaid Services (CMS) issued a final rule (CMS-1851-F) that would update Medicare hospice payments and the aggregate cap amount for fiscal year (FY) 2027 under existing statutory and regulatory requirements.” * * *
    • “For FY 2027, CMS updated the hospice payment rate by 2.3% (an estimated increase of $755 million in payments from FY 2026). This figure results from the finalized 3.2% inpatient hospital market basket percentage increase reduced, as required by law, by a finalized 0.9 percentage point productivity adjustment. The finalized FY 2027 rates for hospices that do not submit required quality data information include the finalized FY 2027 hospice payment update percentage of 2.3% minus four percentage points as required by law, which would result in a 1.7% reduction over the previous year’s payment rate. These finalized payment rates reflect the most accurate, updated data available on the cost of goods, services, and labor.
    • “Hospice payments are subject to a statutory aggregate cap limiting the overall payments made to a hospice annually. The finalized hospice cap amount for FY 2027 is $36,174.75 (FY 2026 cap amount of $35,361.44 increased by the FY 2027 hospice payment update percentage of 2.3%).” 
  • Beckers Hospital Review shares 11 things to know about these new CMS rules.
  • U.S. Office of Personnel Management, writing in Substack, added another post to this Secrets of OPM blog titled “Plans are good, Execution is better.”
    • “Last year, I wrote about how the federal government needed to adopt a more disciplined approach to workforce planning. Every successful organization develops a thoughtful plan for the talent it needs to accomplish its mission. The federal government should be no different.
    • “Today, we’re taking the next step.
    • “The guidance OPM has issued to agencies on Annual Staffing Plans is about much more than compliance with a new planning process. It is about changing how the federal government thinks about hiring. Rather than defaulting to last year’s staffing levels or treating hiring as a series of isolated decisions, agencies will build comprehensive staffing strategies that begin with a simple question: “What workforce do we need to best serve the American people?””
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) today issued an interim final rule removing references to the Uniform Guidelines on Employee Selection Procedures (UGESP) from OPM’s federal personnel regulations, bringing the agency’s regulations into conformity with the Department of Justice Office of Legal Counsel’s June 9, 2026, legal opinion concluding the Uniform Guidelines are unlawful and unconstitutional by encouraging race-conscious decision-making via “disparate impact” liability.
    • “The rule removes UGESP regulatory provisions while preserving longstanding federal requirements that employment practices be job-related, professionally developed, based on sound job analysis, and administered without prohibited discrimination.” * * *
    • “Federal hiring should be based on merit, qualifications, and the ability to perform the job,” OPM Director Scott Kupor said. “This rule ensures OPM’s regulations reflect legal guidance while preserving the rigorous, job-related standards that help agencies recruit and hire the most qualified workforce in service to the American people.”
    • “The interim final rule is effective upon publication in the Federal Register. OPM will accept public comments for 60 days before determining whether to revise, withdraw, or finalize the rule.”
  • NextGov adds,
    • “The General Services Administration on Wednesday celebrated the graduation of 71 U.S. Digital Corps fellows, marking the largest graduating class since the program’s inception. Those graduates updated the FedRAMP website, helped streamline Agriculture Department environmental reviews and supported other technology projects during their stints in the federal government.
    • “This government has starved for talent, for people who understand how to do all the things that we want to do to deliver better,” OPM Director Scott Kupor said during graduation remarks.
    • “Some of the graduates of the two-year fellowship program are continuing civil service while others are headed to the private sector.”
  • Tammy Flanagan, writing in Govexec, explains “Why time, not timing, is the biggest retirement advantage for federal employees.”
    • “A look at decades of market shifts and TSP data shows the biggest driver of retirement wealth isn’t picking the right stock. It’s starting early, contributing consistently and letting compounding do its work.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “A Food and Drug Administration advisory panel voted 10-3 Thursday for Replimune Group’s experimental melanoma therapy, after a contentious meeting in which experts raised doubts about whether the company’s data and trial design could be trusted to show the skin-cancer drug works.
    • “Thursday’s recommendation is the latest turn in a regulatory saga that has stretched nearly two years.” * * * 
    • “Thursday’s meeting came a day after another closely watched advisory session, in which FDA advisers voted against Capricor Therapeutics’ cell therapy for Duchenne muscular dystrophy—a rejection that, like Replimune’s, followed a prior FDA denial.” 
  • MedTech Dive relates,
    • “Artificial intelligence is here to stay at the FDA, but its integration and evolution may not be a straight line now that one of its biggest proponents, former commissioner Marty Makary, has stepped down.” * * *
    • “Acting commissioner Kyle Diamantas said AI remains a top priority for the FDA. Still, recent high-level departures, including Makary, Jeremy Walsh, chief artificial intelligence officer, and Sridhar Mantha, acting chief information officer, have raised questions about the future of AI implementation.
    • “It’s unclear now what the leadership and governance structure are around FDA-wide efforts,” said Tala Fakhouri, chief artificial intelligence and regulatory strategy officer at Parexel, and a former FDA AI policy official.”

No Surprises Act news,

  • Beckers Payer Issues reports,
    • “Another health insurance CEO is taking aim at the No Surprises Act’s arbitration system.
    • “We do support the overall strategic intent of consumer protection from surprise billing. However, we’re seeing some clear abuses of the IDR vehicle in practice,” Cigna Group President and CEO Brian Evanko said on the company’s second-quarter earnings call July 30, adding that the system is seeing “unsustainable volume levels, much of which is concentrated amongst a small number of providers.” 
    • “On July 22, a Wall Street Journal analysis of CMS data put 2025 arbitration payouts at nearly $15 billion, up from $4.08 billion in 2024, with arbitration firms collecting about $1.3 billion in fees. On the earnings call, Mr. Evanko referenced last year’s payout figure but said the impact “has been manageable” within Cigna’s insurance business.”

From the judicial front,

  • Fierce Healthcare reports,
    • “A federal judge has rejected a request from 26 states for a preliminary injunction in the Trump administration’s rollout of work requirements in Medicaid.
    • “The Centers for Medicare & Medicaid Services finalized implementation guidelines for states in June, with the eligibility requirements set to take effect on Jan. 1. States have until Aug. 31 to communicate with enrollees about the impacts of the changes.
    • “In an order issued Wednesday, Massachusetts District Judge Richard Stearns wrote that the states did not prove that establishing the systems necessary to make the eligibility determinations would cause them irreparable harm, as CMS said it would reimburse them for 90% of the costs for setting up those mechanisms.
    • :However, he said that the order does not reflect the court’s opinion on the merits of the broader litigation, which challenge provisions of the rule under the Administrative Procedure Act. Making a determination on that, as it questions whether officials hewed closely to Congressional intent in regulating the rollout of the requirements, requires a more complete picture.”
  • Healthcare Dive relates,
    • “The Federal Trade Commission is suing Hims & Hers [in a California federal court], alleging the telehealth company illegally shared sensitive health information with advertisers and misled customers about its billing practices. 
    • “The agency says California-based Hims & Hers made it difficult for users to cancel subscriptions, charged patients for medications before they consulted with a provider and shared their health data with third-party advertising platforms like Meta and Snap. 
    • “Hims & Hers called the FTC’s claims “baseless,” saying in a Wednesday statement that the agency “contorts the law to try to manufacture claims.”
  • Per a Justice Department news release,
    • “Access DX Laboratory, located in Houston, Texas, its former CEO Michael Stewart, and Florida businessman Harold Shatz, have each entered into settlements and will pay a combined total of $36.4 million to the United States to resolve allegations that they violated the False Claims Act (FCA) by paying kickbacks and billing Medicare and Medicaid for medically unnecessary genetic testing.
    • “The United States alleged that, from January 2018 through January 2020, Access DX, Stewart, and Shatz paid kickbacks to marketers in return for referrals of patients for genetic testing, unbundled billing codes for genetic testing, paid telemedicine providers for false and fraudulent doctors’ orders, and submitted and caused the submission of false claims for genetic testing.” * * *
    • “Except to the extent admitted by Stewart and Shatz in their plea agreements, the claims resolved by the settlement are allegations only and there has been no determination of liability.” 

From the public health and medical/Rx research front,

  • The AP reports,
    • “A first-of-its-kind U.S. study suggests invasive mold infections may be an underappreciated — and potentially deadly — threat.
    • “The researchers detected about 450 cases in Atlanta-area hospitals over five years. About a third of the patients died in the hospital.
    • “The findings, published this week by the U.S. Centers for Disease Control and Prevention, come from an attempt to better gauge how common these kinds of illnesses are. The government does not require doctors to report the illnesses.
    • “It’s kind of the first time we’ve had an estimate like this,” said the CDC’s Dr. Jeremy Gold, the study’s senior author.”
  • Per a Department of Health and Human Services news release,
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. today announced the launch of The Real Food Show, a new cooking series designed to help Americans prepare healthy, affordable meals using real, everyday ingredients.
    • “More than a cooking show, The Real Food Show is a national initiative that empowers families to make healthy eating practical, approachable, and affordable. Each episode combines simple recipes with the science behind them, translating the new Dietary Guidelines for Americans into meals that Americans can prepare in their own kitchens.”
    • “Visit The Real Food Show webpage for more details.”
  • Radiology Business tells us,
    • “Adult CT radiation doses have decreased substantially over the last decade in the U.S., according to new research published Tuesday. 
    • “About 10 years have passed since data underlying the most recent national benchmarks for radiation dosing were collected. This underscores the need for updated reference values, as these guidelines may not reflect new advances in scanner technology, reconstruction methods and protocol changes, experts write in RSNA’s Radiology. 
    • “Researchers recently aimed to address this information gap, analyzing adult CT acquisitions performed across U.S. facilities in 2025. They discovered clear progress, with CT diagnostic reference levels declining an average of nearly 22% since 2014.
    • “The magnitude and consistency of these reductions across examination categories suggest that such advances have translated into measurable, population-level dose reductions in routine clinical imaging in the United States,” Kalpana M. Kanal, PhD, with the Department of Radiology at the University of Washington, Seattle, and colleagues wrote July 28.”
  • The July 30 issue of NIH Research Matters covers the following topics:
    • Tracking diets via wastewater
      • “Measuring DNA from food in wastewater could provide snapshots of dietary patterns.
      • “Monitoring these patterns could be a powerful tool for informing nutrition policy.” 
    • Lung tumor signals may tamp down food intake
      • “Researchers found that a high-fat diet in mice amplifies nerve signals between certain lung cancers and the brain, leading to reduced appetite and weight loss.
      • “If confirmed in further studies, the results could inform strategies to improve nutrition and survival in certain patients with cancer.”
    • Bacteria share proteins to survive antibiotics
      • “Researchers found that some bacteria share proteins that help others survive antibiotics.
      • “The study suggests a novel approach that may help treat persistent bacterial infections.”
  • MedPage Today informs us,
    • “Consuming less sugar before birth and during the first 1 to 2 years of life was tied to a lower risk of dementia decades later, U.K. Biobank data showed.
    • “The study used the abrupt end of World War II rationing as a natural experiment to test whether early-life sugar exposure was associated with late-life dementia.
    • “Previous research has linked early-life sugar rationing to less risk of diabetes and hypertension in adults and better cardiovascular outcomes.”
  • Health Day adds,
    • “Want to give your tot a brain boost when it comes to learning language?
    • “Maintain eye contact as much as possible when you’re talking to them, a new study suggests.
    • “Eye contact helps a baby decide what is important, acting as a switch that triggers synchronization of their brain waves with those of the speaker, researchers reported recently in the journal Nature Communications.”
  • Genetic Engineering and Biotechnology News lets us know,
    • “An international team of researchers has identified multiple new genetic risk factors associated with fibromyalgia, a syndrome characterized by widespread pain and tenderness, fatigue, and problems with sleep, memory and mood.
    • :The team analyzed genetic data from more than 2.5 million adults, of which 55,000 were fibromyalgia patients. They identified DNA sequence variants in 26 regions of the genome that affect the risk of developing fibromyalgia. Many of the genes implicated in these regions are involved in brain and nerve function.
    • “The results provide the strongest evidence yet that fibromyalgia is primarily a nervous system disorder rather than an autoimmune disease, as has long been debated. “This work changes how we think about fibromyalgia at a fundamental level,” said Michael Wainberg, PhD, an investigator at the Lunenfeld-Tanenbaum Research Institute, part of Sinai Health, and the University of Toronto. “For decades, patients have been dismissed or told their pain is simply psychological. Our findings confirm the condition has a clear biological basis.”
    • “Weinberg is co-senior author of the researchers’ published paper in Nature Medicine, titled “The genetic architecture of fibromyalgia across 2.5 million individuals,” in which they concluded, “This study provides robust genetic evidence defining fibromyalgia as a central nervous system disorder, thereby establishing a biological framework for its complex pathophysiology and extensive clinical comorbidities.”
  • Fierce Pharma points out,
    • “Investors anxiously waiting for Bristol Myers Squibb’s key Alzheimer’s disease psychosis readout for Cabenfy will have to wait a little longer. The company has once again delayed the expected phase 3 data from its Adept trial program, even as it delivered a group-wide quarterly beat that’s driving a significant forecast raise. 
    • “Rather than readouts in 2026, BMS now expects data from the three Adept trials to arrive beginning in early 2027 and be “spread across the year,” CEO Chris Boerner, Ph.D., said on the company’s earnings call Thursday.
    • “The delay was attributed to slower enrollment in the Adept-2 and Adept-4 studies and slower relapse event accrual in Adept-1, Boerner explained. Adept-1 could undergo an interim analysis as early as later this year, and BMS also plans to share safety and efficacy data this year from the trial’s open-label lead-in portion, he added.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Cigna’s employer-sponsored plans reaped higher profits than expected in the second quarter after hiking premiums, spurring the company to raise its earnings outlook for 2026.
    • “Cigna results released Thursday are a relief for investors worried about broader pressures in the employer-sponsored market, which covers the majority of U.S. adults and has been a buoy for insurers slammed with higher spending in government programs in recent years.” * * *
    • “Cigna’s health services division Evernorth — which includes Express Scripts, one of the largest pharmacy benefit managers in the U.S. — brought in $1.7 billion in operating income in the quarter, down 2% year over year despite revenue growth.”
  • Modern Healthcare adds,
    • “The weight-loss drug boom is beginning to show signs of a slowdown as employers and insurers pull back on coverage, signaling the market could be entering a more restrained phase after years of breakneck expansion.
    • “In the past few months, growth in prescriptions for GLP-1 drugs for weight loss like Novo Nordisk A/S’ Wegovy and Eli Lilly & Co.’s Zepbound have moderated, according to Cigna Group Chief Executive Officer Brian Evanko. The insurer’s unit that manages drug benefits has noted coverage declines and slower utilization growth compared to prior periods, executives said during an earnings call with Wall Street analysts Thursday.”
  • Optum Rx, writing in LinkedIn, discusses “how plan sponsors can stay ahead of the latest drug cost trends.”
  • Fierce Healthcare relates,
    • “Teladoc Health trimmed its 2026 revenue outlook as its virtual behavioral health unit, BetterHelp, faces revenue pressure with consumer demand for insurance-covered services outpacing clinical capacity.
    • “Teladoc shares fell more than 27% on Thursday following the company’s release of its second-quarter financial performance report on Wednesday.
    • “The company is shifting from subscription to visit-based revenue models, while also transitioning its virtual mental health business to accept insurance, moving from a cash-pay model to an in-network, insurance-covered model. The company is making “considerable progress” in building the insurance offering, including establishing a baseline national footprint a year after launching its first state, Teladoc Health CEO Chuck Divita told analysts and investors on a call Wednesday. 
    • “We have contracted for over $150 million in-network lives and credentialed more than 8,000 mental health professionals for the network at this point,” he said.”
  • and
    • “Nearly three-quarters of patients with gambling disorder achieved clinically meaningful symptom improvement through Birches Health, a new study finds.
    • “The peer-reviewed outcomes study was recently published in the Journal of Medical Internet Research. It was a retrospective analysis of 1,305 adults treated by Birches between mid-2024 and mid-2026. 
    • “Birches, a virtual provider for digital addictions, says the study is the largest real-world dataset on virtual gambling disorder treatment in the U.S.” ‘
  • Beckers Hospital Review tells us,
    • “Forbes rated the country’s hospitals state by state for 2026, with 259 earning the top mark of five stars.
    • “The Forbes Top Hospitals by State list, published July 14, draws on the national Forbes Top Hospitals 2026 ratings, which score general acute-care hospitals on measures pulled from the CMS Provider Data Catalog across four areas: patient outcomes (weighted at 55%), hospital best practices (20%), value (15%) and patient experience (10%). Each hospital lands on a single Forbes Overall Hospital Quality Rating of one to five stars.
    • “The article includes] the top of that scale: every hospital awarded five stars for overall quality, grouped by state. The five-star tier spans 42 states, ranging from a single hospital in states such as Alabama, Delaware and Wyoming to 19 in Wisconsin. Eight states — Alaska, Connecticut, Hawaii, Mississippi, Nevada, New Hampshire, Rhode Island and Vermont — along with the District of Columbia had no hospital reach five stars.”
  • Radiolology Business informs us,
    • “A new analysis from Definitive Healthcare pinpoints [and the article lists] the 10 largest imaging center corporations in the U.S., based on location count. 
    • “RadNet tops the list with approximately 383 outposts at the time of the analysis, followed by the US Oncology Network (141), a chain of independent cancer docs backed by McKesson. Definitive Healthcare, a publicly traded commercial-intelligence firm, based the findings off data from its ImagingView product, which includes info from more than 22,000 centers. 
    • “As demand for outpatient imaging continues to rise, larger imaging companies are expanding through acquisitions, new site development, and care models focused on improving access and convenience for patients,” Definitive Healthcare said in an update posted July 23. “Several factors are contributing to this growth, including advances in imaging technology, increased demand for preventive diagnostic screenings, and an aging U.S. population.”
  • Fierce Healthcare notes,
    • “Health tech company Stellarus announced Thursday the launch of an artificial intelligence-driven copilot geared towards helping health plan customer service representatives.
    • ‘The solution—dubbed Customer Service Representative (CSR) Chat—provides representatives with real-time guidance and contextual support during live interactions, surfacing relevant information, policy and recommended responses directly in workflows. 
    • ‘Stellarus president and CEO Vanessa Colella told Fierce Healthcare in an interview that “unsustainable healthcare costs” have been dominating conversations about the American healthcare system.
    • “It’s not about talking about someday it might not be working,” Colella said. “It is not working today. One of the places that it’s not working is cost. And another place it’s not working is member experience.”
    • “The solution hopes to address both core issues through administrative burden reduction and allowing representatives and members “to have the conversation that matters,” according to Colella.”

Midweek report

David Ermer–Agentic & Generative AI, CDC, CMS, FDA, Medical / Rx research, Medicare, Obesity, Rx coverage, Telehealth, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC

  • Per Centers for Medicare and Medicaid Services fact sheets
    • “On July 29, 2026, the Centers for Medicare & Medicaid Services (CMS) issued a final rule to update Medicare payment policies and rates for Inpatient Psychiatric Facilities (IPFs) under the IPF Prospective Payment System (PPS) (CMS-1847-F) for fiscal year (FY) 2027. CMS is publishing this final rule consistent with its statutory authority to update Medicare payment policies for IPFs annually. 
    • “This fact sheet discusses the provisions of the final rule, including annual updates to the prospective payment rates, the outlier threshold, the wage index, and associated impact analysis. In addition, the rule finalizes a policy effective for FY 2028 (October 1, 2027) to limit outlier payments at the facility level to no more than 20% of an IPF’s total IPF PPS payments in a year, for IPFs with at least 50 stays per year. For the IPF Quality Reporting Program, CMS is removing two measures from the program, as well as implementing a standardized IPF patient assessment instrument.
    • “For FY 2027, CMS is updating the IPF PPS payment rates by 2.3%, based on the 2021-based IPF market basket increase of 3.2% less a 0.9 percentage point productivity adjustment. Additionally, CMS is updating the outlier threshold so that estimated outlier payments remain at 2% of total IPF PPS payments. Total estimated payments to IPFs would increase by 2.3%, or $60 million, in FY 2027, relative to IPF payments in FY 2026.”
  • and 
    • “On July 29, 2026, the Centers for Medicare & Medicaid Services (CMS) issued a final rule for updates to Medicare payment policies and rates for skilled nursing facilities under the Skilled Nursing Facility (SNF) Prospective Payment System (PPS) for fiscal year (FY) 2027. CMS is publishing this final rule consistent with the legal requirements to update Medicare payment policies for SNFs annually. This fact sheet discusses the final rule’s provisions.
    • “For FY 2027, CMS finalized updating SNF PPS rates by 2.4% based on the final SNF market basket of 3.3%, reduced by a 0.9% productivity adjustment, for an estimated increase of $882.74 million in aggregate payments to SNFs.”
  • Beckers Hospital Review points out twelve things to know about these rules.
  • The American Hospital Association News relates,
    • “The Health and Human Services Secretary today announced that dozens of insurers, medical societies, healthcare providers and behavioral health experts have pledged to strengthen the nation’s behavioral health system by advancing best practices aimed at improving mental health and addiction treatment. The pledge commits participants to promoting timely access, improving quality measurement and accountability, supporting patient-centered recovery services and expanding whole-person treatment that addresses behavioral and physical health needs. HHS said the initiative aligns with the administration’s broader efforts to address addiction and mental illness and improve long-term patient outcomes.” 
  • Federal News Network clears up common misconceptions about federal retirement benefits.
    • “Misconception: Federal Employee Health Benefits (FEHB) go away at retirement, or become more expensive.
    • “Fact: Under certain eligibility requirements, federal employees can continue their FEHB coverage into retirement. These requirements include enrollment in FEHB for at least five consecutive years leading up to, and having coverage on, the retirement date. It is important to note that qualified spouses, dependent children, and children with disabilities can be covered without meeting this five-year rule. Employees become classified as annuitants upon retiring, at which point the government will continue to cover about 72% of the FEHB premium.
    • In addition, retirees can also enroll in Medicare parts A and B, offering nearly comprehensive coverage, with Medicare as the primary payer and FEHB as secondary. To reduce costs, some retirees opt for a basic FEHB plan.”
    • “Misconception: Spouses will automatically continue to be covered by FEHB into retirement
    • “Fact: This is the biggest caveat about survivor’s benefits: If survivors were on the federal retiree’s health insurance plan, that health insurance will cease if there is no survivor’s benefit. Any amount of survivor’s benefit will continue the health insurance plan, so prospective retirees and their spouses should speak with a federal retirement consultant, and consider the holistic picture of their assets, the spouse’s income, their needs and budget, life insurance, and whether they have any additional financial obligations, like debt or a child in college.”
    • “Misconception: Survivor’s benefits are automatic and free
    • “Fact: Federal employees will need to make some decisions about survivor’s benefits on their retirement application. The pension is the main place where retirees need to consider their options along with their potential beneficiaries — these will primarily be spouses, except in a few special circumstances. Each of these options comes with a cost, in the form of a monthly percentage deducted from the overall pension. The options and percentages vary between the Federal Employees Retirement System and the Civil Service Retirement System.”
  • Beckers Hospital Review tells us,
    • “Federal policy changes could reshape pharmacy reimbursement, drug pricing and hospital operations in 2027, according to a new Vizient outlook. The report, published July 27, highlights four pharmacy developments health systems should monitor as they plan for the year ahead.
    • “The four policy developments:
      • “340B outpatient drug reimbursement: CMS has proposed reducing reimbursement for 340B-acquired drugs from average sales price plus 6% to ASP-33.4%. 
      • “340B remedy offset: CMS has proposed increasing the offset from -0.5% to -3%, a change the agency estimates would reduce payments by $2.3 billion in 2027.
      • “Section 232 tariffs: New pharmaceutical tariffs and ongoing investigations into medical devices could affect supply chains and costs.
      • “Medicare Drug Price Negotiation Program: CMS has issued draft guidance for implementing negotiated prices in 2028, including drugs covered under Medicare Parts B and D.

From the Food and Drug Administration front,

  • Per a FDA news release,
    • “The U.S. Food and Drug Administration today licensed Ezplaz Freeze Dried Plasma (FDP), making it the first freeze-dried plasma product licensed for use in the United States. Ezplaz is intended for transfusion in adult patients who need plasma and for whom other plasma products are not available.
    • “Patients experiencing life-threatening bleeding in combat zones, disasters, rural settings, or other austere environments may now have faster access to plasma when conventional frozen plasma is unavailable,” said Karim Mikhail, B. Pharm., M.S., Acting Director of the Center for Biologics Evaluation and Research (CBER). “This milestone action addresses an important unmet medical need — particularly for our military personnel and others who may be far from traditional hospital infrastructure.”
    • “Ezplaz is a freeze-dried (lyophilized) plasma product derived from a single unit of fresh frozen plasma collected from FDA-licensed blood establishments. It is available in Group AB and Group A with low-titer anti-B blood types, chosen to mitigate risk of giving to patients in emergencies before their blood type is determined.”
  • Contemporary OB/GYN relates,
    • “On July 29, 2026, the FDA approved norelgestromin and ethinyl estradiol transdermal system (Gwyn Lo; Viatris Inc.) as a once-weekly combined hormonal contraceptive (CHC) patch with a low dose of estrogen for women of childbearing potential with a body mass index (BMI) below 30 kg/m², the company announced in a news release.1
    • “The approval was granted under the FDA’s 505(b)(2) regulatory pathway and was supported by results from the phase 3 Luminous Study (NCT05139121).2 Norelgestromin and ethinyl estradiol delivers norelgestromin 220 mcg/day and ethinyl estradiol 20 mcg/day over each 7-day wear interval. The patch, which is reversible and non-invasive, is applied once weekly for 3 consecutive weeks, followed by 1 patch-free week.” * * *
    • “Viatris expects norelgestromin and ethinyl estradiol to be commercially available later in 2026.”
  • and
    • “Natural Cycles has received its sixth FDA clearance, this time for an updated version of the algorithm underlying its FDA-cleared birth control app. The company described the update as combining statistical modeling with machine learning trained on real-world fertility data to generate more individualized fertility predictions for users, according to a news release published July 27, 2026.”
  • Cancer Network tells us,
    • “The FDA has granted fast track designation to ISM6331, an AI-designed pan-TEAD inhibitor, for the treatment of adult patients with unresectable malignant pleural mesothelioma whose disease has progressed on or after prior anti–PD-1 antibody therapy, with or without anti–CTLA-4 antibody therapy, and platinum-based chemotherapy, according to a news release from the developer, Insilico Medicine.”
  • Cardiovascular Business points out,
    • “The U.S. Food and Drug Administration (FDA) has granted de novo market clearance for the first and only biomarker technology to directly see and quantity coronary inflammation from routine coronary CT angiography (CCTA). 
    • “The CaRi-Heart technology from Caristo Diagnostics has been heralded by numerous cardiac CT experts as a potential paradigm shift in cardiology. It is the first technology that can visualize and clearly quantify coronary inflammation using fat attenuation index (FAI) scores. This helps care teams estimate the residual risk of heart attacks in patients who otherwise appear to be managed well on optimal medical therapy.
    • “We’ve spent decades building the scientific case that coronary inflammation is an important contributor to the development and progression of coronary plaque,” Ron Blankstein, MD, director of cardiac CT at Brigham and Women’s and a former Society of Cardiovascular Computed Tomography (SCCT) president, said in a statement. “And now for the first time, clinicians can specifically measure coronary inflammation, obtaining a more complete picture of cardiovascular risk compared to standard CCTA, or calcium scoring alone. It is exciting to see Caristo’s long-awaited, pioneering solution available in the U.S.”
  • STAT News informs us.
    • “A group of outside experts convened Wednesday by the Food and Drug Administration concluded clinical data for a treatment for Duchenne muscular dystrophy from Capricor Therapeutics did not provide “substantial evidence” of efficacy.  
    • “The vote was 9-3, sending to the FDA a recommendation that the Capricor treatment, called deramiocel, should not be approved. 
    • “The FDA is not required to adhere to the expert panel’s stance, but it typically does. The agency review is still underway with a decision expected by Aug. 22. 
    • “The negative vote came at the end of an all-day meeting during which disputed results from a Phase 3 clinical trial were discussed and debated. Capricor’s presentation highlighted an analysis showing deramiocel preserved upper-arm function and staved off the heart failure most patients with Duchenne eventually experience.
    • “The FDA countered with a critique of the data that reached opposite conclusions — deramiocel was unable to separate from placebo at all. The agency also spent a good deal of time during Wednesday’s meeting calling out Capricor, saying it made major changes to the study’s statistical analysis plan that degraded the robustness of the data and made even seemingly positive outcomes hard to interpret.” 
  • Beckers Hospital Review notes,
    • “The FDA has published 17 revised draft product-specific guidances for peptide products, updating its recommendations for the development and assessment of certain generic peptide drugs.” * * *
    • “The FDA said the updates provide recommendations in five areas: submission of recombinantly, synthetically or semi-synthetically produced peptides as abbreviated new drug applications, innate immune response testing, impurity thresholds, higher order structure assessment and biological activity assessment.
    • “The FDA also said it is withdrawing its May 2021 guidance, ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin, because it no longer reflects the agency’s current scientific thinking. The Center for Drug Evaluation and Research plans to revise that guidance this year.”

From the public health and medical / Rx research front

  • The Washington Post reports,
    • “About 12,000 pounds of smoked bacon imported from Canada were recalled because of lack of proper reinspection before entering the country, the Agriculture Department’s Food Safety and Inspection Service said.
    • “The bacon from Maple Leaf Foods was shipped to grocery distributors and retailers in Idaho, Oregon and Washington state. FSIS inspects imported products for packaging, documentation, condition and contamination.” * * *
    • “There are currently no confirmed cases of illness or injuries due to the products, FSIS said.”
  • The American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention yesterday reported 18,207 confirmed or suspected cases of cyclosporiasis across the U.S. from the current outbreak. The agency said it is investigating multiple case clusters, including an outbreak impacting nine states that is linked to iceberg lettuce. A July 17 Food and Drug Administration notice said that Taylor Farms recalled iceberg lettuce sourced from central Mexico that was distributed to 27 states, due to the potential of being contaminated with cyclospora.” 
  • The New York Times lets us know about “Nine Things Experts Wish You’d Do in Midlife to Increase Longevity.”
    • “How you treat your body and brain in your midlife years, loosely defined as 40 to 60, can hugely influence how you age in the decades to come.
    • “The seeds for many age-related diseases, including cardiovascular disease, diabetes, cancer and dementia, are sown in middle age, so it’s important to start thinking about prevention early. And it takes a lifetime of healthy habits, not just a few weeks, to move the needle on your longevity.
    • “Midlife is the ideal time to make changes, not only to benefit you in the present, but also in the future,” said Margie Lachman, a psychology professor at Brandeis University and the author of “Primetime: A New Vision for Midlife.”
    • “After all, she added, “What happens in midlife doesn’t stay in midlife.”
    • “We spoke with experts about some small habits that can make a big difference.”
  • Health Day tells us,
    • “Childhood obesity can be effectively treated through a family-based program provided through their local pediatrician, a new clinical trial says.
    • “About 42% of kids in the program lost enough weight to improve their heart health and lower their diabetes risk within a year and a half, researchers reported July 27 in JAMA Pediatrics.
    • “The program teaches families how to establish healthy eating and exercise habits, including positive reinforcement and supportive routines, researchers said.
    • “Our results show that an established, effective obesity treatment for children and adolescents can be successfully delivered in their pediatrician’s office,” lead researcher Amanda Staiano said in a news release. She is director of the Pediatric Obesity and Health Behavior Laboratory at Pennington Biomedical Research Center at Louisiana State University.”
  • Drug Topics informs us,
    • “Alcohol use, binge drinking, and heavy drinking have all increased significantly among pregnant women in the US from 2011 to 2024, according to a JAMA study. Likewise, with no end in sight for the trends in their findings, study authors consider them “concerning,” highlighting the need to address the growing trends among expecting mothers and their alcohol consumption.
    • “It is well established that alcohol is a teratogen, and numerous existing guidelines advise women to abstain from alcohol during pregnancy and while breastfeeding,” wrote the authors of a study in Drug and Alcohol Review. “However, many women consume alcohol in pregnancy even after learning they are pregnant. Worldwide, approximately 10% of women in the general population consume alcohol in pregnancy, although the European region has the highest rate of consumption (25%).
    • “The JAMA analysis revealed that from 2011 to 2024, the relative increase in current alcohol use among pregnant individuals reached 59%, and binge drinking rose by 77% and heavy drinking surged by a startling 166%. These absolute increases, 5.4%, 2%, and 1.2%, respectively, represent a significant shift in behavior that researchers indicate has no clear sign of reversal.”
  • Genetic Engineering and BioTechnology New lets us know,
    • “Engineers and neuroscientists at the University of California (UC) San Diego have developed a soft, wearable fingertip patch that continuously tracks a Parkinson’s disease (PD) patient’s levodopa medication levels by measuring chemicals in their sweat, with no batteries required. Tests in healthy volunteers and in Parkinson’s disease patients showed that measurements generated using the device were comparable to those obtained by standard laboratory blood tests.
    • “The wearable device offers a way to continuously track real-time concentrations of levodopa in the body and could enable doctors to precisely customize daily medication schedules for patients at home.
    • “The research was led by Tamoghna Saha, PhD, a postdoctoral researcher in the lab of Joseph Wang, DSc, professor in the Aiiso Yufeng Li Family Department of Chemical and Nano Engineering at the UC San Diego Jacobs School of Engineering. Saha is co-first author of the team’s published paper in PNAS titled “A wearable patch for continuous levodopa monitoring in sweat: Towards exertion and power-free pharmacodynamic assessment in Parkinson’s disease.” In their paper the authors wrote in summary, “Overall, our easy-to-use, energy-efficient wearable supports real-time, stimulation-free monitoring, potentially enabling at-home dosage adjustments and paving the way for future autonomous closed-loop L-dopa therapeutic system development.”
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of tavapadon (AbbVie Inc.) for Parkinson’s Disease.
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.
    • “On August 5, as part of ICER’s Early Insights Webinar Series, ICER’s Chief Scientific Officer and Director of Health Technology Assessment Methods and Engagement, Dan Ollendorf, PhD, MPH, will present the initial findings of this draft report. This webinar is exclusively available to all users of the ICER Analytics platform; registration for the webinar is now open.”
  • Per STAT News,
    • “For decades, efforts to develop non-opioid pain drugs were marked by failure. But what was once a graveyard of drug discovery is quickly turning into a race for a multibillion-dollar market, with Latigo Biotherapeutics publishing positive data on Wednesday for a therapy meant to rival a Vertex medicine already on the market.
    • “The startup’s Phase 2 trial enrolled 343 patients who’d gotten tummy tuck surgery; they were randomized to receive a high or low dose of Latigo’s experimental pill, a placebo, or a combination of acetaminophen and the opioid hydrocodone. Those given either dose of Latigo’s oral drug, LTG-001, showed statistically significant pain relief compared to placebo after 48 hours. And while participants in all groups had the option to use the opioid oxycodone if they needed additional pain management, those on a high dose of Latigo’s therapy were significantly less likely to do so than participants on placebo.” * * *
    • “The biotech plans to start a Phase 3 study later this year of patients who’ve had bunion removal surgery, with results expected in the second half of 2027.”

From the U.S. healthcare business and articifical intelligence fronts,

  • Beckers Payer Issues reports,
    • “Humana reported a $694 million profit for the second quarter, up more than 27% year over year, according to its July 29 earnings report.
    • “Revenue reached $40.8 billion, a 26% increase from the same period in 2025, driven by Medicare membership growth, higher per-member Medicare Advantage and standalone prescription drug plan premiums from increases in benchmark funding and the Part D direct subsidy, and a payer-agnostic CenterWell client base. Star ratings headwinds persisted.
    • “Total Medicare membership reached 11.1 million, up from 8.2 million in the comparable quarter. Total medical membership was 17.9 million, an increase from 14.8 million.
    • “The company’s benefit ratio was 91.1%, up from 89.7% in the second quarter of 2025, spurred by the star ratings revenue issue, new individual MA members with higher benefit ratios and an expectation of lower favorable prior period development. However, MA recontracting, pricing and clinical excellence efforts offset that growth.”
  • Beckers Hospital Review notes,
    • “Jaewon Ryu, MD, the founding CEO of Risant Health, will step down, and Dale Maxwell has been named interim CEO.
    • “According to a July 29 news release, Dr. Ryu made the decision to leave the role to focus on his family. Mr. Maxwell, former president and CEO of Albuquerque, N.M.-based Presbyterian Healthcare Services, will serve as interim CEO while the Risant Health board conducts a national search for a permanent successor.
    • “Washington, D.C.-based Risant Health is a nonprofit created by Oakland, Calif.-based Kaiser Permanente to expand value-based care by partnering with community health systems. As the organization’s inaugural CEO, Dr. Ryu built its leadership team and operating model and oversaw the additions of Danville, Pa.-based Geisinger, which operates 10 hospital campuses, and Greensboro, N.C.-based Cone Health, which has five hospitals and more than 150 locations.
    • “Jaewon has been instrumental in turning the vision for Risant Health into reality,” Greg Adams, chair and CEO of Kaiser Permanente and chair of the Risant Health board, said in the release. Mr. Adams said Dr. Ryu built an exceptional leadership team and positioned the organization to expand value-based care.”
  • Fierce Healthcare relates,
    • “AI doctor startup Doctronic aims to broaden its reach beyond adult primary care by acquiring text-based pediatric care platform Summer Health.
    • “The companies did not disclose the financial terms of the deal.
    • “Fast-growing Doctronic is an AI-native primary care provider that has supported 30 million health encounters in just two years. It offers a proprietary AI doctor and nationwide network of licensed clinicians delivering personalized medical guidance and video visits for $39, according to the company.
    • “The startup offers a free personal AI doctor via chatbot to help navigate symptoms and answer medical questions and can connect users with a licensed physician through a virtual visit. Doctronic, available in all 50 states, is being tested by the state of Utah to refill prescriptions as part of a pilot program.”
  • and
    • “Hospitals should plan for their supply chain expenses to climb in 2027, with the prices for indirect spending categories like IT, construction and even food projected to grow at an even faster rate than those for drugs, Vizient warned in its most recent forecast report. 
    • “Vizient’s latest twice-yearly report mapped out overall supply chain price inflation of 3.39% for 2027, an increase of 0.61 percentage points compared to the forecast it released in February for the 12-month period beginning in H2 2026. 
    • “The primary culprits, Vizient research and intelligence director Jeff King told Fierce Healthcare, are AI demand and elevated costs of logistics and energy that are being felt across the world.”
  • and
    • “Alongside an update to its 2026 ratings, national nonprofit Leapfrog Group announced Monday the launch of an expanded ambulatory service center (ASC) reporting program. The expanded Leapfrog ASC Public Reporting Program, first unveiled in April, reports safety and quality information for facilities nationwide. More than 3,900 ASCs are now included in the 2026 ratings, along with more than 2,400 hospitals—which the nonprofit says is the highest level of participation in its 26-year history.”
  • Fierce Pharma points out,
    • “With increased sales of its newer drugs compensating for declining revenues from its multiple sclerosis (MS) portfolio, Biogen is once again positioned for a “growth story,” CEO Chris Viehbacher said Wednesday during the company’s second-quarter earnings call.
    • “To that end, Biogen reported revenue of $2.74 billion for the period, marking its highest quarterly haul since Q3 of 2021. With the result, the company flipped its 2026 revenue guidance from an expected mid-single digit decline in 2026 to a mid-single digit increase.  
    • “This quarter is a reflection of the significant progress Biogen has made repositioning the company for long-term growth,” Viehbacher added.
  • Beckers Hospital Review tells us what 17 pharmacy leaders think about “the biggest shifts they’re seeing in patient expectations.”
  • MedCity News informs us,
    • “For many people, managing a disease means chronic therapy. Scribe Therapeutics has a different vision: genetic medicines that offer durable effects for the masses. With its lead program on a path to report its first human data next year, Scribe has joined the public markets, raising $128.7 million. 
    • “While current genetic medicines are largely limited to rare disorders, we are engineering our technologies for use in common diseases affecting millions,” Scribe said in its IPO filing. “By targeting prevalent diseases with significant unmet need and high clinical burden, we aim to usher in a new era of broadly scalable, transformative, and preventative genetic medicines.”
    • * * * “Alameda, California-based Scribe has selected cardiometabolic disorders as its first focus. Lead therapeutic candidate STX-1150 is intended to lower the “bad” form of cholesterol, which is a risk factor for atherosclerotic cardiovascular disease (ASCVD). This therapy is designed to lower LDL-cholesterol by repressing expression of PCSK9, a protein that in high amounts, reduces the ability of the liver to clear cholesterol from the blood. Injectable PCSK9 inhibitors are already available from Amgen, Regeneron Pharmaceuticals, and Novartis. Last week, Merck received FDA approval for Lipfendra, an oral PCSK9 inhibitor. While dosing frequency for these therapies varies, all of them are taken chronically.”
  • STAT News reports,
    • “Hundreds of thousands of U.S. doctors use clinical large language models, pitched by companies like OpenEvidence, Doximity, and UpToDate as an antidote to the dangers of hallucination-prone generalist models from Big Tech. Yet few studies have pitted them against each other — and this summer brought a high-profile head-to-head. 
    • “Researchers from NYU Langone Health had tested general and clinical models, including OpenEvidence and UpToDate Expert AI, on three sets of clinical questions. The findings, published in Nature Medicine in June: The clinical AI performed worse than the general models. 
    • “The results rang out like a gunshot. “I’ve never seen a single paper trigger the kind of reactions this one has in the health AI community,” wrote Kaiser Permanente’s vice president of AI and emerging technologies on LinkedIn. The paper’s findings, like all science, are subject to interpretation and debate — but many online reactions treated them more like a clear victory for general frontier models.” * * *
    • “Scientists acknowledge that no one test will ever tell the whole story about clinical AI performance. And day-to-day, the choice of when and how to use large language models in care — by individual doctors, and increasingly health system leaders — is shaped by more than research.
    • “I don’t see the benchmarks really playing a role among doctors,” said OpenEvidence’s Nadler. “Academics like talking about them.” 
    • “The more important question, companies, doctors, and researchers agree, is how these tools impact patients. 
    • “Anytime a new technology is introduced into medicine, its impact on those outcomes depends on how it’s used by physicians. Are they using the tool safely and correctly, on the right patients, in the right situations?
    • “In the case of AI, that often comes down to trust. An accurate model inspires confidence, but it can still occasionally be wrong — potentially leading a physician astray, if they rely on it outright. Conversely, a good model can leave gains on the table if a physician doesn’t trust its output.” 


Monday report

David Ermer–CMS, Congress, FDA, Medical / Rx research, Medicare, NIH, Obesity, Rx coverage, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC,

  • Roll Call reports,
    • “As the Senate speeds toward its upcoming August recess, President Donald Trump is turning up the pressure on Senate Majority Leader John Thune to keep his chamber in session and in Washington instead. 
    • “So far, that’s unlikely.  “You could stay here till Christmas” and the situation wouldn’t change, Thune said. “If I thought there was a path to getting a result, I’m all for it.” 
    • “The president posted to Truth Social on Monday morning that “Thune should not allow the United States Senate to ‘leave town’ until it passes” the SAVE America Act, a GOP-crafted package that would require proof of citizenship to register to vote and photo ID at the polls.
    • “The sweeping bill does not have the 60 votes needed to advance through the Senate — a message the South Dakota Republican leader has reiterated both publicly and privately to the other end of Pennsylvania Avenue.” 
  • Per a U.S. Senate Committee news release,
    • “On Thursday, July 30, the Senate Health, Education, Labor, and Pensions (HELP) Committee will vote on bills to increase Americans’ educational opportunities and give them more tools to secure a strong retirement. The Committee will also vote the nominations for Assistant Secretary for Preparedness and Response for the U.S. Department of Health and Human Services, the Director of the Centers for Disease Control and Prevention, and the Secretary of the U.S. Department of Labor.”
  • Govexec relates,
    • “While lawmakers are debating what an appropriate regulatory framework for artificial intelligence should be, experts who spoke at a panel on Monday noted that federal employees have been using the technology for years to develop all sorts of regulations. 
    • “Cary Coglianese, a regulation professor at the University of Pennsylvania, said that agencies, for example, have been using AI to analyze thousands of public comments that some proposed rules receive. 
    • “Back in the day, contractors would literally photocopy comments, clip them out and sort them in different categories — and do what essentially natural language processing tools can do now so quickly and rather effectively,” he said. 
    • “But as the technology advances, speakers on the panel — which was sponsored by the Coalition for Sensible Safeguards, a left-leaning group of more than 220 regulatory-focused organizations — argued that AI could take over more steps in the rulemaking process, potentially supercharging the Trump administration’s efforts to slash regulations and downsize the federal government.”
  •  FEHBlog observation: The government can use AI for many more tasks, and you don’t have to be left leaning to be concerned about this development.
  • Fierce Healthcare tells us,
    • “A tiny federal agency tasked with protecting the public from injuries caused by lawn mowers and coffeemakers is demanding that some of the nation’s biggest health systems turn over detailed, personally identifiable medical records of all patients who seek help at their emergency rooms.
    • “The Consumer Product Safety Commission, responsible for tracking and issuing recalls of dangerous products sold in the U.S., began discreetly pressuring hospital executives this year to share personally identifiable health data with a private contractor. But hospital lawyers and other industry experts have questioned the agency’s authority to collect, its ability to safeguard such a swath of sensitive information, and whether it has followed the legal process to overhaul its surveillance system.
    • “After KFF Health News asked the CPSC about the new system, the agency announced the program on July 21. Left unmentioned, however, is the alarm it has raised among hospital executives, as well as the nature and extent of the agency’s data demands.”
  • and
    • “A new analysis finds that Medicare Advantage enrollees spend less on average than those in the traditional program, but report similar satisfaction levels.
    • “ATI Advisory conducted the study on behalf of the Better Medicare Alliance, analyzing data from the Medicare Current Beneficiary Survey and Cost Supplement files from 2021 to 2023. The analysis found that MA enrollees spent $2,824, or 36%, less out-of-pocket on average in 2023 compared to those in fee-for-service Medicare.
    • “And the difference in spending has risen over time, with savings 16% higher in 2023 than in 2022, according to the report.
    • “Twelve percent of MA beneficiaries said they faced a significant cost burden, or spent more than 20% of their income on healthcare, compared to 24% of people enrolled in traditional Medicare.”
  • Beckers Payer Issues adds,
    • Medicare Advantage will account for 57% of overall Medicare enrollment by 2036, up from 51% this year, according to a July report from the Congressional Budget Office.
  • and
    • “Four more Medicare Advantage prescription drug plans have received five-star ratings thanks to CMS’ recalculation.” * * *
    • In a July 21 letter to MA organizations, CMS said ratings stayed the same for 61%, increased for 9% and declined for 30% of contracts. The agency did not change ratings for plans that had worse performance in the latest review. The threshold for MA plans earning additional payments is four out of five stars. Top plans get their own perks, though, such as special enrollment period privileges and further rebate benefits.
    • CMS clarified to Becker’s that it only updated overall ratings, not the separate Parts C and D summary ratings, on the plan finder.
    • Here are the four contracts joining the five-star club:
      • Renown Health
        • Hometown Health Plan (Senior Care Plus) — Contract H2960
      • Rifkin Managed Care Holding
        • Provider Partners Health Plan of Texas — Contract H4054
        • Provider Partners Health Plan of Pennsylvania — Contract H4093
      • Longevity Health Founders

From the Food and Drug Administration front,

  • MedPage Today tells us,
    • Nearly 100 people in 17 states have been sickened in a salmonella outbreak tied to recalled eggs, federal health officials said Friday.
    • The 98 people had illnesses that started between Nov. 21 and June 30, according to the FDA. No deaths have been reported, but 26 people have been hospitalized.
    • Investigators have determined that shell eggs recalled by Midwest Poultry Services are a likely source of the germ, but the Indiana-based company doesn’t account for all the illnesses.
  • BioPharma Dive reports,
    • “The Food and Drug Administration has approved Freenome’s blood-based screening test for colorectal cancer, called SimpleScreen CRC. Abbott will exclusively market the test in the U.S., starting this fall, the companies said Monday.
    • “Abbott already sells the Cologuard stool test for colorectal cancer screening, following its $21 billion acquisition of Exact Sciences earlier this year. Through its collaboration with Freenome, Abbott now adds a blood test to its colorectal cancer screening portfolio.
    • “SimpleScreen will compete with Guardant Health’s Shield blood test for colorectal cancer screening, which gained FDA approval in 2024. TD Cowen analysts said that with a very large population of patients who are unscreened, “We see room for multiple players.”
  • Fierce Pharma relates,
    • “The FDA has approved Otsuka Pharmaceutical’s once-daily extended-release capsule Simtriyo (centanafadine) for attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 years and older.
    • “Approval of the first-in-class norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) gives the Japanese drugmaker its “next major CNS launch” and positions the therapy to become a potential blockbuster in a large, under-penetrated market, according to Jefferies analysts in a July 26 note.
    • “Before Simtriyo can launch in the U.S. market, it must clear controlled-substance review by the Drug Enforcement Administration (DEA), a standard, up-to-three-month procedure for all central nervous system stimulants.”
  • Contemporary OB/GYN informs us,
    • “Roche received FDA 510(k) clearance for its cobas BV/CV (Bacterial vaginosis/Candida vaginitis) assay, a molecular diagnostic test that returns results for both conditions from a single vaginal swab. The assay is intended for professional laboratory use, based on a clinician’s order, the company noted in a July 24, 2026, news release.
    • “The test uses real-time polymerase chain reaction technology to identify the specific bacteria and yeast species that are responsible for BV and CV in symptomatic patients. Roche stated that the assay is designed to support faster, more accurate diagnosis than syndromic evaluation alone, with the goal of improving both patient outcomes and laboratory efficiency.
    • “BV and CV are among the most common causes of vaginal symptoms in the United States, and both conditions can present with overlapping symptoms that complicate clinical diagnosis based on history and examination alone.”
  • NBC News San Diego CA points out,
    • “The Food and Drug Administration has recalled a commonly prescribed thyroid medication.
    • “The recall involves levothyroxine sodium tablets that are used to treat hypothyroidism and decrease the size of enlarged thyroid glands, according to Mayo Clinic.
    • “The FDA said they had been functioning as “subpotent drugs,” meaning they had less of an active ingredient and were ultimately less effective.
    • “Major Pharmaceuticals packaged and distributed the recalled tablets, while Cardinal Health also distributed some of the recalled products.
    • “Twelve different dosages and cartons from the two companies were listed in the FDA’s recall notice. You can read the full list here.”

From the judicial front,

  • Bloomberg Law reports,
    • “Novo Nordisk A/S is asking a federal judge to halt Eli Lilly & Co.’s advertisements for its GLP-1 drugs, escalating a legal fight against the company’s campaign for weight loss treatments.
    • “The company said Friday [July 24] it filed a motion for preliminary injunction seeking to block Lilly’s advertisements of its obesity drugs, days after filing a lawsuit accusing the company of deceptive promotions. 
    • “Misleading advertisements that selectively compare lower doses of Novo Nordisk’s medicines against higher doses of Lilly’s medicines, based on outdated studies, leave patients with the mistaken impression that Lilly’s drugs are vastly superior, and that is simply not true,” John F. Kuckelman, senior vice president and group general counsel of Novo, said in a statement.”
  • and
    • “Johnson & Johnson on Monday said it agreed to a $5.5 billion commitment to resolve litigation related to claims that its talc products caused ovarian cancer. 
    • “The drugmaker said the proposed resolution represents “an efficient conclusion” to the lawsuits. The agreement requires the participation of lead plaintiff firms in ovarian talc litigation pending in state and federal court that represent at least 95% of claims, according to J&J. 
    • “While we are confident the company would have ultimately prevailed with further litigation, as it has in the vast majority of cases tried to date, this resolution allows the Company to put this matter behind it and remain focused on its mission to develop medicines and devices that save lives,” J&J Vice President of Litigation Erik Haas said in the statement on the company’s website.” 
  • Beckers Payer Issues identifies five health system vs. payer lawsuits to watch.

From the public health and medical / Rx research front,

  • Health Day reports,
    • “More than one-third of women and one-quarter of men engage in intentional outdoor tanning, with variance observed by age, race, physical activity level, and alcohol use, according to a study published online July 22 in JAMA Dermatology.
    • “Dawn M. Holman, M.P.H., from the U.S. Centers for Disease Control and Prevention in Atlanta, and colleagues examined the prevalence of intentional outdoor tanning among U.S. adults. The analysis included 31,615 adults participating in the 2024 National Health Interview Survey.” * * *
    • “These findings support the need to address intentional outdoor tanning in the context of skin cancer prevention,” the authors write. “The variation in demographic and behavioral factors points to venues for future research and interventions.”
  • The American Medical Association lets us know “what doctors want patients to know about summer skin safety” and “what doctors want patients to know about cardiac stress tests.“
  • The American Hospital Associagtion News relates,
    • “The Substance Abuse and Mental Health Services Administration July 27 released results from its latest national survey on drug use and mental health. The survey found that fewer adolescents 12-17 and adults 18-25 used alcohol, tobacco, marijuana and other drugs between 2021 and 2025. In addition, 27.6% of adolescents received mental health treatment in the past year, while 21.6% of adults 18 or older received treatment. The survey highlighted additional findings on suicide, substance use treatment and recovery.”
  • and
    • “The Association for the Advancement of Blood and Biotherapies Interorganizational Task Force on Domestic Disasters and Acts of Terrorism announced July 24 that the U.S. blood supply is at significant risk for shortages due to weeks of decline in blood donations. The task force said the reduced supply is more pronounced in certain areas of the country, and in some areas blood collectors are already reporting an impact on the availability of blood for some patients. The organization is urging eligible donors to make and keep an appointment to donate blood as soon as possible. An AHA Member Advisory will be issued on the matter, which will include a call to action and resources for conserving blood supplies.” 
  • MedPage tells us,
    • “Despite the availability of multivalent pneumococcal vaccines, infants remain susceptible to invasive pneumococcal diseases.
    • “In this French study, infants immunized against RSV with nirsevimab were about 35% less likely to be hospitalized for invasive pneumococcal disease through 9 months.
    • “The rise in pneumococcal disease cases in kids involving serotypes not covered by vaccines highlights the need for complementary prevention strategies, the researchers said.”
  • and
    • “Diabetes and weight loss are associated with an increased risk of fragility fractures, which can be associated with substantial morbidity and mortality.
    • “In this retrospective study of adults with type 2 diabetes, those starting a GLP-1 drug had a 21% lower risk of fragility fractures over 3 years compared with initiators of a DPP-4 inhibitor.
    • “The lower fracture risk associated with GLP-1 drugs was independent of changes in body mass index.”
  • Health Day adds,
    • “Worried that your Ozempic is becoming less effective over time?
    • “Don’t worry — you’re still eating less, even if you are feeling a bit hungrier, a new study says.
    • “People on semaglutide for weight loss continue to eat less even after they’ve taken the drug for more than a year, researchers report in the August issue of The American Journal of Clinical Nutrition.
    • “While some of the drug’s early reduction of hunger and food-related thoughts wanes over time, people continue to eat substantially fewer calories compared to others provided a placebo, researchers found.”
  • MedScape notes,
    • “A compression device worn around the abdomen during colonoscopy reduced cecal intubation time by more than 1.5 minutes and significantly lowered post-procedural pain, the need for manual abdominal pressure, and patient position changes. Greatest improvements were seen in patients who were lean or had obesity.”
  • Per a National Institutes of Health news release,
    • “Months to several years before amyotrophic lateral sclerosis (ALS) symptoms arise, levels of certain blood proteins may dramatically shift. Researchers analyzed data from the long-running, National Institutes of Health (NIH)-funded Pre-symptomatic Familial ALS (Pre-fALS) study, to identify a lineup of key proteins that may predict the emergence of clinically manifest ALS. By anticipating the arrival of symptoms, investigators could intervene with preventative therapies before the irreversible motor neuron damage that is characteristic of ALS sets in.
    • “If someone carrying an ALS-associated genetic variant had asked me in the past when they would become symptomatic, I would have struggled to provide a reasonable estimate,” said senior author Michael Benatar, M.D., Ph.D., a professor of neurology and public health sciences at the University of Miami. “These biomarkers give us a far better idea of the timing, allowing us to estimate the time to symptom onset with an average error of about 18 months. That’s something we can work with.”

From the U.S. healthcare business and artificial intelligence front,

  • Beckers Payer Issue tells us eight things to know about healthcare spending trends. 
  • Modern Healthcare reports,
    • “Cone Health CEO Dr. Paul Krakovitz said the system is focusing on value-based care coordination.
    • “Cone’s parent system, Risant Health [,a subsidiary of Kaiser Permanente], provides a national network with added scale and expertise to operate in a highly competitive healthcare market.
    • “Krokovitz said the system is expanding to take advantage of North Carolina’s booming population growth.” * * *
    • “We’re coming up on our second anniversary soon. The tools that Risant is bringing us in terms of value-based care and giving us national scale have been impressive. They’ve been very open-minded. Most importantly, they’ve stuck to the value of the deal, which has been making sure Cone Health remains a community-based health system.”
  • Beckers Hospital Review relates,
    • “King of Prussia, Pa.-based Universal Health Services recorded an operating income of $516.7 million (11.1% operating margin) during the second quarter of 2026, compared to an operating income of $500.3 million (11.7% margin) during the same period last year, according to its July 27 financial report.” * * *
    • “UHS operates 30 inpatient acute care hospitals, 346 inpatient behavioral health facilities, about 170 outpatient and other facilities, a health plan and a physician network in 40 states, Washington, D.C., Puerto Rico and the United Kingdom.”
  • Leapfrog posted its 2026 hospital safety ratings.
  • The Wall Street Journal informs us,
    • “Argenx agreed to buy Forte Biosciences for $2.2 billion to strengthen its immunology pipeline.
    • “The purchase price of $77 a share in cash represents a 41% premium to Forte’s closing price on Friday.
    • “The deal adds Forte’s experimental drug FB102, which Argenx said has potential to address multiple autoimmune diseases.”
  • and
    • “AstraZeneca reported higher second-quarter sales driven by cancer medicines and said it remains on track to hit its 2030 revenue target.
    • “AstraZeneca’s second-quarter revenue rose to $15.38 billion from $14.46 billion, driven by a 15% increase in oncology product sales.
    • “Chief Executive Pascal Soriot sought to reassure investors after a recent trial failure raised doubts about the company’s 2030 revenue goal.”
  • MedCity News discusses “What Happens When Patients Trust AI Over Their Doctor?”
    • As patients increasingly bring AI chatbot advice into exam rooms, where does liability land when that advice goes wrong? Health law attorney Meghan O’Connor said the answer still isn’t clear, but silence is the riskiest response for providers.

Cybersecurity Saturday

David Ermer–Agentic & Generative AI, Cybersecurity, Uncategorized–

From the War with Iran front,

  • Cybersecurity Dive reports,
    • “Threat actors linked to Iran are using artificial intelligence to enhance their cyber and information warfare capabilities, putting the U.S. and its allies at higher risk of asymmetric attack, according to a report released Thursday by Recorded Future. 
    • “Iran-nexus actors have used generative AI and large language models in a range of activities, including the development of malware, conducting research on industrial control systems, exploiting software vulnerabilities and other uses. 
    • “There are no indications yet that Iran has developed fully autonomous models, but the country is clearly using AI to accelerate its existing capabilities. 
    • “AI has not transformed Iran into a fundamentally different cyber power, but it has compressed the distance between intent and action,” Alexander Leslie, senior advisor at Recorded Future, told Cybersecurity Dive.” 

From the Project Glasswing front.

  • CRN reports,
    • “Microsoft’s unprecedented July security update—which potentially includes patches for more than 600 vulnerabilities—is confirmation that ultra-powerful AI models for discovering software flaws are already starting to signal massively bigger challenges in vulnerability management, according to MSP executives.
    • “For months, the industry has been watching for indicators that vulnerability discovery capabilities from frontier AI models such as Anthropic’s Claude Mythos would lead to increased CVEs (Common Vulnerabilities and Exposures). While some hints of this had surfaced previously, the hundreds of CVEs that received software patches Tuesday as part of Microsoft’s monthly release of software bug fixes is the clearest sign of this yet, MSP executives told CRN.
    • “Estimates of the number of vulnerabilities disclosed by Microsoft during the release, colloquially known as “Patch Tuesday,” have varied but could be above 600, according to TrendAI’s Zero Day Initiative. Dustin Childs, head of threat awareness at TrendAI, counted 621 new Microsoft CVEs for the July security update.
    • “The bug apocalypse has fully descended upon us,” Childs wrote in a post.” * * *
    • “Microsoft has been among the tech industry vendors that have received access to Anthropic’s Claude Mythos model for the purposes of proactively discovering vulnerabilities in its own products, as part of the Project Glasswing initiative announced in April. Similarly, OpenAI has provided Microsoft with access to its frontier AI vulnerability-discovery models through its Trusted Access for Cyber initiative.”

From the cybersecurity and law enforcement front,

  • Cybersecurity Dive reports,
    • “The Trump administration on Tuesday [July 14] announced the launch of a program that will coordinate the security community’s use of frontier AI models to rapidly identify and fix vulnerabilities.
    • “The vulnerability management clearinghouse, which the administration is calling Gold Eagle, is a response to the skyrocketing number of vulnerabilities that AI models are finding and the strain that that surge is placing on the security community. Through the clearinghouse, the government will coordinate efforts by private companies and independent researchers to scan critical software packages for flaws, fix any flaws that surface and deploy those fixes to end users.” * * *
    • “Gold Eagle “has already begun to intake and prioritize identified cybersecurity vulnerabilities from across industries and sectors, coordinate scanning verifications, and ultimately ensure the security of our nation’s software and networks,” the White House said in a statement.
    • “The core of the Gold Eagle program is the Vulnerability Information and Coordination Environment (VINCE), which the government is operating in partnership with Carnegie Mellon University’s Software Engineering Institute. The VINCE platform will allow anyone to report vulnerabilities to the Gold Eagle program for triage and mitigation.
    • “VINCE will enable “vulnerability and patching coordination at a speed and scale never seen before,” National Cyber Director Sean Cairncross told reporters during a briefing on Tuesday.
    • “Gold Eagle will focus heavily on open-source software, whose code underpins a wide range of critical infrastructure but is often poorly scrutinized.”
  • Dark Reading adds,
    • “Katie Moussouris, founder and CEO of Luta Security as well as a pioneer in vulnerability remediation, tells Dark Reading that the cross-sector vulnerability coordination gap Gold Eagle targets “is real,” as the Known Exploited Vulnerabilities (KEV) catalog, National Vulnerability Database (NVD), and Information Sharing and Analysis Center (ISACs) do not address cross-sector prioritization. And as she has long said, vulnerability management policy problems don’t resolve on their own.
    • “The bottleneck was never knowing about more bugs. It was having the people and process to prioritize and fix them and ensure they do not recur,” she says. “Remediation prioritization according to the new BOD 26-04 will take skills and process at each affected organization, by definition, since two and possibly three out of four of the prioritization criteria are subjective and specific per organization.” * * *
    • “Moussouris cited CISA’s recent postmortem on its AWS keys being exposed in a public GitHub repository for six months as an example of something that highlights pre-existing process weaknesses at the federal level.” * * *
    • Knostic chief AI officer Sounil Yu says that if the government wants to help stakeholders via “frontier AI capabilities,” the most useful application would be something that accelerates the implementation of vulnerability fixes.
    • “Finding vulnerabilities proactively has not been the constraint. Even finding a fix or patch has not been a significant constraint. The constraint has traditionally been in implementing the fix wherever the software has been deployed,” he says. “But if you unpack it further, it’s deploying the fix and then recertifying that everything is working as expected.”
    • “Similarly, Sachin Jade, chief product officer at Cyware, tells Dark Reading that while AI tools can surface vulnerabilities faster than anyone can currently act on them, there is also a lag in determining which findings are real, prioritizing severity, and developing and deploying a fix.
    • “This program is a good start, and we as the industry have to work collectively to sharpen our approaches, increase defense velocity, empower sharing and collective defense, and become proactive in our mindsets,” Jade says.”
  • Beckers Health IT asks and answers “Healthcare Security Teams Have More Alerts Than Ever. So Why Is Risk Still Getting Through?”
    • “People remain the core of healthcare cybersecurity. When automation handles repetitive work, analysts can focus on meaningful threats, response planning and the gaps most likely to affect the organization.
    • “IBM found that organizations extensively using AI and automation in security operations identified and contained breaches 80 days faster and experienced an average of $1.9 million less in breach costs. That does not mean technology replaces experienced professionals. It shows what can happen when they receive better-organized information sooner.
    • “The most resilient healthcare organizations will be the ones that can work through data faster, identify what is relevant and act within clear safeguards before a security gap interrupts claims or patient care.”
  • Security Week relates,
    • “The Department of War has suspended CMMC Phase 2’s mandatory third-party assessment requirement, citing concerns that the assessor ecosystem couldn’t scale to meet demand and that compliance costs were pushing small and mid-sized firms out of the defense industrial base. 
    • “A newly formed CMMC Reform Task Force will spend 60 days reviewing the program, gathering industry feedback, and reporting recommendations by mid-September. 
    • Crucially, the pause only affects independent verification, with Phase 1 self-assessment obligations, SPRS score submissions, and the underlying DFARS 252.204-7012 requirement to protect controlled unclassified information (CUI) remaining fully in effect. 
    • “Industry professionals broadly agree that the suspension pauses third-party CMMC audits but not the underlying legal obligation to protect CUI, warning that self-attestation without verification raises False Claims Act exposure. However, experts are split on whether the fix should be to scope assessments down, automate them, or preserve them largely as-is.”
  • Per a July 15, 2026, Cybersecurity and Infrastructure Security Agency (CISA) news release,
    • “Today, the Cybersecurity and Infrastructure Security Agency (CISA), in partnership with the National Security Agency (NSA), Japan Computer Emergency Response Team Coordination Center (JPCERT/CC), Netherlands’ National Cyber Security Centre (NCSC-NL), and United Kingdom’s National Cyber Security Centre (NCSC-UK), published Establishing a Coordinated Vulnerability Disclosure Program to Work With Security Researchers.
    • “This guidance helps software manufacturers and online service providers collaborate effectively with security researchers who identify weaknesses in software, networks, and hardware in a structured, transparent framework. A well-defined coordinated vulnerability disclosure (CVD) program enables software manufacturers and online service providers to better assess potential risk, improve their vulnerability management processes, and make informed decisions that improve product security for their customers.
    • “Coordinated vulnerability disclosure is foundational to building a secure software ecosystem. The practices in this guide help protect customers, strengthen products and support CISA’s Secure by Design initiative, which encourages companies to be transparent and responsible in how they build and maintain their technology,” said Acting Executive Assistant Director for Cybersecurity Chris Butera. “CISA encourages suppliers to establish a coordinated vulnerability disclosure program and build constructive, collaborative relationships with security researchers to enhance product security.”  
  • Cyberscoop tells us
    • “A total of eight cyber personnel have served in a program that began in 2022 to rotate workers between federal agencies to bolster the workforce, a watchdog report said Thursday.
    • “Over the life of the Federal Rotational Cyber Workforce program that effectively went away last year, 13 agencies offered 106 positions and received 634 applications, according to the Government Accountability Office. Eight workers won approval to participate.
    • “The goal of the Office of Personnel Management-led program, established by bipartisan legislation, was that “participating employees develop knowledge and skills that they can bring back to their home agencies,” as the GAO noted.
    • “OPM evaluated possible shortcomings in implementing the program in late 2024 and developed plans for improving it, but never followed up on them, the GAO said. As of next summer the program will officially end, OPM said.”
  • and
    • “A pair of young men were sentenced to 66 months in jail for committing acyberattack on the Transport for London that brought the network’s operations to a standstill in 2024, the United Kingdom’s National Crime Agency said Thursday [July 16].
    • “Thalha Jubair and Owen Flowers were arrested at their homes in September 2025, barely a year after the attack, and pleaded guilty last month just as their trials were set to begin. Flowers was previously arrested in connection with the attack in September, but was released after questioning by officers.
    • “Jubair and Flowers were leading members and highly involved in Scattered Spider, a nebulous hacker subset of The Com, according to researchers. The 20-year-old Jubair was a prolific cybercriminal and core member of the unbound collective. 
    • “U.S. authorities last year accused Jubair of direct, prominent involvement in at least 120 cyberattacks, including extortion of 47 U.S.-based organizations and the January 2025 attack on the federal court system. 
  • Beckers Health IT identified 11 cases from a Federal crackdown on hospital hackers.
    • “Federal authorities are intensifying their pursuit of the cybercriminals behind hospital and healthcare ransomware attacks, bringing charges against ransomware developers, state-sponsored hackers and even insiders from the cybersecurity industry.
    • “The latest move came July 14, when the Justice Department indicted three Russian nationals and two “bulletproof hosting” companies tied to $62 million in U.S. victim losses. The action is part of Operation Riptide, the FBI’s ongoing campaign against cybercrime infrastructure, after Americans reported more than $20 billion in cybercrime losses last year, a 26% single-year increase.”

From the cybersecurity breaches and vulnerabilities front,

  • HIPAA Journal posted its May 2026 Healthcare Data Breach report last Tuesday.
    • “Based on the current data on the HHS’ Office for Civil Rights (OCR) breach portal, 61 healthcare data breaches affecting 500 or more individuals were reported in May 2026. May’s current total represents a 27.1% month-over-month increase in data breaches. Over the past 12 months, an average of 64 large healthcare data breaches were reported each month.”
  • MedTech Dive reports,
    • “Abbott disclosed on Thursday [July 16] that a cyberattack hit its cancer diagnostics business.
    • The medical device company said in a statement posted to its websitethat there was unauthorized access to a limited number of internal systems in its cancer diagnostics business. There was no impact on other Abbott businesses, sites or systems.
    • Abbott’s cancer diagnostics business includes Exact Sciences, which the company acquired in a $21 billion deal earlier this year. The legacy Exact Sciences systems are separate from Abbott’s, according to the statement.
  • Beckers Health IT relates,
    • “A cyberattack on New Jersey law firm Greenbaum Rowe Smith & Davis has exposed data on 12,801 patients across three health systems in the state.
    • “Greenbaum discovered unauthorized access to its systems through a compromised user account in November 2025 and traced the intrusion to Nov. 25-27, 2025, according to the firm’s notification. Affected organizations include Edison, N.J.-based Hackensack Meridian Health, Morristown, N.J.-based Atlantic Health and Trinitas Regional Medical Center in Elizabeth, N.J., part of West Orange, N.J.-based RWJBarnabas Health.
    • “An investigation completed in April found an unauthorized third party accessed patient names, addresses, medical record numbers, medical history, provider details, medical bill amounts and health insurance information. For a subset of individuals, Social Security numbers or dates of birth also were exposed, Greenbaum said.”
  • Bleeping Computer tells us,
    • “Ernst & Young is notifying customers of a data breach caused by the compromise of a third-party support ticket system used by its IT personnel.
    • “According to the company, support tickets submitted through the platform may have included documents containing client tax information.
    • “Ernst & Young (EY) is among the world’s four largest auditing and professional services providers, offering auditing, tax, consulting, and transaction advisory services to major organizations in more than 150 countries.” * * *
    • “Ernst & Young says it secured its systems and notified federal law enforcement authorities, while it has assured that the unauthorized access has been removed.
    • “The company also states that it is not aware of any misuse or further exposure of the stolen files and has no indication that particular individuals were targeted by the threat actors.”
  • CISA added ten known exploited vulnerabilities to its catalog this week.
    • July 13, 2026
      • CVE-2008-4128 Cisco IOS Cross-Site Request Forgery Vulnerability
        • Security Affairs discusses this KVE here.
    • July 14, 2026
      • CVE-2026-15409 SonicWall SMA1000 Appliances Server-Side Request Forgery Vulnerability
      • CVE-2026-15410 SonicWall SMA1000 Appliances Code Injection Vulnerability
      • CVE-2026-56155 Microsoft Active Directory Federation Services Insufficient Granularity of Access Control Vulnerability
      • CVE-2026-56164 Microsoft SharePoint Server Missing Authentication for Critical Function Vulnerability
        • The Hackers News discusses the SonicWall KVEs here
        • Cybersecurity News discusses the Microsoft Active Directory KVE here.
        • Cybersecurity News discusses the Microsoft Sharepoint Server KVE here.
    • July 15, 2026
      • CVE-2023-4346 KNX Association KNX Protocol Connection Authorization Option 1 Overly Restrictive Account Lockout Mechanism Vulnerability
      • CVE-2026-46817 Oracle E-Business Suite Improper Privilege Management Vulnerability
        • The Hacker News discusses these KVEs here.
    • July 16, 2026
      • CVE-2026-25089 Fortinet FortiSandbox OS Command Injection Vulnerability  
      • CVE-2026-39808 Fortinet FortiSandbox OS Command Injection Vulnerability  
      • CVE-2026-58644 Microsoft SharePoint Deserialization of Untrusted Data Vulnerability 
        • Bleeping Computer discusses the Fortinet KVEs here.
        • The Hackers News discusses the Microsoft Sharepoint KVE here.
  • The American Hospital Association News adds,
    • “The Cybersecurity and Infrastructure Security Agency has issued an alert warning of four Microsoft SharePoint vulnerabilities being exploited by cyber threat actors. CISA said the vulnerabilities affect all supported on-premises versions of SharePoint Server, including the Subscription Edition, 2019 and 2016. Threat actors can establish remote code execution and perform other actions to deploy malware. CISA said organizations should monitor SharePoint Servers closely for any signs of exploitation or unusual activity. An additional vulnerability was found, but it is not yet known to have been exploited. Microsoft identified it as a potential risk if it is left unpatched. CISA urged organizations to apply the latest patches and security updates from Microsoft, among other recommendations. 
    • “Nearly everyone using Microsoft products is using SharePoint, the backbone of the Office suite,” said Scott Gee, AHA deputy national advisor for cybersecurity and risk. “Hospitals with their SharePoint instances housed on premises should pay particular attention to this alert. The common vulnerabilities and exposures listed in the report have patches available, and they should be deployed as soon as possible. Hospitals should also verify that the security measures mentioned are in place.” 
  • and
    • “The Cybersecurity and Infrastructure Security Agency and other U.S. and international agencies released a joint advisory July 13, warning of Russian cyber actors targeting vulnerable network devices, primarily routers, in critical infrastructure sectors globally, including healthcare. The advisory details how the threat actors primarily use scanning to identify poorly configured devices for exploitation. The actors then exfiltrate sensitive information and facilitate malicious activity. The advisory includes recommendations to help defend against potential threats.
    • “This malicious cyber activity has been attributed to the Russian Federal Security Bureau, a foreign intelligence agency of the Russian government,” said John Riggi, AHA national advisor for cybersecurity and risk. “Therefore, this represents an advanced and persistent cyber threat targeting U.S. healthcare that should be prioritized. The first step in mitigating this threat and other nation-state cyber threas is to install the latest network router encryption standard, Simple Network Management Protocol v3.”
  • Cybersecurity Dive tells us,
    • “Businesses should be on guard for a hacking campaign in which attackers spoof OAuth client IDs to collect information about targets’ user directories, the security firm Proofpoint said on Monday.
    • “The security firm said it had observed “multiple campaigns at scale abusing spoofed OAuth application identifiers, with distinct tooling, infrastructure, and execution patterns indicating independent adoption by multiple threat actors.”
    • “The report explains how organizations should monitor their networks for this reconnaissance technique.”
  • Cyberscoop points out,
    • “Cyberstalkers are increasingly exploiting a feature in Google Chrome meant for mobile phone user convenience, but can give intruders broad access to a device owner’s private information, according to researchers.
    • “Certo Software said in a blog post Tuesday that stalkers are making use of Chrome’s sync capability — meant to make it so signing into Chrome on one device makes it easier to do so on other devices, too — to spy on a phone owner’s browsing history and gain access to their stored passwords.”
  • Bleeping Computer adds,
    • “A flaw in Anthropic’s Claude for Chrome browser extension could allow a malicious extension to trigger predefined AI actions by simulating user clicks, potentially allowing it to abuse Claude’s access to connected services such as Gmail, Google Docs, Google Calendar, and Salesforce.
    • ‘The issue was discovered by Ax Sharma of Manifold Security, who says it stems from how the Claude extension determines whether a user intentionally requested one of its built-in tasks.
    • “Chrome extensions with permission to run on a website can inject JavaScript into the page, allowing them to read and modify its contents. This includes changing page elements, reading information displayed on a site, and generating click and keyboard events programmatically.
    • “According to Manifold’s report, the Claude extension listens for click events on a specific page element that launches one of its built-in AI workflows. These workflows are predefined tasks that allow Claude to perform actions in connected services such as Gmail, Google Docs, Google Calendar, and Salesforce.”

From the ransomware front,

  • Cybersecurity Dive reports,
    • “Coca-Cola on Thursday said it is investigating a ransomware attack that impacted its Fairlife dairy unit and has suspended production at the company’s U.S. production facilities. 
    • “In a filing with the Securities and Exchange Commission, the company said it trying to determine the full scope of the attack and what impact it might have on its business. Coca-Cola said the attack has had no effect on the quality and safety of its Fairlife products, which include ultra-filtered, lactose-free milk as well as protein and nutritional shakes.”
  • Per a Sophos news release,
    • “This year’s data has a few eyebrow-raising departures from the patterns of past State of Ransomware reports. Exploited vulnerabilities lost their three-year grip on the top root-cause spot. Median ransom demands and payments both dropped, yet the average recovery bill still climbed. And small organizations (100-250 employees) are falling further behind their larger peers on the one metric that matters most: stopping the attack before data gets encrypted.
    • “The seventh annual Sophos State of Ransomware report is based on a vendor-agnostic survey of 2,158 IT and security leaders whose organizations were hit by ransomware in the last 12 months.
    • “Click here to access the full report now.”
  • Dark Reading adds,
    • “According to Sophos’ survey, malicious email (26%) and phishing (24%) dethroned the three-year reign of vulnerabilities (18%, down from 32%) as the top root cause of ransomware attacks. Two-thirds (67%) of victims also said the ransomware attack they suffered was their most significant identity attack over the past year.
    • “With phishing and malicious email now accounting for half of all ransomwareroot causes in this report, organizations should deploy advanced email filtering, implement DMARC/DKIM/SPF protocols, and invest in regular phishing awareness training,” Sophos said. “The shift toward email-based attacks suggests that technical vulnerability patching alone is insufficient.”
    • “The third most common root cause of ransomware attacks was also identity related, with compromised credentials used in 23% of cases. This is particularly significant because of one of the most startling findings: Multifactor authentication (MFA) was deployed for 97% of instances where compromised credentials were the root cause of ransomware attacks.” * * *
    • While staying patched remains important as always, it appears the fight against ransomware is moving from patch management to identity protection.
    • “Organizations should prioritize identity threat detection and response (ITDR), enforce multifactor authentication across all access points, and regularly audit both human and non-human identity credentials,” Sophos said. The vendor stopped short of recommending a specific type of MFA, suggesting the biggest failure wasn’t MFA itself but rather incomplete deployment or perhaps a lack of comprehensive inventorying.”
  • InfoSecurity Magazine lets us know,
    • “The number of ransomware attacks which target government departments and agencies has risen to the extent that one has its services restricted by encryption every single day.
    • “The figure comes from analysis by researchers at Comparitech, who studied ransomware incidents which targeted government entities between January and June 2026.
    • The research, published on July 16, recorded that 187 government organizations were hit with ransomware during the first six months of 2026. That represents a 13% increase on the 165 ransomware attacks recorded during the second half of 2025.
    • “The increase in recorded ransomware events is notable because the figure of 187 incidents across 182 days means that the average number of ransomware attacks against government bodies now stands at an average of one every day.
    • “Of those 187 recorded incidents, just over half (89) were publicly confirmed by the organization which was hit.”
  • Bleeping Computers warns
    • “A new ransomware actor called Spirals completed a corporate intrusion, from initial access to data theft and encryption, in less than 24 hours.
    • “The attack occurred in June and breached an IT services firm in South Asia after compromising an Internet Information Services (IIS) server exposed on the public web.” * * *
    • “Symantec’s report provides network indicators and file hashes associated with the documented Spirals attack to help organizations worldwide set up defenses against this threat group.”

From the cybersecurity business and defenses front,

  • The Wall Street Journal reports
    • “Cybersecurity mergers and acquisitions reached 219 in the first half of 2026, putting the sector on track to surpass last year’s 400 deals.
    • “The rush to acquire artificial-intelligence capabilities is driving the surge in cybersecurity dealmaking.
    • “Technology and cybersecurity companies accounted for 88% of disclosed cyber acquisition spending in the first half of the year.”
  • Cybersecurity Dive relates,
    • “Enterprise security teams are incorporating AI into their programs at a faster rate than ever before, but a significant gap exists in the governance policies that are designed to support that expansion, according to a report released Monday by the SANS Institute.
    • “Four out of 10 security practitioners said there is no formal policy in their organization for AI adoption, according to the report. More than six of 10 practitioners said they have no visibility into where AI models are being used or what kind of information is being exposed. 
    • “About 75% of security practitioners have a governance role related to enterprise AI, yet more than half of respondents said there are no established frameworks for AI audits, the report showed.”
  • Dark Reading adds,
    • “Having completed its $32 billion acquisition of Wiz earlier this year, Google is fulfilling its plan to automate threat detection, investigation, and remediation with a new “agentic defense” platform built around intelligent security agents.
    • “Wiz, founded in 2020, quickly became one of the fastest-growing cloud security companies by introducing graph-based analysis to correlate cloud assets, identities, vulnerabilities, and exposures across multicloud environments. The acquisition gives Google a cloud-native security platform that supplements its existing artificial intelligence (AI), threat intelligence, and incident response features.
    • “On Monday [July 13], Google revealed it had integrated Wiz attack surface management (ASM) and Google Threat Intelligence (TI). When Wiz ingests posture and workload telemetry from Google Cloud, it enriches detections in real time with Google TI and pushes prioritized exposure data directly into SecOps playbooks and cases, enabling SOC teams to investigate and respond to cloud‑native risks without switching between tools.
    • “The integration builds on Google’s AI Threat Defense, launched in May, and other automation capabilities that combine Gemini with Wiz’s scanning, simulation, and remediation to counter AI-powered threats. It leverages the reasoning capabilities of its Gemini AI modeling platform and other frontier models alongside Wiz’s contextual risk prioritization capabilities. Google AI Threat Defense uses Gemini’s code remediation features and CodeMender, along with expertise from Mandiant.”
  • Cyberscoop notes,
    • “As AI-enabled hacking becomes a bigger threat for cybersecurity and national security, public attention has focused on mainly a few leading frontier AIcompanies developing more powerful large language models.
    • “These models, and the billions of dollars behind them matter, but they’re only part of a larger shift. Enterprises are now building their own technology platforms that take these general-purpose LLMs and turn them into bespoke cybersecurity tools.
    • “Industry professionals refer to these tools as a “harness.” They control the model’s behavior, limit its risks, and connect it to internal IT systems and networks so it can work reliably at scale.
    • “New research from Cato Networks shared exclusively with CyberScoop shows how much power can come from a harness. It paired OpenAI’s ChatGPT 5.5 and GPT 5.5-Cyber models with its own tool and tested the abilities of the agent to hack into a victim network with as little human direction as possible.” * * *
    • “Dan Rapp, chief AI and data officer at Proofpoint, said their harness, “Satori,” has become a critical tool for keeping their agentic AI on track while giving humans the ability to step in when things go awry.
    • “I think what you’re seeing in the foundation of frontier models is you have raw intelligence, raw reasoning power, but to get these systems to perform the way you want to, both context engineering – the content provided ensuring that its accurate and relevant – and the harness engineering are essential to actually get the systems to perform well,” Rapp told CyberScoop.”
  • Dark Reading explains how to “Manage Vendor Risk in a Few Practical Steps.”
    • “Risk tolerance, exposure visibility, board oversight — handling third-party risk is complicated but achievable with disciplined, precise governance.”
  • Tech Target highlights “Multifactor authentication: 5 examples and strategic use cases.”
    • “Before implementing MFA, conduct a careful study to determine which security factors offer the strongest protection. Passwords and PINs aren’t cutting it any longer.”
  • Here’s a link to Dark Reading’s CISO Corner.

Friday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, Rx coverage, Telehealth, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC

  • Politico reports,
    • “House GOP leaders released text Friday for a bill to fund the vast majority of the federal government from the start of the next fiscal year on Oct. 1 until after the midterm elections — bypassing the bipartisan appropriations process and daring Democrats to pick a shutdown fight months before voters head to the polls.
    • “Speaker Mike Johnson said Thursday he plans to put the legislation on the floor next week.
    • “The measure would fund the government through Dec. 4 and, as Republican leaders promised, would not include additional policy riders or unrelated provisions.”
  • Roll Call offers a wrap up of this week’s activities on Capitol Hill.
  • STAT News relates,
    • “Pretty much everyone who cares about public health agrees that it’s a good idea to help people quit smoking, the No. 1 cause of preventable death in the U.S. Doctors may soon get some extra encouragement to lend a hand, thanks to proposed changes in Medicare’s physician fee schedules.
    • “Physicians who offer counseling on quitting cigarettes or other tobacco products during visits with patients would get a 19% increase in reimbursement, according to a few paragraphs buried in the 1,592-page document released this week. The same adjustment would also apply to assessments of, and interventions for, alcohol and substance misuse during doctors’ visits.
    • “Given the evidence supported role these services play in preventing and managing chronic disease […] we believe that valuation should more accurately reflect the clinical intensity and work associated with these time-based services,” the proposal from the Centers for Medicare and Medicaid Services explains. Comments on the proposal are due Sept. 14. 
    • “The prioritization of cessation as a service is long overdue, and we’re very excited about it,” said Anne DiGiulio, the American Lung Association’s senior director of nationwide tobacco cessation and health policy.”
  • Health Day adds,
    • “For people assigned to smoking very low nicotine-content cigarettes (VLNCs), there is minimal evidence for compensation for reduced nicotine levels, according to a review published online July 15 in JAMA Network Open.
    • “Rachel L. Denlinger-Apte, Ph.D., M.P.H., from the Wake Forest University School of Medicine in Winston-Salem, North Carolina, and colleagues examined whether people who smoke may increase their smoking to compensate for the reduced nicotine levels when smoking VLNCs for prolonged periods. Data were obtained from 17 randomized controlled trials published between 2010 and 2024, representing 5,500 adolescents and adults who smoked cigarettes daily or nondaily. A subset of 2,454 participants from seven trials were included in the pooled meta-analysis.”
  • Food Dive relates,
    • “The FDA’s acting head of food on Tuesday [July 14] admitted crafting its highly anticipated definition of ultraprocessed foods is proving “quite challenging,” though he added it’s still a “priority” for the agency.
    • “Just because it’s a tough challenge, it doesn’t mean it’s something that we should shy away from,” Donald Prater, FDA’s acting deputy commissioner for food, said during a keynote at the IFT First conference in Chicago.
  • Genetic Engineering and Biotechnology News adds,
    • “Ketogenic diets, originally developed in the 1920s to treat epilepsy, have been adapted in the past few decades as a strategy to lose weight or increase lifespan. This type of diet (a high percentage of fat, low percentage of carbohydrates, and normal or reduced amounts of protein) forces the body to burn fatty acids for energy in place of carbohydrates such as glucose. Burning these lipids produces ketone bodies—primarily β-hydroxybutyrate (BHB) and acetoacetate—as byproducts of fatty acid metabolism. The impact of ketogenic diets on the gastrointestinal tract remains poorly understood.
    • “In recent years, scientists investigated whether this type of diet might affect the development of cancer. While some research has shown that the diet may protect against the development of colon cancer, a new study suggests that in the small intestine, a ketogenic diet may increase the risk of cancer—with a mechanism through fatty acid oxidation rather than ketone metabolism.”
    • “This work appears in Nature in the paper, “Ketogenic diet mediates intestinal tumorigenesis through lipids not ketones.”

From the Food and Drug Administration,

  • Fierce Pharma reports,
    • “With two approved medicines to treat primary immunoglobulin A nephropathy (IgAN) and a third therapy in phase 3 testing, Novartis is on its way to cornering the market for the indication.
    • “On Friday its first drug to hit the market for IgAN, Fabhalta, gained a full blessing from the FDA, with the U.S. regulator converting the drug’s accelerated approval into a traditional nod. Fabhalta is now endorsed to slow kidney function decline in adult IgAN patients who are at risk for disease progression. 
    • “The original, speedy IgAN approval for the first-in-class factor B complement inhibitor came two years ago to reduce proteinuria.”
  • Cardiovascular Business relates,
    • “The U.S. Food and Drug Administration (FDA) has shared updated recommendations about recalled thoracic stent grafts. Customers were previously told they could still use the devices as long as they were aware of the risk and knew how to respond if an issue occurred. Now, however, the FDA is emphasizing that these devices should be returned to the manufacturer and not be used to treat any other patients.”

From the judicial front,

  • Healthcare Dive reports,
    • “A federal judge has temporarily halted provisions of a rule from the Trump administration meant to reshape the Affordable Care Act exchanges days before they were scheduled to go into effect.
    • “On Thursday, a Maryland district court determined the coalition of cities and provider groups that filed a lawsuit challenging the rule would suffer “irreparable harm” from the policies, including the expansion of bare-bones catastrophic coverage and stricter verification of enrollees’ eligibility for subsidies.
    • “The stay is a victory for insurers, given it staves off further disruption to the already destabilized ACA marketplaces. However, the relief may be short-lived, as some of the policies codified in the GOP’s “Big Beautiful Bill” will be enacted in 2028.”

From the public health and medical / Rx research front,

  • The Centers for Medicare and Medicaid Services announced today,
    • “As of July 17, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity is very low in most areas of the country. Emergency department visits and hospitalizations for RSV are low but remain highest among infants and children younger than 4 years old.
    • “COVID-19 activity is very low and stable nationally but is beginning to show early signs of an increase, mainly in the South.
    • “Seasonal influenza activity is low.
    • “Parainfluenza (PIV), a respiratory virus that can cause illnesses such as croup, is elevated nationally. Rhinovirus/enterovirus (RV/EV) activity is elevated in some regions. Whooping cough (pertussis) continues to circulate at lower levels compared to post-pandemic peaks.”
  • The University of Minnesota’s CIDRAP reports,
    • “With 29 newly confirmed cases, the the US measles total is just 29 cases short of last year’s sobering total, the Centers for Disease Control and Prevention (CDC) said in an update today.
    • “The CDC announced 2,260 confirmed cases so far in 2026, all but 15 of them locally acquired. The total for all of last year was 2,289 infections, which was the most since 1991. The country could lose its measles elimination status this fall, which it gained in 2000.
    • Of the 2,260 cases for the year, 20% of infections are in children age 5 and under, and 70% involve kids and young adults to age 19. Six percent of patients have been hospitalized, compared with 10% in 2025. Among all measles patients, 93% are unvaccinated or have unknown vaccine status. 
    • “No measles deaths have been reported this year, compared with three in 2025.”
  • MedPage Today adds,
    • “Declining U.S. vaccination rates have led to a resurgence in large measles outbreaks.
    • “Two papers examining South Carolina and Utah’s outbreak showed that hypoxemia and pneumonia were the most common conditions leading to hospitalization for measles.
    • “In the South Carolina report, two of 13 hospitalized patients developed measles encephalitis, a life-threatening complication that can cause brain damage.”
  • The American Hospital Association points out,
    • “A Centers for Disease Control and Prevention report released July 16 found that wastewater surveillance failed to detect an internationally circulating measles genotype that accounted for about 5% to 10% of U.S. measles cases in 2025, highlighting potential challenges of using wastewater surveillance as a public health tool. The report said that of two unrelated measles cases reported to the Wisconsin Department of Health Services in February 2026, wastewater surveillance detected one case before the case was reported. The second, caused by the international B3 genotype, was undetected. Public health officials later released a modified laboratory procedure that improved the detection of the B3 genotype. The CDC said that wastewater testing should be standardized and revalidated against circulating viruses and supported by publicly available whole-genome sequencing data.”
  • The Washington Post reports,
    • “Taylor Farms announced Friday that it is “voluntarily removing all iceberg lettuce sourced from central Mexico from the U.S. market,” after federal investigators identified some of the lettuce it provided to Taco Bell restaurants as linked to one of the largest U.S. outbreaks of cyclosporiasis this summer. 
    • “The company said in a statement that it made the decision based on information provided by the Food and Drug Administration, whose investigators had traced the outbreak to “a specific independent farm” representing less than 1 percent of the U.S. iceberg lettuce supply. The company added that it would remove all iceberg lettuce from the region indefinitely “out of an abundance of caution.”
    • “The company said no other Taylor Fresh Foods products across the country are impacted. It said no Taylor Farms branded salad kits contain iceberg lettuce.” * * *
    • “Other companies have begun to respond to a parasite-borne illness that has sickened thousands, and the federal health investigation has widened beyond Taco Bell restaurants. Sysco, one of the world’s largest food suppliers, on Thursday voluntarily stopped distributing certain iceberg lettuce products from Mexico after the agency said it was tracing where the contaminated lettuce may have been distributed throughout the food supply.”
  • The Wall Street Journal explains “What to Know About the Cyclosporiasis Outbreak and How to Stay Safe”
    • “More than 30 states have reported cases of the illness. Taco Bell’s lettuce is linked to cases in at least five states.” * * *
    • “Norovirus is a highly contagious virus that can cause vomiting and diarrhea, but it typically comes on within 12 to 48 hours of exposure and lasts one to three days. 
    • “Cyclospora, on the other hand, can cause weeks of relapsing diarrhea where someone gets sick, feels better, and then gets sick again, said Caitlin Rivers, director of the Center for Outbreak Response Innovation and an associate professor at the Johns Hopkins Bloomberg School of Public Health. “It lasts much longer than a stomach bug where you’re sick for a day and you bounce back.” 
    • “Another big difference: Many foodborne illnesses, like norovirus, are highly infectious and spread between humans through something as simple as touching a doorknob. 
    • “One piece of good news: Cyclosporiasis is rarely contagious between people.” 
  • The Washington Post tells us,
    • “Plumes of thick, toxic wildfire smoke from fires burning in Canada are billowing into the United States. The phenomenon, where smoke blots out the blue sky overhead, making the air appear milky-white or even orange, has become a relatively regular fixture of summers where out-of-control wildfires in the West bring noxious smoke downwind.” * * *
    • “There’s essentially a west-to-east conveyor belt that’s pumping high-altitude smoke eastward. That’s because the smoke is surfing the jet stream, a river of swiftly moving winds in the upper atmosphere. The jet stream is cresting around a ridge of high pressure parked over the central states.
    • “The smoke is also being steered by persistent troughing, or areas of low pressure, east of the Hudson Bay in northern Quebec. That counterclockwise-spinning low induces northwesterly winds, which are winds that blow from the northwest and pump the smoke in a southeast direction.
    • “That brings surface-level smoke into the Lower 48 in copious quantities. Medium-range weather models suggest a similar pattern continues into late July, meaning smoke will continue taking this trajectory.” * * *
    • “As of early Friday morning, Chicago, Detroit, D.C. and New York City were the most polluted major cities in the world — exceeding Delhi and Kolkata, India; Jakarta, Indonesia; and most major cities in China.”
  • Kaufmann Hall notes,
    • “Less than half of adults in rural communities have had a routine medical visit or cancer screening in the past year, according to a recent survey by the Prevent Cancer Foundation. The broader survey of U.S. adults found that half of all respondents expressed concerns and confusion about the cost of medical screenings. Nearly 15% of respondents also expressed concerns about the costs of follow-up appointments and lost wages. The news comes as the American Association for Cancer Research’s latestprogress report finds that declines in cancer death rates have been slower among rural residents than those living in urban areas.”
  • The Wall Street Journal journalist lets us know “I Tested My Blood for Microplastics. I Got a Number, but Few Answers.
    • “Plastics are accumulating in our bodies, but scientists aren’t sure how bad that is for our health.”
    • “Microplastics are ubiquitous. Bottled water and processed food are big culprits. So is clothing, furniture and just about everything else.
    • “It’s hard to find things that are not made of plastic,” says Phoebe Stapleton, an associate professor in the department of pharmacology and toxicology at the Ernest Mario School of Pharmacy at Rutgers University. 
    • “And they get into our bodies through both ingestion and inhalation. There hasn’t been a tissue or organ in the body where microplastics haven’t been found. Lungs, heart, kidneys, liver, brain, testicles, the fluid in our eyes, and ovaries—all have microplastics, says Stapleton.
    • “No wonder there’s more interest in testing. The blood test has been commercially available since 2023. I purchased it for $135 through Bryan Johnson’s longevity health site, Blueprint.” 
  • STAT News informs us,
    • “For the last year, a small California startup has been making extraordinary claims about the ability of its technology to potentially treat Duchenne muscular dystrophy — and maybe a slew of other genetic diseases, too.
    • “The company, Sonothera, does not yet have clinical data. But it’s presented data in animals so stunning that other experts can’t quite wrap their minds around it.” * * *
    • “The technology in question is ultrasound — yes, the same technology used for imaging pregnancies. Sonothera is using it to deliver replacement genes into the muscles of mice and monkeys.
    • “The approach marks a radical departure in the gene-therapy field, which has long relied on viruses to ferry genes into cells. Those viruses, while occasionally powerful, have severe drawbacks. They can only deliver genes of a certain size and can only be administered once, after which patients develop immunity. If the first treatment didn’t get enough of the gene to enough cells — well, you’d better have some other fix.” * * *
    • “Answers may come soon in clinical trials. Sonothera’s backers point to multiple pieces of supporting evidence, including improved muscle function in mice. And the company is still optimizing its therapy. 
    • “For humans, Sonothera’s goals are far more modest than what was achieved in some of its studies: a 15% increase in dystrophin, while creating protein in at least 20% of a patient’s muscle fibers.”
  • Per BioPharma Dive,
    • “GSK is discontinuing trials of an experimental chronic cough medicine it bought in a $2 billion deal three years ago, announcing Friday that camlipixant had failed to meet nearly all of the goals in two Phase 3 trials. The British pharmaceutical giant said the “limited efficacy demonstrated is unlikely to transform patient care.”
    • “The termination closes a blockbuster opportunity for GSK, which hoped to add camlipixant to a portfolio of respiratory drugs that includes asthma and COPD treatments like Trelegy and Anoro. The company said it is continuing Phase 2 trials in people with irritable bowel syndrome.
    • “Camlipixant’s failure follows that of two others in the “P2X3 antagonist” class that were developed by Bayer and Merck & Co, the latter of which spent more than $500 million to gain control of its drug. The setback also clears away a threat to Trevi Therapeutics, which is advancing a different type of treatment in chronic cough.”
  • and
    • “Merck & Co.’s partner Kelun-Biotech said its experimental medicine sac-TMT helped patients with a form of lung cancer stave off disease progression better than a standard regimen including chemotherapy in a new Phase 3 study.
    • “The trial, conducted in China, included patients with locally advanced or metastastic non-squamous non-small cell lung cancer whose tumor cells don’t have enough of a protein called PD-L1. When working properly, PD-L1 helps the immune system focus on killing diseased cells instead of healthy ones. But too much or too little of this protein can throw the system off kilter.
    • “Kelun previously saw success with sac-TMT in PD-L1-positive patients and is now tackling the “negative” patients who represent what it calls a “therapeutic bottleneck.” Sac-TMT is the first so-called antibody drug conjugate to succeed in a Phase 3 study of this patient population in combination with an immunotherapy like Keytruda, Kelun said Tuesday [July 14].”

From the U.S. healthcare and artificial intelligence front,

  • Beckers Hospital Review reports,
    • “Vascular surgery is projected to have the highest shortages of physicians, the Health Resources and Services Administration’s National Center for Health Workforce Analysis found.
    • “The HRSA workforce simulation model assesses the adequacy of the nation’s projected workforce supply for 35 physician specialties from 2023 through 2038.
    • “Across all specialties, there is a projected shortage of 141,160 full-time equivalent physicians by 2038. Only five of the 35 physician specialties are expected to see a surplus of workers. The shortages in some specialties can be mitigated by increasing the use of nurse practitioners and physician assistants, according to the center.”
  • and 
    • “Novant Health is the latest health system to launch round-the-clock virtual primary care that uses AI to assess patients before connecting them with a clinician, joining at least seven other systems offering similar 24/7 care models.”
    • The article lists seven other health systems using this model.
  • and
    • The pandemic revealed a demand for telehealth, forcing the healthcare industry to rethink how and where care could be delivered. 
    • Patients and providers alike discovered that high-quality care doesn’t have to mean an in-person visit. Hospitals, health systems and healthcare companies rapidly expanded their telehealth offerings accordingly.
    • The momentum hasn’t slowed, and today’s telehealth landscape is defined by smarter platforms, broader access and solutions designed to bring expert care directly to patients regardless of geography, mobility, or circumstance. 
    • [The article lists] 272 telehealth companies to know. 
  • STAT News relates,
    • “Every day, doctors turn to specialized calculators to make decisions about their patients’ care. Kidney performance? There’s a calculator for that. Chance of a successful vaginal birth after a previous C-section? There’s a calculator for that. 
    • “Medicine has accumulated hundreds of these clinical scores and decision-making tools, and their numbers continue to grow along with the scale of clinical data. But just because a calculator exists doesn’t mean doctors should always trust its output. 
    • “In clinical practice, a lot of the tools that we use, we genuinely have no idea how limited it is in its validation,” said health systems researcher and gastroenterologist Shazia Siddique. That is why MDCalc, the company Siddique joined last year, is launching a quality-rating system to apply to the more than 800 clinical tools and calculators that doctors use through its site.”
  • Per Fierce Pharma,
    • “Following the Independence Day holiday, the overall GLP-1 market was down 5.1% week over week as measured by total prescriptions across obesity and diabetes uses, according to IQVIA data cited by Citi.
    • “In the obesity field specifically, total scripts for Eli Lilly’s Zepbound shrank by 3.1% sequentially to a little below 660K, while Novo Nordisk’s Wegovy dipped 4.4% to about 448.5K.
    • “Against this backdrop, Lilly’s oral Foundayo seemed to enjoy a small inflection point, with a total 24,303 scripts notably breaking away from its roughly 20K level in the prior five weeks.  
    • “Meanwhile, joining the bigger trend, Wegovy pill scripts dropped to 147.5K during the week, versus about 153K the prior week or 161.5K at its peak. But the contribution of the oral version to the overall Wegovy scripts remained stable at around a third, per Citi’s note.” 
  • Per BioPharma Dive,
    • “Cash-strapped biotechnology company Jasper Therapeutics has gained a financial lifeline through a merger with a privately held immune drug developer.
    • “Jasper said Thursday it has completed an all-stock acquisition of Kira Pharmaceuticals and, alongside that deal, raised $132 million in a private stock offering. The new funding will enable Jasper, which had just $14 million in cash at the end of March, to operate through the second half of 2028. The combined company will retain the Jasper stock ticker, but have a bigger pipeline that now includes two immune disease drugs Kira has been developing.” 

Friday report

David Ermer–Uncategorized–

Simplicity is a virtue.

  • OPM Director Scott Kupor added a second Secrets of OPM blog post about the FEHB and PSHB programs today.
    • “One of OPM’s cultural values is to “ask why.” Why do we do things the way we do them? Why does a process exist? Why do we collect one piece of data and not another? Why are we still relying on a framework developed for a bygone era?
    • “Today, we are asking “why” in the context of one of our most important responsibilities: helping ensure that federal employees, retirees, postal workers, and their families have access to high-quality, affordable health benefits. To that end, we have updated our Guiding Principles for Federal Employees Health Benefits and Postal Service Health Benefits carriers.”
      • In the FEHBlog’s opinion, what’s missing from the guiding principles is any mention of deregulating the FEHB and PSHB programs. Deregulation would be the straightest path to restoring competition and thereby lowering premiums. See motto above.
  • OPM also proposed a new workforce rule today which will appear in Monday’s Federal Register.
    • “The Office of Personnel Management (OPM) proposes to amend its regulations to more fully address the appropriate uses of administrative leave, including use in connection with deferred resignation programs and other workforce realignment initiatives, and for other purposes. OPM is also proposing to amend its regulation on resignations to clarify when an agency may accept or deny an employee’s request to withdraw a resignation in the context of a deferred resignation program.”
    • The public comment deadline should be July 29, 2026.
  • Modern Healthcare reports,
    • “President Donald Trump intends to nominate Medicare Director Chris Klomp to be deputy secretary of the Health and Human Services Department.
    • “The pending nomination, which Trump announced on his Truth Social platform Thursday, would further elevate the former healthcare and investment executive within the Trump administration.
    • “Klomp has been director of the Center for Medicare and deputy administrator of the Centers for Medicare and Medicaid Services since April 2025 and senior adviser to HHS Secretary Robert F. Kennedy Jr. since February.
    • “Prior to his government service, Klomp was CEO and chair of the health information technology company Collective Medical from 2014 to 2020, when it was acquired by PointClickCare. He previously held numerous positions at the consulting and investment firm Bain & Co.”
  • The American Hospital Association News tells us,
    • “The Department of Health and Human Services June 26 announced new efforts to improve the Trusted Exchange Framework and Common Agreement. TEFCA is a common set of rules required by the 21st Century Cures Act of 2016 that securely and more easily exchanges healthcare information between networks and providers. HHS said the Office of the National Coordinator for Health Information Technology awarded a new contract to improve oversight of the network and verify that participating organizations are following TEFCA requirements. ONC is also conducting additional reviews of Qualified Health Information Networks and their participants to help ensure compliance. HHS said that the number of health records exchanged through TEFCA has grown from 10 million to more than 1 billion in less than one year.”
  • STAT News adds,
    • “A new charter for the panel that advises the Centers for Disease Control and Prevention on vaccine use substantially refocuses the responsibilities of the committee, downplaying its role in recommending the use of new vaccines and giving it responsibility to assess alternatives for disease prevention.
    • “Whereas previous iterations of the committee’s charter stressed the importance of vaccine research-relevant experience in the selection of its members, the new version, posted to the CDC’s website on Thursday, merely stipulates that the panel as a whole should “represent a balanced range of scientific, clinical, and public health expertise relevant to the Committee’s mission” — a broad umbrella under which people with little experience in vaccines or vaccination policy might conceivably fit.” * * *
    • “The new charter is dated May 14. Several news outlets have reported having seen copies of it in the weeks since. But it’s not clear why it has only been posted now, and the Department of Health and Human Services, which oversees the CDC, has not answered previous questions about why it had not been posted.”
  • Healthcare Dive relates,
    • “The HHS provided an update Thursday on its plans to help speed the adoption of artificial intelligence in clinical care, part of a bid to improve Americans’ health and bring down healthcare costs.
    • “During a webinar, department leaders laid out takeaways from a request for information released late last year asking the sector how the HHS could use its regulatory, research and reimbursement powers to accelerate the use of AI in healthcare. 
    • “The industry wants coordination across HHS agencies, support in AI implementation and governance, and assistance in determining what makes a good AI tool, Arman Sharma, the HHS’ deputy chief AI officer, said. “We believe that starting with these three things and acting on constant engagement from this community is what’s needed to establish trust,” he said. “And trust in this technology is the only thing that will lead to responsible, but also effective, adoption.”
  • The U.S. Census Bureau notes,
    • “The nation’s fertility rate has dropped nearly every year since 2007, but this national decline masks substantial geographic variation.
    • “Fertility rates differ widely across U.S. counties, and even within individual states there are often both high and low fertility counties.
    • “By combining population estimates data released today on the age characteristics of U.S. counties with birth data released in March, we calculated the general fertility rate (GFR) for every county in the nation.” * * *
    • “There are clusters of high GFR counties in many, but not all, states.
    • “For example, there are high GFR counties in southeastern North Carolina that extend into South Carolina, and in southern Georgia that extend into northern Florida.
    • “Moving westward, many states have at least one cluster of counties with high GFRs.
    • “Notably, there are only a few states that do not have any counties with a GFR above 60, including the entirety of New England: Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont.”

From the Food and Drug Administration front,

  • Genetic Engineering and BioTechnology News reports,
    • “The U.S. Food and Drug Administration (FDA) is in the middle of a cultural and operational shift that goes beyond leadership changes. U.S.–China biotechnology competition is driving discussions around regulatory reform in the U.S. where traditional paradigms are being reviewed and reconsidered, particularly for rare diseases. And patient perspectives need to be a more integral part of the drug development continuum.  
    • “Those were some of the major themes that emerged from a town hall that took place at this year’s Biotechnology Innovation Organization (BIO) meeting in San Diego, which featured members of the current FDA leadership team. 
    • “John Crowley, BIO president and CEO, moderated the discussion with the acting directors of Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) and the acting chief of staff at the FDA. During the hour-long conversation in a room packed to the hilt with BIO attendees, they spoke about the agency’s current priorities and its plans to increase its headcount, among other initiatives. 
    • “Much of the discussion centered on ongoing plans to stabilize the agency’s workforce following the massive reduction in staffing implemented by the Department of Government Efficiency (DOGE) as well as departures of several leaders in rapid succession. The panelists acknowledged the disruptions to operations, the loss of institutional knowledge, and the past unpredictability at the agency, but did not dwell on it.  
    • “The consensus seems to be that stabilizing the agency’s workforce is an important prerequisite for successfully launching several planned initiatives. In fact, Michael Davis, MD, PhD, acting director of CDER, noted that this has been one of his top priorities. His initial efforts were aimed at “fortifying the center and specifically the workforce” as well as finding ways to retain staff retention and boost recruitment.”  
  • MedTech Dive relates
    • “Aidoc has received the Food and Drug Administration’s breakthrough device designation for an artificial intelligence feature designed to read chest X-rays and generate draft report text, the company said Thursday.
    • “The system, called First Read, is expected to generate preliminary reports on more than 100 pre-specified findings, a spokesperson for Aidoc wrote in an email. A radiologist still must sign every report made by First Read. Aidoc declined to provide the full list of findings as the product is not yet on the market. 
    • “Aidoc CEO Elad Walach said in a statement the feature is intended to help reduce the time radiologists spend on reporting and interpretation.”
  • Radiology Business adds,
    • “The U.S. Food and Drug Administration has cleared a new artificial intelligence-enabled tool designed to assist with the segmentation of brain tumors. 
    • “Denmark-based Cercare Medical has received 510(k) clearance for its Oncology Virtual Expert, an AI-powered brain tumor segmentation tool that can streamline and standardize neuro-oncology imaging workflows. It enables fast, consistent and semi-automated tumor delineation directly from routine MRI studies. The clearance marks a key milestone in the company’s expansion into the North American market. 
    • “The module generates automated tumor segmentation maps from standard MRI data. This reduces reliance on manual contouring, which can be a cumbersome and time-intensive process that is vulnerable to inter-reader variability. The on-premise system can be integrated directly into existing PACS and workflows. It was designed this way so that it can operate within hospital IT constraints, such as strict HIPAA and data governance requirements that can inhibit cloud-based AI adoption in some networks.” 
  • and
    • “The U.S. Food and Drug Administration (FDA) updated its list of cleared artificial intelligence (AI) algorithms, and radiology still maintains its vast lead over the rest of medicine.
    • “The agency’s June 16 update showed 68 new radiology algorithms were cleared just in the first three months of 2026. There are now a total of 1,524 FDA-cleared AI algorithms as of March 30, 2026, and 1,163 of them are for radiology, which now accounts for 76.31% of all FDA-cleared AI. The actual total for medical imaging AI listed under other specialties like orthopedics, cardiology and neurology brings the total closer to 80%.
    • “The FDA has seen an increasing number of AI approvals for the past several years, now clearing about 30 a month. In 2024, the  FDA was clearing an average of 21 per month.”
  • Cardiology Business informs us,
    • “Medline, the Illinois-based medical supplier, is recalling thousands of procedure kits used by cardiac surgeons due to quality issues identified during a U.S. Food and Drug Administration (FDA) inspection. The recall includes more than 6,500 cardiovascular procedure kits primarily used during open-heart surgeries, and more than 500 general surgery trays.
    • “All convenience kits contain Lidocaine Hydrochloride Injection, USP and/or Bupivacaine Hydrochloride in Dextrose Injection, USP. Quality issues with these anesthetics are what prompted the recall.” * * *
    • “Click here for more information from the FDA.” 

From the judicial front,

  • KFF reports,
    • “A major Medicare Advantage company has paid the government more than $342 million to help settle allegations that it overcharged the federal healthcare program for years.
    • “Elevance Health, which covers about 2 million people on Medicare, sent the money to the Centers for Medicare & Medicaid Services via wire transfer on May 27, court records show. Government lawyers disclosed the payment in a June 22 court filing.
    • “In an email to CMS staff, Elevance described the money as a “remittance of the total overpayment amount” estimated by government audits, court records show. Company spokesperson Leslie Porras told KFF Health News in a statement that Elevance Health “continues to engage in constructive dialogue” with CMS. “We remain optimistic that a resolution can be reached and value our longstanding relationship with CMS,” she said.
    • “The payment was made in response to a CMS enforcement action in February, in which the agency threatened to halt enrollments in Elevance Medicare Advantage plans unless the company corrected what CMS called “substantial and persistent noncompliance” with federal regulations that require health plans to submit accurate billing data and return any overpayments when they are discovered.”
  • HR Dive relates,
    • “The U.S. Equal Employment Opportunity Commission sued automotive manufacturer Dana Sealing Manufacturing, alleging the company illegally acquired genetic information from its employees, and issued a warning to other employers as well.
    • “Between 2022 and 2024, the Kentucky-based employer allegedly required applicants to state whether their parents, grandparents or siblings ever had certain listed medical conditions, in violation of Title II of the Genetic Information Nondiscrimination Act of 2008, the complaint claimed.
    • “The Genetic Information Nondiscrimination Act prevents employers from requesting family medical history information from employees and applicants, except in narrow circumstances, none of which applied here,” Kenneth Bird, regional attorney for the EEOC’s Indianapolis District, said in a statement Wednesday. “The EEOC will continue to enforce GINA and other federal anti-discrimination laws.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of June 26, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity is low in most areas of the country. Emergency department visits and hospitalizations for RSV are low but remain highest among infants and children younger than 4 years old.
    • “COVID-19 activity is low in most areas of the country.
    • “Seasonal influenza activity is low.
    • “Parainfluenza (PIV), a respiratory virus that can cause illnesses such as croup, is elevated nationally. Human metapneumovirus (HMPV) and rhinovirus/enterovirus (RV/EV), which often cause cold-like respiratory illness, are also elevated nationally but declining. Whooping cough is still circulating.”
  • The University of Minnesota’s CIDRAP reports,
    • “After confirming 31 new measles cases last week, the Centers for Disease Control and Prevention (CDC) today added 30 new infections to the US total, which has now climbed to 2,134 confirmed cases. The numbers move the needle closer to the 2025 total of 2,288 cases.
    • “All but 12 of this year’s cases were locally acquired, with the rest related to travel outside the country. Of the total, 21% of infections are in children age 5 and under, and 72% involve kids and young adults to age 19. Six percent of patients have been hospitalized, compared with 11% in 2025. Among all measles patients, 93% are unvaccinated or have unknown vaccine status. 
    • “No measles deaths have been reported this year, compared with three in 2025.”
  • and
    • “In January 2026, the Health Resources and Services Administration announced that women could choose self-testing for the human papillomavirus (HPV) instead of having a doctor conduct a Pap or cervical cancer test. Experts hoped that this would increase screening for the virus, which is responsible for 90% of cervical cancer. 
    • “A study published today in JAMA Network Open looked at which patients follow through with home testing. While some participated, more outreach needs to be done to include diverse communities, say the authors, from The Permanente Medical Group and Kaiser Permanente Northern California.   
    • “The findings suggest that a substantial proportion of eligible patients will elect home-based screening, but efforts are needed to support participation across demographic groups,” the authors wrote.” * * *
    • “While one in five people asked for a self-test, only one in 10 people returned it. The researchers suspect patients’ history influences their willingness to use a home test. 
    • “Higher uptake observed among older patients may reflect experience with cancer screenings, concern regarding cancer, or discomfort with pelvic examinations,” the authors wrote.” 
  • Beckers Clinical Leadership tells us,
    • “The Trump administration is asking Congress for $1.4 billion to respond to the Ebola outbreak in the Democratic Republic of Congo, Politico reported June 25.”
  • The American Hospital Association News relates.
    • “Emergency department visits for suspected suicide attempts from 2021-2025 were highest among adolescents age 12-17 at 24.8%, according to a report released June 25 by the Centers for Disease Control and Prevention. That age group also had the highest proportion of ED visits for suspected suicide attempts at 82.2 per 10,000 visits. Overall, 60.3% of ED visits for suspected suicide attempts were by women, while men consisted of 39.5% of such visits. The proportion of total ED visits decreased from 2021-2025, with adolescents age 12-17 and adolescent females having the largest decreases. Visit proportions increased among adults older than 26.”
  • Health Day adds,
    • “Poison control calls linked to GLP-1 drugs have risen sharply.
    • “Semaglutide is named in most reported cases.
    • “Most incidents are due to accidental dosing errors.”
  • and
    • “Women on the pill appear to have healthier brains as they grow older, a new study says.
    • “Taking hormone-based birth control as a younger woman appears to protect the brain, maintaining the size of regions vital to memory, cognition and information, researchers report in the July 1 issue of the journal NeuroImage.
    • “Women’s brains also benefited if they took birth control pills during their reproductive years, and then hormone therapy when they entered menopause, results show.
    • “It’s showing a protective effect — using estrogen-based hormone therapies was beneficial for the brain in older women,” co-lead author Amber Watts, a professor of psychology at the University of Kansas, said in a news release.”
  • NBC News lets us know,
    • “People are more worried about severe muscular problems when taking statins than they should be: Such side effects are exceedingly rare, research published Thursday in the journal The Lancet Digital Health reaffirms.” * * *
    • “The new study, which used medical record data from nearly 6 million adults in the United Kingdom, found that only about 0.04% of people had a 10-year risk of statin-related serious muscle disorders above 10%.
    • “That’s even lower than previous figures, including from an American Heart Association report, which put the rate of myopathy at less than 1% and the rate of rhabdomyolysis at less than 0.1%.
    • “Even if you increase that tenfold, that is still a very tiny risk,” said Dr. Bart Duell, a professor of medicine at Oregon Health and Science University in Portland, who co-authored the AHA report but was not involved in the new research. The risk of muscular side effects “really isn’t a reason to not use statins,” he added.”
  • The Wall Street Journal reports,
    • “Decades of information-based efforts have failed to improve eating habits, requiring bolder action on several fronts.
    • “A new category of “health-span professionals” with graduate degrees would focus on nutrition and healthy longevity.
    • “Time-restricted eating and fasting-mimicking diets are proposed, alongside treating food as medicine via government and insurer support.”
  • MedPage Today adds,
    • “Lower-inflammatory dietary patterns were tied to reduced dementia risk among biomarker-positive older adults.
    • “Benefits appeared strongest for participants with elevated p-tau217, NfL, or GFAP levels.
    • “Findings suggest diet quality may still matter after early Alzheimer’s-related biological changes emerge.”

From the U.S. healthcare business and artificial intelligence front,

  • The Wall Street Journal reports
    • “Germany’s Merck MRK KGaA said it struck a deal to buy U.S. life-sciences tools supplier Bio-Techne TECH 0.38%increase; up pointing triangle for $11.3 billion, in an early move under its new chief executive to bulk up its lab-tools business.
    • “The proposed acquisition represents Merck’s biggest deal since its $17 billion buyout of Sigma-Aldrich more than a decade ago and comes weeks after the appointment of Kai Beckmann as CEO.”
  • Health Exec relates,
    • “Irish-American medical device manufacturer Medtronic announced today that it is making a major purchase that will expand its offerings for the treatment of nerve-based chronic pain.
    • “In an announcement, the company confirmed its “intent to acquire” SPR Therapeutics, an Ohio-based developer of non-opioid, non-surgical pain management treatments. The deal—valued at $650 million—would give Medtronic full control of SPR’s offerings, including its core “percutaneous peripheral nerve stimulation” devices, which manage pain unrelated to an acute injury.
    • “Medtronic already has a neuromodulation business, meaning the acquisition will add new options to its portfolio. The group boasted that it has been a leader in neuromodulation—which is most simply defined as the use of nerve stimulation to relieve pain—with the division dating back 50 years.
    • “It said the purchase of SPR will allow it to “reach and support more people” who would benefit from non-pharmaceutical pain relief offerings.”
  • MedTech Dive tells us,
    • “Labcorp has made the colorectal cancer screening test ColoSense available nationwide, boosting access to a challenger to Exact Sciences’ Cologuard.
    • “The nationwide rollout, which Labcorp disclosed Monday, comes weeks after the Centers for Medicare and Medicaid Services approved coverage for ColoSense, and the American Cancer Society named the test as a preferred option in its colorectal cancer screening guidelines.
    • “Labcorp secured the right to distribute the test from Geneoscopy in 2023. The Food and Drug Administration approved the test in 2024 and authorized a collection kit in 2025.”
  • Beckers Health IT informs us,
    • “Oakland, Calif.-based Kaiser Permanente has reduced MRI patient wait times by more than 60% using an FDA-cleared AI tool that shortens scan duration without degrading image quality.
    • “The AI solution reduces image noise during MRI scans, trimming average scan time from roughly 45 minutes to about 30, according to a June 24 news release. The shorter sessions allowed Kaiser Permanente to schedule more scans on existing equipment — eliminating the need for costly new machines to meet rising demand.
    • “Daniel Yang, MD, the health system’s vice president of AI and emerging technologies, credited governance as being equally important as the technology itself. Kaiser Permanente’s AI councils review proposed deployments before launch, then continue monitoring performance metrics such as scan time, image quality, appointment availability and repeat scan requests.”