Blog | 12/12/2025

Sharp Strategy Spotlight: December 12, 2025

Strategic perspectives on the trends, policies, and ideas shaping healthcare.

NOTE: All words/analysis are those from the source noted, opinions are those of the original authors and not reflective of Health Advances in general nor any individual. All sources are non-confidential and in the public domain (but some may be behind paywalls).

This issue reflects news as of 11 AM on December 11, 2025. The details and broad themes may have changed.

KEY HEALTH NEWS (Global)

US and Kenya sign first of what are expected to be dozens of ‘America First’ global health deals

  • The Trump administration has signed the first in what are expected to be dozens of “America First” global health funding agreements that will prioritize combating infectious diseases in countries deemed to be aligned with the president’s broader foreign policy goals and positions.
  • The five-year, $2.5 billion agreement with Kenya was signed Thursday by Kenyan President William Ruto and Secretary of State Marco Rubio to replace a patchwork of previous health agreements that had traditionally been run by the U.S. Agency for International Development for decades until the Trump administration dismantled it earlier this year.
  • Rubio said the agreement with Kenya “aims to strengthen U.S. leadership and excellence in global health while eliminating dependency, ideology, inefficiency, and waste from our foreign assistance architecture.”
  • Under the health deal with Kenya, the U.S. will contribute $1.7 billion of the total amount, with the Kenyan government covering the remaining $850 million. The agreement focuses on preventing and treating diseases such as HIV/AIDS, malaria and tuberculosis with an emphasis on faith-based medical providers, although all clinics and hospitals enrolled in Kenya’s health insurance system will be eligible to receive funding, according to U.S. officials.
  • Family planning programs that comply with U.S. restrictions on the provision of abortion services will also be eligible, according to Jeremy Lewin and Brad Smith, two State Department officials involved in the negotiations. They said the agreement would not discriminate against gay and transgender people or sex workers.
  • A number of other African countries are expected to sign similar agreements with the U.S. by the end of the year, according to the officials, although two of the continent’s most populous nations — Nigeria and South Africa — are not expected to be among that group due to political differences with Trump, according to Lewin and Smith.
  • Press: https://apnews.com/article/kenya-health-agreements-rubio-trump-usaid-cb80e0dafa3f458cf9e7416481f67edf
  • Department of State: https://www.state.gov/releases/office-of-the-spokesperson/2025/12/secretary-of-state-marco-rubio-with-kenyan-president-william-ruto-at-the-signing-of-a-health-framework-of-cooperation

Biosecure Act slips into key US defense bill, teeing up potential China biopharma constraints in '26

  • While the China-targeting Biosecure Act failed to pass muster in a key defense spending bill last year, a retooled version of the legislation looks increasingly poised to become law, albeit with a few adjustments.
  • Over the weekend, the Senate and House released the final text of the National Defense Authorization Act for the 2026 fiscal year, tucking in language that would significantly stymie the ability of certain Chinese life sciences companies and businesses that work with them from securing federal contracts with the U.S.
  • According to the bill’s text, executive agencies would be prohibited from procuring biotechnology equipment or services from so-called companies “of concern”—which the legislation defines as those with ties to the Chinese military. Moreover, executive agencies would be barred from entering or renewing contracts with drugmakers and other life sciences outfits that leverage those blacklisted companies’ services, effectively icing certain Chinese service providers out of the U.S. market.
  • The legislation repackages and tweaks certain terms included in the Biosecure Act, which failed to make the cut last year when it was omitted from the National Defense Authorization Act vote for 2025. The previous version of Biosecure sparked controversy by explicitly naming five Chinese companies of concern: WuXi AppTec, WuXi Biologics, BGI Group, MGI and Complete Genomics.
  • The legislation now relies on a preexisting Defense Department list of companies that calls out genetic testing outfit BGI Group and its spinoff MGI Tech, but notably omits the WuXi companies, which are prominent forces for contract manufacturing and research in the biopharma industry.
  • Original Press: https://www.fiercepharma.com/pharma/biosecure-legislation-makes-way-key-us-defense-bill-teeing-potential-china-biopharma
  • Updated Press (House passed tine bill): https://endpoints.news/house-backs-biosecure-act-aimed-at-chinese-companies/  (subscription required for full text)
  • Text of the NDAA: https://www.congress.gov/bill/119th-congress/senate-bill/2296/text

KEY FEDERAL GOVERNMENT NEWS

Republicans block bill to extend expiring health insurance subsidies 

  • Senate Republicans on Thursday blocked a motion to advance a Democrat-drafted bill to extend enhanced health insurance premium subsidies that are due to expire at the end of 2025, tax credits that Democrats say are needed to keep premiums from rising by double digits next year.
  • The legislation, which needed 60 votes to advance, failed by a vote of 51 to 48.
  • The proposal, unveiled by Senate Democratic Leader Chuck Schumer (N.Y.), would have extended the enhanced subsidies, which were first enacted during the COVID-19 pandemic, another three years.
  • Earlier in the day, they voted on a Republican plan to convert funding for enhanced insurance premium subsidies into contributions to health savings accounts to pay for out-of-pocket costs. That proposal failed to advance on a mostly party-line vote.
  • The cost of health plans on the Affordable Care Act (ACA) are projected to increase by 26 percent on average in 2026, according to an analysis by KFF, a health policy research group.
  • Enrollees on the ACA’s marketplace who receive enhanced premium subsidies are expected to see their monthly premium payments more than double if those tax credits expire in January.
  • https://thehill.com/homenews/senate/5644455-democratic-bill-health-insurance-subsidies/

Trump orders overhaul of U.S. vaccine schedules

  • President Trump ordered his top health officials Friday night to review all U.S. childhood vaccination recommendations and align them with the "best practices" from other developed countries.
  • Why it matters: It's a vote of confidence in Health Secretary Robert F. Kennedy Jr.'s handpicked advisory panel on vaccines, which voted earlier Friday to to drop the decades-old federal recommendation that all infants receive the hepatitis B vaccine at birth.
    • The Centers for Disease Control panel "made a very good decision to END their Hepatitis B Vaccine Recommendation for babies, the vast majority of whom are at NO RISK of Hepatitis B," Trump wrote in a Truth Social post.
  • The big picture: Kennedy and his allies have gained the power to pursue sweeping changes in U.S. vaccine policies, driven by their embrace of discredited theories about vaccines' link to autism and other diseases.
  • What's inside: Trump's memorandum orders Kennedy and the CDC director to "review best practices from peer, developed countries for core childhood vaccination recommendations — vaccines recommended for all children — and the scientific evidence that informs those best practices."
    • If they determine that other countries' practices are better, Trump ordered them to "update the United States core childhood vaccine schedule to align with such scientific evidence and best practices from peer, developed countries while preserving access to vaccines currently available to Americans."
  • Analysis: https://www.axios.com/2025/12/06/trump-overhaul-rfk-jr-vaccine-schedules  (subscription required for full text)

F.D.A. Expands Covid Vaccine Inquiry to Adult Deaths

  • The Food and Drug Administration has expanded its investigation of deaths possibly linked to the Covid vaccine to include adults as well as children, according to a Trump administration official.
  • The inquiry began in September, spurred by Health Secretary Robert F. Kennedy Jr.’s repeated claims that the coronavirus vaccine is dangerous and deadly despite the widespread scientific consensus that the shots are safe.
  • At the time, the agency said that it was looking into children’s deaths, in apparent response to the vocal concerns of vaccine skeptics who are allies and supporters of Mr. Kennedy.
  • “F.D.A. is doing a thorough investigation, across multiple age groups, of deaths potentially related to Covid vaccines,” Andrew Nixon, a spokesman for the Department of Health and Human Services, said on Tuesday.
  • The broader review follows a memo in late November by Dr. Vinay Prasad, the F.D.A.’s top vaccine regulator, who informed staff members that the agency had linked about 10 children’s deaths to the Covid shots. He highlighted the dangers of myocarditis, or inflammation of the heart muscle, which the agency has for years cautioned is a rare but worrying side effect, especially among teenage boys and young men.
  • https://www.nytimes.com/2025/12/09/health/fda-covid-vaccine-adult-death-claims.html  (subscription required for full text)

Panel Votes to End Hepatitis B Shot at Birth

  • Recent weeks have brought good news about vaccines, with studies indicating that flu vaccination reduces heart disease, shingles vaccines can prevent or slow dementia, and a single human papillomavirus shot protects a girl from cervical cancer for the rest of her life.
  • But in the upside-down world of Health and Human Services Secretary Robert F. Kennedy Jr., vaccines are on the ropes. A vaccine committee dominated by skeptics he chose for the panel voted 8-to-3 Friday to end a 34-year recommendation to inoculate newborns against hepatitis B, a practice that helped reduce childhood infections of the virus by 99%, from around 16,000 in 1991 to only seven in 2023.
  • Typically, slides and data for the panel’s meetings are posted on the CDC’s website several days beforehand. This time they weren’t posted at all.
  • The committee’s working group that studied hepatitis B vaccines did not include recognized hepatitis experts.
  • ACIP recommendations aren’t binding but have been used by health insurers in the past to establish coverage decisions.
  • Press: https://kffhealthnews.org/news/article/cdc-acip-hepatitis-b-birth-dose-reversal-recommendation-rfk/

States, medical societies reject CDC panel’s revised hepatitis B shot guidance

  • Multiple states and major medical societies say they will continue to universally recommend hepatitis B vaccination for newborns in a break with newly revised guidance from the CDC’s Advisory Committee on Immunization Practices.
  • The ACIP committee voted Dec. 5 to end a decades-old recommendation that all newborns receive their first dose of the hepatitis B vaccine at birth. Instead, the panel voted in favor of shared-decision making for mothers who test negative for the virus. For mothers who test negative and choose to vaccinate their baby, the committee recommends waiting until the child is at least 2 months old. Acting CDC Director Jim O’Neill has not officially signed off on the recommendations.
  • Major medical societies, including the American Academy of Pediatrics and the American Medical Association, have condemned the committee’s revised guidance and are calling on the CDC director to reject it, arguing the decision was not based on scientific evidence and creates confusion for parents.
  • Connecticut, New York, Maine and New Jersey are among states that will continue following the AAP’s recommendation that all newborns receive a dose within 24 hours of birth, according to reports from Bloomberg and CIDRAP News.
  • Major health insurance groups including the Blue Cross Blue Shield Association and AHIP have said they will continue to cover all vaccines recommended by ACIP, as of Jan. 1, 2025, including the hepatitis B birth dose.
  • https://www.beckershospitalreview.com/quality/public-health/states-medical-societies-reject-cdc-panels-revised-hepatitis-b-shot-guidance/

US FDA launches fresh safety scrutiny of approved RSV therapies for infants

  • U.S. health regulators informed senior executives at Merck, Sanofi and AstraZeneca last week that their approved protective RSV treatments for infants would face fresh safety scrutiny following concerns raised by vaccine skeptics, multiple sources familiar with the situation told Reuters.
  • The preventive therapies - Beyfortus from Sanofi and AstraZeneca, and Enflonsia from Merck - would be the latest called into question under U.S. Health Secretary Robert F. Kennedy Jr., a long-time promoter of anti-vaccine views who is presiding over a review of routine childhood immunizations.
  • FDA officials appointed under Kennedy began making inquiries into the respiratory syncytial virus therapies over the summer, according to sources and internal documents.
  • Senior FDA adviser Tracy Beth Hoeg initiated safety questions at the agency as early as June, Health and Human Services Department spokesman Andrew Nixon told Reuters.
  • Nixon did not say what prompted the RSV review.
  • It is unclear whether the FDA will take any actions to change the product label or restrict availability of the therapies.
  • https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-launches-fresh-safety-scrutiny-approved-rsv-therapies-infants-2025-12-09/

FDA official: CDER warning letters up 50% in FY 2025

  • The US Food and Drug Administration's (FDA) Jill Furman, director of the Center for Drug Evaluation and Research's (CDER) Office of Compliance (OC), reported that there has been a 50% increase in warning letters issued by CDER in FY 2025. She noted that a significant portion of this increase is due to letters sent to telehealth platforms that are making false claims about compounded drug products.
  • Furman offered her thoughts on recent enforcement efforts undertaken by the OC, as well as emerging trends at the Food and Drug Law Institute’s 2025 Enforcement, Litigation, and Compliance Conference. Her remarks addressed noncompliance issues in CDER’s domain, which includes manufacturing, unapproved drugs, compounding, and clinical trials oversight.
  • She called the 50% bump in warning letters a “very significant increase” and added that “this shows that our teams are continuing to do the critical work to protect the public.”
  • One of the factors contributing to the increase has been the uptick in warning letters to telehealth platforms that make false and misleading claims about compounded products. These letters accounted for 22% of the warning letters issued in FY 2025. This includes companies illegally marketing and advertising of glucagon-like peptide-1 (GLP) agonist drugs for diabetes and weight loss. “This was a significant effort we took in FY 2025,” Furman said.
  • The remaining warning letters issued in FY 2025 cited drug manufacturing facilities for good manufacturing practice (GMP) violations (35%), unapproved drug and misbranding violations (18%), or clinical research and Institutional Review Board (IRB) violations (5%).
  • https://www.raps.org/news-and-articles/news-articles/2025/12/fda-official-cder-warning-letters-up-50-in-fy-2025

DOJ Establishes Health & Safety Unit within the Criminal Division’s Fraud Section

  • The Department of Justice (“DOJ”) has published a website for a dedicated Health & Safety Unit (“HSU”) within the Criminal Division’s Fraud Section.
  • The HSU will investigate and prosecute criminal schemes that jeopardize health and safety, including criminal offenses under the Food, Drug, and Cosmetic Act (“FDCA”) involving “food, prescription medications and other drugs, counterfeit pills, medical devices, dietary supplements, and tobacco.”
  • The unit’s scope, as described by DOJ, spans misconduct involving product quality and safety, integrity of safety data and certifications, and failures in systems, controls, or disclosures that conceal or perpetuate safety risks.
  • The unit also “brings criminal enforcement actions under the Consumer Product Safety Act, the Federal Hazardous Substances Act, and related statutes” and works with the Department of Transportation (“DOT”) and DOT’s National Highway Traffic Safety Administration (“NHTSA”) to bring criminal actions.
  • The establishment of HSU follows the disbanding of the Civil Division’s Consumer Protection Branch (as we discussed in our September 2025 Legal Update) and the transfer of multiple experienced former Consumer Protection Branch prosecutors to the Criminal Division’s Fraud Section.
  • Analysis: https://www.mayerbrown.com/en/insights/publications/2025/12/doj-establishes-health-and-safety-unit-within-the-criminal-divisions-fraud-section

Cassidy Escalates AMA Probe, Seeks Stakeholder Input on CPT System

  • Senate health chair Bill Cassidy (R-LA) is escalating his investigation into the American Medical Association’s (AMA) control of the Current Procedural Terminology (CPT) code set, launching a questionnaire Tuesday (Dec. 9) for providers, payers, health IT companies and other stakeholders to document how CPT licensing fees, contracts and related royalties affect their operations and health care costs.
  • https://insidehealthpolicy.com/daily-news/cassidy-escalates-ama-probe-seeks-stakeholder-input-cpt-system   (subscription required for full text)

CMS Issues New State Guidance on Transformative Medicaid Reforms

  • The Centers for Medicare & Medicaid Services (CMS) is providing additional guidance outlining how states should implement landmark community engagement requirements created by the Working Families Tax Cut (WFTC) legislation (Public Law 119-21).
  • Four key principles will guide policy development on community engagement:
    • Connect Members to Work and Community. Center the connection between health and work through community engagement and build habits that lead to success.
    • State Flexibility. Balance the benefits of state flexibility with the potential costs of options, including systems and operational costs.
    • Promote Alignment. Where possible, align policies with existing statutory and regulatory requirements including existing requirements for Medicaid, SNAP, TANF, IRS, and the Marketplace. This will help defray operations costs and streamline business flows.
    • Protect Taxpayers. Ensure state community engagement determinations and verifications are easily auditable.
  • Future guidance and planned rulemaking will address specific provisions and implementation requirements.
  • https://www.cms.gov/newsroom/press-releases/cms-issues-new-state-guidance-transformative-medicaid-reforms

HHS Enforcement Actions Warns Providers & Grant Recipients To Honor Religious Conscience Rights

  • The U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) announcement of its fifth investigation examining compliance with Federal laws that safeguard conscience rights for health care professionals during President Trump’s second Administration warns States and other federal health program recipients against discriminating against or failing to appropriately accommodate faith-based organization and providers.
  • OCR announced the launch of “a major investigation” into a State health department to assess whether its licensing policies, interpretations, or enforcement practices for behavioral health residential facilities and licensed behavioral health personnel violate Federal law by: 
    • Discriminating against faith-based organizations in the administration and/or enforcement of licensing requirements, including requiring any facilitation of sex-rejecting procedures and female genital mutilation (FGM) and treating religious objections as grounds for adverse licensure action, including denial or termination of professional licenses;
    • Discriminating against institutional and/or individual health care entities for their religious objections to provide, pay for, provide coverage of, or refer for abortion, including through licensing, certification, or other determinations of legal status or participation; or
    • Requiring any individual in a health service program funded by HHS to perform or assist in the performance of services contrary to that individual’s religious beliefs or moral convictions, including counseling or other assistance related to abortion, sex-rejecting procedures, or FGM.
  • Analysis: https://slphealthcareupdate.com/2025/12/10/hhs-enforcement-actions-warns-providers-grant-recipients-to-honor-religious-conscience-rights/
  • HHS Press: https://www.hhs.gov/press-room/ocr-investigates-state-to-protect-conscience-and-faith-based-organizations.html

KEY REVERSALS – RESCINDED ITEMS - LAWSUITS

House Democrat files articles of impeachment against RFK Jr.

  • Rep. Haley Stevens (D-Mich.) said Wednesday she filed articles of impeachment against Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., calling him “the biggest self-created threat to our health and safety.”
  • “RFK Jr. has got to go. Today, I introduced articles of impeachment to remove him from office. RFK Jr. has turned his back on science and public health and on the American people,” Stevens said in a video statement released on the social platform X.
  • Stevens, a candidate for U.S. Senate in Michigan, accused Kennedy of dismantling decades of medical research and said he bears some responsibility for rising health care costs.
  • Stevens has repeatedly called for Kennedy’s removal from his role since he became HHS secretary and said in September she intended to file impeachment articles against him over the “heath care chaos” under his watch.
  • The measure is not likely to pass in a Republicans-controlled Congress.

Solicitor general urges Supreme Court to review ‘skinny labeling’ and generic drug access

  • In a closely watched case, the U.S. solicitor general has urged the Supreme Court to review a controversy over so-called skinny labels for medicines, arguing that an appeals court finding threatens the availability of lower-cost generic drugs.
  • Skinny labeling refers to a process in which a generic drug company seeks regulatory approval to market its medicine for a specific use, but not other patented uses for which a brand-name drug is prescribed. For instance, a generic drug could be marketed to treat one type of heart problem, but not another. In doing so, the generic company seeks to avoid lawsuits claiming patent infringement.
  • The tactic has been a mainstay among generic companies ever since a federal law known as the Hatch-Waxman Act went into effect more than four decades ago. The law established the mechanisms by which generic drugs can more readily enter the marketplace, and skinny labeling, which amounts to a carve-out, is one way that Congress attempted to foster more competition to benefit consumers.
  • https://www.statnews.com/pharmalot/2025/12/09/patents-pharma-generics-scotus-skinny-labels-medicines/   (subscription required for full text)

Texas and Florida sue FDA in latest effort to restrict abortion pill access

  • Texas and Florida have launched the latest lawsuit seeking to restrict access to the abortion pill mifepristone, following the US Food and Drug Administration’s recent approval of a new generic version.
  • In the lawsuit, filed late on Tuesday in federal court in Wichita Falls, Texas, the states’ Republican attorneys general argue that the FDA has failed to thoroughly evaluate the drug’s safety and effectiveness since its initial approval in 2000 and disregarded the risks to the women who take it.
  • The lawsuit challenges the initial 2000 approval and approval of Evita’s generic. The states also claim that regulations adopted under Democratic former presidents Barack Obama and Joe Biden expanding access to mifepristone are unlawful.
  • The lawsuit alleges that the FDA’s actions were arbitrary and capricious, contrary to federal law or beyond the agency’s powers in violation of the federal Administrative Procedure Act.
  • Press: https://www.theguardian.com/world/2025/dec/10/texas-florida-sue-fda-abortion-pill-approval
  • Lawsuit: https://tmsnrt.rs/44heT8b (this link opens a PDF)

KEY BIOPHARMA NEWS

FDA finalizes guidance on promotional materials for biologics and biosimilars

  • A new guidance document issued by the FDA this week offers recommendations for how makers of prescription biosimilars and biologic reference products should approach promotional advertising and labeling for those meds.
  • The document finalizes a draft guidance issued by the agency in April 2024 and replaces a previous guidance on the topic that was initially published in 2020.
  • Differences from last year’s draft version are minimal, including only an addition in the introduction that its recommendations “apply regardless of the medium of the communication (e.g., paper, digital)” and a few extra lines about considerations for comparisons between biosimilars and their reference products, along with “editorial changes for consistency, readability, and clarity,” per the FDA.
  • At the core of the guidance is a call for all promotional materials to be “accurate, truthful, and non-misleading.”
  • Though the guidance document outlines recommendations suggested by the FDA for compliance with its legal requirements, it’s technically legally nonbinding, and the agency noted that companies are free to take “an alternative approach” so long as it “satisfies the requirements of the applicable statutes and regulations.”
  • Press: https://www.fiercepharma.com/marketing/fda-finalizes-guidance-promotional-materials-biologics-and-biosimilars
  • Guidance: https://www.fda.gov/media/134862/download  (this link opens a PDF)

FDA steers cancer CAR-T developers toward randomized superiority trials in policy shift

  • The FDA is raising the bar for approval of CAR T-cell therapies in oncology. Under plans outlined by the FDA’s biologics chief Vinay Prasad, M.D., the agency will require developers of many CAR-Ts to show superiority over existing treatments.
  • Single-arm trials have been common in the CAR-T field to date. The labels of the seven CAR-Ts approved to date describe multiple single-arm studies, although, in many cases, there is also at least one trial versus an active control. Under new leadership, the FDA has assessed whether the approach it has taken since approving Novartis’ Kymriah in 2017 remains the best model for CAR-T regulation.
  • Writing in the medical journal JAMA, Prasad and three colleagues said the goal was to maintain high evidentiary standards for approval and exercise regulatory flexibilities, when necessary, to advance CAR-T development.
  • The leaders said randomized control trials (RCTs) with a survival or acceptable time-to-event endpoint should be the preferred approach for initial approval of new CAR-Ts. Prasad and his colleagues expect a new CAR-T to beat the comparator.
  • Press: https://www.fiercebiotech.com/biotech/fda-steers-cancer-car-t-developers-toward-randomized-superiority-trials-policy-shift
  • JAMA: https://jamanetwork.com/journals/jama/article-abstract/2842439   (subscription required for full text)

KEY DIAGNOSTICS – LIFE SCIENCE RESEARCH NEWS

Testing labs rally to kill Medicare pay cuts

  • Lab testing companies including giants Quest Diagnostics and LabCorp are pressing Congress to stop hundreds of millions of dollars of Medicare cuts for diagnostic tests that are due to take effect at the end of January.
  • Why it matters: Their push could add to the health care issues piling up on lawmakers' plates as the calendar flips over.
    • Congress has given the testing industry short-term reprieves for the past five years. But because of recent changes to how congressional scorekeepers analyze the sector, pushing off the scheduled cuts now would add to the deficit, instead of saving tax dollars.
  • The issue has stayed largely under the radar as Congress debates whether to extend enhanced Obamacare premium subsidies. But testing policy has big implications as precision medicine evolves and patients show up with more complicated cases.
    • The testing industry and allied medical groups want a permanent fix, arguing that member companies' laboratory services influence 70% of clinical decisions.
  • Driving the news: A 15% reduction to Medicare payments for nearly 800 lab tests is set to take effect Jan. 31, followed by additional cuts in following years.
    • The change stems from 2014 legislation that aimed to align Medicare reimbursements for lab tests more closely with commercial payments.
    • Medicare cuts that previously went into effect from the legislation cost labs nearly $4 billion over three years. Since then, the diagnostics industry has successfully argued the cuts are based on incomplete and outdated pricing information.
  • Analysis: https://www.axios.com/2025/12/10/lab-test-companies-delay-medicare-cut   (subscription required for full text)

KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS

CMS taps CLEAR to ‘kill the clipboard’

  • CLEAR has signed a contract with the Centers for Medicare & Medicaid Services to bring its digital identity platform to Medicare.gov beginning in early 2026.
  • Here are three things to know about the partnership:
    • Under the agreement, Medicare.gov will integrate CLEAR1, the company’s secure identity technology, to support account creation, account recovery and access to healthcare information for Medicare beneficiaries and providers.
    • CMS is pursuing the update as part of a broader effort to strengthen fraud prevention and streamline digital access, according to a Dec. 9 news release.
    • CLEAR said the platform is designed to address increasingly sophisticated identity threats, including synthetic identities, deepfake impersonation and fraud attempts using publicly available personal data. The company said CLEAR1 replaces legacy verification checks with multi-layered authentication intended to reduce identity-related fraud and protect sensitive information.
  • The work aligns with priorities laid out in CMS’ Health Tech Ecosystem initiative, announced July 30 at the White House. That initiative aims to build a more connected and interoperable digital health environment and advance the agency’s long-term goal of eliminating manual, paper-based processes.
  • https://www.beckershospitalreview.com/healthcare-information-technology/innovation/cms-taps-clear-to-kill-the-clipboard/

HHS health IT chief hints at a new approach to EHR certification

  • At a health care AI summit in Washington D.C. [December 10th], heavy hitters weighed in on the prospects for interoperability — the effort to make health data currently scattered about the health care system more readily accessible to patients, their providers, and maybe even researchers.
  • Thomas Keane, who is the top health IT regulator at HHS, said that before Christmas his office hopes to introduce a rule that would eliminate 34 certification criteria for electronic medical records and modify seven.
  • These certification criteria have been much maligned for various reasons including that they create a huge burden on small companies that might want to compete with dominant vendors like Epic Systems.
  • “We would like the EHR companies to have to do less conformance testing and concern themselves less with this aspect of our regulatory regime,” said Keane. “What we will pivot towards in the spring is regulating the application programming interfaces by which the EHRs talk to each other. And we can say that you have to adopt these features, you have to support this functionality, and if that functionality exists, then these EHRs and other technological applications in the ecosystem should all be able to talk to each other.”
  • https://www.statnews.com/2025/12/11/hhs-new-approach-ehr-certification-health-tech/   (subscription required for full text)

More than 100 provider groups tell HHS to pull proposed HIPAA update

  • More than 100 health systems and other provider organizations “have united to oppose” cybersecurity and privacy regulations proposed back in January.
  • The groups, corralled by the College of Healthcare Information Management Executives, wrote the Department of Health and Human Services this week, warning that the financial burdens and “unreasonable implementation timelines” outlined by the prior administration run counter to President Donald Trump’s deregulatory agenda.
  • “This rule … should be immediately withdrawn without further consideration,” the groups wrote in their letter. “We instead encourage HHS to conduct a collaborative outreach initiative with our organizations and other regulated entities that are impacted to develop practical and actionable cybersecurity standards for more robust protections of individuals’ health information, without the extreme and unnecessary regulatory burden that healthcare providers and other stakeholders would face under the crushing and unprecedented provisions of this Proposed Rule.”
  • Major organizations that signed onto the letter include the American Medical Association, the Federation of American Hospitals, the Association of American Medical Colleges, the American Health Care Association/National Center for Assisted Living and several specialty-based associations. Among the health system signatories were Advocate Health, Christus Health, Cleveland Clinic, Inova Health, Orlando Health, SSM Health and Yale New Haven Health System.
  • HHS said back in January that its proposed rule would be the first significant update to the Health Information Portability and Accountability Act (HIPAA) Security Rule since 2013. The department, via its Office for Civil Rights, proposed updating the administrative, technical and physical safeguards expected of HIPAA-covered entities, as well as an organization’s ability to recover in the event of a safety breach.
  • Other portions propose updates to various term definitions, including a clarification that “all” electronic protected health information is subject to the rule, and float a six-month effective compliance date from its finalization.
  • The updates, HHS said at the time, are necessary considering the substantial changes in technology over the past decade, as well as recent years’ upticks in cyberattacks and security breaches.
  • https://www.fiercehealthcare.com/regulatory/over-100-provider-groups-tell-hhs-pull-proposed-hipaa-update

Keane: HHS May Enroll Apps As Providers Under ACCESS

KEY MEDTECH NEWS

FDA introduces TEMPO model as companion to CMS ACCESS model for uncleared devices

  • The Food and Drug Administration plans to select about 40 devices not yet cleared by the agency to receive special agency discretion to participate in the new chronic care Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model.
  • The ACCESS Model would offer stable, recurrent payment for technology used to treat diabetes, hypertension, chronic kidney disease, obesity, depression and anxiety that meets certain clinical outcomes that have not yet been defined.
  • In most cases, devices used to treat chronic conditions would have to undergo review by the FDA and be cleared for that use, it wrote in a notice about the program. The new pilot, called TEMPO, will allow the agency to offer enforcement discretion to devices in the ACCESS program that have not yet undergone the FDA premarket authorization process.
  • TEMPO stands for Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot (“TEMPO pilot”). The pilot program expects to select about 10 devices for each condition category laid out by the CMMI in the ACCESS model.
  • The four categories are early cardio-kidney-metabolic, cardio-kidney-metabolic, musculoskeletal and behavioral health, equaling 40 total devices across the condition categories.
  • The devices may use off-the-shelf computing platforms or wearable devices, FDA wrote, including devices that leverage artificial intelligence.
  • Procedures for device manufacturers to participate in TEMPO include device description, data to demonstrate safety and patient benefit, a plan for mitigating risk to patients and providers, proposed performance goals and a proposed timeline for data collection and submission of a premarket notification to FDA.
  • https://www.fiercehealthcare.com/health-tech/fda-introduces-tempo-model-complement-cms-access-model

KEY ACRONYMS

  • ACCESS = Advancing Chronic Care with Effective, Scalable Solutions
  • CDC = Centers for Disease Control and Prevention
  • CDER = Center for Drug Evaluation and Research
  • CMS = Centers for Medicare & Medicaid Services
  • CPT = Current Procedural Terminology
  • DOJ = Department of Justice
  • FDA = Food and Drug Administration
  • FDCA = Food, Drug, and Cosmetic Act
  • HHS = Department of Health and Human Services
  • HSU = Health & Safety Unit
  • IRB = Institutional Review Board
  • NIH = National Institutes of Health
  • OC = Office of Compliance
  • OCR = Office for Civil Rights
  • RSV = respiratory syncytial virus
  • TEMPO = Technology-Enabled Meaningful Patient Outcomes
  • WFTC = Working Families Tax Cut

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