Blog | 1/9/2026

Sharp Strategy Spotlight: January 9, 2026

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 January 8, 2026. The details and broad themes may have changed.

KEY HEALTH NEWS (Global)

US signs new health deals with 9 African countries that mirror Trump’s priorities

  • The U.S. government has signed health deals with at least nine African countries, part of its new approach to global health funding, with agreements that reflect the Trump administration’s interests and priorities and are geared toward providing less aid and more mutual benefits.
  • The agreements signed so far, with Kenya, Nigeria and Rwanda among others, are the first under the new global health framework, which makes aid dependent on negotiations between the recipient country and the U.S.
  • Some of the countries that have signed deals either have been hit by U.S. aid cuts or have separate agreements with the Trump administration to accept and host third-country deportees, although officials have denied any linkage.
  • The Trump administration says the new “America First” global health funding agreements are meant to increase self-sufficiency and eliminate what it says are ideology and waste from international assistance. The deals replace a patchwork of previous health agreements under the now-dismantled United States Agency for International Development.
  • https://apnews.com/article/us-africa-health-agreements-nigeria-kenya-trump-60ff22d1bc58009962dadd9f5ce53131

KEY FEDERAL GOVERNMENT NEWS

House takes step toward extending Affordable Care Act subsidies, overpowering GOP leadership

  • Overpowering Speaker Mike Johnson, a bipartisan coalition in the House voted Wednesday to push forward a measure that would revive an enhanced pandemic-era subsidy that lowered health insurance costs for roughly 22 million people, but that had expired last month.
  • The tally of 221-205 was a key test before passage of the bill, which is expected Thursday. And it came about because four GOP centrist lawmakers joined with Democrats in signing a so-called discharge petition to force the vote.
  • In the end, nine Republicans joined Democrats to advance the measure.
  • If ultimately successful in the House this week, the voting would show there is bipartisan support for a proposed three-year extension of the tax credits that are available for those who buy insurance through the Affordable Care Act, also known as Obamacare. The action of forcing a vote has been an affront to Johnson and GOP leaders, who essentially lost control of their House majority as the renegade lawmakers joined Democrats for the workaround.
  • But the Senate is under no requirement to take up the bill.
  • Instead, a small group of members from both parties is working on an alternative plan that could find support in both chambers and become law.
  • https://apnews.com/article/affordable-care-act-subsidies-aca-84607bbaee9bc782d0b685eadba75303

Health Dept. Freezes $10 Billion in Funding to 5 Democratic States

  • The Trump administration on Tuesday froze $10 billion in funding for child care subsidies, social services and cash support for low-income families in five states controlled by Democrats, claiming without evidence widespread fraud throughout those states after a major welfare fraud scheme in one of them.
  • Minnesota, New York, California, Illinois and Colorado will be cut off from around $7.3 billion in funding for the Temporary Assistance for Needy Families program, which provides cash assistance to households with children, the Department of Health and Human Services announced. The five states will also lose access to nearly $2.4 billion for the Child Care and Development Fund, which supports child care for working parents, and around $870 million for social services grants that mostly benefit children at risk.
  • The funding pause could jeopardize programs that serve hundreds of thousands of low-income households in the five states.
  • The department, which disburses the funds, said it would require the five states to submit documentation like receipts and to justify their spending before releasing any payment. The three programs that the administration targeted had allowed states broad discretion to design specific ways to support families and children in need.
  • https://www.nytimes.com/2026/01/06/us/politics/child-care-funding-cuts-trump.html   (subscription required for full text)

ACCESS arrives: Key highlights for potential applicants

The CDC Just Sidelined These Childhood Vaccines. Here’s What They Prevent.

  • Vaccines against the three diseases, as well as those against respiratory syncytial virus, meningococcal disease, flu, and covid, are now recommended only for children at high risk of serious illness or after “shared clinical decision-making,” or consultation between doctors and parents.
  • The CDC maintained its recommendations for 11 childhood vaccines: measles, mumps, and rubella; whooping cough, tetanus, and diphtheria; the bacterial disease known as Hib; pneumonia; polio; chickenpox; and human papillomavirus, or HPV.
  • Federal and private insurance will still cover vaccines for the diseases the CDC no longer recommends universally, according to a Department of Health and Human Services fact sheet; parents who want to vaccinate their children against those diseases will not have to pay out-of-pocket.
  • Here’s a rundown of the diseases the sidelined vaccines prevent:
    • RSV. Respiratory syncytial virus
    • Hepatitis A
    • Hepatitis B
    • Rotavirus
    • Meningococcal vaccines
    • Flu and COVID
  • Under the changes, decisions about vaccinating children against influenza, covid, rotavirus, meningococcal disease, and hepatitis A and B will now rely on what officials call “shared clinical decision-making,” meaning families will have to consult with a health care provider to determine whether a vaccine is appropriate.
  • Analysis: https://kffhealthnews.org/news/article/cdc-childhood-vaccine-schedule-changes-diseases-history-data/
  • HHS Press: https://www.hhs.gov/press-room/fact-sheet-cdc-childhood-immunization-recommendations.html

CMS to stop requiring states to report childhood vaccination levels

  • States will no longer be required to report how many children they vaccinate to the Centers for Medicare and Medicaid Services (CMS), according to a December 30 letter to state health officials.
  • As a measure of the quality of the care, states have been required to report the percentage of patients covered by Medicaid and the Children's Health Insurance Plan who are immunized.
  • About 40% of children are covered by Medicaid, a federal health program administered by states for people with low incomes, pregnant women, those with disabilities, and others. CHIP provides health insurance to children whose families do not qualify for Medicaid.
  • States may continue to provide the information voluntarily, according to the letter, “to allow CMS to maintain a longitudinal dataset while exploring alternative immunization measures.”
  • In the future, however, CMS will explore “new vaccine measures that capture information about whether parents and families were informed about vaccine choices, vaccine safety and side effects, and alternative vaccine schedules,” according to the letter.
  • Press: https://www.cidrap.umn.edu/childhood-vaccines/cms-stop-requiring-states-report-childhood-vaccination-levels
  • CMS: https://www.medicaid.gov/federal-policy-guidance/downloads/sho25005.pdf

Trump green-lights these "no charge" marijuana products for Medicare enrollees

  • President Trump signed an executive order that launches a pilot program authorizing Medicare to cover cannabis products for seniors.
  • Why it matters: Trump's embrace of marijuana could be a game-changer for older people who are seeking alternative treatments for common ailments.
  • Driving the news: Marijuana use among older adults in the U.S. is growing fast.
    • In 2023, 7% of adults aged 65 or older reported that they had used it in the past month, per an NYU study published this summer.
    • That's up from 4.8% in 2021 and 5.2% in 2022 — a nearly 46% increase in just two years.
  • Catch up quick: The executive order reclassifies marijuana as a Schedule III drug under the U.S. Drug Enforcement Agency in addition to authorizing the Medicare pilot.
    • The reclassification puts cannabis in a category with Tylenol with codeine, rather than with Schedule I drugs such as heroin and LSD.
    • It also authorizes Medicare to fully cover CBD products for patients.
  • The Centers for Medicare & Medicaid Services (CMS) did not immediately respond to Axios' request for comment.
  • Analysis: https://www.axios.com/2025/12/18/schedule-3-drugs-trump-weed-medicare   (subscription required for full text)
  • White House: https://www.whitehouse.gov/presidential-actions/2025/12/increasing-medical-marijuana-and-cannabidiol-research/

Rural Health Transformation Program awards announced

  • Texas and Alaska will receive the largest amount of funding from the $50 billion Rural Health Transformation Program in fiscal year 2026, while New Jersey and Connecticut will see the least, the Centers for Medicare & Medicaid Services (CMS) announced Monday.
  • All 50 states had submitted applications to the federal government in November outlining plans to improve rural healthcare with their share of funds from the five-year program, which was authorized this summer under the One Big Beautiful Bill Act (OBBBA).
  • Under the statute, half of the $10 billion-per-year distribution is split between the states evenly. The remaining half is determined by the CMS based on how well the states’ pitches met goals of strengthening rural health prevention, standing up sustainable access, developing a rural workforce and introducing innovative care delivery and technology.
  • While this process translates to an average receipt of $200 million per fiscal year, the decision from the CMS on exactly how much each state will receive has been hotly anticipated as healthcare providers across the country prepare to navigate upcoming Medicaid funding cuts included in the OBBBA.
  • Press: https://www.fiercehealthcare.com/providers/rural-health-transformation-program-awards-announced-heres-whos-getting-most
  • CMS: https://www.cms.gov/newsroom/press-releases/cms-announces-50-billion-awards-strengthen-rural-health-all-50-states

CMS Funds 400 New Residency Slots

  • he decision to fund 400 new medical residency positions at hospitals across the U.S. marks a meaningful -- though limited -- step toward addressing a looming physician shortage expected to worsen over the next decade, public health officials said.
  • The Centers for Medicare & Medicaid Services (CMS) allocated the 400 Medicare-funded residency slots to 135 hospitals in 37 states. Nearly two-thirds of the positions will support primary care and psychiatry residency programs.
  • "These additional residency positions demonstrate bipartisan support for continued investment in physician training and are instrumental to increasing access to care for patients by allowing more residents to serve communities nationwide," David J. Skorton, MD, president and CEO of the Association of American Medical Colleges (AAMC), said in a statement. "Although there is still a lot of work to be done to help alleviate the persistent physician shortage in this country, today is another very meaningful step forward."
  • The AAMC projects the U.S. could face a shortfall of up to 86,000 physicians by 2036, driven by a growing and aging population alongside a workforce of physicians nearing retirement age. According to the organization's 2024 report, the country would have needed more than 200,000 additional physicians in 2021 if underserved communities had access to care at the same rate as populations with fewer barriers.
  • Press: https://www.medpagetoday.com/hospitalbasedmedicine/graduatemedicaleducation/119139

CMS Launches Voluntary Model to Expand Access to Life-changing Medicines, Promote Healthier Living

  • The Centers for Medicare & Medicaid Services (CMS) announced today a new voluntary test of a model that is designed to enable Medicare Part D plans and state Medicaid agencies to cover GLP-1 medications used for weight management and metabolic health improvement, while helping control costs for patients and taxpayers. … Under the model, CMS negotiates directly with pharmaceutical manufacturers of GLP-1 drugs for lower net prices and standardized coverage terms.
  • Negotiation areas include:
    • Guaranteed net pricing and potential out-of-pocket limits for beneficiaries
    • Standardized coverage criteria
    • Evidence-based lifestyle support offerings
  • As part of this voluntary model, CMS will negotiate drug pricing and coverage terms with manufacturers of GLP-1 medications on behalf of state Medicaid agencies and Medicare Part D plan sponsors.
  • State Medicaid agencies can join the model beginning in May 2026, and Part D plans in January 2027. Model testing will conclude in December 2031.
  • Press: https://primarynewssource.org/sourcedocument/cms-launches-voluntary-model-to-expand-access-to-life-changing-medicines-promote-healthier-living/
  • CMS BALANCE: https://www.cms.gov/priorities/innovation/innovation-models/balance

NIH instability grows with exit of neuro director, leaving half of institutes under interim leadership

  • The National Institutes of Health (NIH) is adding another leader to its lengthy string of departures, this time in the form of National Institute of Neurological Disorders and Stroke (NINDS) Director Walter Koroshetz, M.D.
  • The agency has rebuffed the request to reappoint Koroshetz, according to an internal email the neuroscience leader sent to staff late last week. The letter was obtained by Stat, the first publication to report on the departure.
  • Koroshetz’s exit—expected Jan. 24—means that 14 of the NIH’s 27 units will be helmed by interim leaders. NINDS acting Deputy Director Amy Adams is expected to guide the institute as it searches for a new permanent successor.
  • “NIH has received robust interest in its open [institute chief] director positions,” Department of Health and Human Services’ (HHS') spokesperson Andrew Nixon told Fierce Biotech. “Following closure of the announcements, an NIH leadership team with experience in scientific agency management will consider the applicant pool and make recommendations to the NIH director.”
  • Nixon did not respond to Fierce Biotech’s question about how the agency plans to address the dearth of permanent leadership.
  • https://www.fiercebiotech.com/biotech/nih-instability-grows-exit-neuro-director-half-institutes-under-interim-leadership

CMS proposes new price transparency rules

  • President Donald Trump’s administration proposed significant updates Dec. 19 to healthcare price transparency rules to help make costs more “clear, accurate and actionable for Americans.” The proposal, shared by CMS, in partnership with the labor and the treasury departments, builds on rules established during President Trump’s first term.
  • Some of the suggested improvements, which mainly apply to health plans and insurers, feature excluding unlikely services from in-network rate files, adding change-log and utilization files to improve tracking, reorganizing files by provider network to cut back on redundancy, reducing reporting frequency from monthly to quarterly and growing out-of-network pricing data with longer reporting periods and lower claims thresholds.
  • Price comparison tools are also strengthened under the proposed rule, requiring issuers to provide detailed, consistent cost-sharing information by phone, in print and online. The No Surprises Act would have updated disclosures reflect protections to help patients know their rights and potential financial responsibilities.
  • Major changes to prescription drug disclosure requirements are not included in the proposed rule, which the department plans to separately address.
  • Press: https://www.beckershospitalreview.com/finance/cms-proposes-new-price-transparency-rules/
  • CMS Press: https://www.cms.gov/newsroom/press-releases/trump-administration-proposes-significant-updates-disclosure-requirements-make-health-care-prices

KEY REVERSALS – RESCINDED ITEMS - LAWSUITS

After judge’s ruling, HHS authorized to resume sharing some Medicaid data with deportation officers

  • The nation’s health department starting Monday can resume sharing the personal data of certain Medicaid enrollees with deportation officials, according to a federal judge’s ruling, in a blow to states that had sued the administration over privacy concerns.
  • But the judge’s decision, issued last Monday, strictly limits the scope of data from the 22 plaintiff states that can be shared — for now only allowing the agency to hand over basic biographical information about immigrants residing in the United States illegally. The states’ lawsuit came after an Associated Press report identified the data sharing policy.
  • The ruling from U.S. District Judge Vince Chhabria in San Francisco comes after the Centers for Medicare and Medicaid Services said it planned to share the data again as part of the Trump administration’s immigration crackdown.
  • Chhabria in August had initially blocked the U.S. Department of Health and Human Services from sharing the personal data, which includes home addresses, with Immigration and Customs Enforcement officers. In December, he extended that temporary order.
  • Press: https://apnews.com/article/medicaid-data-hhs-rfk-sharing-immigration-trump-30784ce01a403a16aca504980e4c7bc9
  • Decision: https://storage.courtlistener.com/recap/gov.uscourts.cand.452203/gov.uscourts.cand.452203.148.0.pdf

340B rebate pilot put on hold in temporary win for hospitals

  • A Maine district court temporarily enjoined the pilot, which was set to take effect on Jan. 1, from kicking in. Still, the controversial payment experiment isn’t dead in the water.
  • A federal judge halted a controversial drug discount pilot over the holiday break, determining that the HHS didn’t adequately consider the consequences for safety-net hospitals in a setback for the Trump administration and for drugmakers.
  • The pilot set to take effect on Jan. 1 would have allowed drugmakers to divvy out savings to providers in the 340B drug discount program through post-sale rebates instead of upfront discounts.
  • Hospitals sued to block the pilot in early December, arguing the Trump administration had illegally rushed it into implementation.
  • On Dec. 29, a Maine district court judge paused the payment experiment, agreeing that regulators likely violated the Administrative Procedure Act.
  • Hospital groups cheered the news, while the Trump administration quickly appealed the ruling.
  • https://www.healthcaredive.com/news/340b-rebate-pilot-paused-trump-hrsa-aha-lawsuit/808707/

Judge allows providers' lawsuit against RFK Jr.'s ACIP changes to move forward

  • A federal judge has denied the Department of Health and Human Services' motions to dismiss a lawsuit challenging last summer's COVID-19 vaccine recommendation changes and Secretary Robert F. Kennedy Jr.'s overhaul of a key vaccine advisory panel.
  • Judge Brian Murphy, of the U.S. District Court for the District of Massachusetts, wrote in a memo and order Jan. 6 that the case's healthcare provider plaintiffs have sufficient standing to survive a dismissal. He also wrote that "at this stage of the litigation," the plaintiffs' allegations that the new composition of the Centers for Disease Control and Prevention’s (CDC’s) Advisory Council on Immunization Practices (ACIP) is unfairly balanced toward skeptics of COVID-19 vaccines and mRNA vaccines more broadly are plausible.
  • Plaintiffs in the case are the American Academy of Pediatrics (AAP), the American College of Physicians, the American Public Health Association, the Infectious Diseases Society of America, the Massachusetts Public Health Alliance and the Society for Maternal-Fetal Medicine, as well as three individual healthcare providers.
  • https://www.fiercehealthcare.com/providers/providers-lawsuit-against-rfk-now-asks-court-nullify-acips-recent-vaccine-recommendations

Department of Veterans Affairs quietly bans abortion services, counseling

  • The Trump administration has quietly banned the Department of Veterans Affairs (VA) from providing abortion services to veterans and their dependents, including those who become pregnant as a result of rape or incest.
  • The ban followed a memo authored by Joshua Craddock, deputy assistant attorney general of the Department of Justice’s Office of Legal Counsel (OLC) issued Dec. 18 that concluded the VA may not provide abortion services under any provision of the law. 
  • The memo revoked a Biden-era OLC opinion that allowed the VA to provide limited abortion counseling and services to pregnant veterans and their beneficiaries. 
  • The Biden policy allowed abortions for those who became pregnant as a result of rape or incest, or if a pregnancy endangered the “life and health” of the person seeking an abortion. 
  • According to screenshots of an internal VA memo dated Monday and sent to the leaders of the VA’s 18 regional integrated service networks that were shared with The Hill, the agency “must comply” with the Dec. 18 memo and that “effective immediately,” the VA will no longer provide abortion or abortion counseling.
  • https://thehill.com/policy/healthcare/5661427-abortion-ban-trump-administration-veterans-affairs/

Appeals court rules against NIH’s indirect cost cut plan 

  • The government is barred from setting a 15% cap on overhead research cost reimbursements for NIH grantees under a federal appeals court order.
  • The plain text of each appropriations law enacted since 2018 prohibits NIH from “imposing an across-the-board indirect cost reimbursement rate,” a panel of judges on the US Court of Appeals for the First Circuit said Monday. The appeals court affirmed a lower court’s injunction on the plan.
  • The decision is a long-awaited win for universities and research organizations that have said the NIH’s indirect costs proposal could jeopardize their work.
  • Unlike direct research costs, indirect costs can’t easily be tied to a single project, often funding maintenance, administrative and other work that supports research. The First Circuit judges said in their opinion that “the public-health benefits of NIH-funded research are enormous,” and that direct and indirect costs “are both essential to research.”
  • Some research institutions had previously negotiated indirect cost rates higher than 50%. Several states, universities and organizations challenged the proposed cap in Massachusetts federal court.
  • https://endpoints.news/appeals-court-rules-against-nihs-indirect-cost-cut-plan/   (subscription required for full text)

KEY BIOPHARMA NEWS

CMS issues mandatory Medicare models implementing Most Favored Nation drug pricing: GLOBE (Part B) and GUARD (Part D)

  • On December 19, 2025, the Centers for Medicare & Medicaid Services (CMS) issued two proposed rules to implement mandatory Most Favored Nation (MFN)-based drug pricing models: the Medicare Part B Global Benchmark for Efficient Drug Pricing Model (GLOBE) Model and the Medicare Part D Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model.
  • As proposed, the models would test alternative methods for calculating manufacturer rebates under the Medicare Part B and Part D inflation rebate programs by tying applicable pricing benchmarks for model drugs to international pricing information, among other changes.
  • The proposed rules for the GLOBE and GUARD Models were published in the Federal Register on December 23, 2025. Comments on the proposed rules are due on February 23, 2026.
  • Each model would apply to a defined set of single-source drugs and sole-source biological products that meet specified eligibility criteria, including spending thresholds, and would only apply to units dispensed or administered to beneficiaries selected for participation in the models.
  • CMS proposes to test each model in geographic areas comprising approximately 25% of Medicare Part B fee-for-service (FFS) or Medicare Part D beneficiaries, respectively.
  • Analysis: https://www.hoganlovells.com/en/publications/cms-issues-mandatory-medicare-models-implementing-most-favored-nation-drug-pricing
  • CMS GLOBE: https://www.cms.gov/priorities/innovation/innovation-models/globe
  • CMS GUARD: https://www.cms.gov/priorities/innovation/innovation-models/guard

Trump announces lower drug price deals with 9 pharmaceutical companies

KEY DIAGNOSTICS – LIFE SCIENCE RESEARCH NEWS

Expanded cervical cancer screenings to be covered by most private insurance

  • The Department of Health and Human Services is endorsing self-collected vaginal samples for cervical cancer screening and requiring most private insurance plans to cover testing without cost sharing.
  • The Health Resources and Services Administration, an agency within HHS, announced updated cervical cancer screening guidelines Monday that expand screening options to include self-collection to test for human papillomavirus, or HPV, a sexually transmitted infection that causes nearly all cervical cancer cases. The new guidelines also aim to lower out-of-pocket costs for screening that could deter people from getting care.
  • “The guideline is designed to help close the screening gap by expanding access and reducing cost barriers,” a spokesperson for HRSA said. “About one in four women are not up to date on cervical cancer screening, and the disease often has no symptoms in its early stages, making regular screening critical.”
  • Press: https://www.washingtonpost.com/health/2026/01/05/cervical-cancer-screening-self-collection-insurance/   (subscription required for full text)
  • JAMA article: https://jamanetwork.com/journals/jama/fullarticle/2843501

KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS

FDA Issues Key Guidance Updates for Digital Health and Wellness

Federal Regulatory Update: HHS Proposes Rule to Deregulate Health IT and Advance AI-Interoperability (HTI-5)

  • The Department of Health and Human Services (HHS), through the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC), has released a proposed rule that would significantly roll back federal certification requirements for health IT developers. The proposal—known as HTI-5, the fifth iteration of the Health Data, Technology, and Interoperability rulemaking—marks one of the most consequential shifts in federal health IT policy in years.
  • ASTP/ONC frames the proposal as a targeted deregulatory effort designed to eliminate duplicative or outdated requirements, reduce compliance costs, and redirect industry focus toward interoperable, AI-enabled health data exchange. The rule explicitly advances President Trump’s Executive Orders on Unleashing Prosperity Through Deregulation and Reducing Anti-Competitive Regulatory Barriers.
  • Why This Matters
    • If finalized, HTI-5 would materially reshape the federal health IT regulatory landscape—reducing compliance obligations, accelerating AI-driven data exchange, and shifting oversight from prescriptive certification requirements toward market-driven standards and targeted enforcement. Organizations operating in or adjacent to certified health IT should assess how these changes affect product development, data governance, interoperability strategy, and competitive positioning—and consider engaging during the comment period to shape the final rule.
  • Analysis: https://www.nelsonmullins.com/insights/blogs/healthcare_essentials/data_privacy_and_security/federal-regulatory-update-hhs-proposes-rule-to-deregulate-health-it-and-advance-ai-interoperability-hti-5
  • HHS: https://public-inspection.federalregister.gov/2025-23896.pdf

DEA extends telemedicine flexibilities for controlled substance prescribing for 2026

KEY MEDTECH NEWS

FDA announces regulatory exemptions for ‘non-medical grade’ devices

  • The US Food and Drug Administration (FDA) is moving to relax regulatory requirements for low risk health and wellness wearables, software, and certain other non-medical grade devices.
  • Outlining the plans during a presentation at the 2026 Consumer Electronics Show (CES), taking place between January 6-9 in Las Vegas, Makary told attendees the FDA needed to move at “the speed of Silicon Valley”, as per a report by ConsumerAffairs.
  • The exemptions will apply to low risk devices such as heart rate monitors and other wearables that are intended for tracking general healthcare metrics, while devices used for the diagnosis or treatment of specific medical conditions will remain in scope of existing premarket requirements.
  • In an interview with Fox Business programme Varney & Co, Makary explained: “We want to let companies know, with very clear guidance, that if their device or software is simply providing information, they can do that without FDA regulation.
  • “The only stipulation is if they make claims of something being medical grade, like a clinically appropriate, clinical grade blood pressure measurement. We don’t want people changing their medicines based on something that’s just a screening tool or an estimate of a physiologic parameter.”
  • The relaxed oversight plans will also influence health and wellness devices that use artificial intelligence (AI), resonating more broadly with an executive order issued by the White House in December 2025 that seeks to remove barriers to and encourage adoption of AI applications across sectors.
  • https://www.medicaldevice-network.com/news/fda-announces-regulatory-exemptions-for-non-medical-grade-devices/

KEY ACRONYMS

  • AAMC = Association of American Medical Colleges
  • ACCESS = Advancing Chronic Care with Effective, Scalable Solutions
  • ACIP = Advisory Council on Immunization Practices
  • ASTP/ONC = Assistant Secretary for Technology Policy/Office of the National Coordinator
  • CDC = Centers for Disease Control and Prevention
  • CDS = Clinical Decision Support
  • CHIP = Children's Health Insurance Program
  • CMS = Centers for Medicare & Medicaid Services
  • FDA = Food and Drug Administration
  • FFS = fee-for-service
  • GLOBE = Global Benchmark for Efficient Drug Pricing Model
  • GUARD = Guarding U.S. Medicare Against Rising Drug Costs
  • HHS = Department of Health and Human Services
  • HPV = human papillomavirus
  • HRSA = Health Resources and Services Administration
  • NIH = National Institutes of Health
  • NINDS = National Institute of Neurological Disorders and Stroke
  • OAPs = outcome-aligned payments
  • OBBBA = One Big Beautiful Bill Act
  • OLC = Office of Legal Counsel
  • SaMD = Software as a Medical Device
  • VA = Department of Veterans Affairs

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