Blog | 2/6/2026

Sharp Strategy Spotlight: February 6, 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 February 5, 2026. The details and broad themes may have changed.

KEY HEALTH NEWS (Global)

Global Health Funding in the FY 2026 National Security, Department of State and Related Programs (NSRP) Conference Bill & Explanatory Statement

  • On February 3, 2026, the President signed the “Consolidated Appropriations Act, 2026” which includes funding provided in the FY 2026 National Security, Department of State and Related Programs (NSRP) appropriations bill and accompanying explanatory statement detailed below.
  • Decreased: Funding for the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund), bilateral HIV, tuberculosis (TB), global health security, neglected tropical diseases (NTDs), and vulnerable children declined; while the Global Fund accounted for the largest decrease (-$400 million or -24%), this funding supports the administration’s pledge of $4.6 billion for the eighth replenishment and serves as the first installment of that pledge. In addition, the explanatory statement accompanying the bill states that there are also “sufficient unobligated balances” from prior Acts “to fulfill the United States pledge for the seventh replenishment.”
  • Remained Flat: Funding for malaria, maternal and child health (MCH), nutrition, and family planning and reproductive health (FP/RH) remained flat.
  • Analysis: https://www.kff.org/global-health-policy/global-health-funding-in-the-fy-2026-national-security-department-of-state-and-related-programs-nsrp-conference-bill-explanatory-statement/

Global Health Funding in the FY 2026 Labor, Health and Human Services, Education, and Related Agencies (Labor HHS) Conference Bill & Accompanying Report

  • On February 3, 2026, the President signed the “Consolidated Appropriations Act, 2026” which includes funding provided in the FY 2026 Labor, Health and Human Services, Education, and Related Agencies (Labor HHS) conference bill and accompanying report detailed below.
  • Funding for global health in the Labor HHS bill remained flat compared to the FY 2025 level as follows:
    • CDC: Funding for global health programs at CDC totals $693 million, the same level as the FY 2025 enacted amount. Within CDC, funding for each specific global health program area was also maintained at the FY 2025 level.
    • NIH: Funding for global health research activities at the Fogarty International Center (FIC) at NIH totals $95 million, the same level as the FY 2025 enacted amount.
  • Analysis: https://www.kff.org/global-health-policy/global-health-funding-in-the-fy-2026-labor-health-and-human-services-education-and-related-agencies-labor-hhs-conference-bill-accompanying-report/

New York City Partners with W.H.O. as U.S. Withdraws From Global Effort

KEY FEDERAL GOVERNMENT NEWS

White House Debuts Drug-Buying Site TrumpRx, With Roughly 40 Medications

  • The White House on Thursday launched its drug-pricing website, dubbed TrumpRx, the culmination of efforts by the administration to bring down pharmaceutical costs for some consumers.
  • When it launched, it had roughly 40 drugs available, including obesity treatments Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound and infertility treatments such as Gonal-F from EMD Serono.
  • The prices for the drugs on TrumpRx were generally much lower than their sticker price, with President Trump touting some discounts of hundreds of dollars a month.
  • The website, TrumpRx.gov, allows customers to search for specific medicines and purchase them through a manufacturer’s direct-to-consumer site, or in some cases gives users coupons that they can present at certain pharmacies.
  • The website likely won’t have a substantial impact on the amount most Americans pay for their prescriptions, as most of Americans are insured—either through private or government plans—and are likely to get a better deal on the drugs via their coverage.
  • The roughly 27 million Americans who are uninsured are those most likely to benefit from the direct-to-consumer offerings.
  • https://www.wsj.com/health/pharma/trump-rx-drug-website-dd69f565  (subscription required for full text)

Trump signs $1.2T spending package that funds HHS, enacts PBM reforms, telehealth and hospital-at-home measures

  • President Donald Trump on Tuesday afternoon signed a massive funding package that ends a brief government shutdown and provides full-year funding for the federal government through the end of the year.
  • The House voted earlier in the day to pass the package by a vote of 217-214.
  • As part of negotiations between Senate Democrats and the White House, the House moved forward to vote on a package that included five appropriations bills while splitting off a funding bill for the Department of Homeland Security (DHS). The legislation will provide temporary funding to DHS for two weeks to allow both parties to try to hash out a deal to impose new restrictions on federal immigration enforcement. Senate Democrats demanded time to negotiate new oversight policies for immigrant [sic] agents after two recent fatal shootings in Minneapolis.
  • The stalled funding package includes $116.6 billion in discretionary funding for the Department of Health and Human Services and reduces spending on "federal bureaucracy" at the agency by $100 million, according to a fact sheet from the House Appropriations Committee.
  • The legislation also finalizes several key healthcare extenders including provisions of the Medicare telehealth program and the Acute Hospital Care at Home waiver as well as major supplementary funding programs for rural hospitals and those with high proportions of government-covered patients. The bill provides a five-year extension of the Acute Hospital Care at Home program and a two-year extension for Medicare telehealth flexibilities. The telehealth provisions in the bill include removing Medicare’s geographic requirements for telehealth and expanding the types of practitioners able to furnish telehealth services for the government health program.
  • Press: https://www.fiercehealthcare.com/providers/partial-government-shutdown-looms-threatening-stall-health-funding-package-telehealth
  • House Appropriations Committee Factsheet: https://appropriations.house.gov/sites/evo-subsites/republicans-appropriations.house.gov/files/evo-media-document/final-fy26-lhhs-minibus-4-summary.pdf
  • Consolidated Appropriations Act: https://www.congress.gov/bill/119th-congress/house-bill/7148/related-bills

Rare pediatric PRV program reauthorized until 2029 via government funding law

  • President Donald Trump on Tuesday signed the government funding extension that also reauthorized the FDA’s ability to issue rare pediatric priority reviews through 2029, reviving an incentive program that industry has fought to keep.
  • The program expired in late 2024 after providing transferable vouchers for a dozen years to companies that won approval for drugs to treat rare pediatric illnesses, including certain cancers and genetic diseases. The vouchers can be used to speed approval of a future drug and can also be sold. In recent years, they’ve often gone for more than $100 million each.
  • The reauthorization has lingered for more than a year, but the FDA has continued to award PRVs that had already received rare pediatric designations prior to the program’s sunsetting in December 2024. The FDA issued at least three PRVs last year.
  • Congress was slow in reauthorizing the program, mostly because it had to be attached to a wider bill, with the Senate most recently failing to pass it in late 2025 despite bipartisan support.
  • https://endpoints.news/rare-pediatric-prv-program-reauthorized-until-2029-via-government-funding-law/   (subscription required for full text)

NIH Chief Details Plans for Modernization at Senate Hearing

  • The NIH must be structurally overhauled to deliver more cures, spend taxpayer dollars more wisely, and regain public trust, NIH Director Jay Bhattacharya, MD, PhD, said Tuesday during a Senate hearing on modernizing the agency.
  • In the wide-ranging Senate Committee on Health, Education, Labor, and Pensions hearing, Bhattacharya outlined his plan to make NIH more accountable, better coordinated, and more focused on measurable impact for patients.
  • "Meaningful reforms that increase transparency, strength, and scientific rigor, and ensure accountability are necessary to bolster the NIH's ability to meet America's current and future public health needs," Bhattacharya said. "As science itself evolves, so too must the structures that support it."
  • Sen. Bill Cassidy, MD (R-La.), the committee's chair, broadly agreed about the need for reform but warned that modernization should not also destabilize the nation's premier biomedical research agency.
  • Bhattacharya emphasized reforms already underway at NIH, including centralized peer review to reduce duplication, a new analytic office in the Office of the Director to address the replication crisis, and a unified funding strategy to better align investments with national health priorities. He also called for stronger federal oversight to "ensure that NIH-funded research does not lead to significant adverse social consequences" and said portfolios under his leadership would be evaluated by their impact on disease and population health, not publication count.
  • "We also need to move the needle and incentivize high-risk, high-reward research," he said. Research "will be judged by their success at curing disease, improving population health, and creating fundamental scientific breakthroughs, rather than simply how many scientific papers each project yields," he added.
  • Press: https://www.medpagetoday.com/washington-watch/washington-watch/119722
  • Video link: https://www.help.senate.gov/hearings/modernizing-the-national-institutes-of-health-faster-discoveries-more-cures

HHS plans to invest $100M to support addiction recovery and address homelessness

  • The Department of Health and Human Services (HHS) will invest $100 million to improve homelessness, opioid addiction and public safety, it announced Monday.
  • The department's initiative is dubbed STREETS, or Safety Through Recovery, Engagement and Evidence-based Treatment and Supports. STREETS will fund targeted outreach, psychiatric care, medical stabilization and crisis intervention for individuals experiencing homelessness and substance use disorder (SUD).
  • The program is part of President Donald Trump’s new Great American Recovery Initiative, which aims to drive stronger coordination across government, the healthcare sector, faith communities and the private sector to address the crisis.
  • Additionally, RFK Jr. announced a $10 million Assisted Outpatient Treatment (AOT) program to support adults with serious mental illness. AOT is a civil court-ordered, community-based outpatient mental health treatment program. This type of treatment reduces hospitalizations and lowers incarceration and homelessness, RFK Jr. said at the event. No other details about how the program would work or to whom the funds would go were provided in the announcement.
  • Press: https://www.fiercehealthcare.com/regulatory/hhs-invests-100m-support-addiction-recovery-homelessness
  • HHS Press: https://www.hhs.gov/press-room/secretary-kennedy-announces-100-million-investment-great-american-recovery.html

CMS Finalizes Rule Closing Medicaid Provider Tax Loophole

  • The Centers for Medicare & Medicaid Services (CMS) has finalized a major Medicaid financing rule aimed at closing what the agency has described as a long-standing “healthcare-related tax loophole.” The rule, finalized on January 29, 2026, implements statutory changes enacted last summer and significantly restricts how states may use provider and managed care organizations (MCO) taxes to fund their share of Medicaid expenditures.
  • According to CMS, the affected financing arrangements have generated roughly $24 billion annually for a small number of states and shifted and [sic] increasing share of Medicaid costs onto the federal government. CMS estimates the final rule will save more the $78 billion over the next decade.
  • How the Loophole Developed
    • CMS concluded that some states structured provider and MCO taxes in a way that technically passed the statistical test while undermining its purpose.
  • What the Final Rule Does
    • The final rule closes these pathways by reinforcing statutory guardrails and prohibiting structures CMS views as exploitative.
  • Analysis: https://www.jdsupra.com/legalnews/cms-finalizes-rule-closing-medicaid-4904953/
  • CMS Press: https://www.cms.gov/newsroom/fact-sheets/preserving-medicaid-funding-vulnerable-populations-closing-health-care-related-tax-loophole-final

New data shows how HHS is implementing Trump AI mandates

  • The Department of Health and Human Services is rapidly acquiring and integrating artificial intelligence tools, according to recently released data from the agency’s technology office.
  • The data give a first look into how HHS is implementing directives to aggressively implement AI across the government under President Trump’s revamped federal AI plans. Information in the data release also shed light on how the Trump administration plans to implement new programs with thousands fewer HHS staff than it had a year ago.
  • Notably, even though memos on how to implement President Trump’s January 2025 executive order on AI promised more transparency on high-impact AI use cases, HHS’ data release does not answer questions about monitoring AI tools to identify adverse impacts, appeal processes, and incorporating feedback from users and the public. Rules from the Trump administration require that such assessments be completed for “high-impact” AI use cases.
  • Press: https://www.statnews.com/2026/02/03/new-data-shows-how-hhs-is-implementing-trump-ai-mandates/   (subscription required for full text)
  • HHS Data: https://www.hhs.gov/programs/topic-sites/ai/use-cases/index.html

FDA Removes Warning Page About Dangerous Autism Treatments

  • The FDA removed a webpage that warned consumers about potentially dangerous products and therapies marketed as autism treatments.
  • An archived version of the page said the agency had warned or taken action against companies that made improper claims that their products could treat or cure autism or autism-related symptoms.
  • The page warned that "some of these so-called therapies carry significant health risks," citing chelation therapy, hyperbaric oxygen therapy, detoxifying clay baths, and products including raw camel milk and Miracle Mineral Solution (chlorine dioxide).
  • The page was removed at the end of 2025, an HHS spokesperson told MedPage Today. The article had not been updated since 2019 and "was retired along with other older articles" as part of "routine housekeeping," the spokesperson said.
  • The spokesperson did not say whether the warning page will be updated soon or whether the FDA still regards the treatments as potentially dangerous.
  • https://www.medpagetoday.com/neurology/autism/119734

NIH looks to turn primate research center into a sanctuary

  • The National Institutes of Health wants to transition at least one of seven national primate research centers into an animal sanctuary, aiming to move away from animal testing in favor of alternative methods.
  • The NIH-funded centers, hosted by universities and research institutions, conduct primate research on conditions and diseases that affect human health. They have been a primary target of animal rights organizations, like People for the Ethical Treatment of Animals.
  • The NIH approached the Oregon Health & Science University, which operates one of the centers, about the move, offering to potentially help finance the transition. The university’s board of directors will hold a public meeting Monday to consider negotiationing with NIH about the potential change.
  • NIH Director Jay Bhattacharya confirmed the plans to POLITICO in an interview last week.
  • “We’re working to transition at least one of them,” he said of the seven centers.
  • It’s not clear whether the agency will pursue similar moves at the other six centers or why it selected the Oregon National Primate Research Center.
  • https://www.politico.com/news/2026/02/04/nih-is-looking-to-turn-a-primate-research-center-into-a-sanctuary-00765449

FDA opens submissions for PreCheck program to speed up US factory builds

  • The FDA has started accepting pitches for drugmakers to participate in the agency’s PreCheck program, a new initiative aimed to speed up the construction of US manufacturing sites.
  • The agency said it will select an initial cohort of facilities for the program based on the medicines the site will manufacture, the status of the building’s construction, and the site’s ability to quickly produce products for the US market. The FDA will prioritize factories that will produce “critical” drugs for the US, according to a Sunday press release.
  • The agency’s PreCheck program, announced last August, is a two-phase approach. The first phase will allow drug manufacturers to communicate with the FDA earlier, before a facility is operational, through “pre-operational reviews.” The second phase will involve pre-submission meetings between the agency and manufacturers to resolve any factory-related issues.
  • The FDA said Sunday it will begin “conducting PreCheck activities” this year.
  • Press: https://endpoints.news/fda-opens-submissions-for-precheck-program-to-speed-up-us-factory-builds/   (subscription required for full text)
  • FDA Press: https://www.fda.gov/news-events/press-announcements/fda-launches-precheck-pilot-program-strengthen-domestic-pharmaceutical-manufacturing

HHS launches $100M antiviral prize to develop broad-spectrum therapies

  • As the Trump administration continues to pivot away from vaccinations, it is pushing for the development of new antiviral therapies via the launch of a $100 million competition.
  • The inaugural Small Molecule Approaches for Rapid and Robust Treatment (SMART) Prize was unveiled by the Biomedical Advanced Research and Development Authority (BARDA), an initiative within the Administration for Strategic Preparedness and Response (ASPR), in collaboration with VITAL, BARDA’s therapeutics and vaccines accelerator hub.
  • The SMART Prize will target the development of broad-spectrum, small-molecule antiviral therapies targeting viruses in the Togaviridae and Flaviviridae families.
  • The competition is meant to unite experts in drug development, virology, artificial intelligence, medicinal chemistry and public health to develop easily accessible and resilient antiviral drugs that can target multiple viruses within the same family.
  • The first stage of the SMART Prize solicits concept papers describing plans to discover or advance broad-spectrum small-molecule antivirals for the Togaviridae and Flaviviridae families.
  • Future stages of the competition include identifying drug candidates that show reproductive antiviral activity, optimizing drug features and selecting a candidate for studies used to submit investigational new drug applications.
  • Press: https://www.fiercebiotech.com/biotech/hhs-launches-100-million-antiviral-prize-develop-broad-spectrum-therapies
  • BARDA Press: https://vitalhubhealth.com/smart-antiviral-prize/

KEY REVERSALS – RESCINDED ITEMS - LAWSUITS

Planned Parenthood drops challenge over Trump administration Medicaid cuts

  • The Planned Parenthood Federation of America (PPFA) has filed to voluntarily dismiss its lawsuit against the Trump administration that sought to challenge the decision to cut off Medicaid funding to abortion providers.
  • The PPFA on Friday filed a notice of voluntary dismissal in the U.S. District Court of Massachusetts.
  • The organization filed its lawsuit in July of last year after President Trump signed the GOP’s budget reconciliation bill, which included a section that disallowed federal funding from going to abortion providers.
  • The PPFA sought to have this portion of the bill declared unconstitutional and sought to exclude Planned Parenthood members that do not provide abortions.
  • “The goal of this lawsuit has always been to help Planned Parenthood patients get the care they deserve from their trusted provider. Based on the 1st Circuit’s decision, it is clear that this lawsuit is no longer the best way to accomplish that goal,” the PPFA, Planned Parenthood League of Massachusetts and Planned Parenthood Association of Utah said in a joint statement.
  • A network of medical clinics in Maine filed a similar lawsuit last year challenging the funding cuts. This lawsuit was filed around the same time as the PPFA’s, seeking appeals in the U.S. Court of Appeals for the 1st Circuit.
  • After plaintiffs were denied their requested preliminary injunction, they moved to halt legal proceedings in October. At the time, they also cited the fact that the federal government had shut down and attorneys for the government were unable to work. Attorneys for the plaintiffs stated in court filings that they did not plan to appeal to the Supreme Court, and they ultimately filed a notice of voluntary dismissal in December.
  • The PPFA cited this unfavorable legal outcome in their decision to voluntarily dismiss their own lawsuit.
  • https://thehill.com/policy/healthcare/5719397-planned-parenthood-lawsuit-dismissal-trump

Newsom files a civil rights complaint against Dr. Oz over allegations of hospice fraud

  • California Gov. Gavin Newsom’s office is demanding a civil rights investigation of Dr. Mehmet Oz, saying he discriminated against Armenians in a video claiming hospice fraud in Los Angeles, the latest front in the state’s ongoing battle with the Trump administration.
  • The Democratic governor’s complaint, filed Thursday, came after Oz posted a video on social media in front of an Armenian bakery in Los Angeles, alleging that roughly $3.5 billion in hospice and home care fraud has taken place in the city and “quite a bit of it” was run by “the Russian Armenian mafia.”
  • Oz is the administrator for the Centers for Medicare and Medicaid Services, which certifies hospice providers to accept patients on government-subsidized health insurance.
  • Newsom’s office argued in the complaint that Oz “spewed baseless and racially charged allegations” that risked chilling participation in hospice and home care programs among the community targeted. His office said the claims had “already caused real-world harm” by dampening business at an Armenian bakery that is shown in the video.
  • Oz in a post on X accused Newsom of trying to change the subject and failing to talk about Medicare fraud, though Medicare is a federally administered program.
  • “The problem isn’t isolated to California, though as far as our team can tell, it is the worst,” Oz said. He hasn’t shared details about the fraud being alleged.
  • https://apnews.com/article/dr-oz-newsom-fraud-medicare-hospice-trump-611ee3156c37f2cff70190fb417a694d

Texas and Eight Other States Renew Attack on Section 504 and the Right of Disabled People to Live in their Communities

  • A lawsuit targeting a landmark disability law has received new life after nine states filed an update that seeks to undercut federal mandates that people with disabilities receive care in their communities.
  • Texas, Florida, and seven other states allege that the Biden administration’s 2024 update to Section 504 of the Rehabilitation Act of 1973 is unconstitutional — specifically, the requirement that states must fund services in the “most integrated setting.”
  • Section 504 prohibits discrimination against people with disabilities in any setting that receives federal financial assistance, including health care facilities. Disability advocates say a retreat from this protection could eventually funnel people requiring long-term care back into facilities that sequestered them from society and that they fought for decades to escape.
  • Press: https://www.statnews.com/2026/01/29/states-lawsuit-challenge-section-504-rehabilitation-act   (subscription required for full text)
  • Lawsuit: https://dredf.org/wp-content/uploads/2026/01/89.-Am.-Compl.-1.23.26-Access-Pass.pdf

KEY BIOPHARMA NEWS

PBM Reform Within 2026 Appropriations Bill Signed Into Law

  • Key reforms to pharmacy benefit managers (PBM) have been codified as part of HR 7148, the Consolidated Appropriations Act of 2026, which was passed by Congress and signed by President Donald Trump in the Oval Office on February 3, 2026.
  • The bill contains key provisions of HR 4317, the PBM Reform Act of 2025, which aims to foster transparency, increase pharmacy access, and reform the business practices of PBMs within Medicare and Medicaid.
  • What Reforms Are in the Legislation?
    • Health Plan Transparency
    • PBM Accountability for Medicare Part D Beneficiaries
    • “Any Willing Pharmacy” Protections
  • Analysis: https://www.pharmacytimes.com/view/pbm-reform-within-2026-appropriations-bill-signed-into-law
  • PBM Reform Act of 2025: https://www.congress.gov/bill/119th-congress/house-bill/4317/text

FDA signals tailored approach to ‘carefully shepherd’ CAR-T therapy for autoimmune diseases

  • As the first CAR-T treatment for an autoimmune disease draws ever closer, officials at the FDA have signaled a willingness to support the development of these novel cell therapies with a flexible regulatory approach.
  • While interested in CAR-T therapies’ potential to achieve durable, drug-free remission in serious autoimmune conditions, the FDA is equally wary of their “unpredictable long-term toxicity,” according to an article published Monday in the Annals of Internal Medicine.
  • In the article, Vinay Prasad, M.D., director of the FDA’s Center for Biologics Evaluation and Research, and two other regulators said that, recognizing the complexity of autoimmune conditions in terms of seriousness and type, the agency will work with CAR-T makers “on a case-by-case basis to encourage appropriate study populations in rheumatologic autoimmune disease.”
  • Simultaneously, citing a need to monitor a drug’s effect on fertility, the FDA officials recommended that industry conduct long-term follow-up studies for CAR-T products in the autoimmune setting, “as is standard for genetic therapies and CAR T-cells for oncologic indications.”
  • While the FDA “shares enthusiasm for this class of products,” it will “carefully shepherd” the advancement of clinical studies “focused on the development, durability, and long-term safety of CAR T-cell therapies,” the regulators wrote.
  • Press: https://www.fiercebiotech.com/biotech/fda-signals-tailored-approach-carefully-shepherd-car-t-therapy-autoimmune-diseases
  • Paper: https://www.acpjournals.org/doi/10.7326/ANNALS-25-04559   (subscription required for full text) 

Senators raise concerns about TrumpRx in letter to HHS watchdog

  • The Trump administration soon plans to launch TrumpRx, a website it says will allow patients to buy prescription drugs directly from pharmaceutical companies at a discount. Over several months, the administration has made deals with more than a dozen pharmaceutical manufacturers to expand access to their drugs through the platform.
  • On Thursday, Sens. Dick Durbin (D-Ill.), Elizabeth Warren (D-Mass.), and Peter Welch (D-Vt.) sent a letter to the Office of Inspector General at the Department of Health and Human Services raising questions about TrumpRx — whose structure has yet to be described in detail — and the direct-to-consumer platforms that patients may be funneled toward in search of the lower costs touted by the website.
  • “Legitimate concerns about inappropriate prescribing, conflicts of interest, and inadequate care have been raised about the exact types of DTC platforms to which TrumpRx would route patients,” the senators wrote in the letter.
  • Press: https://www.statnews.com/2026/01/29/trumprx-concerns-in-senators-letter-to-hhs-watchdog   (subscription required for full text)
  • Letter: https://www.durbin.senate.gov/imo/media/doc/durbin_hhs_oig_letter_on_trumprx.pdf

The CLEAR LABELS Act Proposes Changes to the U.S. Prescription Drug Supply Chain

  • Senator Rick Scott introduced the Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act (the “CLEAR LABELS Act” or “Act”).
  • If passed and enacted, the Act would require all prescription medications dispensed in the United States to include clear labeling that identifies the country, or countries, of origin of both the finished drug product and its individual active pharmaceutical ingredients (“APIs”).
  • The proposed legislation would :
    • Labeling Requirement: require drug manufacturers to clearly display, for each included API in a finished drug product, the name and location of the API’s original manufacturer, packer, and distributor. This information would need to appear on all prescription labels provided to consumers.
    • Reporting and Accountability: require FDA to maintain and update a publicly accessible electronic database of country of origin information for all APIs used in prescription drugs approved for use in the U.S.
    • Enhanced Oversight: support existing FDA oversight efforts to strengthen monitoring, inspections, and enforcement against manufacturing practices that could impact drug quality or safety.
  • Analysis: https://www.jdsupra.com/legalnews/the-clear-labels-act-proposes-changes-2910929/
  • Press release: https://www.medpagetoday.com/washington-watch/washington-watch/119677

KEY DIAGNOSTICS – LIFE SCIENCE RESEARCH NEWS

PAMA Clinical Lab Cuts Delayed Again in Federal Spending Bill

KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS

ASTP issues RFI on diagnostic imaging accessibility

  • The U.S. Department of Health and Human Services is issuing a request for information, seeking ways to improve the access, exchange and use of electronic imaging information through the ONC Health IT Certification Program.
  • WHY IT MATTERS
    • The RFI from the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology was announced with an ASTP/ONC blog post on Thursday.
    • The request, Diagnostic Imaging Interoperability Standards and Certification, invites the public to comment on how standards and certification criteria can support the exchange of diagnostic images for the benefit of patients and providers.
    • The agency's leader has deep experience with medical imaging and said he wants to make diagnostic image data more accessible to the providers and patients who need them.
  • Most providers have moved from films to picture archiving and communication systems (PACS), but the sharing of medical images between different institutions is still a challenge. The secure exchange of medical images requires cloud-based image-sharing platforms, encrypted PACS-to-PACS and potentially virtual private networks – which still leaves many providers still asking patients to bring along physical media, like CDs.
  • With high-resolution 3D imaging medical images, such as CT scans, relying on the Digital Imaging and Communications in Medicine (DICOM) imaging standard, the file sizes can be massive.
  • Press: https://www.healthcareitnews.com/news/astp-issues-rfi-diagnostic-imaging-accessibility
  • Federal Register: https://www.federalregister.gov/documents/2026/01/30/2026-01866/request-for-information-diagnostic-imaging-interoperability-standards-and-certification

KEY MEDTECH NEWS

FDA reissues cybersecurity guidance to align with QMSR

Key Acronyms

  • ACA = Affordable Care Act
  • AOT = Assisted Outpatient Treatment
  • ASPR = Administration for Strategic Preparedness and Response
  • BARDA = Biomedical Advanced Research and Development Authority
  • CDC = Centers for Disease Control and Prevention
  • CMS = Centers for Medicare & Medicaid Services
  • DHS = Department of Homeland Security
  • FDA = Food and Drug Administration
  • HHS = Department of Health and Human Services
  • MCO = managed care organization
  • NIH = National Institutes of Health
  • NSRP = National Security, Department of State and Related Programs
  • PAC = picture archiving and communication system
  • PAMA = Protection Access to Medicare Act
  • PBM = pharmacy benefit manager
  • PPFA = Planned Parenthood Federation of America
  • QSMR = Quality System Management Regulation
  • QSR = Quality System Regulation
  • RFI = request for information
  • SMART = Small Molecule Approaches for Rapid and Robust Treatment
  • STREETS = Safety Through Recovery, Engagement and Evidence-based Treatment and Supports
  • WHO = World Health Organization

Share this: