Regulation

88 items from the daily briefing

Regulators, payers and courts: FDA, CMS and Medicare, HHS, Congress, the states, and who gets sued. Each item links to the day it ran and to its original source.

WatchRegulation Nov 6, 2026
FDA asks how to weigh the benefits and risks of robots that operate on their own or are run from afar
FDA takes feedback on docket FDA-2026-N-13135 through Jan. 5, 2027, and will discuss the paper at a Dec. 2 to 3 workshop.
General surgeryHospitals
From the Nov 9, 2026 post · Sources: FDA, FDA (workshop notice), FDA (draft guidance)
FYIRegulation Nov 5, 2026
FDA grants accelerated approval to subcutaneous amivantamab for head and neck cancer after platinum and immunotherapy, with a 42% response rate
Oncology Otolaryngology
From the Nov 9, 2026 post · Source: FDA
WatchRegulation Nov 5, 2026
Medicare proposes scrapping hospital obstetric and emergency readiness training rules and asks about loosening CRNA supervision
CMS proposes removing hospital obstetric training and quality rules that would otherwise take effect Jan. 1, 2027.
HospitalsRural
From the Nov 6, 2026 post · Source: CMS fact sheet
FYIRegulation Nov 5, 2026
FDA clears PulseAI's model that reads atrial fibrillation on smartwatch and other wearable ECGs
Cardiology
From the Nov 6, 2026 post · Source: PulseAI release
ActRegulation Nov 4, 2026
Medicare cuts the physician conversion factor 2.31% for 2027 and pays 20% less for visits billed the same day as minor procedures
The new conversion factors, the B1 and B2 visit modifiers and the same-day reduction apply from Jan. 1, 2027, under the final rule.
All physicians
From the Nov 5, 2026 post · Sources: CMS fact sheet, CMS press release, Medical Economics, Chief Healthcare Executive
ActRegulation Nov 4, 2026
Medicare limits remote monitoring to established patients and delays its ban on outside monitoring vendors to 2029
From Jan. 1, 2027, Medicare pays remote monitoring only for established patients after a separately billable initiating visit, the final rule says.
PracticesRural
From the Nov 5, 2026 post · Sources: CMS fact sheet, American Hospital Association
WatchRegulation Nov 4, 2026
Federal regulators push out two surprise-billing arbitrators, one of which sided with clinicians in 89% of 2023 cases
Both firms may appeal within 30 business days, and the departments are reviewing eight more firms' recertification petitions.
Emergency medicine Anesthesiology
From the Nov 5, 2026 post · Sources: CMS No Surprises Act notices, Health Affairs Scholar
FYIRegulation Oct 30, 2026
Epic says hospitals will keep its AI model documentation and evaluation tools after HHS dropped the federal requirement
Hospitals
From the Nov 2, 2026 post · Source: Becker's Hospital Review
FYIRegulation Oct 30, 2026
FDA authorizes Virtuoso's endoscopic surgery robot, whose needle-sized arms work through a rigid endoscope
Hospitals
From the Nov 2, 2026 post · Sources: FDA De Novo database, DEN250054, Virtuoso Surgical
FYIRegulation Oct 30, 2026
FDA approves Voceryq, the first plasmid DNA immunotherapy, for adults with recurrent respiratory papillomatosis
Otolaryngology
From the Oct 31, 2026 post · Source: FDA
FYIRegulation Oct 29, 2026
AMA says physicians should answer only for AI judgments they can meaningfully exercise, not errors they cannot detect
All physicians
From the Oct 30, 2026 post · Sources: American Medical Association, AMA framework page, Becker's Hospital Review
WatchRegulation Oct 29, 2026
Judge blocks Medicare and Medicaid agency's stricter test for 'medically frail' patients weeks before Medicaid work requirements start
Medicaid work requirements for expansion enrollees aged 19 to 64 begin Jan. 1; HHS and CMS had not commented on the ruling, the AP reported.
Primary careHospitals
From the Oct 30, 2026 post · Sources: PBS NewsHour (Associated Press), STAT
WatchRegulation Oct 28, 2026
HHS will let physicians and pharmacies compound BPC-157, TB-500 and four other unapproved peptides without FDA enforcement
HHS says the policy lasts until a final rule on the 503A bulks list and may be revisited if safety signals arise.
All physicians
From the Oct 29, 2026 post · Sources: HHS, The Independent
WatchRegulation Oct 26, 2026
HHS finalizes HTI-5, dropping the AI 'model card' requirements for decision support tools in certified health record software
The rule is scheduled for Federal Register publication Oct. 28 and takes effect 60 days later; some changes start Jan. 1, 2027.
HospitalsPractices
From the Oct 27, 2026 post · Sources: Federal Register (public inspection), Final rule text (PDF), HHS, ASTP/ONC, Fierce Healthcare, Healthcare Innovation
FYIRegulation Oct 23, 2026
FDA clears Coreline Soft software that segments the aorta on chest CT and measures its diameter by zone
Radiology Cardiology
From the Oct 26, 2026 post · Source: Coreline Soft release (PR Newswire)
FYIRegulation Oct 22, 2026
FDA clears RIVANNA machine learning module that color-codes bone on automated musculoskeletal ultrasound
Radiology Orthopedic surgery
From the Oct 26, 2026 post · Source: RIVANNA release (BioSpace)
FYIRegulation Oct 20, 2026
HHS plans a no-bid award to keep its workforce on Anthropic's Claude until it competes an enterprise AI contract
All physicians
From the Oct 24, 2026 post · Sources: FedScoop, Becker's Hospital Review
ActRegulation Oct 20, 2026
FDA adds five Olympus devices, including a capsule endoscope and two bronchovideoscopes, to an import block and posts a warning letter
FDA asks providers to check model numbers against its Oct. 20 table; devices already in use may continue if they show no problems.
Gastroenterology Pulmonary and critical care
From the Oct 24, 2026 post · Sources: FDA, MedTech Dive
FYIRegulation Oct 21, 2026
Australian regulator finds eight of 12 AI scribes it reviewed likely meet the definition of a medical device; none of their makers said so
Practices
From the Oct 24, 2026 post · Sources: Healthcare IT News, The Medical Republic
WatchRegulation Oct 21, 2026
FDA digital health chief says draft generative AI device guidance is coming; device center lost about 22% of its staff
Abramson said FDA draft guidance on generative AI devices will come in the coming months; he set no date.
All physicians
From the Oct 23, 2026 post · Sources: MedTech Dive (generative AI policy), MedTech Dive (CDRH staffing)
FYIRegulation Oct 21, 2026
FDA approves Edwards' Pascal Precision system for transcatheter repair of severe tricuspid regurgitation
Cardiology
From the Oct 23, 2026 post · Sources: Edwards Lifesciences, TCTMD
FYIRegulation Oct 19, 2026
Hospital association asks FDA to make developers primarily responsible for monitoring generative AI devices after they are sold
HospitalsRural
From the Oct 22, 2026 post · Sources: American Hospital Association, AHA letter (PDF), Becker's Hospital Review
WatchRegulation Oct 21, 2026
Amazon, Google, Meta, Oracle and Axon back extending electronic prior authorization to self-funded employer plans
Certain payers under CMS's interoperability and prior authorization rule must implement electronic prior authorization by Jan. 1, 2027, CMS said.
PracticesHospitals
From the Oct 22, 2026 post · Source: CMS
FYIRegulation Oct 21, 2026
FDA clears Elucid's FFR-IQ, which estimates fractional flow reserve from coronary CT angiography using plaque features
Cardiology Radiology
From the Oct 22, 2026 post · Sources: Elucid (Business Wire), HIT Consultant, Diagnostic Imaging
FYIRegulation Oct 20, 2026
FDA clears NeuroXT's NEXT-Cue, AI software for assessing whether mild cognitive impairment will progress to Alzheimer's dementia
Neurology
From the Oct 22, 2026 post · Source: NeuroXT (PR Newswire)
FYIRegulation Oct 20, 2026
FDA finalizes guidance on when apps sold with prescription drugs belong in the drug's prescribing information
All physicians
From the Oct 21, 2026 post · Sources: FDA, Federal Register
WatchRegulation Oct 15, 2026
CMS deputy administrator says "a lot of things" about WISeR, Medicare's AI prior-authorization pilot, are not working
CMS has published no changes to WISeR, which is scheduled to run through Dec. 31, 2031, according to the Congressional Research Service.
PracticesOrthopedic surgeryArizonaNew JerseyOhioOklahomaTexasWashington
From the Oct 19, 2026 post · Sources: Nextgov/FCW, Congressional Research Service, WISeR overview, Becker's Payer Issues
FYIRegulation Oct 16, 2026
FDA clears Sequel's twiist automated insulin delivery system for adults with insulin-treated type 2 diabetes
EndocrinologyPrimary care
From the Oct 19, 2026 post · Sources: Sequel Med Tech release, Healio, MassDevice
FYIRegulation Oct 15, 2026
FDA clears SimBioSys software that estimates breast cancer recurrence risk from MRI, pathology and clinical data
Oncology Radiology
From the Oct 18, 2026 post · Source: SimBioSys release (BioSpace)
FYIRegulation Oct 13, 2026
AMA framework says AI agents taking on clinical functions must earn authority through evidence and keep it through performance
All physicians
From the Oct 16, 2026 post · Sources: American Medical Association, AMA framework (PDF), Healthcare Dive
WatchRegulation Oct 14, 2026
States ask bankruptcy court to make any Character.AI buyer remove bots posing as therapists, doctors and other licensed professionals
The states reserved the right to object to any sale, bidding procedures or plan in the Delaware bankruptcy case, their Oct. 14 notice says.
Psychiatry Pediatrics
From the Oct 16, 2026 post · Sources: States' notice of interest, Michigan Advance
WatchRegulation Oct 14, 2026
Medical board federation drafts guidelines for AI working with little or no physician supervision; AMA, AHA, Anthropic and Elevance sit on the panel
A draft could be public in weeks to months and will be open for feedback before formal adoption, the federation said, according to STAT.
All physicians
From the Oct 15, 2026 post · Sources: STAT, Becker's Hospital Review
WatchRegulation Sept 8, 2026
Repeal of Medicare's breakthrough-device pathway to add-on payments will likely disadvantage independent AI developers, authors say
The final rule ends the pathway after fiscal 2029 applications; devices designated by Sept. 30, 2026, need authorization by May 1, 2028.
Hospitals
From the Oct 14, 2026 post · Sources: NEJM AI, Federal Register: FY 2027 IPPS final rule, Federal Register: FY 2027 IPPS proposed rule, eCFR: 42 CFR 412.87, CMS: FY 2027 IPPS final rule page
FYIRegulation Oct 5, 2026
FDA clears Click Therapeutics' Motivista app, the first authorized treatment for negative symptoms of schizophrenia
Psychiatry
From the Oct 13, 2026 post · Sources: Fierce Biotech, Psychiatric Times, JAMA Network Open, PubMed record
WatchRegulation Oct 9, 2026
CMS-run Slack workspace of about 1,700 members gave AI and tech firms direct access to Medicare and FDA officials, KFF Health News reports
CMS has not said how apps join its Medicare App Library or when a payment program for them would start, KFF Health News reported.
All physicians
From the Oct 12, 2026 post · Source: KFF Health News
ActRegulation Oct 9, 2026
Device makers ask CMS to widen its RAPID pathway to more breakthrough devices and diagnostics before comments close Oct. 13
Public comments on CMS's proposed RAPID coverage pathway for breakthrough devices are due Oct. 13, according to MedTech Dive.
All physicians
From the Oct 12, 2026 post · Sources: AdvaMed, MedTech Dive
FYIRegulation Oct 8, 2026
FDA grants De Novo to BridgeSource's SmartRead, a handheld device that names a pacemaker or defibrillator maker in about 20 seconds
Emergency medicine Cardiology
From the Oct 12, 2026 post · Source: MassDevice
ActRegulation Oct 9, 2026
Comments close Oct. 13 on Medicare's RAPID pathway, which would propose coverage of some breakthrough devices on the day FDA authorizes them
Comments on CMS's RAPID coverage pathway notice, docket CMS-2026-2674, are due Oct. 13, according to the Federal Register.
All physicians
From the Oct 11, 2026 post · Sources: Federal Register, AdvaMed, MedTech Dive, American College of Radiology, Cooley (secondary)
FYIRegulation Oct 8, 2026
FDA clears Epic's Deterioration Index Version 2, an inpatient decline model hospitals have run inside Epic for years
Hospital medicineHospitals
From the Oct 10, 2026 post · Sources: FDA 510(k) database, Becker's Hospital Review, Innolitics
ActRegulation Oct 8, 2026
CMS and CDC propose letting pathologists review digital slides and images remotely under the testing lab's own certificate
Comments on the proposed CLIA rule are due Dec. 7, 2026, according to the Federal Register notice.
Pathology
From the Oct 9, 2026 post · Sources: Federal Register, Rural Health Information Hub
Regulation Oct 6, 2026
UK accepts all 44 recommendations on regulating health AI, shifting device oversight toward monitoring after approval
From the Oct 8, 2026 post · Sources: UK government response (MHRA), The Pharmaceutical Journal, Reuters (StreetInsider)
Regulation Oct 5, 2026
Utah approves August AI pilot to renew diabetes and heart prescriptions for $4, with a physician reviewing each renewal
From the Oct 7, 2026 post · Sources: MobiHealthNews, Healthcare Dive
Regulation Oct 6, 2026
Thirty-two House members ask CMS to reconsider proposed rule paying for remote monitoring only when a practice's own staff furnish it
From the Oct 7, 2026 post · Sources: Becker's Hospital Review, Rep. David Kustoff (H.R. 3108), AAFP (summary of the CY 2027 proposed rule)
Regulation Oct 5, 2026
FDA clears AIRS Medical's AI body-composition MRI software, aimed at wellness and whole-body imaging programs
From the Oct 7, 2026 post · Sources: AuntMinnie, Radiology Business
Regulation Oct 5, 2026
Utah lets Nolla Health's AI issue first-time acne prescriptions from a physician-approved list of topical drugs
From the Oct 6, 2026 post · Sources: MobiHealthNews, Becker's Hospital Review, STAT, Nolla Health agreement with Utah
Regulation Oct 2, 2026
CPT panel creates Category I code for AI arrhythmia analysis, adds three AI Category III codes and rejects liver, LVEDP and skin-lesion AI
From the Oct 5, 2026 post · Sources: AMA CPT Editorial Panel, September 2026 summary of panel actions, AMA summary of panel actions page, AMA Category III codes, AMA CPT process calendar
Regulation Oct 1, 2026
Palmetto and Noridian propose Medicare noncoverage for AI brain MRI quantification software in 20 states
From the Oct 5, 2026 post · Sources: Palmetto GBA proposed LCD DL40464, Noridian proposed LCD DL40454, CMS Coverage API, proposed LCDs, CGS final LCD L40224
Regulation Oct 2, 2026
FDA puts final AI device and surgical robot guidance on its fiscal 2027 A-list, with a draft on generative AI for mental disorders
From the Oct 4, 2026 post · Sources: FDA (CDRH fiscal 2027 guidance list), MedTech Dive
Regulation Oct 1, 2026
Senate passes Health Care Cybersecurity and Resilience Act by unanimous consent, with provisions for rural providers
From the Oct 4, 2026 post · Sources: Senate HELP Committee, Becker's Hospital Review, Bill text as passed by the Senate
Regulation Oct 2, 2026
Trump orders federal agencies to call artificial intelligence "super intelligence"; order sets no health care requirements
From the Oct 3, 2026 post · Sources: Federal Register (EO 14434), White House (EO 14432), Fierce Healthcare
Regulation Sept 30, 2026
FTC confirms investigation of OpenAI, Anthropic and other AI companies over possible harms from their products
From the Oct 2, 2026 post · Sources: ABC News, Becker's Hospital Review (FTC inquiry), Becker's Hospital Review (ChatGPT for Healthcare)
Regulation Sept 30, 2026
Pennsylvania House passes HB 1925, 144-59, requiring AI disclosure to patients and clinician review of AI-assisted coverage denials
From the Oct 2, 2026 post · Sources: LegiScan (HB 1925), Bill text, Printer's No. 3963, Pennsylvania House Democratic Caucus, Becker's Hospital Review
Regulation Oct 1, 2026
Alabama law requiring a physician or other clinician to make AI-assisted prior authorization denials takes effect
From the Oct 2, 2026 post · Sources: Alabama Legislature (enrolled act), LegiScan (SB 63)
Regulation Sept 30, 2026
HHS launches four ARPA-H programs to speed clinical trials with AI, digital twins and agents; funding not disclosed
From the Oct 2, 2026 post · Sources: HHS, STAT, BioSpace
Regulation Sept 30, 2026
Newsom signs AB 1979 and SB 503 on clinical AI, vetoes AB 2575's override protection and SB 903's limits on AI in psychotherapy
From the Oct 1, 2026 post · Sources: Office of the Governor of California, Governor's legislative update, Sept. 30, Veto message, SB 903, Veto message, AB 2575, LegiScan (AB 1979), LegiScan (SB 503), National Nurses United (AB 1979), National Nurses United (AB 2575), CalMatters
Regulation Sept 30, 2026
AHA asks Senate to hold AI vendors outside HIPAA to its standards and to fund cybersecurity staff for rural hospitals
From the Oct 1, 2026 post · Sources: American Hospital Association, Becker's Hospital Review
Regulation Sept 29, 2026
Kennedy tells MAHA Summit that AI gives a second opinion "much better informed than any doctor in the country"
From the Sept 30, 2026 post · Sources: The Hill, Forbes, Washington Examiner
Regulation Sept 29, 2026
Newsom's deadline arrives on four California health-AI bills, including SB 903's limits on AI marketed as therapy
From the Sept 30, 2026 post · Sources: LegiScan (SB 903), LegiScan (AB 1979), LegiScan (AB 2575), LegiScan (SB 503), Sen. Steve Padilla
Regulation Sept 29, 2026
Senate health committee schedules no vote on FDA nominee Heidi Overton; STAT reports vote waits until after midterms
From the Sept 30, 2026 post · Source: STAT
Regulation Sept 24, 2026
Senate Finance Committee advances Klomp, who said WISeR "must be done appropriately," to full vote for HHS deputy secretary
From the Sept 28, 2026 post · Sources: AHA News, STAT, Roll Call, Sen. Patty Murray (Sept. 16 hearing)
Regulation Sept 24, 2026
FDA schedules Dec. 2-3 workshop on autonomous and remotely teleoperated robots, the systems its surgical draft guidance leaves out
From the Sept 27, 2026 post · Sources: FDA (workshop notice), FDA (draft guidance), FDA CDRH updates, Healthcare Dive
Regulation Sept 25, 2026
FDA drafts premarket rules for surgical robots that exclude remote telesurgery and autonomous systems; comments due Nov. 24
From the Sept 26, 2026 post · Sources: FDA, FDA draft guidance (PDF), Federal Register, MobiHealthNews, AHA News, Healthcare Dive
Regulation Sept 24, 2026
FDA grants breakthrough designation to insulin dosing software for hospitalized newborns and infants under 2
From the Sept 26, 2026 post · Sources: Glytec, HIStalk
Regulation Sept 24, 2026
Oz says AI will be "inflationary" in the short term and points to accountable care organizations as the fix
From the Sept 25, 2026 post · Source: Healthcare Dive
Regulation Sept 23, 2026
UnitedHealth, CVS and Kaiser urge CMS not to ban vendor-run remote patient monitoring; UnitedHealthcare earlier tried to stop paying for most of it
From the Sept 24, 2026 post · Source: STAT
Regulation Sept 18, 2026
AMA asks CMS to hold Jan. 1, 2027, electronic prior authorization deadline, reject "broad enforcement discretion"; 40,000 fee schedule comments split
From the Sept 23, 2026 post · Sources: Fierce Healthcare (AMA letter), Holland & Knight (fee schedule comments), CMS (prior authorization rule CMS-0057-F)
Regulation Sept 22, 2026
Senate HELP Committee hears FDA nominee Heidi Overton on Thursday at 10:30 a.m. as agency's AI-enabled device list passes 1,600
From the Sept 23, 2026 post · Sources: Senate HELP Committee (hearing page), Senate HELP Committee (announcement), FDA (AI-enabled medical devices), The Cancer Letter, BioSpace, FDA (generative-AI discussion paper), STAT (guidance coming), Federal Register (radiology AI final order), STAT (FDA hiring)
Regulation Sept 21, 2026
OpenAI, Anthropic, Hims & Hers, Noom, Sword, Tempus, Prenuvo and Centene sponsor the Sept. 29 MAHA Summit; sponsors get dinner with the speakers
From the Sept 22, 2026 post · Sources: MAHA Summit (sponsors and speakers), Becker's Hospital Review, Economic Times via inkl (Bloomberg's reporting)
Regulation Sept 20, 2026
Newsom vetoes AB 539, a one-year prior authorization bill that passed 64-4 and 31-0, and has not acted on four health-AI bills with eight days left
From the Sept 22, 2026 post · Sources: Governor of California (legislative update, September 20), LegiScan (AB 539), California Hospital Association (AB 539), LegiScan (AB 1979), Governor of California (data center bills, September 21)
Regulation Sept 18, 2026
Consumer Technology Association CEO asks Congress for one federal health-AI framework, citing more than 240 health AI bills in 43 states this year
From the Sept 20, 2026 post · Sources: Fierce Healthcare (CTA op-ed), Governor of California (executive order)
Regulation Sept 17, 2026
FDA final order keeps all four categories of radiology AI under 510(k) review, denying Harrison.ai's bid for a track-record exemption
From the Sept 19, 2026 post · Sources: Federal Register (final order), PYMNTS, AuntMinnie (April denial), Harrison.ai response
Regulation Sept 17, 2026
Johns Hopkins, Teladoc, Talkiatry and ATA Action form coalition seeking a federal pathway around state medical licensure
From the Sept 19, 2026 post · Sources: ATA Action, Healthcare IT News, HIT Consultant
Regulation Sept 18, 2026
Fourth California health-AI bill on governor's desk, SB 503, would require physician offices to "regularly monitor" decision support AI for bias
From the Sept 19, 2026 post · Sources: LegiScan (SB 503 status), SB 503 enrolled text, Transparency Coalition (legislative update), Governor of California (executive order N-9-26)
Regulation Sept 18, 2026
California's SB 903 would bar offering or advertising therapy unless a licensed human delivers it; backers press Newsom to sign by Sept. 30
From the Sept 18, 2026 post · Sources: LegiScan (SB 903 status), SB 903 enrolled text, California Senate Democratic Caucus release, Senator Padilla (Senate passage), KQED (governor's deadline)
Regulation Sept 10, 2026
Washington court rules patients have no right to ambient AI audio of their own visits, siding with clinic backed by AMA
From the Sept 18, 2026 post · Sources: American Medical Association, HIStalk, Source One (Confluence Health), Becker's Hospital Review
Regulation Sept 16, 2026
Klomp tells Senate HELP hearing WISeR "must be done appropriately, or it should not expand"; Murray vows to fight oncology expansion
From the Sept 17, 2026 post · Sources: Senator Patty Murray (HELP hearing), STAT (hearing coverage), Electronic Frontier Foundation (WISeR records), STAT (WISeR records)
Regulation Sept 16, 2026
Connecticut comptroller bars AI-only denials and downcoding for 270,000 on state health plans, seeks statewide rule in 2027
From the Sept 17, 2026 post · Sources: Connecticut Office of the State Comptroller (policy), Comptroller's announcement, CT Mirror, WSHU, Manatt Health (state law tracker)
Regulation Sept 16, 2026
Von der Leyen tells European Parliament "AI needs to empower our doctors. Not to replace them," promises health AI initiative for November
From the Sept 17, 2026 post · Sources: European Commission (State of the Union 2026 text), Euronews
Regulation Sept 16, 2026
Payers covering 165 million Americans pledge to adopt ACCESS outcomes-based payment structure; CMS offers Medicaid a toolkit
From the Sept 17, 2026 post · Sources: CMS, Fierce Healthcare, CMS (ACCESS participants)
Regulation Sept 15, 2026
House Health Subcommittee hears Patients First Act, which would give Medicare physician pay a permanent inflation update, and three other bills
From the Sept 16, 2026 post · Sources: House Energy and Commerce Committee, AMA
Regulation Sept 14, 2026
22 states put about $240 million of rural transformation money into remote monitoring as CMS proposes to bar vendor-staffed monitoring Jan. 1
From the Sept 16, 2026 post · Source: Fierce Healthcare
Regulation Sept 14, 2026
Federal officials discuss paying company-run "AI physicians" 60% to 80% of the human fee, New York Times reports
From the Sept 16, 2026 post · Sources: The New York Times, Becker's Hospital Review, STAT (John Whyte)
Regulation Aug 18, 2026
FDA proposes "competency-based" premarket evaluation for generative-AI devices; docket open until Oct. 19
From the Sept 16, 2026 post · Source: FDA
Regulation Sept 15, 2026
Medicare's ACCESS model reaches about 160 organizations as uncleared AI tools treat beneficiaries under enforcement discretion
From the Sept 16, 2026 post · Sources: CMS, CMS (ACCESS participants), FDA (TEMPO participants), STAT, Fierce Healthcare
Regulation Sept 15, 2026
WISeR records show two vendors denied more than 20,000 Medicare requests in three months, with vendors paid per denial
From the Sept 16, 2026 post · Sources: STAT, Fierce Healthcare, Electronic Frontier Foundation, U.S. Senate roll call
Regulation Aug 12, 2026
Manatt tracker counts 33 health-AI laws in 22 states through July; no state has authorized AI to practice medicine
From the Sept 16, 2026 post · Source: Manatt Health
Regulation Sept 10, 2026
California AB 1979, barring AI from independently performing licensed clinical work, and companion AB 2575 await governor's action by Sept. 30
From the Sept 15, 2026 post · Sources: National Nurses United, Paubox, KALW, AB 1979 (LegiScan), AB 2575 (LegiScan)
Regulation Sept 15, 2026
WISeR records show Virtix under corrective action plan and a CMS plan that considered AI prior auth for MRI, cancer treatment and air ambulance
From the Sept 15, 2026 post · Sources: Fierce Healthcare, Electronic Frontier Foundation

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