Healthcare AI Regulation (FDA / ONC) — regulation & compliance changes
Health systems, medical-device companies, and digital-health startups navigating the fast-evolving intersection of AI/ML regulation and medical-device law — where FDA SaMD guidance, clinical decision support rules, and state healthcare AI mandates determine what can ship and how it must be disclosed.
Aforeworn watches Healthcare AI Regulation (FDA / ONC) around the clock so you never have to refresh a government page again. Every detected change becomes a plain-English briefing covering what changed, who it affects, what you must do, and by when. Forewarned is forearmed.
Stay ahead of every Healthcare AI Regulation (FDA / ONC) change
Real-time alerts, plain-English impact briefs, and a full searchable history — 100+ changes tracked in Healthcare AI Regulation (FDA / ONC) so far.
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Recent changes in Healthcare AI Regulation (FDA / ONC)
- FDA Issues AI Guidance for Wearables, Decision Support Tools - MeriTalk
- New California AI Laws Taking Effect in 2026 - JD Supra
- Utah Law Aims to Regulate AI Mental Health Chatbots - The National Law Review
- California's Legislative Push on AI: A Wave of New Obligations and Prohibitions - Freshfields
- California Enacts Health AI Bill and Protections for Neural Data - Inside Privacy
- California Passes Law Regulating Generative AI Use in Healthcare - The National Law Review
- California’s Landmark AI Law Demands Transparency From Leading AI Developers - Crowell & Moring LLP
- Illinois Extends Statute of Limitations for Filing Discrimination Claims Under Illinois Human Rights Act, Adds Protected Classes, and Clarifies AI Use in Employment Decisions - Littler Mendelson P.C.
- New State Law Will Restrict Health Insurers’ Use of AI - Medscape
- FDA sets cross-center framework for digital measures in clinical trials - AllSci
- Michigan Civil Rights Commission Passes Resolution to Establish Guiding Principles for Use of AI in Michigan - State of Michigan (.gov)
- Vermont Enacts First-of-Its-Kind AI Mental Health Law, Raising Concerns About Therapist Oversight - Earnings Analysis - vinanet.vn
- Illinois BIPA’s Healthcare Exemption Not Limited to Patient Information, Illinois Supreme Court Rules - Jackson Lewis
- Illinois Outlaws AI in Therapy Sessions - Psychiatrist.com
- Wisconsin Creates Statutory Presumption That Billing Statements and Invoices Reflect the Reasonable Value of Reasonably Necessary Health Care Services - Hinshaw & Culbertson LLP
- Wisconsin Department of Health Services Issues New Guidance on the Preparation of Consumer Reports Required Under the New Health Care Transparency Law - Hinshaw & Culbertson LLP
- Renewed Proposal Would Require Consent For Pelvic Exams On Unconscious Patients In Wisconsin - WPR
- The AI Doctor Is Out? How California’s AB 489 Could Limit AI Development in Healthcare - Epstein Becker Green
- State AGs Put Businesses on Notice: Existing Laws Already Apply to AI - PYMNTS.com
- Bill Banning AI from Using the Title “Nurse” Is Approved In OR – Only Humans Are Nurses - Nurse.org
- Oregon Becomes First State to Ban AI from Using “Nurse” Title - BABL AI
- OR AG Issues Guidance Regarding OR State Laws and AI - Hunton Andrews Kurth LLP
- CMS Launches WISeR Model to Curb Overuse of Medicare Services - Davis Wright Tremaine
- Senate Votes to Keep the AI Medicare Pilot In Place - cepr.net
- Rhode Island General Assembly Advances Healthcare, AI, Self-Checkout Bills This Week - Newport Buzz
- Washington State Passes My Health, My Data Act to Safeguard Health Data Privacy - TechTarget
- CMS Addresses Use of AI by Medicare Advantage Plans - AAMC
- HHS Recent Guidance on AI Use in Health Care - Reed Smith LLP
- Connecticut Governor Signs Bill Limiting Hospital Billing and Collection Efforts and Revising Connecticut’s Facility Fee Laws - The National Law Review
- Connecticut governor signs bill calling for ‘AI bill of rights’ - StateScoop
- Connecticut passes AI regulations after years in development - CT Mirror
- Eko Health’s AI for Cardiac Diagnoses Earns CMS Reimbursement Rate - MedCity News
- Louisiana Governor Signs Legislation to Mitigate Workplace Violence Against Healthcare Workers Into Law - Ogletree
- US-CONGRESS BILLS-119hr10134ih: Local Health Care Protection Act of 2026
- Alaska Settles HIPAA Security Case for $1.7 Million; HHS Reinforces Need for Adequate Policies and Procedures for the Safeguarding of ePHI - Hinshaw & Culbertson LLP
- Evaluation of Therapeutic Equivalence; Guidance for Industry; Availability
- Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
- Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 066
- Delaware primary healthcare reform bill advances after lengthy hearing - Beinsure
- Vermont’s H. 583 Restricts Private Equity and Hedge Funds with Ownership and Controlling Interests from Interfering with Clinical Judgment of Health Care Providers - Epstein Becker Green
- Illinois bans therapeutic use of AI without clinician input - Healthcare Finance News
- Colorado Law Mandates Real-Time Therapist Oversight for AI Psychotherapy, Raising Compliance Questions - Revenue Growth Report - vinanet.vn
- FDA Issues Draft Guidance on AI-Enabled Medical Devices - orrick.com
- FDA finalizes recommendations simplifying approval process for medical devices that use AI - American Hospital Association
- Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles - fda.gov
- Vermont Enacts Two Landmark Health Care Laws Targeting Drug Prices and Hospital Oversight - JD Supra
- As Healthcare AI Expands, States Are Passing Laws to Protect Consumers - ArentFox Schiff
- Transparency, Safety Are Focuses for Illinois AI Laws - GovTech
- 2026 State Chatbot Laws: Key Provisions and Regulatory Trends - orrick.com
- The Colorado AI Act: What you need to know - IAPP
- US-CONGRESS S5287: Colorectal Cancer Early Detection Act
- GA HB 9: Safer States Act
- Governor Polis signed Colorado’s restrictive AI law, but supports a federal moratorium on similar legislation - Reason Foundation
- South Carolina Amends The Adult Healthcare Consent Act - JD Supra
- Utah Enacts Consumer Disclosure Requirements for Businesses Using Bots and Generative AI - Davis Wright Tremaine
- Mainers testify to ban AI-only decisions in health insurance claims - Maine Beacon
- Oklahoma bill would make medical care requiring prior authorization more transparent - Oklahoma Voice
- Trump signs order blocking states from enforcing own AI rules - BBC
- Committee backs bill to prevent arbitrary limits on brain‑injury rehabilitation - Citizen Portal AI
- US-CONGRESS HR8170: MATCH Act
- Proposed bill would allow AI to write prescriptions; workout supplements linked to muscle dysmorphia in youth; early-onset breast cancer rates rising, varying by location – Morning Medical Update - Congressman Schweikert (.gov)
- Virginia Legislature Passes Weak AI Bill Full of Loopholes - EPIC – Electronic Privacy Information Center
- AI in litigation series: Pennsylvania sues Character.AI alleging unlicensed practice of medicine - Norton Rose Fulbright
- Connecticut’s Lamont Signs AI Law With Employer Notice Mandate - Bloomberg Law News
- FDA Proposes Draft Guidance on Assessing the Credibility of AI Models Used in Drug and Biological Product Submissions - orrick.com
- Connecticut Bill Would Prohibit Using AI in Patient Care - GovTech
- Montana Joins Other States in Establishing New Rights Over Brain Data - Governing
- Nevada’s New Consumer Health Data Privacy Law: 6 Things to Know - orrick.com
- Illinois 1st US state to ban AI in mental healthcare - techtarget.com
- HTI 5 Proposal Signals Health IT Deregulation and FHIR-first Interoperability and Refines Information Blocking Rule - Reed Smith LLP
- Vermont Enacts AI Mental Health Law: Concerns Over Therapist Oversight of Automated Advice - Guidance Revision Trend - Vinanet
- Colorado Delays AI Act to June 2026; Businesses Get Breathing Room - PYMNTS.com
- The Texas Responsible AI Governance Act and Its Potential Impact on Employers - klgates.com
- Hawaii Enacts AI Companion Disclosure and Safety Law - Hunton Andrews Kurth LLP
- Recon: FDA releases draft guidance on gen AI-enabled devices; Industry warns Germany must reform drug pricing - RAPS
- New Illinois law looks to put guardrails on AI in mental health as researchers push for innovation - IPM Newsroom
- Charting the Future of AI Regulation: Virginia Poised to Become Second State to Enact Law Governing High-Risk AI Systems - ogletree.com
- Virginia Gov. Youngkin signs one AI bill, vetoes another - Transparency Coalition
- Vermont’s Neurological Rights Law Reshapes AI Privacy Standards - AI CERTs
- Vermont Lawmakers Advance Limits on AI in Mental Health Care - Seven Days Vermont
- Utah Enacts Multiple Laws Amending and Expanding the State's Regulation of the Deployment and Use of Artificial Intelligence - Davis Wright Tremaine
- Navigating TRAIGA: Texas’s New AI Compliance Framework - Ropes & Gray LLP
- Texas Signs Responsible AI Governance Act Into Law - Latham & Watkins LLP
- Texas Passes New Law Regulating Electronic Health Records and the Use of AI by Healthcare Professionals - JD Supra
- Texas Takes a Shot at AI Regulation With ‘Responsible Artificial Intelligence Governance Act’ - ogletree.com
- Texas Enacts Comprehensive AI Governance Law with Specific Requirements for Health Care Service Providers – Are You Ready for TRAIGA? - Spencer Fane
- Texas Enacts Comprehensive AI Governance Laws with Sector-Specific Healthcare Provisions - Holland & Knight
- The Texas Responsible AI Governance Act: What your company needs to know before January 1 - Norton Rose Fulbright
- New Law Requires Texas Physicians to Disclose AI, Provide Guardians EHR Access - Texas Medical Association
- Legislators OK bill to disclose AI use in healthcare visits - Providence Business News
- Rhode Island enacts three new AI laws, including a therapy chatbot ban - Transparency Coalition
- Rhode Island’s new AI and healthcare privacy law - Data Protection Report
- Oregon Just Passed the Country’s Toughest Chatbot Law. Your Company May Already Be Breaking It. - PYMNTS.com
- Washington and Oregon Regulate AI Companions: Key Compliance Changes - Morgan Lewis
- Oregon and Washington Join California in Enacting Companion Chatbot Laws - Mayer Brown
- Oregon Advances AI Chatbot Law With Private Liability Provision - PYMNTS.com
- Oregon SB 1546: The First Chatbot Law With Real Teeth (via Passle) - ourtake.bakerbotts.com
- North Dakota Law Expected to Curb AI Influence in Health Care - govtech.com
- A controversial bill to rein in AI use in medical billing advances in NC Senate - NC Newsline
- Landmark AI Safety Bill Signed Into Law - The New York State Senate (.gov)
Frequently asked questions
What does Aforeworn monitor for Healthcare AI Regulation (FDA / ONC)?
Aforeworn continuously tracks the official rules, ordinances, fee schedules and licensing requirements that affect Healthcare AI Regulation (FDA / ONC), detects every change, and explains in plain English what changed, who it hits and what to do.
How fast will I hear about a change in Healthcare AI Regulation (FDA / ONC)?
Changes are detected automatically as sources update, and subscribers are alerted in real time — often before the change is widely reported.
Why does staying current on Healthcare AI Regulation (FDA / ONC) matter?
A single missed change can mean fines, a lapsed licence, or lost eligibility. Forewarned is forearmed — knowing first lets you act before it costs you.