BEGIN:VCALENDAR VERSION:2.0 PRODID:-//Physician in the Loop//AI health law map//EN CALSCALE:GREGORIAN METHOD:PUBLISH X-WR-CALNAME:AI health laws taking effect: federal X-WR-CALDESC:Dates AI health laws and rules take effect\, from the AI healt h law map at physicianintheloop.org. BEGIN:VEVENT UID:us-eo-14365-2025-20251211@physicianintheloop.org DTSTAMP:20261015T120000Z DTSTART;VALUE=DATE:20251211 DTEND;VALUE=DATE:20251212 SUMMARY:Federal: Executive Order 14365\, Ensuring a National Policy Framewo rk for Artificial Intelligence\, 90 FR 58499 (Dec. 16\, 2025) takes effect DESCRIPTION:Directs the attorney general to set up within 30 days an AI Lit igation Task Force to challenge state AI laws inconsistent with the order' s policy\; the Commerce Department to publish within 90 days an evaluation identifying onerous state AI laws\, whose states become ineligible for BE AD non-deployment funds to the extent federal law allows\; an FCC proceedi ng on a federal reporting and disclosure standard\; an FTC policy statemen t on how the FTC Act's ban on unfair and deceptive practices applies to AI \; and a legislative recommendation for a federal framework preempting con flicting state AI laws.\n\nhttps://physicianintheloop.org/law-map/federal/ #law-us-eo-14365-2025 URL:https://physicianintheloop.org/law-map/federal/#law-us-eo-14365-2025 TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:us-cms-0057-f-2024-20260101@physicianintheloop.org DTSTAMP:20261015T120000Z DTSTART;VALUE=DATE:20260101 DTEND;VALUE=DATE:20260102 SUMMARY:Federal: Medicare and Medicaid Programs\; Patient Protection and Af fordable Care Act\; Advancing Interoperability and Improving Prior Authori zation Processes\, final rule (CMS-0057-F)\, 89 FR 8758 (Feb. 8\, 2024)\, RIN 0938-AU87 takes effect DESCRIPTION:Requires impacted payers other than qualified health plan issue rs on the federally facilitated Exchanges to decide prior authorization re quests for items and services other than drugs within 72 hours for expedit ed and seven calendar days for standard requests from 2026\; requires all impacted payers to give a specific reason for denials from 2026 and to pos t prior authorization metrics annually starting March 31\, 2026\; and requ ires them\, beginning in 2027\, to run a Prior Authorization API that list s covered items and services\, identifies documentation requirements and s upports requests and responses.\n\nhttps://physicianintheloop.org/law-map/ federal/#law-us-cms-0057-f-2024 URL:https://physicianintheloop.org/law-map/federal/#law-us-cms-0057-f-2024 TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:us-cms-wiser-2025-20260101@physicianintheloop.org DTSTAMP:20261015T120000Z DTSTART;VALUE=DATE:20260101 DTEND;VALUE=DATE:20260102 SUMMARY:Federal: Medicare Program\; Implementation of Prior Authorization f or Select Services for the Wasteful and Inappropriate Services Reduction ( WISeR) Model\, notice (CMS-5056-N)\, 90 FR 28749 (July 1\, 2025) takes eff ect DESCRIPTION:A six-year CMS Innovation Center model\, running Jan. 1\, 2026 through Dec. 31\, 2031\, in which participating companies use technologies such as AI and machine learning\, with human clinical review\, to conduct prior authorization or prepayment review of selected services in Original Medicare and are paid a percentage of the spending averted by their revie ws.\n\nhttps://physicianintheloop.org/law-map/federal/#law-us-cms-wiser-20 25 URL:https://physicianintheloop.org/law-map/federal/#law-us-cms-wiser-2025 TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:us-fda-general-wellness-2026-20260106@physicianintheloop.org DTSTAMP:20261015T120000Z DTSTART;VALUE=DATE:20260106 DTEND;VALUE=DATE:20260107 SUMMARY:Federal: General Wellness: Policy for Low Risk Devices: Guidance fo r Industry and Food and Drug Administration Staff (docket FDA-2014-N-1039) \, issued Jan. 6\, 2026 takes effect DESCRIPTION:Describes the low-risk products intended only for general welln ess that FDA does not intend to regulate as devices\, and says products us ing non-invasive sensing to estimate values such as blood pressure\, oxyge n saturation\, blood glucose or heart rate variability can qualify when in tended solely for wellness uses\, but not if they reference specific disea ses or diagnostic thresholds\, prompt specific clinical action\, or claim clinical accuracy or medical grade.\n\nhttps://physicianintheloop.org/law- map/federal/#law-us-fda-general-wellness-2026 URL:https://physicianintheloop.org/law-map/federal/#law-us-fda-general-well ness-2026 TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:us-fda-cds-guidance-2026-20260129@physicianintheloop.org DTSTAMP:20261015T120000Z DTSTART;VALUE=DATE:20260129 DTEND;VALUE=DATE:20260130 SUMMARY:Federal: Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration Staff (docket FDA-2017-D-6569)\, issued J an. 29\, 2026 takes effect DESCRIPTION:Explains how FDA applies the four statutory criteria that exclu de some clinical decision support software from device regulation\; softwa re intended for a critical\, time-sensitive task or decision does not meet the fourth criterion\, and FDA intends not to enforce device requirements when software that otherwise meets all four criteria gives a single recom mendation because only one option is clinically appropriate.\n\nhttps://ph ysicianintheloop.org/law-map/federal/#law-us-fda-cds-guidance-2026 URL:https://physicianintheloop.org/law-map/federal/#law-us-fda-cds-guidance -2026 TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:us-omb-m-25-21-2025-20260403@physicianintheloop.org DTSTAMP:20261015T120000Z DTSTART;VALUE=DATE:20260403 DTEND;VALUE=DATE:20260404 SUMMARY:Federal: OMB Memorandum M-25-21\, Accelerating Federal Use of AI th rough Innovation\, Governance\, and Public Trust (April 3\, 2025) takes ef fect DESCRIPTION:Rescinds and replaces M-24-10 and requires agencies to designat e chief AI officers\, publish AI strategies and compliance plans\, and\, w ithin 365 days\, document minimum risk management practices for high-impac t AI\, which is presumed to include AI serving as a principal basis for ag ency decisions on the medically relevant functions of medical devices\; pa tient diagnosis\, risk assessment or treatment\; allocation of care in pub lic insurance\; and control of health insurance costs and underwriting.\n\ nhttps://physicianintheloop.org/law-map/federal/#law-us-omb-m-25-21-2025 URL:https://physicianintheloop.org/law-map/federal/#law-us-omb-m-25-21-2025 TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:us-cms-access-model-2025-20260705@physicianintheloop.org DTSTAMP:20261015T120000Z DTSTART;VALUE=DATE:20260705 DTEND;VALUE=DATE:20260706 SUMMARY:Federal: CMS Innovation Center\, Advancing Chronic Care with Effect ive\, Scalable Solutions (ACCESS) Model (request for applications issued D ec. 5\, 2025\; version 1.1\, Feb. 12\, 2026) takes effect DESCRIPTION:A 10-year Innovation Center model\, begun July 5\, 2026 and run ning through June 30\, 2036\, that pays participating organizations recurr ing outcome-aligned payments for managing qualifying chronic conditions wi th technology-supported care\, which CMS says may include FDA-authorized d evices or software\, with full payment tied to measurable outcomes\; parti cipants may not bill Medicare fee-for-service for aligned beneficiaries du ring active care periods.\n\nhttps://physicianintheloop.org/law-map/federa l/#law-us-cms-access-model-2025 URL:https://physicianintheloop.org/law-map/federal/#law-us-cms-access-model -2025 TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:us-cms-fy2027-ipps-ntap-2026-20261001@physicianintheloop.org DTSTAMP:20261015T120000Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20261002 SUMMARY:Federal: Medicare Program\; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Pr ospective Payment System and Policy Changes and Fiscal Year (FY) 2027 Rate s\, final rule (CMS-1849-F)\, 91 FR 49570 (Aug. 4\, 2026)\, RIN 0938-AV79\ ; new technology add-on payments under 42 CFR 412.87 and 412.88 takes effe ct DESCRIPTION:Approves FY 2027 new technology add-on payments\, including for AI tools such as Aidoc's BriefCase-Triage: CARE (Clinical AI Reasoning En gine) Multi-Triage CT Body (up to $137.53 per case) and the Bayesian Healt h Sepsis Flagging Device\, described by its applicant as AI and machine le arning-based software (up to $61.84 per case)\, each capped at 65 percent of the technology's average cost.\n\nhttps://physicianintheloop.org/law-ma p/federal/#law-us-cms-fy2027-ipps-ntap-2026 URL:https://physicianintheloop.org/law-map/federal/#law-us-cms-fy2027-ipps- ntap-2026 TRANSP:TRANSPARENT END:VEVENT END:VCALENDAR