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Primary/authoritativeFDA2026-06-16
The list is explicitly non-comprehensive and periodically updated. Inclusion means FDA identified the device as AI-enabled and authorized it for marketing; omission proves neither lack of authorization nor lack of AI functionality, and inclusion does not establish comparative effectiveness, superiority, real-world performance, or adoption.
Primary/authoritativeCMS2026-07-14
This is a proposal, not final policy; provisions may change before the final rule. The September 14, 2026 date is the public-comment deadline.
Primary/authoritativeCMS Innovation Center2026-07-20
The model is ongoing. Its design does not establish participant-specific effectiveness, final participation, coverage for every service, or future outcomes.
Primary/authoritativeFDA2026-07-22
Pilot participation is not FDA approval or proof of effectiveness. FDA states that effectiveness for the participating intended uses has not yet been evaluated.
Primary/authoritativeASTP/ONC2026-07-23
Release of a new USCDI version does not mean every health IT product immediately implements it, nor does it erase prior-version SVAP or certification relevance.
Primary/authoritativeCMS2026-07-29
These are published participation and listing requirements, not proof that a particular app is clinically effective, CMS-endorsed, covered by Medicare, accepted into the library, or eligible for ACCESS payment. Requirements and listings can change. The pages checked also do not publish every product-specific evidence, usability, accessibility, equity, or technical threshold.
Primary/authoritativeCMS2026-08-17
Accepted-applicant status is not CMS endorsement and does not guarantee final participation; participation remains contingent on Medicare enrollment, an executed agreement, final approval, and other requirements.
Primary/authoritativeFDA2026-08-21
FDA states that effectiveness for the participating intended uses has not yet been evaluated. Participation does not establish general FDA approval or clearance, Medicare coverage, endorsement, final CMS ACCESS participation, or scaled adoption. Reverify the maintained table before consequential use.
Primary/authoritativeCMS2026-08-11
The showcase is a demonstration space, not a rating. Inclusion and early-adopter status do not establish CMS endorsement, validation, uniform production availability, or equivalent maturity across organizations and use cases.
Primary/authoritativeASTP/ONC2025-12-22
HTI-5 remains a proposed rule whose comment period closed February 27, 2026. It is not adopted law, a current certification requirement, permission to access EHI, or authorization for autonomous AI; final language may differ materially.
Primary/authoritativeARPA-H2026-01-13
The solicitation submission window closed April 1, 2026. The program objective remains prospective and does not establish a selected performer, deployed system, clinical validation, FDA authorization, effect, or result.
Primary/authoritativeARPA-H2026-02-24
The seven awards and funding ceiling are program facts, not evidence that the full ceiling will be paid or that an endpoint or intervention works. Continued funding is milestone-contingent, and the work remains investigational.
Primary/authoritativeARPA-H2026-02-24
The source describes prospective work. It reports no validated score, calibration, intervention result, regulatory qualification, or completed trial.
Primary/authoritativeARPA-H2026-02-24
The trial is prospective. Existing approvals for the repurposed drugs do not establish approval for aging or healthspan, and the source reports no enrollment, effect, safety finding, new indication, or regulatory result.
Primary/authoritativeFDA2026-04-28
The initiated reporting proofs do not establish comparative benefit or suitability for every trial. The separate AI-enabled pilot RFI closed June 29, 2026; the cited source does not establish a later selection or broader-pilot launch outcome.
Primary/authoritativeFDA CDER2026-05-01
FDA's statement describes an agency-reported submission trend, not an approval count, comparative-performance finding, or blanket endorsement of an AI method, submission, or output.
Primary/authoritativeARPA-H2026-05-05
The stated 10× acceleration is a program target, not an achieved result. The stated full-proposal deadline passed August 13, 2026; the cited page does not establish awards or performance results.
Primary/authoritativeCMS + HHS OIG2026-05-14
The finding concerns 2022 claims and encounter data, not a current rate. CMS did not require providers to bill all three components, so no claim or encounter record does not prove a component was not furnished; the finding also does not establish inappropriate care or ineffectiveness.
Primary/authoritativeFDA2025-09-30
The request's comment period ended December 1, 2025. It is discussion-only—not draft or final guidance, an adopted framework, an enforceable requirement, or a policy change.
Primary/authoritativeASTP/ONC2026-06-30
Approval through SVAP does not guarantee immediate implementation across all certified health IT products.
Primary/authoritativeFDA2026-07-23
A historical funding opportunity does not establish an award, a validated digital measure, regulatory endpoint acceptance, guidance, or clinical benefit.
Primary/authoritativeNIA2026-07-29
The summit has not occurred. Its scheduled dates do not establish completed proceedings, scientific consensus, outcomes, or post-event materials.
Primary/authoritativeCMS2026-01-22
Permanent describes the list-addition category after CMS removed the provisional/permanent distinction. It does not make every telehealth flexibility permanent, guarantee payment in every setting, or establish coverage for every use case.
Primary/authoritativeARPA-H2026-02-24
The project will test whether the compound improves aging outcomes. The award and prior characterization do not establish an aging or healthspan benefit.
Primary/authoritativeARPA-H2026-04-22
The awards indicate contract R&D, not clinical validation, regulatory clearance, commercial adoption, full disbursement, or successful outcomes. Exact amounts and continued funding are milestone-contingent.