AI Governance in Health Care

How federal agencies are regulating clinical and administrative AI: FDA device pathways, ONC transparency requirements, FTC enforcement and payer use of algorithms.

There is no single federal AI law for health care, and waiting for one misreads how this is being governed. Authority is already distributed across agencies that each reach a different part of the same system: FDA through device classification and clearance, ONC through certification and algorithm transparency, OCR through nondiscrimination, FTC through deception and unfairness, and CMS through coverage, payment and program integrity.

The practical question for a physician is rarely whether an AI tool is legal. It is who is accountable when the tool is wrong, and which of those agencies has said anything about that.

What this covers

FDA device classification, De Novo and 510(k) pathways for clinical decision support and notification software, and the special controls attached to them. ONC transparency requirements for predictive decision support interventions. Payer use of algorithms in utilization management and the coverage rules that constrain it. Federal procurement and agency use of AI. Enforcement theories developing at FTC and OCR. Consensus standards and assurance frameworks as they start to be referenced in rules.

Why it is hard to track

The governance arrives as classification orders, guidance documents, enforcement statements and certification criteria rather than as legislation, so it does not look like AI policy when it is published. A device classification order in the Federal Register can settle the regulatory status of a whole category of software without ever using the phrase artificial intelligence in its title.

In this area

22 briefs, newest first. Tag archives: AI Governance

Dates that bind

Open comment windows and effective dates are on the regulatory tracker, which regenerates every weekday. Compliance dates are on the compliance page. Verify any date you intend to rely on against the primary document linked in the brief; see disclosures for how these briefs are produced.