Source assessmentCore
Department of Health and Human Services OMB M-21-06 Response from HHS
OMB M-21-06 AI regulationsRegulatory/legal
Assessment outcome
total 5/6 (actionability 2 + authority 2 + currency 1)
Total5/6
Actionability2/2
Authority2/2
Currency1/2
Authorship & scope
Attribution (G4 evidence)
No evidence recorded for this source.
Issuer authority (evidence)
No evidence recorded for this source.
Issuers, who it governs, legal force and content are on the full record.
Eligibility gates
G1 · Retrievablepass
Passed in screening.
G2 · AI nexuspass
Passed in screening.
G3 · Governance nexuspass
Passed in screening.
G4 · Attributablepass
Passed in screening.
G5 · In forcepass
Passed in screening.
Scored criteria
Actionability
2/2No rationale recorded.
Manufacturers must ensure that medical devices meet design specifications and that design specifications are effectively transferred from research and development to production.
Authority
2/2No rationale recorded.
This document constitutes the Department of Health and Human Services (HHS) response to OMB Memorandum 21-06
Currency
1/2No rationale recorded.
Classification
Coverage topicOMB M-21-06 AI regulations
PerspectiveRegulatory/legal
Lifecycle stageN/A cross-cutting
Layerboth
GranularityNot recorded