Record STMT-W660012Legally binding

Department of Health and Human Services OMB M-21-06 Response from HHS

Report State lawNorthern America · USadopted

This document details the Department of Health and Human Services (HHS) response to OMB Memorandum M-21-06 regarding the regulation of artificial intelligence applications. It outlines statutory authorities, active paper work reduction act collections of information, private sector AI use cases, regulatory barriers, and planned regulatory actions related to AI/ML technologies in healthcare.

Summary and content fields are drawn from the document text and are pending editorial review.

Who issued it

Department of Health and Human ServicesGovernment (executive) · US

Lead issuer

Legal forceLegally binding

Under whose authorityState law

Judged fromfull text

Who it governs

RegulatorsPublic sector bodiesCompaniesAI developers and providersAI deployers and usersResearchers and academics

This document is for government officials, regulators, and health-sector stakeholders seeking to understand how HHS regulates artificial intelligence applications.

Sectors

Healthcare · health and human servicesResearch and science · biomedical research

What the document contains

What's covered

The document covers HHS statutory authorities, information collections, use cases, regulatory barriers, and planned actions concerning AI applications in the private sector health and human services industry.

What's missing

It does not detail internal agency AI deployments beyond brief mentions, nor does it provide definitive final rules, as it serves as an initial planning response to OMB Memorandum M-21-06.

Key takeaways

HHS regulates private sector AI applications primarily in medical devices, healthcare standards, and civil rights compliance.
The agency manages numerous information collections under the Paperwork Reduction Act that intersect with AI-enabled medical technologies.
Data sharing hurdles, interoperability issues, and HIPAA interpretations represent major barriers to AI development and deployment.
HHS is pursuing a more flexible total product lifecycle (TPLC) regulatory approach for AI/ML-based software as a medical device (SaMD).
Internal agency use cases like the Predicting Risk of Adult Maltreatment (PRAM) project may indirectly influence private-sector tools.

Principles it states

public trust in AIpublic participationscientific integrity and information qualityrisk assessment and managementfairness and discriminationflexibilitydisclosure and transparencysafety and security

Outline

· Statutory Authorities Directing or Authorizing Agency Regulation of AI Applications
· Active Collections of AI-Related Information
· AI Use Case Priorities
· AI Regulatory Barriers
· Planned Regulatory Actions Concerning AI Applications

IssuedNot recorded

Length9,021 words · 9 pages

FormatNot recorded

Scopenational

How it scores

Pending review

Each score is backed by a quote verified against the document text. Editorial review has not yet confirmed them.

Accountability

3/5

Clear responsibility for AI outcomes

FDA would assess the culture of quality and organizational excellence of a particular company and have reasonable assurance of the high quality of their software development, testing, and performance monitoring of their products.

Planned Regulatory Actions Concerning AI Applications

screening score · 2026-10-24

Fairness

3/5

Non-discrimination and equitable treatment

The Civil Rights Act of 1964 is an Act that outlaws discrimination based on race, color, or national origin.

Statutory Authorities Directing or Authorizing Agency Regulation of AI Applications

screening score · 2026-10-24

Human Oversight

2/5

Humans remain in control of consequential decisions

FDA approved device for use by trained and qualified healthcare providers for evaluation of palpable and non-palpable breast abnormalities

AI Use Case Priorities

screening score · 2026-10-24

Privacy

3/5

Protection of personal data and private life

As stated in CIPSEA section 512, data or information acquired under a pledge of confidentiality and for exclusively statistical purposes shall be used for exclusively statistical purposes and shall not be disclosed for a nonstatistical purpose

Statutory Authorities Directing or Authorizing Agency Regulation of AI Applications

screening score · 2026-10-24

Transparency

3/5

Openness about how AI systems work and are used

The purpose of the workshop will be to 1) highlight the role of information sharing to enhance trust and identify unique considerations in achieving transparency for users of AI/ML-enabled devices

Active Collections of AI-Related Information

screening score · 2026-10-24

Enforcement

4/5

Consequences and compliance mechanisms with real force

HHS has authority to enforce this statute in the context of AI to the extent such applications result in unlawful discrimination prohibited by the statute.

Statutory Authorities Directing or Authorizing Agency Regulation of AI Applications

screening score · 2026-10-24

Impact Assessment

4/5

Required assessment of an AI system's risks/impacts before or during use

The information that is obtained from these reports will be used to evaluate risks associated with medical devices and enable FDA to take appropriate regulatory measures to protect the public health.

Active Collections of AI-Related Information

screening score · 2026-10-24

Topics

artificial_intelligence healthcare_regulation medical_devices data_sharing administrative_law