Artificial Intelligence Regulatory Resource Guide
Know the Latest AI Guidelines from Washington, DC
Artificial Intelligence (AI) and its widespread applicability in healthcare became the center of health technology discussion in 2023. While used in various areas of healthcare for the better part of a decade, the release of easy to use, open-source machine learning and generative AI created an environment for rapid deployment of new technology. The US healthcare technology regulatory framework aims to provide limited guardrails for the use of AI in healthcare, however, gaps remain.
The Biden-Harris Administration has taken several steps to establish guardrails around the use of AI. That said, federal agencies have limited authority to regulate AI tools. As a result, agencies have attempted to provide guidance to the healthcare continuum despite limited statutory authority.
This timeline provides an overview of the AI regulations related to healthcare that are in place, or proposed. This includes the Executive Order on AI released by the Biden-Harris Administration and the Office of Management and Budget (OMB) guidance for federal departments and agencies themselves, as well as agency regulation and guidance.
The AHIMA Policy & Government Affairs team continues to monitor the federal regulatory environment for developments and changes to the current government compliance framework. If you have questions or would like to discuss your experiences with AI and the regulatory implications, please contact us at advocacy@ahima.org.
This resource will be updated as needed to reflect the AI regulatory landscape in Washington, DC.
Artificial Intelligence Regulatory Enforcement Timeline: 2024-2026
5/27/24
01/01/25
* Reported annually
* Every two years until 2036
FDA Role in AI Regulatory Oversight:
The FDA reviews medical devices through an appropriate premarket pathway, such as premarket clearance (510(k)), De Novo classification, or premarket approval. The FDA may also review and clear modifications to medical devices, including software as a medical device, depending on the significance or risk posed to patients of that modification.
Annual Agency Requirements:
- Inventory AI use cases
- Submit report on use cases to OMB and post publicly
- Report and release metrics about use cases
Referenced Regulatory Texts:
- Executive Order (EO) on the Safe, Secure, and Trustworthy Development and Use of AI
- OMB Memo Advancing Governance, Innovation, and Risk Management for Agency Use of AI
- ONC HTI-1
Regulatory Agencies
Learn more about the agencies participating in the AI regulatory conversation.
AI Resource Guide
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