USA Law and Practice Contributed by: Nadia de la Houssaye, Andy Lee, Jason Loring and Graham Ryan, Jones Walker LLP
low-risk applications from medical device regulation. In January 2025, proposed legislation (The Health Technology Act of 2025 (H.R. 238) was introduced to amend the FFDCA and allow AI systems to prescribe FDA-approved drugs autonomously. Cybersecurity Requirements The Consolidated Appropriations Act of 2023 amend - ed the FFDCA to require cybersecurity information in pre-market submissions for “cyber devices”. Medical device manufacturers must now include cybersecurity information in pre-market submissions for AI-enabled devices that connect to networks or process elec - tronic data. Health Information Privacy Regulation The HIPAA and the HITECH Act establish comprehen - sive privacy and security requirements for protected health information (PHI) used in AI systems. The intro - duction of AI does not change the traditional HIPAA rules on permissible uses and disclosures of PHI. AI-Specific Privacy Considerations AI tools must be designed to access and use only the PHI strictly necessary for their purpose, even though AI models often seek comprehensive datasets to optimise performance. Healthcare organisations must ensure that AI vendors processing PHI operate under robust business associate agreements (BAAs) that specify permissible data uses and required safe - guards. Executive Branch AI Initiatives President Biden’s Executive Order on Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence established government-wide AI govern - ance requirements that affected healthcare applica - tions. The order was rescinded by President Trump on 20 January 2025, within hours of his inauguration. Further White House action in this area is uncertain. State-Level AI Regulation Multiple states have enacted healthcare-specific AI legislation addressing various aspects of AI deploy - ment and use. In the 2024 legislative session, 45 states, Puerto Rico, the US Virgin Islands and the Dis - trict of Columbia introduced artificial AI bills, and 31
states, Puerto Rico and the US Virgin Islands adopted resolutions or enacted legislation. Federal Anti-Discrimination Requirements In July 2024, new requirements were put in place to help protect consumers from discrimination when AI tools are used in healthcare. A final rule, published by the Department of HHS Office for Civil Rights (OCR) as part of Section 1557 of the Affordable Care Act (ACA), stated that healthcare entities must ensure AI systems do not discriminate against protected classes and must take corrective action when discrimination is identified. Given President Trump’s opposition to diversity, equity and inclusion (DEI) initiatives, how - ever, it is uncertain whether or how compliance with the final rule will be enforced. 2.3 Approval and Certification Processes FDA Pre-Market Pathways Healthcare AI developers must navigate established FDA pre-market pathways depending on their sys - tem’s risk classification and intended use. The FDA reviews medical devices through an appropriate pre- market pathway, as follows. • 510 (k) pre-market notification: Most AI-enabled medical devices receive market authorisation through the 510 (k) pathway, which requires demonstration of substantial equivalence to exist - ing legally marketed devices. This pathway may require less extensive clinical testing compared to other approval routes but requires comprehensive technical documentation and validation data. • De novo classification: Novel AI systems without suitable predicate devices may pursue de novo classification, which establishes new device clas - sifications and regulatory pathways. This process requires more extensive documentation and often includes clinical validation requirements. • PMA: High-risk AI systems supporting life-sustain - ing functions or presenting significant safety risks require PMA, the most stringent FDA review pro - cess. PMA requires extensive clinical trials demon - strating safety and effectiveness through rigorous scientific evidence.
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