USA Law and Practice Contributed by: Nadia de la Houssaye, Andy Lee, Jason Loring and Graham Ryan, Jones Walker LLP
organisations have developed technical requirements and best practices for interoperability of such sys - tems. Among others, the Health Level Seven Interna - tional (HL7) Fast Healthcare Interoperability Resourc - es (FHIR) standard enables AI systems to exchange data with electronic health record systems and other healthcare technologies. The FDA recognises consensus standards devel - oped by organisations such as ASTM International, the Institute of Electrical and Electronics Engineers (IEEE), and the International Organization for Stand - ardization (ISO) that address AI system safety, per - formance and cybersecurity requirements; establish quality management system requirements for medi - cal device development; and address design controls, risk management and validation processes through - out the AI development life cycle. The Department of HHS proposed regulations in January 2025 that require covered entities to con - duct vulnerability scanning at least every six months and penetration testing at least annually. The National Institute of Standards and Technology (NIST) pub - lishes comprehensive cybersecurity frameworks that provide guidelines for protecting AI systems and the health information they process. Adherence to established data exchange standards, application programming interface (API) specifications and workflow integration protocols enable AI tools to function within complex healthcare technology envi - ronments. 3. Regulatory Oversight of Healthcare AI 3.1 Regulatory Authorities US federal regulatory bodies that oversee healthcare AI include the following. • FDA: The FDA’s Digital Health Center of Excel - lence, Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radio - logical Health (CDRH), and Office of Combination Products (OCP) share responsibility for regulating
different aspects of healthcare AI depending on the specific application and product type. • Department of HHS: The Department of HHS serves as the primary federal department respon - sible for healthcare policy and regulation, with multiple agencies addressing different aspects of healthcare AI oversight. The department co- ordinates AI governance across healthcare pro - grammes while establishing government-wide policies for AI use in federal healthcare services. • The HHS OCR: The OCR has placed a heavy focus on the potential for unauthorised use or disclosure of PHI through the use of emerging technologies. The OCR enforces the HIPAA Privacy, Security, and Breach Notification Rules for healthcare AI systems, ensuring patient privacy and data security compliance. • Centers for Medicare & Medicaid Services (CMS): The CMS establishes coverage and reimburse - ment policies for AI-enabled healthcare services and technologies through Medicare, Medicaid and other federal health programmes. • Office of the National Coordinator for Health Infor - mation Technology (ONC): The ONC co-ordinates nationwide efforts to implement health information technology and promote secure electronic health information exchange. • Centers for Disease Control and Prevention (CDC): The CDC provides leadership in disease prevention and public health emergency response, utilising AI tools for population health monitoring, disease surveillance and epidemiological analysis. • Federal Trade Commission (FTC): The FTC regu - lates AI-related advertising claims, the privacy practices of non-HIPAA covered entities, competi - tion in digital health markets, and compliance with consumer protection laws and truth-in-advertising principles. 3.2 Pre-Market Requirements Healthcare AI developers must comply with a range of pre-market requirements involving the following, among other issues. • Clinical validation: Healthcare AI developers must provide comprehensive clinical validation dem - onstrating safety and effectiveness for intended uses; ensure that the relevant characteristics of the
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