USA Law and Practice Contributed by: Nadia de la Houssaye, Allison Bell, Emily Degan Vorhoff and Keiana Palmer, Jones Walker LLP
• state comprehensive privacy laws continue to proliferate, with growing attention to sensitive health data categories. Interoperability advancement includes the fol- lowing: • the CMS Interoperability and Prior Authoriza- tion Final Rule of January 2024 establishes requirements for FHIR-based APIs to improve data exchange and streamline prior authori- sation processes; and • the Trusted Exchange Framework and Com- mon Agreement (TEFCA) implementation continues to advance nationwide health information-exchange capabilities. AI governance includes the following: • Executive Order 14110 on Safe, Secure, and Trustworthy Artificial Intelligence includes provisions specifically addressing AI use in healthcare; • in January 2025, the FDA published the Draft Guidance: Artificial Intelligence-Enabled Device Software Functions: Lifecycle Man- agement and Marketing Submission Recom- mendations – this draft guidance proposes both life cycle considerations and specific recommendations to support marketing sub- missions for AI-enabled medical devices; and • the proposed federal Algorithmic Account- ability Act would require impact assessments
for automated decision systems, including those used in healthcare. Cybersecurity enhancement includes the follow- ing: • implementation of FFDCA Section 524B establishes cybersecurity requirements for medical device pre-market submissions; and • the proposed federal Healthcare Cybersecuri- ty Act aims to improve collaboration between the HHS and the Cybersecurity and Infra- structure Security Agency (CISA). These reforms collectively seek to balance inno- vation promotion with appropriate safeguards for patient safety, privacy and equity. Policy driv- ers include: • pandemic-era lessons regarding healthcare access; • growing recognition of digital health’s poten- tial to address healthcare disparities; • concerns about health data monetisation; and • the need for appropriate oversight of increas- ingly sophisticated healthcare technologies. The reform landscape reflects an evolving under- standing that digital healthcare requires regula- tory frameworks that can accommodate rapid technological change while maintaining funda- mental protections for patients and healthcare systems.
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