USA Law and Practice Contributed by: Nadia de la Houssaye, Allison Bell, Emily Degan Vorhoff and Keiana Palmer, Jones Walker LLP
Regulatory Sandboxes and Innovation Pathways The FDA’s Digital Health Center of Excellence provides regulatory advice on digital health pol- icy, cybersecurity and AI/ML applications. The Digital Health Software Precertification Program pilots new approaches to regulate software- based medical devices. Public-Private Partnerships Government agencies collaborate with industry leaders and academic institutions to develop standards and best practices. For example, in 2023 the Biden administration secured voluntary commitments from major healthcare providers and payors regarding responsible AI use. Stakeholder Engagement Regulatory agencies conduct public workshops, request comments on proposed rules, and establish advisory committees with technology experts to inform policy development. Flexible Guidance Agencies issue non-binding guidance docu- ments that can be updated more rapidly than formal regulations, allowing for responsiveness to evolving technologies. Specialised Expertise Regulatory bodies have established dedicated divisions focused on digital health technologies, recruiting staff with relevant technical back- grounds. Legislative Reform Congress periodically updates healthcare laws to address emerging technologies, as demon- strated by provisions in the 21st Century Cures Act that clarified the FDA’s authority over certain software functions.
Telehealth and remote care delivery: • Interstate Medical Licensure Compact legisla- tion; • the Ryan Haight Online Pharmacy Consumer Protection Act; • state-level telehealth parity laws; and • Medicare telehealth provisions under the Consolidated Appropriations Act and other federal and state legislation, waivers and exemptions. AI and machine learning (ML): • ongoing state-level legislation (in 2025, to date, at least 45 states have introduced more than 550 AI bills); and • voluntary AI standards and frameworks devel- oped by federal agencies. Reimbursement and payment: • Affordable Care Act provisions supporting preventative healthcare; • Centers for Medicare & Medicaid Services (CMS) rules on telehealth billing; and • No Surprises Act provisions affecting digital health billing. The complex patchwork of regulations creates compliance challenges, particularly for digital health solutions operating across state lines or addressing multiple aspects of healthcare deliv- ery. 2.3 Role of Policymakers Policymakers in the United States employ sev- eral strategies to stay current with technological developments in healthcare and ensure appro- priate regulation.
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