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This paper provides an overview of US laws and related guidance documents affecting transfer of genomic data to third countries, addressing the domains of consent, privacy, security, compatible processing/adequacy, and oversight. In general, US laws governing research and disclosure and use of data generated within the health care system do not impose different requirements on transfers to researchers and service providers based in third countries compared with US-based researchers or service providers. Of note, the US lacks a comprehensive data protection regime. Data protections are piecemeal, spread across bodies of law that target specific kinds of research or data generated or held by specific kinds of actors involved in the delivery of health care. Oversight is also distributed across a range of bodies, including institutional review boards and data access committees. The conclusion to this paper examines future directions in US law and policy, including proposals for more comprehensive protections for personal data.

United States: law and policy concerning transfer of genomic data to third countries