Remove Accountability Remove Biotechnology Remove Patient Safety
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EU and US Regulatory Challenges Facing AI Health Care Innovator Firms

Bill Of Health

The main federal health privacy law, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) applies only to “covered entities” like health insurers, claims- processing clearinghouses, and health care providers and their business associates, and only to a subset of protected health care information.

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A Brief Quantum Medicine Policy Guide

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These might include the Health Insurance Portability and Accountability Acts (HIPAA) privacy and security rules, the Federal Trade Commission (FTC) Regulations, the International Medical Device Regulators Forum’s ( IMDRF ) framework for risk categorization, and international standards like ISO 13485 and the IEC 60601 series.

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What’s on the Horizon for Health and Biotech with the AI Executive Order

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The EO lists biotechnology on its list of examples of “pressing security risks,” and the Secretary of Commerce is charged with enforcing detailed reporting requirements for AI use (with guidance from the National Institute of Standards and Technology) in developing biological outputs that could create security risks.