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Protecting the Consumer at the Heart of DTC Precision Medicine

Bill Of Health

Namely, legal protections concerning personal health data may not apply when the entity offering the service is decidedly not a “provider.” To illustrate the issue, consider that the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA) expressly covers genetic information as a form of health data.

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Perspectives on Data Privacy for Direct-to-Consumer Health Apps

Bill Of Health

She previously served as a Research Fellow in Medicine, Artificial Intelligence, and Law at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School for the Project on Precision Medicine, Artificial Intelligence, and the Law ( PMAIL ).

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

Bill Of Health

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.

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EU and US Regulatory Challenges Facing AI Health Care Innovator Firms

Bill Of Health

On top of that a firm will -in the near future- need to comply with all the specific requirements for ‘high risk’ AI technology as stipulated in the Proposal for a Regulatory Framework for Artificial Intelligence (EU AI Act), and navigate its way through the future European Health Data Space. Sectoral US Laws In the U.S.,