The document “Data Protection and Regulatory Compliance Criteria for Health Data Used to Develop, Validate, Deploy, and Use Digital Health Technologies (DHT) Including AI” provides a framework for ensuring data protection and regulatory compliance in digital health technologies. It aligns with GDPR, the AI Act, and MDR, establishing criteria for health data protection in DHTs assessments. The methodology includes a systematic review of resources and a gap analysis to identify discrepancies between current practices and regulatory requirements. A repository of standardized criteria is created to improve alignment with GDPR and support DHT developers and HTA bodies.

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