Which data protection regulation must AI systems in healthcare comply with?

The Health Insurance Portability and Accountability Act (HIPAA) is the essential regulation that governs the protection of patient health information in the United States. AI systems utilized in healthcare must comply with HIPAA because they often handle, process, or store protected health information (PHI). This regulation ensures that any system managing such sensitive data implements appropriate security measures to safeguard against unauthorized access and breaches.

HIPAA outlines key privacy and security rules to maintain the confidentiality, integrity, and availability of PHI, applying not only to healthcare providers but also to any entities, including AI technologies, that interact with such information. This compliance is crucial to ensure that patient data is treated with the utmost privacy and security, fostering trust in the use of AI in medical settings.

Other regulations mentioned, while relevant in their own contexts, do not specifically address the needs of healthcare data protection as comprehensively as HIPAA does for health-related information within the healthcare industry.