The EU AI Act is the world’s first comprehensive AI regulation, proposed in 2021 and expected to be fully implemented by 2026. It establishes a risk-based approach categorizing AI systems into four levels: unacceptable risk (banned), high-risk, limited risk, and minimal risk. High-risk AI systems, including those used in biometric identification, critical infrastructure, and employment, face strict requirements including conformity assessments, transparency obligations, human oversight, and accuracy requirements. The Act mandates fundamental rights impact assessments and establishes specific obligations for foundation models and general-purpose AI. For data protection, it requires AI systems to be trained on high-quality datasets, implement privacy-preserving measures, and ensure transparency about data processing. Penalties can reach up to €35 million or 7% of global annual turnover for non-compliance.
Health Data Management Policy (under Ayushman Bharat Digital Mission)
ABDM participants must comply with the Health Data Management Policy. Healthcare laws include the Clinical Establishments Act, National Medical Commission Act provisions requiring physician confidentiality,