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How can governments regulate AI use in healthcare?

Healthcare AI regulation requires balancing innovation acceleration with patient protection. Medical device frameworks adapted for AI: FDA's Software as Medical Device (SaMD) program classifies AI tools by risk level, requiring pre-market approval for high-risk applications (diagnostic AI) while allowing lower-risk tools (administrative automation) with simpler notification. The FDA's proposed regulatory framework for AI/ML-based devices includes continuous monitoring and predetermined change protocols, acknowledging AI systems evolve unlike traditional static devices. Performance standards mandate: minimum accuracy thresholds, bias testing across demographic groups, clinical validation in representative populations, and transparency about limitations. Post-market surveillance requires ongoing monitoring for performance drift, adverse event reporting, and periodic revalidation as AI systems update. Data governance regulations like GDPR establish patient rights regarding AI use of health data: right to know when AI influences decisions, right to human review, and data protection requirements. HIPAA in the US addresses AI data security though regulation lags technology. Algorithm transparency requirements could mandate: explainability documentation, bias audits, and disclosure of training data characteristics. Some propose algorithm registries tracking deployed AI systems and their performance. Liability frameworks might establish: no-fault compensation for AI-caused harm, mandatory AI liability insurance, or safe harbor provisions for organizations meeting regulatory standards. International harmonization through organizations like IMDRF (International Medical Device Regulators Forum) prevents fragmentation hindering innovation. Effective regulation requires: technical expertise within agencies, rapid adaptation to evolving technology, stakeholder engagement, and proportionality—not over-regulating low-risk applications while ensuring rigorous oversight of high-stakes AI.