FRANCE
Belgium
Germany
Paris
France
Switzerland
Law and Practice Contributed by: Liliana Eskenazi, Julie Ernewein and Pauline Lecrenais Fréget Glaser et Associés
Italy
Spain
Contents 1. Use of Healthcare AI p.67 1.1 Types and Applications of Healthcare AI p.67 1.2 Key Benefits and Challenges p.67 1.3 Market Trends p.68 2. Legal Framework for Healthcare AI p.69 2.1 Regulatory Definition and Classification of Healthcare AI p.69 2.2 Key Laws and Regulations p.69
2.3 Approval and Certification Processes p.70 2.4 Software as a Medical Device (SaMD) p.70 2.5 Data Protection and Privacy p.71 2.6 Interoperability and Standards p.71 3. Regulatory Oversight of Healthcare AI p.71 3.1 Regulatory Authorities p.71 3.2 Pre-Market Requirements p.72 3.3 Post-Market Surveillance p.72 3.4 Enforcement Actions p.72 4. Liability and Risk in Healthcare AI p.73 4.1 Liability Framework p.73
4.2 Patient Harm and Malpractice p.73 4.3 Risk Management Requirements p.73 4.4 Defences and Limitations p.74 5. Ethical and Governance Considerations for Healthcare AI p.74 5.1 Ethical Frameworks p.74 5.2 Transparency and Explainability p.75
5.3 Bias and Fairness p.75 5.4 Human Oversight p.75 6. Data Governance in Healthcare AI p.76
6.1 Training Data Requirements p.76 6.2 Secondary Use of Health Data p.76 6.3 Data Sharing and Access p.77 6.4 De-Identification and Anonymisation p.77 7. Intellectual Property Issues Regarding Healthcare AI p.77 7.1 Patent Protection p.77 7.2 Copyright and Trade Secrets p.78 7.3 Ownership of AI Outputs p.78 7.4 Licensing and Commercialisation p.78
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