i Table of contents 157

Healthcare AI 2025

Definitive global law guides offering comparative analysis from top-ranked lawyers

INTRODUCTION		5
Contributed by Nadia de la Houssaye, Jones Walker LLP		5
AUSTRALIA		9
Trends and Developments		9
Contributed by Barry Nilsson		9
AUSTRIA		15
Law and Practice		15
Contributed by Kinstellar		15
CANADA		32
Trends and Developments		32
Contributed by Gowling WLG (Canada) LLP		32
CHINA		37
Law and Practice		37
Contributed by Fangda Partners		37
Trends and Developments		58
Contributed by Fangda Partners		58
FRANCE		65
Law and Practice		65
Contributed by Fréget Glaser et Associés		65
Trends and Developments		83
Contributed by Fréget Glaser et Associés		83
POLAND		88
Law and Practice		88
Contributed by Kieltyka Gladkowski KG Legal		88
Trends and Developments		109
Contributed by Kieltyka Gladkowski KG Legal		109
TAIWAN		116
Trends and Developments		116
Contributed by Lee and Li, Attorneys-at-Law		116
USA		122
Law and Practice		122
Contributed by Jones Walker LLP		122
Trends and Developments		142
Contributed by Jones Walker LLP		142
USA – CALIFORNIA		150
Trends and Developments		150
Contributed by ArentFox Schiff LLP		150
1. Use of Healthcare AI		18
1.1 Types and Applications of Healthcare AI		18
1.2 Key Benefits and Challenges		18
1.3 Market Trends		19
2. Legal Framework for Healthcare AI		20
2.1 Regulatory Definition and Classification of Healthcare AI		20
2.2 Key Laws and Regulations		20
2.3 Approval and Certification Processes		21
2.4 Software as a Medical Device (SaMD)		21
2.5 Data Protection and Privacy		22
2.6 Interoperability and Standards		22
3. Regulatory Oversight of Healthcare AI		22
3.1 Regulatory Authorities		22
3.2 Pre-Market Requirements		22
3.3 Post-Market Surveillance		23
3.4 Enforcement Actions		23
4. Liability and Risk in Healthcare AI		23
4.1 Liability Framework		23
4.2 Patient Harm and Malpractice		24
4.3 Risk Management Requirements		24
4.4 Defences and Limitations		24
5. Ethical and Governance Considerations for Healthcare AI		25
5.1 Ethical Frameworks		25
5.2 Transparency and Explainability		25
5.3 Bias and Fairness		25
5.4 Human Oversight		26
6. Data Governance in Healthcare AI		26
6.1 Training Data Requirements		26
6.2 Secondary Use of Health Data		26
6.3 Data Sharing and Access		27
6.4 De-Identification and Anonymisation		27
7. Intellectual Property Issues Regarding Healthcare AI		27
7.1 Patent Protection		27
7.2 Copyright and Trade Secrets		27
7.3 Ownership of AI Outputs		28
7.4 Licensing and Commercialisation		28
8. Specific Applications of Healthcare AI		28
8.1 Clinical Decision Support		28
8.2 Diagnostic Applications		28
8.3 Therapeutic and Treatment Planning		28
8.4 Remote Monitoring and Telemedicine		28
8.5 Drug Discovery and Development		29
9. Future Trends and Regulatory Developments in Healthcare AI		29
9.1 Pending Legislation and Regulation		29
9.2 Regulatory Sandboxes and Innovation Programmes		29
9.3 International Harmonisation		29
9.4 Emerging Legal Challenges		30
10. Practical Considerations in Healthcare AI		30
10.1 Compliance Strategies		30
10.2 Contracting and Liability Allocation		30
10.3 Insurance Considerations		30
10.4 Best Practices for Implementation		31
10.5 Cross-Border Considerations		31
1. Use of Healthcare AI		40
1.1 Types and Applications of Healthcare AI		40
1.2 Key Benefits and Challenges		40
1.3 Market Trends		41
2. Legal Framework for Healthcare AI		41
2.1 Regulatory Definition and Classification of Healthcare AI		41
2.2 Key Laws and Regulations		42
2.3 Approval and Certification Processes		42
2.4 Software as a Medical Device (SaMD)		42
2.5 Data Protection and Privacy		43
2.6 Interoperability and Standards		43
3. Regulatory Oversight of Healthcare AI		44
3.1 Regulatory Authorities		44
3.2 Pre-Market Requirements		45
3.3 Post-Market Surveillance		45
3.4 Enforcement Actions		45
4. Liability and Risk in Healthcare AI		46
4.1 Liability Framework		46
4.2 Patient Harm and Malpractice		46
4.3 Risk Management Requirements		46
4.4 Defences and Limitations		47
5. Ethical and Governance Considerations for Healthcare AI		47
5.1 Ethical Frameworks		47
5.2 Transparency and Explainability		48
5.3 Bias and Fairness		48
5.4 Human Oversight		48
6. Data Governance in Healthcare AI		49
6.1 Training Data Requirements		49
6.2 Secondary Use of Health Data		49
6.3 Data Sharing and Access		49
6.4 De-Identification and Anonymisation		50
7. Intellectual Property Issues Regarding Healthcare AI		50
7.1 Patent Protection		50
7.2 Copyright and Trade Secrets		51
7.3 Ownership of AI Outputs		51
7.4 Licensing and Commercialisation		52
8. Specific Applications of Healthcare AI		53
8.1 Clinical Decision Support		53
8.2 Diagnostic Applications		53
8.3 Therapeutic and Treatment Planning		53
8.4 Remote Monitoring and Telemedicine		53
8.5 Drug Discovery and Development		54
9. Future Trends and Regulatory Developments in Healthcare AI		54
9.1 Pending Legislation and Regulation		54
9.2 Regulatory Sandboxes and Innovation Programmes		54
9.3 International Harmonisation		55
9.4 Emerging Legal Challenges		55
10. Practical Considerations in Healthcare AI		55
10.1 Compliance Strategies		55
10.2 Contracting and Liability Allocation		56
10.3 Insurance Considerations		56
10.4 Best Practices for Implementation		56
10.5 Cross-Border Considerations		57
1. Use of Healthcare AI		68
1.1 Types and Applications of Healthcare AI		68
1.2 Key Benefits and Challenges		68
1.3 Market Trends		69
2. Legal Framework for Healthcare AI		70
2.1 Regulatory Definition and Classification of Healthcare AI		70
2.2 Key Laws and Regulations		70
2.3 Approval and Certification Processes		71
2.4 Software as a Medical Device (SaMD)		71
2.5 Data Protection and Privacy		72
2.6 Interoperability and Standards		72
3. Regulatory Oversight of Healthcare AI		72
3.1 Regulatory Authorities		72
3.2 Pre-Market Requirements		73
3.3 Post-Market Surveillance		73
3.4 Enforcement Actions		73
4. Liability and Risk in Healthcare AI		74
4.1 Liability Framework		74
4.2 Patient Harm and Malpractice		74
4.3 Risk Management Requirements		74
4.4 Defences and Limitations		75
5. Ethical and Governance Considerations for Healthcare AI		75
5.1 Ethical Frameworks		75
5.2 Transparency and Explainability		76
5.3 Bias and Fairness		76
5.4 Human Oversight		76
6. Data Governance in Healthcare AI		77
6.1 Training Data Requirements		77
6.2 Secondary Use of Health Data		77
6.3 Data Sharing and Access		78
6.4 De-Identification and Anonymisation		78
7. Intellectual Property Issues Regarding Healthcare AI		78
7.1 Patent Protection		78
7.2 Copyright and Trade Secrets		79
7.3 Ownership of AI Outputs		79
7.4 Licensing and Commercialisation		79
8. Specific Applications of Healthcare AI		79
8.1 Clinical Decision Support		79
8.2 Diagnostic Applications		79
8.3 Therapeutic and Treatment Planning		80
8.4 Remote Monitoring and Telemedicine		80
8.5 Drug Discovery and Development		80
9. Future Trends and Regulatory Developments in Healthcare AI		80
9.1 Pending Legislation and Regulation		80
9.2 Regulatory Sandboxes and Innovation Programmes		81
9.3 International Harmonisation		81
9.4 Emerging Legal Challenges		81
10. Practical Considerations in Healthcare AI		81
10.1 Compliance Strategies		81
10.2 Contracting and Liability Allocation		82
10.3 Insurance Considerations		82
10.4 Best Practices for Implementation		82
10.5 Cross-Border Considerations		82
1. Use of Healthcare AI		92
1.1 Types and Applications of Healthcare AI		92
1.2 Key Benefits and Challenges		92
1.3 Market Trends		93
2. Legal Framework for Healthcare AI		93
2.1 Regulatory Definition and Classification of Healthcare AI		93
2.2 Key Laws and Regulations		93
2.3 Approval and Certification Processes		94
2.4 Software as a Medical Device (SaMD)		94
2.5 Data Protection and Privacy		95
2.6 Interoperability and Standards		95
3. Regulatory Oversight of Healthcare AI		96
3.1 Regulatory Authorities		96
3.2 Pre-Market Requirements		96
3.3 Post-Market Surveillance		96
3.4 Enforcement Actions		97
4. Liability and Risk in Healthcare AI		97
4.1 Liability Framework		97
4.2 Patient Harm and Malpractice		98
4.3 Risk Management Requirements		98
4.4 Defences and Limitations		98
5. Ethical and Governance Considerations for Healthcare AI		99
5.1 Ethical Frameworks		99
5.2 Transparency and Explainability		99
5.3 Bias and Fairness		99
5.4 Human Oversight		100
6. Data Governance in Healthcare AI		100
6.1 Training Data Requirements		100
6.2 Secondary Use of Health Data		100
6.3 Data Sharing and Access		101
6.4 De-Identification and Anonymisation		101
7. Intellectual Property Issues Regarding Healthcare AI		101
7.1 Patent Protection		101
7.2 Copyright and Trade Secrets		102
7.3 Ownership of AI Outputs		102
7.4 Licensing and Commercialisation		103
8. Specific Applications of Healthcare AI		103
8.1 Clinical Decision Support		103
8.2 Diagnostic Applications		103
8.3 Therapeutic and Treatment Planning		104
8.4 Remote Monitoring and Telemedicine		104
8.5 Drug Discovery and Development		105
9. Future Trends and Regulatory Developments in Healthcare AI		105
9.1 Pending Legislation and Regulation		105
9.2 Regulatory Sandboxes and Innovation Programmes		106
9.3 International Harmonisation		106
9.4 Emerging Legal Challenges		106
10. Practical Considerations in Healthcare AI		106
10.1 Compliance Strategies		106
10.2 Contracting and Liability Allocation		107
10.3 Insurance Considerations		107
10.4 Best Practices for Implementation		107
10.5 Cross-Border Considerations		107
1. Use of Healthcare AI		126
1.1 Types and Applications of Healthcare AI		126
1.2 Key Benefits and Challenges		126
1.3 Market Trends		127
2. Legal Framework for Healthcare AI		128
2.1 Regulatory Definition and Classification of Healthcare AI		128
2.2 Key Laws and Regulations		128
2.3 Approval and Certification Processes		129
2.4 Software as a Medical Device (SaMD)		130
2.5 Data Protection and Privacy		130
2.6 Interoperability and Standards		130
3. Regulatory Oversight of Healthcare AI		131
3.1 Regulatory Authorities		131
3.2 Pre-Market Requirements		131
3.3 Post-Market Surveillance		132
3.4 Enforcement Actions		132
4. Liability and Risk in Healthcare AI		132
4.1 Liability Framework		132
4.2 Patient Harm and Malpractice		133
4.3 Risk Management Requirements		133
4.4 Defences and Limitations		134
5. Ethical and Governance Considerations for Healthcare AI		134
5.1 Ethical Frameworks		134
5.2 Transparency and Explainability		135
5.3 Bias and Fairness		135
5.4 Human Oversight		135
6. Data Governance in Healthcare AI		136
6.1 Training Data Requirements		136
6.2 Secondary Use of Health Data		136
6.3 Data Sharing and Access		136
6.4 De-Identification and Anonymisation		136
7. Intellectual Property Issues Regarding Healthcare AI		137
7.1 Patent Protection		137
7.2 Copyright and Trade Secrets		137
7.3 Ownership of AI Outputs		137
7.4 Licensing and Commercialisation		138
8. Specific Applications of Healthcare AI		138
8.1 Clinical Decision Support		138
8.2 Diagnostic Applications		138
8.3 Therapeutic and Treatment Planning		139
8.4 Remote Monitoring and Telemedicine		139
8.5 Drug Discovery and Development		139
9. Future Trends and Regulatory Developments in Healthcare AI		139
9.1 Pending Legislation and Regulation		139
9.2 Regulatory Sandboxes and Innovation Programmes		139
9.3 International Harmonisation		140
9.4 Emerging Legal Challenges		140
10. Practical Considerations in Healthcare AI		140
10.1 Compliance Strategies		140
10.2 Contracting and Liability Allocation		140
10.3 Insurance Considerations		140
10.4 Best Practices for Implementation		141
10.5 Cross-Border Considerations		141

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