Software as a Medical Device
Second Edition
xi Regulatory Affairs Professionals Society
Role of AI in Healthcare...............................................................................................................................................................131
AI Techniques. ..............................................................................................................................................................................132
Natural Language Processing. .......................................................................................................................................................132
Generative AI................................................................................................................................................................................133
AI System......................................................................................................................................................................................133
AI Model.......................................................................................................................................................................................134
General Purpose AI Models..........................................................................................................................................................134
Foundation Model.........................................................................................................................................................................136
Global Versus Local Change.........................................................................................................................................................136
Federated Learning. ......................................................................................................................................................................136
Change Dynamics.........................................................................................................................................................................137
Adaptive Medical Devices.............................................................................................................................................................138
Predetermined Change Control Plan............................................................................................................................................139
AI-Enabled Commoditization of Medical Device Manufacturing...............................................................................................139
Medical Device Production System..............................................................................................................................................140
A Future for Generalist Medical AI Systems................................................................................................................................140
Challenges to the Adoption of GMAI Systems............................................................................................................................140
International Medical Device Regulators Forum’s AI/ML Working Group.................................................................................141
AI-based Medical Devices in China. ............................................................................................................................................141
Risk-Based Approach of AIA. ......................................................................................................................................................142
AIA’s Stakeholders. .......................................................................................................................................................................143
AIA Joint Conformity Assessment of High-Risk AI Systems......................................................................................................143
Requirements for Providers of High-Risk AI Systems. ...........................................................................................................146
The Role of AI Standards. ........................................................................................................................................................147
AIA Obligations for Deployers of High-Risk AI Systems. .....................................................................................................147
Conclusion. ...................................................................................................................................................................................147
Chapter 12: Quality and Reliability of Health Apps. .......................................................................................................151
Petra Hoogendoorn, MSc, and Charles McCay
Introduction. .................................................................................................................................................................................151
CEN ISO/TS 82304-2:2021. .......................................................................................................................................................151
Label2Enable. ...............................................................................................................................................................................152
Conclusion. ...................................................................................................................................................................................152
Chapter 13: Data Governance and Management.............................................................................................................155
Leon Doorn, MSc, and Jouke Waleson
Introduction. .................................................................................................................................................................................155
Defining Data................................................................................................................................................................................155
Definitions................................................................................................................................................................................155
Data Management Use Cases...................................................................................................................................................157
Roles and Responsibilities. ............................................................................................................................................................160
Legal Representative. ...............................................................................................................................................................160
Data Protection Officer ...........................................................................................................................................................160
Quality Affairs/Regulatory Affairs ..........................................................................................................................................160
Security Officer .......................................................................................................................................................................161
Data Scientists..........................................................................................................................................................................162
Other AI-Specific Data Roles..................................................................................................................................................162
Software Engineers. .................................................................................................................................................................162
Clinical Specialist. ....................................................................................................................................................................162
Management Representative. ...................................................................................................................................................163
Data Requirements Framework.....................................................................................................................................................163
Current Data Legislation ........................................................................................................................................................163
Specific Data Legislation..........................................................................................................................................................164
Other Data Protection Legislation...........................................................................................................................................167
Non-Data-Specific Legislation. ...............................................................................................................................................168
Legislation Under Development. .............................................................................................................................................171
AI Data Management Standards..................................................................................................................................................171
Second Edition
xi Regulatory Affairs Professionals Society
Role of AI in Healthcare...............................................................................................................................................................131
AI Techniques. ..............................................................................................................................................................................132
Natural Language Processing. .......................................................................................................................................................132
Generative AI................................................................................................................................................................................133
AI System......................................................................................................................................................................................133
AI Model.......................................................................................................................................................................................134
General Purpose AI Models..........................................................................................................................................................134
Foundation Model.........................................................................................................................................................................136
Global Versus Local Change.........................................................................................................................................................136
Federated Learning. ......................................................................................................................................................................136
Change Dynamics.........................................................................................................................................................................137
Adaptive Medical Devices.............................................................................................................................................................138
Predetermined Change Control Plan............................................................................................................................................139
AI-Enabled Commoditization of Medical Device Manufacturing...............................................................................................139
Medical Device Production System..............................................................................................................................................140
A Future for Generalist Medical AI Systems................................................................................................................................140
Challenges to the Adoption of GMAI Systems............................................................................................................................140
International Medical Device Regulators Forum’s AI/ML Working Group.................................................................................141
AI-based Medical Devices in China. ............................................................................................................................................141
Risk-Based Approach of AIA. ......................................................................................................................................................142
AIA’s Stakeholders. .......................................................................................................................................................................143
AIA Joint Conformity Assessment of High-Risk AI Systems......................................................................................................143
Requirements for Providers of High-Risk AI Systems. ...........................................................................................................146
The Role of AI Standards. ........................................................................................................................................................147
AIA Obligations for Deployers of High-Risk AI Systems. .....................................................................................................147
Conclusion. ...................................................................................................................................................................................147
Chapter 12: Quality and Reliability of Health Apps. .......................................................................................................151
Petra Hoogendoorn, MSc, and Charles McCay
Introduction. .................................................................................................................................................................................151
CEN ISO/TS 82304-2:2021. .......................................................................................................................................................151
Label2Enable. ...............................................................................................................................................................................152
Conclusion. ...................................................................................................................................................................................152
Chapter 13: Data Governance and Management.............................................................................................................155
Leon Doorn, MSc, and Jouke Waleson
Introduction. .................................................................................................................................................................................155
Defining Data................................................................................................................................................................................155
Definitions................................................................................................................................................................................155
Data Management Use Cases...................................................................................................................................................157
Roles and Responsibilities. ............................................................................................................................................................160
Legal Representative. ...............................................................................................................................................................160
Data Protection Officer ...........................................................................................................................................................160
Quality Affairs/Regulatory Affairs ..........................................................................................................................................160
Security Officer .......................................................................................................................................................................161
Data Scientists..........................................................................................................................................................................162
Other AI-Specific Data Roles..................................................................................................................................................162
Software Engineers. .................................................................................................................................................................162
Clinical Specialist. ....................................................................................................................................................................162
Management Representative. ...................................................................................................................................................163
Data Requirements Framework.....................................................................................................................................................163
Current Data Legislation ........................................................................................................................................................163
Specific Data Legislation..........................................................................................................................................................164
Other Data Protection Legislation...........................................................................................................................................167
Non-Data-Specific Legislation. ...............................................................................................................................................168
Legislation Under Development. .............................................................................................................................................171
AI Data Management Standards..................................................................................................................................................171