목차
Foreword 3
Executive summary 4
Introduction 5
1 Empowering trustworthy AI in health: The urgent need for collaboration 7
1.1 Global divergences challenge the scaling of AI in health 8
1.2 The private sector is key to driving progress and standardization 8
1.3 AI regulations must be crafted to keep pace with innovation 9
2 The need for a pragmatic approach: Guidelines, sandboxes and post-market surveillance 10
2.1 Legislation can build a strong baseline for governing AI in health 10
2.2 Sandboxes provide a safe space in which the private sector can innovate 11
2.3 Post-market surveillance can help cope with the evolving nature of AI 12
3 The importance of public–private partnerships for AI in health 13
3.1 The role of public–private partnerships in regulating medical devices, including software 13
3.2 Private-sector capabilities can help test and operationalize the regulatory process 13
3.3 Quality assurance resources: An approach to PPPs for independent testing and training 15
Conclusion 16
Appendix: A selection of regulatory sandbox inititatives 17
Contributors 18
Acknowledgements 18
Endnotes 19
