1、ARTIFICIAL INTELLIGENCEIN HEALTHCARE GUIDELINESVersion 2.0Published March 20262 1.Foreword 4 2.Introduction5 2.1.Objectives 5 2.2.AIHGles Focus 6 3.Ethical Principles 8 4.SettingClearResponsibilitiesbetweenDevelopers,Deployers,andUsers11 5.Developers:HealthcareAIDevelopers14 5.1.Compliance to Regula

2、tory Requirements 14 5.2.Managing AI Solutions Through a Total Product Lifecycle(TPLC)Approach 16 5.3.Planning,Design,and Development 17 5.4.Model Evaluation 19 5.5.Post-Market Surveillance and Maintenance 19 5.6.End of Life 20 5.7.User Communications 20 6.Deployers:HealthcareOrganisations21 6.1.Org

3、anisational Governance and Oversight 21 6.2.Risk Assessment Framework 23 6.3.Pre-Deployment Testing and Validation 24 6.4.Deployment 25Contents3 6.5.Staff Training 26 6.6.Periodic Monitoring 26 6.7.Response to Adverse Events 27 6.8.End of Life 28 6.9.Patient Communications 28 7.Users:HealthcareProfe

4、ssionals30 7.1.Deployment 30 7.2.Staff Training 31 7.3.Periodic Monitoring 32 7.4.Response to Adverse Events 32 7.5.Patient Communications 32 8.EmergingDevelopments33 8.1.AI Solutions with Continuous Learning Capabilities 33 8.2.Generative AI 34 8.3.Direct-to-Consumer(DTC)AI Applications 36 9.OtherR

5、elevantLegislationandGuidelines37 10.Acknowledgements4141ForewordArtificial Intelligence is rapidly transforming healthcare from advanced diagnostic imaging to clinical voice-to-text solutions.When applied responsibly,AI enhances health systems,making them more resilient,efficient,and responsive to

6、patient needs.Importantly,AI empowers our healthcare professionals and augments their clinical decision-making,in enhancing care delivery.We are committed to upholding an agile governance framework that has patient safety at its core,whilst enabling innovation.The responsible development and deploym