1、White PaperThe Human Edge of AI:Building Trust,Safety and Value in Regulated Healthcare SystemsA strategic framework for responsible AI governanceMARIE FLANAGAN,Director,Product,Regulatory&AI Governance SME,IT Design&Development,IQVIAMIKE KING,Senior Director,Product&Strategy,IQVIAJANE REED,Director

2、,Life Sciences,IT Design&Development,IQVIATable of contentsExecutive summary 1Key points 2The hybrid future:AI as amplifier,not replacement 3The human-machine partnership model 3Why humans remain essential 4Governance as trust infrastructure 5The competency challenge:preserving institutional knowled

3、ge 8Strategic responses to the competency cliff 9AI literacy as regulatory compliance 10Three dimensions of AI literacy 10Building literacy programs that work 11Ethics and beneficence:The patient-centric imperative 12Four ethical principles for healthcare AI 12Measuring patient-centric ROI 13The imp

4、lementation reality:Common challenges 14Practical deployment strategies 15Measuring success and driving continuous improvement 17Practical implementation:Case vignettes 18Case vignette 1:Turning off self-learning 18The pragmatic solution 18Case vignette 2:Manufacturing quality control partnership 19

5、The optimal partnership 19Conclusion:The path forward 20Five pillars for responsible implementation 20Seven strategic imperatives for success 21The ultimate measure:Patient benefit 21Next steps:Advancing your AI governance readiness 22 |1Executive summaryAs AI transforms healthcare,organizations fac

6、e a critical challenge:harnessing AIs capabilities while preserving the human expertise,ethical judgment,and institutional knowledge essential to patient safety.This framework synthesizes IQVIAs insights for responsible AI governance in regulated healthcare.The pharmaceutical,medical device and in-v