23. For GenAI tools, regulators could also build upon existing regulations for health professions. Regulators could mandate that GenAI tools undergo specific training, examinations, periodic assessments and retraining. For more insights, see Blumenthal, D., & Patel, B. (2024, September 4). How to regulate generative AI in health care. Harvard Business Review. https://hbr.org/2024/09/how-to-regulate-generative-ai-in-healthcare 24. “Lebanon currently lacks specific strategy, laws, statutes, or regulations that govern AI or its use in health.” “Pakistan hasn’t released any laws yet for AI or AI in health … As a federated republic with healthcare managed at the provincial level, regulating AI in health may face additional challenges due to decentralization.” HealthAI. (2024). Mapping AI governance in health: From global regulatory alignments to LMICs’ policy developments, 56, 60. https://clias.iecs.org.ar/ wp-content/uploads/2024/10/HealthAI_GlobalLandscapeReport_Oct.2024.pdf 25. Schmidt, J., et al. (2024, August 27). Mapping the regulatory landscape for artificial intelligence in health within the European Union. npj digital medicine 7, 229. https://www.nature.com/articles/s41746-024-01221-6 26. World Economic Forum. (2024, January 9). Transforming healthcare: Navigating digital health with a value-driven approach. https://www.weforum.org/publications/transforming-healthcare-navigating-digital-health-with-a-value-driven- approach/; OECD. (2020, June 12). The role of sandboxes in promoting flexibility and innovation in the digital age . https://www.oecd.org/en/publications/the-role-of-sandboxes-in-promoting-flexibility-and-innovation-in-the-digital-age_ cdf5ed45-en.html; World Health Organization (WHO). (2023). Regulatory considerations on artificial intelligence in health. https://iris.who.int/bitstream/handle/10665/373421/9789240078871-eng.pdf 27. UK Government. (2024, May 9). AI Airlock: The regulatory sandbox for AIaMD. https://www.gov.uk/government/ collections/ai-airlock-the-regulatory-sandbox-for-aiamd 28. US Food and Drug Administration. (n.d.). Methods and tools for effective postmarket monitoring of artificial intelligence (AI)-enabled medical devices. Retrieved May 12, 2025, from https://www.fda.gov/medical-devices/medical-device- regulatory-science-research-programs-conducted-osel/methods-and-tools-effective-postmarket-monitoring-artificial- intelligence-ai-enabled-medical-devices 29. Coalition for HealthAI. (n.d.). Responsible use of AI in health. Retrieved May 12, 2025, from https://chai.org/ 30. Muehlematter, U. J., et al. (2021, March). Approval of artificial intelligence and machine learning-based medical devices in the USA and Europe (2015–20): A comparative analysis. The Lancet Digital Health 3(3), e195–e203. https://pubmed.ncbi. nlm.nih.gov/33478929/ 31. American National Standards Institute. (2023, December 27). Using AI responsibly: US leads efforts to develop ISO/IEC 42001, Artificial Intelligence Management System Standard. https://www.ansi.org/standards-news/all-news/2023/12/12- 27-23-using-ai-responsibly-us-leads-efforts-to-develop-iso-iec-42001 32. Galileo. (n.d.). Unlock evaluation intelligence for AI teams. Retrieved May 12, 2025, from https://galileo.ai/ 33. European Commission. (n.d.). Sectorial AI testing and experimentation facilities under the Digital Europe Programme . Retrieved May 12, 2025, from https://digital-strategy.ec.europa.eu/en/policies/testing-and-experimentation-facilities 34. 34 Car, J., et al. (2025, January 31). The Digital Health Competencies in Medical Education Framework: An international consensus statement based on a Delphi study. JAMA Network Open. https://jamanetwork.com/journals/ jamanetworkopen/fullarticle/2829788 35. Ofgem. (n.d.). Energy regulation sandbox. Retrieved May 12, 2025, from https://www.ofgem.gov.uk/energy- regulation-sandbox 36. See Monetary Authority of Singapore. (n.d.). Overview of regulatory sandbox. Retrieved May 12, 2025, from https://www. mas.gov.sg/development/fintech/regulatory-sandbox 37. See Reserve Bank of India. (n.d.). Enabling framework for regulatory sandbox. Retrieved May 12, 2025, from https://www.rbi.org.in/Scripts/PublicationReportDetails.aspx?UrlPage=&ID=938 38. See Ministry of Health Singapore. (2024, October 28). Regulatory sandbox. https://www.moh.gov.sg/others/health- regulation/regulatory-sandbox/ 39. See ARCEP . (2019, January 31). The French government and Arcep issue a call for the creation of 5G trial platforms in the 26 GHz band [Press release]. https://en.arcep.fr/news/press-releases/view/n/5g-16.html 40. See US Federal Aviation Administration. (n.d.). UAS integration pilot program. Retrieved May 12, 2025, from https://www. faa.gov/uas/programs_partnerships/completed/integration_pilot_program 41. See Cabinet Secretariat. On the regulatory sandbox system (Japanese language) https://www.cas.go.jp/jp/seisaku/s- portal/pdf/underlyinglaw/Japans_Regulatory_Sandbox.pdf and IFLR (2019, July 20). Japan: Sandbox reform. https://www. iflr.com/article/2a63afeimueh7mpx1lb0g/japan-sandbox-reform Earning Trust for AI in Health: A Collaborative Path Forward 20

Earning Trust for AI in Health 2025