Earning Trust for AI in Health 2025

Appendix: A selection of regulatory sandbox initiatives Approach Country / Responsible entitySector Objectives Energy regulation sandbox35United Kingdom – OfgemEnergy Allow for innovation in products, services and business models that are restricted by current regulations. Ofgem can provide: – Guidance, comfort and time-limited derogations from specific rules – Confirmation that an activity is permissible – Rule removal through a derogation FinTech regulatory sandbox36Singapore – Monetary Authority of Singapore (MAS)Financial services Temporarily relax regulatory requirements to allow for experiments with innovative business ideas in a live environment. The MAS can support an experiment by loosening selected legal and regulatory requirements during the sandbox. The Sandbox Plus programme also includes grants for first movers. RBI’s regulatory sandbox37India – Reserve Bank of India (RBI)Financial services Governed by oversight and safeguards, market participants can test products, business models and services in a live environment. The test product should include new/emerging technology (such as application program interface, data analytics and mobile technology) or innovative use of existing technology. Products to be tested should address a particular problem and deliver clear benefits for consumers. Licensing Experimentation and Adaptation Programme (LEAP)38Singapore – Ministry of Health of SingaporeHealth Enable safe experimentation in healthcare services in Singapore. Under the programme, which was introduced to support the emergence of telemedicine, regulators work with providers to understand the operating models and risks connected to it and develop regulations. The programme may include subsidies. ARCEP’s regulatory sandbox39France – Telecommunications Regulation Authority for Electronic and Postal Communications (ARCEP)Telecommunications Allow temporarily relaxed regulation for up to two years to enable players to experiment with innovations supported by 5G technology. The sandbox includes a frequency band (26 GHz) allocated to innovators by ARCEP . Sandbox notificationThailand – National Broadcasting and Telecommunication Commission (NBTC) Telecommunications Facilitate testing of the technology for adopting 5G in Thailand. This is an area-based regulatory sandbox, under which experiments in NBTC-designated locations are not subject to existing regulations. Unmanned Aircraft System Integration Pilot Program40United States – Federal Aviation Administration (FAA)Transport Test the safe use of unmanned aerial vehicles (UAVs), also often referred to as drones, for a period of 30 months. Under the scheme, private-sector applicants could partner with state, local or tribal governments to apply for a waiver from United States airspace regulation to test UAVs. Japan Regulatory Sandbox41Japan – Cabinet SecretariatCross-sectoral Enable innovators to demonstrate cutting-edge technologies and business models in any sector. The sandbox framework includes the System to Remove Grey Zone Areas and the System of Special Arrangements for New Business Activities (allowing for a participant to ask for exemption from regulatory requirements). Earning Trust for AI in Health: A Collaborative Path Forward 17