Regulatory Sandboxes for Digital Health

Industry Overview - Digital health technologies, including digital applications, data, and information systems, are transforming healthcare by improving patient experience, operational efficiency, and creating new business models [1] - Regulatory sandboxes are important tools for promoting innovation in highly regulated sectors like digital health, allowing innovators to test new products and services in controlled environments [4] - The use of regulatory sandboxes in digital health is growing globally, with benefits for innovators, patients, governments, and regulators [6] Benefits of Regulatory Sandboxes - Innovators gain access to funding, markets, and regulatory guidance, reducing risks and increasing confidence in their products [8] - Patients benefit from early access to innovative, regulated products at potentially lower costs, with increased transparency and trust [8] - Governments and regulators can better understand the risks and benefits of new technologies, improve regulations, and promote innovation [8] Key Characteristics of Regulatory Sandboxes - Regulatory sandboxes are time-bound, with specific focus areas and regulatory waivers within legal limits [10] - They aim to develop evidence on the effects of innovations and provide insights into future regulation [10] - The AAA model of regulation (Advisory, Adaptive, Anticipatory) is used to characterize different objectives of regulatory sandboxes [12] Global Implementation of Regulatory Sandboxes - The UK has been a pioneer in using regulatory sandboxes across multiple sectors, including healthcare [21] - Singapore ran a regulatory sandbox for telemedicine and mobile medicine from 2018 to 2021 [21] - Malaysia's National Technology and Innovation Sandbox has supported 26% of approved applications in the medical and healthcare sectors [21] - India's National Digital Health Mission Sandbox helps integrate innovations into the national digital health ecosystem [21] Steps to Create a Regulatory Sandbox - Define the leadership model, typically involving the Ministry of Health and other relevant ministries [27] - Identify the problems to be addressed and the relevant emerging technologies [30] - Conduct regulatory mapping to identify applicable laws, regulations, norms, and standards [31] - Identify entities involved in monitoring and evaluating the sandbox, including data protection agencies and health regulators [32] - Build capacity and provide training for all entities involved in the sandbox [38] - Establish working groups to coordinate the design, implementation, and monitoring of the sandbox [40] - Define a risk model to identify possible effects and establish contingency plans [41] - Set eligibility and selection criteria for innovators, focusing on novelty, development stage, and regulatory interest [42] - Design the sandbox with specific objectives, including duration, admission windows, and exit options [45] - Publish plans for public consultation before launching the sandbox [52] - Launch and implement the sandbox, allowing innovators to submit applications [53] - Monitor, evaluate, and learn from the sandbox, publishing exit and final reports [58] Key Success Factors and Challenges - Regulatory sandboxes require significant resources, ranging from $25,000 to $1 million [68] - A well-functioning sandbox needs to meet existing market demand and have a mature digital health market [70] - Challenges include predicting potential risks, resource intensity, cross-sectoral innovations, and limited evidence of effectiveness [77] Design Elements of Regulatory Sandboxes - Eligibility: Defines who can participate in the sandbox [47] - Governance: Defines the internal operating structure and roles [47] - Timing: Includes duration of admission windows and testing periods [47] - Test restrictions: Limits the scope, scale, and conduct of the sandbox test [47] - Exit options: Includes individual test outcomes and program-level KPIs [47]