OBJECTIVES: A “regulatory sandbox” is an environment for testing new regulatory processes without compromising current regulation. This research aims to review the literature on using regulatory sandboxes in healthcare, evaluate potential use of this approach in health policy development and inform establishing a policy sandbox within the Horizon-2020 HTx (Next Generation Health Technology Assessment) project.

METHODS: A literature review was undertaken to identify published papers and reports that described and/or assessed the use of sandboxes in the healthcare sector. Searches were conducted in Medline, Embase, Econlit, Social Policy and Practice, and Health Management Information Consortium. Google search was also conducted to identify the relevant grey literature. Only papers and reports discussing or evaluating the use of sandboxes in healthcare settings and published in English were included.

RESULTS: Overall, 45 papers and reports were included. Findings show that the use of regulatory sandboxes in healthcare is relatively new. The first was launched by the UK Care Quality Commission in 2019 to develop regulatory clarity for deployment of innovative healthcare technologies including digital triage and machine learning. Several regulatory sandboxes have emerged since to support the development and implementation of new medical technologies, particularly those related to e-health. Different models of “policy sandboxes” can be established to aid in the development of methods for the assessment of innovative health technologies for widespread adoption and use. Transferability to low- and middle-income countries’ settings will need to be assessed.

CONCLUSIONS: The use of sandboxes as controlled environments for testing new innovations and regulatory developments is increasingly seen within healthcare. This approach has not yet been used in HTA policy and methodological developments, despite its potential. Research projects working on methodological developments, similar to HTx, should consider establishing policy sandboxes to assess the potential use of this approach in informing real-life decision-making.