The Sandbox Approach and its Potential for Use in Health Technology Assessment: A Literature Review.

Background: The concept of the regulatory sandbox-a safe space for testing new regulatory processes-was first used within the financial technologies (FinTech) sector, but has since expanded into other sectors, including healthcare.

Objectives: This review aims to describe the extent of use of sandboxes in healthcare and assess the potential for the sandbox approach to be used to test and develop emerging health technology assessment (HTA) methods, policies and processes for innovative technologies.

Methods: A systematic 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 databases from inception to March 2020. Free-text Google search was also conducted to identify relevant grey literature. Only papers and reports discussing or evaluating the use of sandboxes in healthcare settings and published in English were included. Included studies were qualitatively summarised using a thematic analysis approach.

Results: Overall, 46 papers and reports were included. The topics covered were classified into 4 major themes: history of the regulatory sandbox, the sandbox as a testing environment, the sandbox as a regulatory approach, examples of using sandboxes in healthcare. Findings show that the use of regulatory sandboxes in healthcare is relatively new and primarily used in high-income countries to support the adoption of new technologies, particularly those related to digital health. Recommendations are made based on these findings to guide its use in HTA policy and methods development.

Conclusions: Sandboxes are increasingly used within healthcare regulation. Despite its potential, this approach has not been used in HTA policy and methodological developments to date. HTA agencies should consider this approach to facilitate developing policies, methods and processes for innovative and disruptive health technologies. Transferability to low- and middle-income countries' settings, however, should be assessed.