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.

中文翻译：

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沙盒方法及其在卫生技术评估中的应用潜力：文献综述

背景

监管沙盒的概念——一个用于测试新监管流程的安全空间——最初在金融技术 (FinTech) 领域使用，但后来扩展到其他领域，包括医疗保健。

目标

本综述旨在描述沙盒在医疗保健中的使用程度，并评估沙盒方法用于测试和开发创新技术的新兴卫生技术评估 (HTA) 方法、政策和流程的潜力。

方法

进行了系统的文献回顾，以确定已发表的论文和报告，这些论文和报告描述和/或评估了医疗保健部门中沙盒的使用。从成立到 2020 年 3 月，在 Medline、Embase、Econlit、社会政策和实践以及健康管理信息联盟数据库中进行了搜索。还进行了自由文本谷歌搜索以识别相关的灰色文献。仅包括讨论或评估在医疗保健环境中使用沙盒并以英文发表的论文和报告。使用主题分析方法对纳入的研究进行定性总结。

结果

总共包括 46 篇论文和报告。涵盖的主题分为 4 个主要主题：监管沙箱的历史、作为测试环境的沙箱、作为监管方法的沙箱、在医疗保健中使用沙箱的示例。调查结果表明，在医疗保健中使用监管沙箱相对较新，主要用于高收入国家以支持采用新技术，特别是与数字健康相关的技术。根据这些发现提出建议，以指导其在 HTA 政策和方法开发中的使用。

结论

沙盒越来越多地用于医疗保健监管。尽管具有潜力，但迄今为止，这种方法尚未用于 HTA 政策和方法的发展。HTA 机构应考虑采用这种方法来促进制定创新和颠覆性卫生技术的政策、方法和流程。然而，应评估向低收入和中等收入国家的环境转移。