Consolidating healthcare Sandbox in KSA: benchmarking against successful global regulatory sandbox using systems thinking framework

Abstract

Aim: This review was intended to provide insights on how the Ministry of Health in KSA can best utilise and expand on regulatory sandboxes for healthcare improvement through partnerships, integration, effective supervision, efficient data gathering and funding. Theoretical Framework: The systems thinking perspective was used to identify the complexity and how elements in the regulatory sandbox are related. Methodology: The present study used a scoping review methodology to identify the available literature on Saudi sandboxes without making an evaluation of the quality of the studies or their risk of bias. To narrow articles, inclusion criteria were restricted to articles published in English from 2016, which yielded a total of 5 studies. Findings: Research established that sandboxes are used mostly in the financial industry but could be useful in the healthcare sector to allow for experimentation of products under legal standards. Nonetheless, questions are raised regarding the development of regulations, limitation of information, data secrecy, involving stakeholders, and sustainability after the sandbox phase. Some of these issues include an increase in inequality, Safety and efficacy data, and applicability to LMICs needs more studies. Recommendations: There is more risk when sandboxing intersectoral to require more precaution to protect the public interest. This means that regulators need to step in and close gaps in the regulation of digital health technologies to ensure that safety and effectiveness are set. Subsequent research must explore if sandboxes meet their purpose and if they are portable. Approval regulations are other facets that should be considered which include regulator discretion, process and/or outcomes orientation, stakeholder participation, and post-sandbox regulation.