Regulating digital health technologies with transparency: the case for dynamic and multi-stakeholder evaluation

Abstract

Abstract Background The prevalence of smartphones today, paired with the increasing precision and therapeutic potential of digital capabilities, offers unprecedented opportunity in the field of digital medicine. Smartphones offer novel accessibility, unique insights into physical and cognitive behavior, and diverse resources designed to aid health. Many of these digital resources, however, are developed and shared at a faster rate than they can be assessed for efficacy, safety, and security—presenting patients and clinicians with the challenge of distinguishing helpful tools from harmful ones. Main text Leading regulators, such as the FDA in the USA and the NHS in the UK, are working to evaluate the influx of mobile health applications entering the market. Efforts to regulate, however, are challenged by the need for more transparency. They require real-world data on the actual use, effects, benefits, and harms of these digital health tools. Given rapid product cycles and frequent updates, even the most thorough evaluation is only as accurate as the data it is based on. Conclusions In this debate piece, we propose a complementary approach to ongoing efforts via a dynamic self-certification checklist. We outline how simple self-certification, validated or challenged by app users, would enhance transparency, engage diverse stakeholders in meaningful education and learning, and incentivize the design of safe and secure medical apps.