Digital health technologies: navigating the regulatory maze

From wearables for health monitoring and self-care apps to machine learning analysis of medical images, the potential of digital technologies to revolutionise healthcare is a leading aspect of modern healthcare. The rapid growth of digital devices, software and machine learning technologies means that the medical device sector is changing. Effective, responsive regulation of digital health technologies requires sound understanding of their technical basis and underlying concepts – but even with this knowledge, identifying where they fit within this complex and evolving regulatory environment is no easy task. A major new report from the PHG Foundation, Algorithms as medical devices, describes how medical device regulation applies to digital health, including machine learning. Based on extensive research and expert stakeholder discussion, this new report is an important resource for manufacturers, software developers, regulators and policy makers working in digital health, and offers policy recommendations for improving the regulation of digital medical devices.