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. It outlines three areas critical to a better understanding of medical device regulation:

• The challenges that the digital health sector may pose for medical device regulators and policy makers
• When digital health devices count as medical devices under EU and US law
• The specific problems that machine learning could pose to medical device regulation

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.

A supplementary report, Regulating algorithms in healthcare: the GDPR and IVDR in practice, sets out findings from an international expert workshop that examined related issues such as how algorithms and software for healthcare applications are defined, and the impact of the General Data Protection Regulation (GDPR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).

Further information on the Regulating algorithms in healthcare project is available here.

For more information on this, or other PHG Foundation reports, please contact
[email protected]