Digital Health: the legal and regulatory issues to consider

The digital health industry has grown significantly in the recent years. With increasing financial investments and rapid technological advances, there is a greater impetus to unlock its potential to improve global healthcare landscape. The developing Covid pandemic has accelerated adoption of digital solutions that can improve or optimise healthcare deliveries.

The rapid pace of innovation in digital health brings with it significant legal, regulatory and policy challenges. In the key global regions, there is an apparent lack of singular legislation to cover digital health, resulting in a patchwork of different regimes being applied which do not address adequately the distinct features of such health technologies. There is also uncertainty about the regulatory status of digitalisation platform in the key global regions in Europe, North America and Asia.

The following trends also emerge:

• Global regions are approaching the challenges of digital health technologies in different ways and timelines. Some countries or regions develop bespoke legislation whereas others are attempting to regulate such technologies under the existing regulatory framework.
• In order to realise access to digital health technologies, an evidence framework should be developed to inform an assessment on whether the technology is clinically effective and offers economic value.
• The value of Real-World Evidence is increasingly recognised to provide its value for regulatory decision-making on the development, authorisation and supervision of medicines throughout the entire product lifecycle. The intersection of digital health and Real-World Evidence cannot be more critical in the overall evidence generation process to provide greater insights into the safe and effective conditions of a new method of treatment in practice.
• There remain a number of important questions relating to (a) risk evaluation, and potential liability exposure, of such digitalised technologies and (b) their pathways for adoption into the national health systems.

My colleagues of Ropes & Gray’s Global Life Sciences Practice have authored a book chapter to address these technological, legal and regulatory questions. To read more on the above, please click here.