Welcome to Mason Hayes & Curran LLP’s Digital Health Annual Review 2020.

In the six months since publication of our 2020 Mid-Year Review, advancement in the regulation of digital health products has continued apace.

Throughout 2020, the Digital Health industry has seen increased focus on the impact of Brexit, the regulation of artificial intelligence (AI), the Medical Device Regulation (MDR) and data privacy issues. In Brexit news, the transitional period where EU law continued to apply to the UK as an EU Member State ended at 11pm (GMT) on 31 December 2020. We discuss some of the key regulatory changes which will form part of the post-Brexit commercial landscape.

In October last year, the European Parliament voted on a new legislative proposal for a civil liability regime for AI and we examine the potential impact of this for AI “operators”. That proposal sets out to tackle big themes and issues like how to ensure safety, transparency and accountability, prevent bias and discrimination, foster social and environmental responsibility, and ensure respect for fundamental rights.

The upcoming implementation of the MDR in May 2021 is also quickly approaching. In the meantime, the European Medical Devices Co-ordination Group (MDCG) has published further guidance documents of particular relevance to Digital Health companies. In terms of data protection and privacy, various significant measures have been introduced throughout the EU as part of the battle against COVID-19 that have resulted in a significant increase in the collection of data relating to individuals’ health, location and social habits. With this, data protection and privacy remains a key issue for Digital Health technology.

We discuss these key issues and we hope you enjoy the first edition of our Annual Digital Health Review.