Digital Health Life Sciences

Welcome to Mason Hayes & Curran LLP’s Digital Health Mid-Year Review 2022.

As we enter the second half of 2022, we cover issues including the IVDR, the proposed AI Act and much more with the aim of providing a useful reference for stakeholders navigating an increasingly sophisticated Digital Health landscape. We hope you enjoy the third edition of our Mid-Year Digital Health Review.

It is now well recognised that as well as improving efficiency and enhancing the integration of healthcare systems, Digital Health technology is only just beginning to demonstrate its true potential in terms of offering personalized health care, better diagnosis and greater quality of treatment to citizens across the world. The EU has been a good example of this exciting growth, with the European Digital Health market expected to approach a value of approximately €46 billion by the end of 2022. Meanwhile, the EU regulatory landscape continues to evolve in order to keep up with the rapid pace of innovation in this space.

  • Since the publication of our Annual Digital Health Review in January 2022, the In Vitro Diagnostic Medical Device Regulation (IVDR) has come into effect, complementing the framework now in force under the Medical Device Regulation (MDR). We take account of this key development, consider the transitional measures provided by the European Commission and assess the actual impact of the implementing legislation on stakeholders.
  • The proposed Artificial Intelligence Act (AI Act) continues its journey through the European legislative process and could potentially become law in 2023. We review proposed amendments to the AI Act which seek to manage the risks associated with the use of autonomous systems and sophisticated computing techniques that are already manifesting in various medical devices incorporating or in use alongside software applications.
  • Novel systems of funding for digital health platforms are also explored, offering insight into theories of reimbursement for Digital Health through inventive use of personal data and we offer an overview of the EU’s new Health Data Space Regulation. Our article on the Consumer Rights Bill 2022 also looks at the use of personal data but from a consumer perspective and gauges the impact of this new national legislation on Digital Health companies.

As we enter the second half of 2022, we cover these issues and much more with the aim of providing a useful reference for stakeholders navigating an increasingly sophisticated Digital Health landscape.

Download your copy of the Review via the link below in Related Downloads.