Welcome to Mason Hayes & Curran LLP’s Digital Health Annual Review 2022.

Even though 2022 has been a year of challenging economic and political conditions, digital health remains the fastest growing segment of the healthcare sector. Amidst a marked drop in digital health funding compared to 2021, and decreasing valuations across the wider technology sector, health systems continue to invest in technologies that will allow them to provide care to growing populations of patients with complex and changing needs. Meanwhile, the regulatory regime governing the sale and use of these technologies in the EU is continuing to transform. In this edition of our Annual Digital Health Review we cover various key legal developments from the last few months:

• Since before the coming into effect of the Medical Device Regulation in May 2021, calls for an extension to Article 120 transition timelines have been steadily growing in order to avoid the possible removal of devices from the EU market. In response to mounting pressure, the EU Commission has now proposed a set of extensions to this transition period. We provide the background to this development and set out the consequences for business
• We take a closer look at the planned changes contained in the proposal for a revised Product Liability Directive, a piece of legislation that would update the EU’s existing no-fault liability framework to account for the increasingly technologically complex nature of modern products. Of note to digital health stakeholders, standalone software would be brought within scope of this new regime and medical devices, as well as AI systems, are referred to at various parts throughout the text
• Further analysis for stakeholders in the sector is provided in our article covering an important decision of the Court of Justice of the European Union on the interpretation of the meaning of “sensitive information” and the restrictions on disclosure under the GDPR
  
• We also provide an overview of cybersecurity for digital health platforms and connected medical devices and review legislative changes taking place in the EU that have the potential to improve security standards and safety for patients.

As we enter 2023, we cover these issues and much more with the aim of providing a useful reference for Digital Health stakeholders navigating an increasingly sophisticated EU regulatory landscape. We hope you enjoy the third edition of our Annual Digital Health Review.

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