Digital Health Technology

2023 was another eventful year for digital health in the EU. For example, in the six months since the publication of our Mid-Year Review we have seen:

  • The start of trilogue negotiations to agree the final text of the EU AI Act
  • Reflection papers issued by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) on the use of AI in drug development
  • Updates to the Manual on Borderline Classification for Medical Devices
  • ‘Principles for Machine Learning in Medtech’ published jointly by the Medicines and Healthcare products Regulatory Agency (MHRA), FDA and Health Canada
  • Further delays to the operationalisation of the EUDAMED system
  • Updated MDCG guidance on hardware/software combinations and Article 120 ‘significant changes’
  • A MedTech Europe statement calling for a major rethink of the features of the revised EU Product Liability Directive
  • An open letter from MedTech Europe to the EU Commissioner for Health calling for comprehensive structural reform of the European regulatory framework for medical technologies made up of the MDR and IVDR

Meanwhile, a lacklustre H1 for digital health funding was followed by a 14% drop in quarter-on-quarter funding in Q3 to $3B – its lowest level since 2016 – with the majority share of top deals going to AI-enabled startups.

As we now enter 2024, we discuss these and a number of other issues that arose during 2023 for digital health stakeholders in the EU. As we prepare for another significant year, we look at topics including:

  • The step up in preparations for the coming into effect of the EU AI Act
  • Enhanced awareness around the need to guard against product liability claims involving software products and software medical devices
  • Increased adoption of at-home diagnostics and biometric tracking using wearable devices, especially in areas like agetech, femtech and mental health, and as part of decentralised clinical trials
  • Further developments in the use and regulation of generative AI in healthcare
  • The continued focus on cybersecurity and data privacy

We hope you enjoy the fourth edition of our Annual Digital Health Review.

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