Marguerite Brac de La Perrière partner in Digital & Data at Lerins, expert in Digital Health, will discuss in this paper, the European Union’s program for health and the new era that is opening up to strengthen the use and reuse of health data.

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Digital health in Europe, a new data era!

With the European Union Health Programme, established by Regulation (EU) 2021/522 (EU4Health)[1] for the period 2021-2027, the EU is investing €5.3 billion in actions with European added value, which complement the policies pursued by EU countries.

This includes strengthening the use and re-use of health data for healthcare delivery and research and innovation, promoting the uptake of digital tools and services, and the digital transformation of healthcare systems, and supporting the creation of a European Health Data Space.
With regard to digital transformation, in line with measures ensuring a common high level of security of networks and information systems in the Union[2], the e-Health Digital Services Infrastructure (eHDSI) aims to ensure continuity of care for European citizens, enabling EU countries to exchange health data in a secure, efficient and interoperable way. Services for the exchange of electronic prescriptions and patient records will be open to all countries by 2025[3].
With regard to the re-use of health data, the GDPR had introduced it for compatible purposes, subject to appropriate safeguards, including health safeguards, noting “By combining information from registries, researchers can gain valuable new insights into widespread medical problems such as cardiovascular disease, cancer and depression. Based on registries, research results can be improved because they are based on a larger population sample.
The draft regulation[4] on the European Health Data Space establishes a secure, health-specific sharing framework for the primary use of data in health care and for the secondary use of non-directly identifiable health data in research, innovation and public health policy-making.
This text is fully in line with the European Data Strategy[5], which foresees a single market for data, with a major benefit for healthcare: “Personalized medicine will better meet patients’ needs by empowering doctors to make data-driven decisions. This will make it possible to define a therapeutic strategy tailored to the needs of the individual and according to an optimal schedule, and/or to determine the predisposition to a disease and/or to ensure targeted and timely prevention.”
In the same vein, it follows on from the draft Data Governance Act (DGA)[6], which aims, among other things, to allow the re-use of data held by public bodies – subject to appropriate and harmonized processing conditions in Europe for “highly sensitive” data held by public health system actors, such as public hospitals.
The DGA also introduces the notion of “data altruism”, noting that “there are many opportunities for the use of data voluntarily made available by data subjects with their consent (…) for public interest purposes”, especially in healthcare. In this respect, solutions such as “Mon Espace Santé” in France (or its operational equivalent in Portugal), offer interesting prospects for centralizing the consents of each citizen, duly informed in a specific manner for each purpose, both for the primary use, and also for the secondary use, of their data.
The beginning of a new era of health data, with exponential individual and collective benefits in terms of prevention, health care, innovations, and public health policies!

[1] Règlement 2021-552 établissant un programme d’action de l’Union dans le domaine de la santé pour 2021-2027

[2] Directive 2016/1148 concernant des mesures destinées à assurer un niveau élevé commun de sécurité des réseaux et des systèmes d’information dans l’Union

[4] Proposition de règlement publié le 3-05-2022

[5] Stratégie européenne pour les données 19-02-2020

[6] Proposition de règlement sur la gouvernance européenne des données 25-11-2020