Data meets healthcare: EU plans European regulation on health data space

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According to a draft legislative proposal leaked by the European Commission, which is expected to be officially published this spring, the EU plans to introduce a new European Health Data Space (EHDS) regulation.

This new law is part of the EU’s broader data strategy to create a single data market to ensure Europe’s global competitiveness and data sovereignty. The EHDS aims to create a European data space for health data and will complement other legislation planned under the European Data Strategy, namely the Data Governance Act and the Data Act . The EHDS would be the first common European data space in a specific domain to emerge from the aforementioned EU data strategy and is considered an integral part of the construction of a European health union by the European Commission.

To these ends, the EHDS will allow individuals to easily access, control and ensure the protection of their personal and non-personal health data. It will thus supplement the existing rights in the GDPR by providing certain rights of access and restriction of individuals with regard to their data.

Additionally, the EHDS is designed to help advance health care delivery, research, and policy. The goal is to enable the use of data for research innovation, policy and regulatory development, and personalized medicine, while ensuring privacy and security. However, the reuse of health data created or collected by providing health services to individuals (so-called primary use) for purposes other than those for which it was originally created or collected (so-called secondary use) raises potential problems.

On this basis, the EHDS aims to:

  • formalizing an EU-wide digital infrastructure to make electronic health data available for primary use, thought to be called “[email protected]’;
  • establish rules and mechanisms supporting the secondary use of health data while establishing safeguards with regard to, for example, the competent public bodies designated by the Member States who are supposed to be responsible for granting access to the data health at the request of data users; and
  • establish an EU-wide infrastructure to facilitate the secondary use of electronic health data.

In addition, the EHDS is intended to contain a variety of specific mandatory requirements for electronic health record (EHR) systems (i.e. solutions or software for storing or processing health data ) which are, among other things, supposed to ensure the safety, security and interoperability of these systems. Apart from these EHR systems, other medical and healthcare software products, such as medical imaging software or medical diagnostic software and wellness applications, are also expected to be impacted by the healthcare data space. .

In addition to this, it is planned that a European digital and health data committee will be created, with at least two sub-groups of experts (responsible respectively for health care delivery and research, innovation, policy development and regulation).

It is also worth noting that the EHDS proposal explicitly contains provisions enabling data altruism activities in the healthcare sector, a legal concept that is also included in the Data Governance Act. The objective here is to promote the sharing and collection of data by giving legal status to non-profit organizations that process data for reasons of general interest, for example in the context of medical research.

Overall, due to the detailed specifications and rules provided in the EHDS proposal, it is expected that the regulations, once in force, will have a major impact and create a great need for organizational and regulatory adaptation. within health as a whole. and the pharmaceutical sector, as well as a need for clarification on difficult legal issues, particularly in relation to the complex interaction of the EHDS with existing rules such as the GDPR.

Although it remains to be seen how the legislative process will evolve, companies with touchpoints in the above-mentioned sectors should assess as soon as possible whether and, if so, to what extent the planned EHDS could be relevant for them and what the possible implications might be. As.

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