The proposal aims to empower people to control and utilise their health data while fostering the single market for digital health services and products. This document is very relevant for the in silico community as health data collaboration – and restrictions – are hugely important for fostering in silico research and innovation.
- The priority issues that the Commission aims to address with the initiative include challenges related to data exchange at EU level - both for treatment and research activities (including collection, management, and re-use of personal health data), the provision of appropriate infrastructures to facilitate citizens' access to data, and the issue of standardisation and interoperability across different health systems.
- The Commission's proposal is ambitious; it has a distinct focus on topics like AI, personalised medicine and several other areas. In light of these many facets, the Regulation must be scrutinised against other complementary initiatives (GDPR, Data Act, AI Act etc) to evaluate synergies as well as possible conflicts.
- Various opportunities for stakeholder engagement are already highlighted in this proposal, for example through the EHDS Board as well as the expert group and the just-opened feedback period.
- Chapter 1 presents the scope of the regulation and its relationship with other EU instruments.
- Chapter 2 declares that Member States shall designate a digital health authority responsible to monitor the rights for natural persons under this regulation.
- Cross-border exchange of electronic health data will be facilitated through a common infrastructure.
- Digital health authorities shall cooperate with stakeholder representatives and industry associations to ensure interoperability, data portability and security of electronic health data.
- Chapter 3 describes the implementation of a mandatory self-certification scheme for electronic health record systems to ensure that electronic health records are compatible between each system and easy to transfer.
- Chapter 4 concerns the secondary use of health data for research, innovation, policy making, patient safety or regulatory activities.
- Member States shall designate national contact points, to be connected with contact points of the different member states for the secondary use of data.
- Provisions for data altruism in health are highlighted. Data holders should cooperate with health data access bodies to ensure the availability of electronic health data.
- The regulation further describes requirements for data access applications and declares how data access bodies will only provide anonymised data in a statistical format.
- Cross-border access of electronic health data is described as a process which shall function without having to request a data permit from the Member States.
- Chapter 5 describes the necessary capacity building to implement the regulation.
- Chapter 6 introduces the creation of the “European Health Data Space Board (EHDS Board)” which shall facilitate the cooperation among the digital health authorities and health data access bodies.
- There will be two sub-groups focusing on primary and secondary use of electronic health data.
- It is composed of high-level representatives of digital health authorities and health data access bodies of all the Member States.
- Stakeholders and relevant third parties shall be invited to attend the meetings of the board and to participate in its work depending on the topics discussed.
- Chapter 7 allows the Commission to create an expert group which shall advise and assist in the preparation of delegated acts.
Background and Next Steps
- The proposal will now be examined by the Council and the European Parliament.
- The reaction of the Member States needs to be carefully taken into account because, as expected, it may affect some crucial aspects of their sovereignty.
- Balancing interoperability, conflicting national laws, and Member State reactions will likely be broadly discussed by stakeholders, including industry and the Parliament and Council as they move forward with this proposal, which has placed significant weight on national contact points for data access permits.
- EFPIA has already set up an event for the 18 May 2022 to discuss the EHDS; RPP will follow this event.
- The European Commission has now opened a feedback period for the European Health Data Space proposal, to which we encourage the Alliance and its members to submit.
- This call for feedback provides all stakeholders with a crucial opportunity to possibly have their perspectives reflected in the upcoming negotiations and final text, for example when it comes to potential conflicts with other complementary initiatives and obligations on the use of secondary health data.
- As a result of the feedback period, the Commission will develop a summary of the responses which will be considered in the negotiation phase.
- The feedback period started on 4 May 2022 and will be open until 29 June 2022. It is an open question with a limit of 4000 characters and the possibility to upload supporting documentation.
The link to the full document can be found here