The European Commission published its roadmap on the European Health Data Space

The published Roadmap provides the context, the main problems and objectives that the EHDS will aim to tackle, as well as policy options foreseen to meet the three core objectives.

1. Objective: Ensure access, share and optimal use of health data for healthcare delivery purposes as well as re-use for research and innovation, policy-making and regulatory activities.

 Policy options:
A. Establish a legal and governance framework to cover the access to and exchange of health data for healthcare provision, research, policy-making and regulatory activities;
B. Lower technical barriers hindering data use and re-use, in particular those related to infrastructure, interoperability, data quality and standards in the health field;
C. Ensure access and control of patients and citizens over their own health data

2. Objective: Foster a genuine single market in digital health covering digital health services and products, including tele-health, tele-monitoring and mobile health.

Policy option: Remove barriers to the cross-border movement of digital health services and products, including data-intensive ones, as well as to the rights of patients to benefit from those services and products, and their interoperability with electronic health records and healthcare systems.

3. Objective: Enhance the development, deployment and application of trustworthy digital health products and services, including those incorporating artificial intelligence (AI) in the area of health.

Policy option: Analyse liability rules related to the use of data-intensive services, including AI.

Next steps 

• Feedback on the this roadmap is due February 3^rd (link: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12663-A-European-Health-Data-Space-). VPHi and AA are drafting a response.  If you also want to submit feedback, feel free to get in touch with us to discuss our current draft, by sending an email to manager@vph-institute.org.
  
• A public consultation is due to be launched during the 1st quarter of 2021.
• All the feedback gathered from stakeholders will feed into the drafting of the proposal of new legislative proposal on the EHDS to be published by the European Commission in Q4 2021.

Analysis

• The launch of this consultation represents the first step in the creation of a new regulatory framework on health data that has been awaited by health stakeholders. With a massive mobilisation of digital health-related services over the past year, the importance of sharing health data is one of the Commission’s priorities for 2021.
• The establishment of the EHDS is expected to have a significant effect on the developments of innovations in health business. Among other things, the Commission wants to push for innovations increasing the cost-effectiveness for patients and healthcare systems, optimising treatment options, facilitating personalised medicine and improving the monitoring of medicinal products and medical devices effectiveness and safety. 
• The increase of researchers’ capability to access health data, both at national and trans-national level is a desired outcome of the EDHS. A special focus is therefore paid on ensuring an easier access to the secondary use of health data while respecting the EU data protection rules (GDPR).
• The Commission’s general statement to support the uptake “digital health products and services”, with particular reference to AI-based services and products, remains very vague compared to the former European data strategy which provided specific reference to other applications ranging from AI to simulation, modelling, digital twins and high performance computing (HPC) resources. It might therefore be good calling to the European Commission to consider other mechanistic models next to phenomenological models (including AI).