On 23 December 2020, the European Commission published its roadmap/inception impact assessment on the European Health Data Space (EHDS), which is open for feedback until 3 February 2021. The document sets out the work plan of the European Commission to create a Regulatory Framework for the EHDS.
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.
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.