On December 23, 2020, the European Commission (the “Commission”) published its inception impact assessment (“Inception Impact Assessment”) of policy options for establishing a European Health Data Space (“EHDS”).  The Inception Impact Assessment is open for consultation until February 3, 2021, encouraging “citizens and stakeholders” to “provide views on the Commission’s understanding of the current situation, problem and possible solutions”.

What is the EHDS?

On November 11, 2020, the Commission and the German Presidency of the Council of the EU announced their intention to work together to establish a EHDS.  The creation of the EHDS forms part of the Commission’s proposed wider “Data Strategy” to leverage quality data for use by public authorities and businesses across certain sectors and areas of public interest (see pages 29 and 30 of the Commission’s Data Strategy Report, and our Covington blog here).  Note also that, as part of this Data Strategy, the Commission published its proposal for regulation of European data governance through the “Data Governance Act”, which also aims to facilitate data sharing across the EU.  (For further information on the Data Governance Act, please see our blog available here.)

The EHDS will provide a common framework across EU Member States for the sharing and exchange of quality health data (such as electronic health records, patient registries and genomic data) throughout the EU.  According to the Inception Impact Assessment, the EHDS has the following three objectives:

  1. ensuring access, sharing and optimal use of health data for healthcare delivery purposes as well as re-use for research and innovation, policy-making and regulatory activities, in a privacy-preserving, secure, timely, transparent and trustworthy way, and with appropriate institutional governance;
  2. fostering a genuine single market in digital health, covering health services and products, including tele-health, tele-monitoring and mobile health; and
  3. enhancing the development, deployment and application of trustworthy digital health products and services, including those incorporating artificial intelligence in the area of health.

The Commission and EU Member States will promote the exchange of health data through improved interoperability between relevant IT systems and infrastructure and ensuring that health data is “FAIR”—findable, accessible, interoperable and reusable.  The Commission intends such sharing of health data to be supported by robust systems for data governance and digital service infrastructure.

The EHDS common framework will set out the conditions for private organisations to participate. In an industry consultation organised by Digital Health Europe in June 2020, organisations were given the opportunity to express their views on the EHDS.  Participants highlighted the importance of ensuring that data sharing remains voluntary, and that such data sharing should not be mandatory, nor be a condition, for access to data in the EHDS.

Data Protection Implications

The EHDS is likely to have GDPR implications for the public authorities and organisations participating in the common framework—particularly since health data and genetic data are granted special protection under the GDPR (Article 9).  The Commission is expected to legislate on issues such as the secondary use of health data for scientific research, among others, to ensure that organisations participating in the EHDS can do so lawfully.  The Inception Impact Assessment states that the Commission will “carefully explore” the interplay between the EHDS and Articles 9 and 89 of the GDPR, in particular.

In November 2020, the European Data Protection Supervisor (“EDPS”), the independent supervisory authority of the European Union, also considered the data protection implications of the EHDS in its preliminary opinion, making a number of recommendations regarding the safeguards that should be taken into account when establishing the EHDS.

Looking Forward

In addition to the consultation on the Inception Impact Assessment (which ends on February 3, 2021), the Commission proposes to organise several targeted consultation activities and events with stakeholders regarding the EHDS in 2021.  During this time, the Commission will also consult with the competent national authorities.  The Commission aims to adopt a number of legislative and policy developments aimed at paving the way for the EHDS in the fourth quarter of 2021 (see the Commission Work Programme for 2021, available here).

The team at Covington will continue to monitor developments.