[co-author: Silvia Lopez Arnao]

The European Commission has published an inception impact assessment for a potential legislative proposal establishing a European Health Data Space. In its document, the European Commission identifies the problems currently faced by the current framework for cross-border exchanges of health data. To tackle these problems, three objectives with related policy options are provided. The inception impact assessment will be open for feedback until 3 February 2021. The European Commission’s legislative proposal will be prepared after an impact assessment is carried out.

The European Commission has published an inception impact assessment for a potential legislative proposal establishing a European Health Data Space. The European Health Data Space is a European Commission’s priority that aims to foster access to and exchange of health data in order to promote healthcare, research, and innovation. It also aims to ensure that citizens have greater control over their own personal health data. The European Health Data Space is part the European Commission Work Programme for 2021.

Under Directive 2011/24 on patients’ rights in cross-border healthcare, EU Member States may already exchange health data through a voluntary network connecting national authorities responsible for eHealth (“the eHealth Network”). However, the inception impact assessment provides that the existing regulatory framework only partly responds to the persisting challenges.

The European Health Data Space initiative and the accompanying impact assessment will be based on the results of an evaluation of the existing framework for cross-border exchanges of health data.

Problems that the initiative aims to tackle

The European Health Data Space is aimed to tackle the following shortcomings in the current regulatory framework:

• The provision of healthcare services is negatively affected by the insufficient exchange of health data. Although the eHealth Network has improved such exchange, its voluntary nature and the non-binding nature of its guidelines has limited its impact.
• Patients often find it difficult to exercise access and control over their own health data. Electronic health records are still not available in all EU Member States, and many patients cannot easily have access to them or transfer them between healthcare providers.
• Under the current framework, there is fragmentation of digital standards and limited digital interoperability between healthcare systems. This fragmentation constitutes a significant challenge for companies and national healthcare systems when integrating innovations in healthcare.
• Access to, and exchange of secondary use of health data is very limited in the EU. Secondary heath data includes data for scientific research and innovation, policy-making, and regulatory activities. Furthermore, the different national legislative measures implementing the General Data Protection Regulation increase the fragmentation of the processing of personal health data in EU Member States.
• Although the use of digital health services and products have increased since the outbreak of the COVID-19 pandemic, the free movement and provision of these services and products is still very limited.

In order to tackle the problems outlined above, the inception impact assessment identifies several objectives to be achieved by the implementation of the European Health Data Space. For each of these objectives, the European Commission provides one or more policy options. These policy options will be further developed based on the evaluation findings and analysis in the impact assessment.

First objective: ensuring access, exhange, and optimal use of health data

The first objective is to ensure access, exchange, and optimal use of health data for healthcare delivery purposes as well as for research and innovation, policy-making, and regulatory activities. This would be performed in a privacy-preserving, secure, timely, transparent and trustworthy way, and with an appropriate institutional governance. In order to achieve this, the European Commission considers the following policy options:

• To establish an appropriate legal and governance framework to cover the access to and exchange of health data for healthcare provision, research, policy-making, and regulatory activities;
• To lower technical barriers hindering data used and re-use, in particular those related to infrastructure, interoperability, data quality and standards in the health field; and
• To ensure access and control of patients and citizens over their own health data.

Second objective: fostering a genuine single market in digital health

The second objective pursued by the initiative is to foster a genuine single market in digital health, covering digital health services and products. These would include tele-health, tele-monitoring, and mobile health.

In relation to the second objective, the European Commission will investigate policy options to remove barriers to the cross-border movement of digital health services and products. The European Commission will also work to promote the rights of patients to benefit from those services and products, and their interoperability with electronic health records and healthcare systems.

Third objective: enhacing the development, deployment, and application of trustworthy digital health products and services

The third identified objective is to enhance the development, deployment, and application of trustworthy digital health products and services, including those incorporating artificial intelligence in the area of health.

The European Commission will analyse policy options concerning liability rules related to the use of data-intensive digital health services, including those incorporating artificial intelligence.

Next steps

This inception impact assessment is only the first step in the development of a legislative framework for the European Health Data Space. The European Commission’s legislative proposal will be prepared after an impact assessment is carried out. Such impact assessment will be supported by several ongoing and planned studies which will finalise by mid-2021. Stakeholders consultation actions will be taken by the European Commission to gather data and opinions. Some of the actors that will be consulted include national public health authorities, data protection authorities, public organisations, private organisations, patients, economic actors, and professional associations.

The inception impact assessment will be open for feedback until 3 February 2021.

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