Digitalisation is advancing rapidly in all areas of society and does not stop at the health sector. The European Commission's proposal for a European Health Data Space promises simplifications and improvements but raises serious concerns among many stakeholders about the consideration of fundamental rights, privacy and autonomy of patients and its feasibility.
The EU Commission has presented a regulation for the creation of a European Health Data Space (EHDS) in spring 2022, which stems from the European Data Strategy. The EHDS is one of the first building blocks in this strategy, and the Commission plans eight more data spaces in similarly strategic areas. These spaces are intended to help realise the full potential of data by harnessing it for research and innovation. In the current draft regulation, the term "health data" is extremely broad. It includes not only data from the health system, such as electronic patient data or disease registers, but also data on health-related factors such as the use of certain substances, homelessness, or occupational status. On top of that, data generated by consumers themselves, such as data from wellness apps or other digital health applications is collected. Although some stakeholders hope that such a data space in the EU will not only improve health care but also increase competitiveness and productivity, there are serious doubts about the project from many sides. These include the panellists at the webinar organised by AK EUROPA, the ÖGB European Office and the European Public Service Union (EPSU) on 28 March 2023.
Feasibility of the proposal in the face of overburdened health systems
According to Jan Willem Goudriaan, Secretary General of EPSU, there are currently very large inequalities in the health systems between, but also within, the individual EU Member States. In view of the severe overload and underfunding of the public health system in many Member States, special focus must be placed on the needs and interests of workers and the involvement of the social partners in the implementation of the European Health Data Space. Goudriaan warned that the EHDS could become a "Trojan horse for further privatisation in the health sector"; the fear is that the EU Commission could once again push for "market solutions" in the health sector. Sara Roda, an expert from the Standing Committee of European Doctors (CPME), called for improving access to healthcare without increasing the administrative burden and costs for doctors and small practices.
Data protection and the right to privacy - focusing on ethical considerations
The EU Commission points out that the EHDS proposal already takes into account the General Data Protection Regulation (GDPR) and that it is aware of the importance of consumer trust in the European Space for Health Data. However, many provisions of the EHDS proposal are in explicit contradiction with the GDPR. Especially problematic for many experts is the secondary use of the collected health data, for example for marketing or insurance purposes. For Daniela Zimmer, expert for consumer protection at AK Vienna, it is highly problematic that electronic health records and patient data are considered from a competitive point of view. It is therefore all the more important to grant those affected an explicit right of consent. Petar Vitanov, MEP of the S&D Group in the EU Parliament, also does not understand the lack of mandatory consent of patients for the release of data in the proposed regulation: “Why should a higher standard apply for the consent to the transfer of personal data to a website than for the consent to the transfer of sensitive health data?” According to Jan Penfrat, an expert at European Digital Rights (EDRi), one should not rely on the alleged anonymisation of data, as there are numerous possibilities to re-identify anonymous data.
AK demands mandatory opt-in and opt-out rights for consumers
Consumer protection is becoming a political and highly relevant task in a digital world, which AK is taking on. In principle, AK supports the pooling of health data to enable better research - but only as long as this really serves better health care for patients and is in line with fundamental rights. It is essential to prevent highly sensitive data from being used for purely commercial purposes. According to AK expert Daniela Zimmer, patients must be offered an opt-out option for the primary use and an opt-in option for the reuse of their data. In addition, the definition of the term "health data" should be much narrower. Strong, independent data protection authorities must play a central role in the project of a European Health Data Space.
AK EUROPA Position Paper: Regulation on the European Health Data Space
EPSU Position on the European Health Data Space
Standing Committee of European Doctor’s (CPME) Position on the European Health Data Space
European Digital Rights (EDRi) Position Paper on the European Health Data Space
European Public Health Alliance Position Paper on the European Health Data Space