A European Heath Data Space (EHDS) – life-saving legislation or bureaucratic mess?

Guest article by the European Respiratory Society

In a fast-paced ever-changing world, research and the free flow of scientific data are key to ensure Europe’s healthy population as well as to prepare for new health challenges. A well-functioning European Health Data Space (EHDS) is a key step in the right direction to ensure that the European Union (EU) remains at the forefront of medical research. Simply put, data saves lives.

Following the European Commission’s proposal, the discussion in the European Parliament has boiled down to two possibilities for adding an extra layer of data protection.

An opt-in mechanism (citizens would have to actively agree to the use of its data); and an opt-out mechanism (citizens would have to ask to be removed from the system should they not want to be included).

Both of these options have a variety of consequences affecting directly medical and scientific research, health care professionals, and patients.

The opt-out mechanism, defined by Article 33, could be the way forward only if supported by detailed governance compliance rules and uniform implementation across Europe. We only have to look to the GDPR regulation to see the consequences of the lack of uniform implementation in Europe.  Conversely, an opt-in mechanism would not allow the EHDS to develop and would actively prohibit progress on a truly borderless health data exchange by adding unnecessary barriers to the data collection process.

While the inter-institutional discussions continue, the co-legislators must be aware that although the opt-out mechanism is the most viable option out of the two, it may still not work for all types of data. It will also be likely to add an additional burden to healthcare professionals, who will need to receive the proper guidance to be able to assist their patients in making informed decisions.

Lost in the debate is the fact that the European Commission’s proposal already provides the necessary safeguards to ensure the privacy of citizens by facilitating data sharing either anonymised or, when necessary, in pseudonymised format.

The co-legislators need to consider that the GDPR regulation has in many cases hindered rather than fostered medical research and that the data space legislation should not make matters worse.   The proposal needs to be fit for purpose not fit for the bin.  We hope the legislators heed the warnings of the medical community – we are doubtful they will, however!

Disclaimer: the opinions – including possible policy recommendations – expressed in the article are those of the author and do not necessarily represent the views or opinions of EPHA. The mere appearance of the articles on the EPHA website does not mean an endorsement by EPHA. 

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