In autumn 2022, EHTEL become one of the 35+ signatories that agreed to join together in a consensus on the general benefits of the proposed European Health Data Space.
The signatories continue to meet up through regular online meetings and focus in sub-groups on specific and challenging topics. One of those is how to operationalise the potential rights of patients/citizens to opt out of the secondary use of their personal health data for research (and other) purposes.
On 20 March 2023, close to 40 people met up online to contribute to discussions on two themes.
First, the group heard from Mr Mario Jendrosekk of the French Health Data Hub who explained how France operates on two lines of activity. France’s work indicates how a country can introduce, and work with, relevant national legislation and structures.
Initially, Mr Jendrosekk described the work of the country’s Health Data Hub. Then, he introduced pilot work that France coordinates on the HealthData@EU Pilot (formerly called the EHDS2pilot).
This European-funded pilot, led by France, is working in close liaison with both data users and data holders. A catalogue is foreseen that will include so-called “meta-data”: it will include many – if not all – the types of health data that are available for research exploration in France. The pilot is focusing on five use cases, many of which are related to non-communicable diseases, i.e., antimicrobial resistance, Covid-19, vaccination, cardiological conditions, and cancer. Its advisory board is due to meet up six months after the pilot’s launch, to offer the pilot advice and guidance.
Mr Jendrossek’s insights into the role of how two options – opt out/opt in – function both in France and potentially when piloting the European Health Data Space. In France, secondary use of health data legislation based on the 2016 General Data Protection Regulation was established. Individuals’ data is used for specific (public health) surveillance and monitoring purposes. People, however, do have the right to opt out of their data being used for specific research projects, if they so wish. The French Health Data Hub, for example, has a “citizen department” with which it is working to ascertain what can be done best to keep citizens informed about their options.
Why are the opt in/opt out options with regard to users’ data of so much interest currently? Earlier in spring 2023, the European Parliament emphasised that the European Health Data Space Regulation should retain the opt out choice approach for people in relation to the European Health Data Space’s secondary use of personal health data.
As a result, the joint consensus statement group of stakeholders decided that it would explore the Parliament’s position on opting out, and what it could imply for the future application of secondary data use in the European Health Data Space.
In contrast to the use of personal data, there are likely to be differences when the data to be used is either anonymised or pseudonymised.
At least two distinct challenges stand out. First, it means getting the balance right between the rights of the individual citizen/patient and more general (e.g., public health) rights. Second, patients/citizens need to be informed about the kinds of data bias that may emerge in the health field if they decide to opt out of their data being made available for re-use.
From the rapid sharing of opinions in this one-hour meeting, it was evident that there are many and varying views about the issues at stake, and considerable ranges of interpretations of terms.
To sum up, as sub-group co-leader Professor Dipak Kalra of i~HD said, it may take some time to develop mechanisms for opt out across the entire EU27 Member States. Until a workable opt out option for Europe is available, other forms of functioning mechanism(s) will, nevertheless. need to operate. Ultimately, solutions will need to be both representative and inclusive, and there will certainly need to be compliance with the GDPR. To quote Professor Kalra, “We’re not saying that opt out is ‘magical’ … we’re not saying opt out is ‘evil’”.
Meanwhile, of course, associations that are members of the sub-group and the overall joint consensus group will be able to submit their own viewpoints to discussants in relevant European Parliament discussion groups.
Ultimately, the joint consensus statement group members will develop a two-page position statement on which they can all agree.