Patient advocates vs European Health Data Space (EHDS) Regulations – a difference in perspectives?

Trilateral Research previously blogged about a workshop the team hosted on Ethical AI at MPNE Consensus Data 2024 for the iToBoS project.

The workshop was held in conjunction with members of the iToBoS project and a group of patient advocates drawn from across Europe. Patients were asked to explore various topics and themes relevant to the iToBoS project, including their perspectives on health data.

Using Slido the team asked participants an open-ended question: “What does ‘health data’ mean to you?”, re-iterating the point to be open and honest. With 41 responses, 5 key words were highlighted – Knowledge, Biomarkers, Weapon, Opportunity, Diagnosis.

Although asked the same question, the participants’ interpretation of “health data” offered an insight as to how it is perceived among the patient advocacy community. While some had taken a literal view and spoke directly to “Biomarkers” and “Diagnosis”, others considered it more liberally with a hint of negative undertones associated with the term. Words such as “Weapon”, “Power” and to a certain extent “Opportunity” suggest that health data is something that can be easily acquired and used as leverage, to control. This thinking might stem from the group's fear that their health data will be unethically accessed and sold to third parties without their consent, posing potential threats to their autonomy, and their data protection and privacy rights.

However, words such as “Knowledge” and “Opportunity” provide a more positive outlook. It reflects on how gathering and sharing health data might build better understanding of disease types, or better insights for diagnosis or prognosis, or even contribute to a “greater good” for humanity.

The group’s opinions might indicate that providing access to anonymized health data, might provide an opportunity to enhance the efficiency of current and future preventative and curative medicine.

It’s interesting to consider these perspectives in relation to the proposal for the European Health Data Space (EHDS) legal framework which states: “The EHDS will also promote better exchange and access to different types of electronic health data, including electronic health records, genomics data, patient registries etc. Not only will this support healthcare delivery (services and personnel involved in providing health care or primary use of electronic health data), but it will also support health research, innovation, policymaking, regulatory purposes and personalised medicine purposes (secondary use of electronic health data). It will also establish mechanisms for data altruism in the health sector.” [1] It touches on the different viewpoints raised in the workshop regarding the need for secure data sharing to promote better avenues for knowledge generation, and open up the sector to more business and research opportunities.

The EHDS framework seems to be written from the viewpoint of those who deliver healthcare, conduct research, and create policies and regulations. Although the outputs are to benefit patients, it is the actual patients’ health data being harvested, stored, and shared, including sharing across different jurisdictions. This, in turn, has generated genuine concern and fears for patients. The EHDS has stated it will provide regulations around how data will be shared and will “establish mechanisms for data altruism in the health sector.” However, when speaking freely from their own perspectives on the term health data, there was a level of cynicism from the patient advocacy group, with the word “Weapon” being one of the top key descriptors.

It will be interesting to see how the European Commission, national governments, research and business communities will communicate emerging regulations such as the EHDS to the broader patient and health care provider communities, especially concerning aspects related to security, data protection, privacy, and rights.

We can only surmise that the patient advocates views shared at MPNE consensus Data 2024 are genuine and honest – and will require open and honest communication from the policy makers and policy implementers to ensure trust is built and maintained, as the health sector evolves towards this altruistically led health data future.

More details at Ethical AI at MPNE Consensus Data 2024.

[1] Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Health Data Space, COM/2022/197 final, p.2, available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52022PC0197