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The following statement, co-written by BBMRI-ERIC and the Stakeholder Forum Patient Pillar, has been made in support of the EHDS opt-out meeting that happened on 6 September 2023. Details can be found here.
The purpose of this statement is to highlight the risks and opportunities of EHDS for biobanking from the viewpoint of patient advocates and patient representatives.
By utilising health data, such as information collected during routine patient care or stored in biobanks, for scientific purposes researchers can uncover valuable insights into disease patterns, treatment effectiveness, and population health trends. This data-driven approach enables the development of personalised medicine, identification of genetic markers, and discovery of novel therapies with increased treatment efficacy and reduced adverse effects. Moreover, the secure sharing, and analysis of health data across borders, particularly at European Reference Network (ERN) level, can foster collaboration among scientists, accelerate medical breakthroughs, and enhance public health strategies.
Embracing the secondary use of health data empowers researchers to make evidence-based decisions, shape healthcare policies, and ultimately improve the well-being of individuals and communities. In the biobanking field, health and clinical data associated with the samples and data stored in biobanks are crucial for advancing biomedical research and medical knowledge. The use of samples for research is much less valuable without the associated health and clinical data. Therefore, the new framework for the secondary use of data will greatly impact the biobanking field.
For BBMRI-ERIC, its National Nodes and the Stakeholder Forum Patient and Citizen Pillar, the European Health Data Space (EHDS) framework and the use of health data to drive innovation and promote scientific discoveries means a paradigm shift. This poses challenges and opportunities which are addressed in this statement.
The current proposal is highly welcome but still does not sufficiently consider the needs of and risks for patients/citizens, while calling for ‘data altruism’ in return. The upcoming EHDS is important because a single law and a standardised opt-out/consent regime in Europe aims to simplify procedures for investigators and patients/citizens alike. Differing jurisdictions in European countries delays research and creates uncertainty for citizens/patients. Nonetheless, the EHDS needs to be complementary to existing laws (e.g., the General Data Protection Regulation, GDPR or national biobank legislations), remain complementary to functional procedures and oversights that are established by the community and work well for biobanks.
Challenges concerning control over data
Whereas the sharing of data by patients/citizens is typically based on altruistic motives, demanding data altruism can risk categorising ‘good’ citizens (in favor of sharing data) and ‘bad’ citizens (not in favour of sharing data) and may stigmatise, rather than integrate, their motivations and concerns.
The European Health Data Space (EHDS) is an ambitious health data sharing framework establishing clear rules, common standards and practices, infrastructures, and a governance framework for the use of electronic health data across the EU. It differentiates between primary use (e.g., health care) and secondary use (e.g., health research).
In June 2023, BBMRI-ERIC joined together with 31 other health stakeholders to share views on specific recommendations for a potential opt-out mechanism in the future European Health Data Space. The June statement is available here (PDF).
Dr. Michaela Th. Mayrhofer, Head of ELSI Services and Research, said:
“We support the approach taken in the Commission’s original legislative proposal from May 2022 as it strikes a sensible balance between protection of personal data while enabling the use of data for research and innovation to create tangible benefits for patients and citizens. We see the proposal for an opt-out mechanism for citizens to withdraw their data from secondary use purposes as the better option for realising the European Health Data Space (EHDS).
At the same time, we call for a balance between the needs of research and patients/citizens, while remaining complementary to existing laws such as national biobank laws while updating anti-discrimination laws and such.”
As outlined in the June statement, the Commission’s EHDS proposal makes no provision for a consent mechanism for HealthData@EU (secondary use) beyond referring to national law (Art 33 (5)). This approach has been justified because (a) data for secondary use are either anonymised or pseudonymised and (b) there are strong mechanisms in place to safeguard against abuse, including lists of permitted uses (Art 34) and prohibited uses (Art. 35) and rules for governance and practical mechanisms.”
Today’s co-written statement puts forward recommendations for the realisation of the EHDS for biobanking from the viewpoint of patient advocates and patient representatives, especially its challenges and opportunities. The upcoming EHDS is important because a single law and a standardised opt-out/consent regime in Europe can simplify procedures for investigators and patients/citizens alike.
Differing jurisdictions in European countries delays research and creates uncertainty for citizens/patients. Nonetheless, the EHDS needs to be complementary to existing laws (e.g., the General Data Protection Regulation, GDPR or national biobank legislations), remain complementary to functional procedures and oversights that are established by the community and work well for biobanks.