Maximising the EHDS impact on better health data sharing
EFPIA was pleased to help organise and participate in the European Health Coalition workshop on 18 May, focused on ‘maximising the EHDS impact on better health data sharing’. The meeting came just a few days after the publication of the European Health Data Space (EHDS) proposal (3 May) from the European Commission. Stakeholders representing patient groups, researchers, health professionals, industry and regulators gathered to discuss this important topic in this hybrid meeting format with several hundred virtual attendees. Speakers included representatives from the European Commission, European Medicines Agency (EMA), Data Saves Lives, Biomedical Alliance Europe, EU Health Coalition, COCIR and EFPIA.
It was clear that all stakeholders welcome the EHDS proposal from the Commission, noting that it has a positive ambition and intent and that we must remain focused on the value that sharing of data can offer, where sharing data from one or several individuals can help treat, cure, or save another. Several presenters focused on the fact that health data sharing is based on a foundation of trust and an understanding of this positive intent for the sharing and use of data. EFPIA discussed how it believes that data sharing at scale can act as a fuel for innovation. The Commission outlined how the legislative proposal on the EHDS complements related European legislative initiatives such as GDPR, Data Act and the proposed Data Governance Act, to provide an unprecedented opportunity to shape the future health data ecosystem.
The EHDS envisages enhanced data access and portability of an individual’s health records, but also envisages greater sharing of non-identifiable health data for the advancement of research and innovation. For this secondary use of data to flourish, EFPIA believes we must first ensure health data is collected and stored electronically. Although the data does not need to be pooled and can remain distributed (federated), it must remain findable and accessible. We must use a common language (common data model) for its assessment, ensuring standardisation and quality, and translating into data becoming interoperable, allowing comparison. This should start within Europe, but eventually should be aligned globally. EFPIA’s points endorsing the use of a common data model and federated data network were supported by other speakers. Also noted as key to fuelling innovation in R&D is creating and maintaining an international flow of data. The EHDS aims to create the infrastructure and harmonised standards needed to enable health data to flow across borders and allow benefits of data driven healthcare to be realised. For citizens and patients to allow sharing they want ongoing assurance that it is safe, secure and anonymised where appropriate.
Appropriate access and secondary use of data permission is a priority for realising all aspects of data rights and unlocking the value of the EHDS. Within the EHDS, Health Data Access Bodies (DABs) are proposed that help to govern whether the intended use of the data is appropriate, and access is granted (a data permit is issued). The Commission assured attendees that the intent was for a simple single access request that would lead to multiple data access bodies working together to respond to access requests across multiple jurisdictions rather than allowing fragmentation, inconsistency and bureaucracy. Once a data access permit has been granted there are time limits (18 months) for the sharing of the results/outcomes of the secondary research and consideration will need to be given to these durations and the extent of transparency in cases where this research is directed towards new innovation that should remain commercially confidential.
It was shared that each member state is at a different level of maturity in creating a vision for digital and connected data and it will be important for countries at an advanced digital maturity to help those who are not to prevent them from experiencing the same delays and issues.
EFPIA has already been supporting the advancement and application of a common data model through the IMI EHDEN (European Health Data Evidence Network) project and have been working alongside the EMA with DARWIN EU (Data Analysis and Real World Interrogation Network, aimed at supporting the use of real world data for regulatory submissions). EFPIA is also working with patient organisations and healthcare professionals, and with member states as they develop their roadmaps for digital health. As data generators, data users, innovators and regulators all work together to develop the network that will form a positive European Health Data Space, EFPIA look forward to participating actively in further dialogue, knowing that each stakeholder will need to invest time and expertise to understand what success will require. We will need to continue to look for simple solutions that minimise the burden to small institutions, while connecting data to fuel the innovation we all want that will lead to better healthcare outcomes for Europe.