Summary of the European Commission Health Data Space
The European Commission (EC) recently presented it long awaited legislative proposals for a European Health Data Space. The aim is to significantly change how medical data is accessed by patients and doctors, and how it can be used to support research and formulate new health policy. The EC claims this will add up to €11 billion to the European economy over the next 10 years through improved data exchanges in health care, and from the use of health data in research and new policy.
The COVID-19 pandemic has highlighted the importance of health data collection and use. This proposal is part of the wider EU policy of digitalisation. It is intended to form the backbone of a European health union with over €800m set aside to fund the required infrastructure.
Some of the reported benefits include:
- Easier cross-border health care – The idea is that patients and medics from one Member State can access for example prescriptions or test results while in another Member State. Infrastructure for this already exists in the form of MyHealth@EU, but the proposal would see this expanded. There would be a mandatory requirement on interoperability and security. Patients would have access to this health data “immediately, free of charge, [and] in an easily readable format,”
- Use of EU data – The EU has masses of health data that could help in the development of new treatments, innovation, lead to better care for patients, save doctors and patients time, and contribute to better-functioning health systems. The proposal aims to make this data available in an easily accessible and understandable common format across all 27 countries.
However, the state of health digitalisation varies significantly across the union and could take time to universalise and implement. For example, Germany has taken 10 years to introduce an electronic health record. The pandemic has also however created a fresh impetus for progress.
- Better deployment of health technology – Pharma and health tech companies have long complained about the difficulties and duplications of procedures and testing for new products. Through this proposal the EU plans to introduce a new legal framework that will make the situation easier. Safeguards will exist to prevent exploitation for advertising, increasing insurance premiums, and for harmful substances.
- Change by 2025 – Noticeable change should be seen by 2025 in the case of data exchange via the MyHealth@EU A new European Digitial and Health Data board will also be set up, chaired by the Commission and consisting of digital health authorities and health data access bodies as well as observers.
The success of these proposals will rely in a large part on citizens’ willingness to trust. The sharing of their sensitive patient health data is crucial to success but is not a given. It will also be essential to have patient groups well represented in monitoring groups and oversight. There are questions about how such sharing of sensitive data will work given the EU’s strict data protection legislation.
Not all Member States are yet on board. There is concern amongst some that the EC will have too much control over health data and states will lose the power to make their own national decisions.