On 3rd May 2022, the European Commission presented its proposal for a Regulation on the European Health Data Space (EHDS), an initiative which aims at providing individuals greater control over their health data and an opportunity for allergy, asthma and chronic obstructive pulmonary disease (COPD) patients in the EU.
EFA welcomes the initiative on the EHDS, especially the framework on the primary use of data, and fully agrees with the contribution of the European Patient Forum (EPF) who highlights the need to setup a framework that enforces the role of patients as the controllers of their health data.
In our response to the public consultation on the proposal, EFA highlighted the potential benefits of the use and application of digital tools for people living with allergy chronic respiratory diseases, from prevention and early diagnosis, to management and better care. Proper use of data can offer a great deal for patient empowerment, modernising health systems, facilitating patient-centricity and enabling a personalised, patient-centred medicine in the delivery of healthcare. However, EFA also emphasised the extreme sensitivity of health data, which creates a great concern for patients when it comes to security and privacy.
Patients as the main users of digital health services
To give patients full control over their electronic data, EFA emphasised that a common MyHealth@EU data format will enable patients to better manage their disease. However, regarding the secondary use of data (data used for research and for individual care), EFA stressed the need for clarification on several points, especially given the ambiguity on the entities who can access and use the data for research purposes.
At the same time, EFA underlined the need of having patients integrated in the governance of the future EHDS, including in the proposed EHDS Board. As the main users of the MyHealth@EU platform and end users of digital health services more broadly, it is imperative that patients and their representatives provide their unique expertise for an effective and transparent implementation of the EHDS.
Coordination with data protection authorities at both EU and national level
Given the rapid developments in the digital sector, it is essential for EFA that the EU seeks further alignment between the EU various data protection frameworks, such as the General Data Protection Regulation (GDPR) and the Data Governance Act. It will also be paramount to clarify on the relationship between the already existing data protection authorities both at the EU and national level and the newly established EHDS authorities. Such coordination and clarity is necessary to ensure that there is no uncertainty regarding the rights of individuals in relation to their data, as well as the obligations of stakeholders handling the data.
Access to justice for patients is essential
EFA also drew attention to the importance of having a robust access to justice provision in the context of the EHDS regulation to ensure further protection of patients. Given the sensitivity of health data shared under the EHDS framework structure and the ambiguity related to the role of data protection entities and interaction with other legislative instruments, for EFA it is crucial that allergy, asthma and COPD patients are assured that proper and effective means to access justice are available to them in order to enforce their rights.
You can access the full EFA response here.
The European Commission proposal for a Regulation on the European Health Data Space (EHDS) is available in their website.