Position paper on EHDS opt-out

Recommendations from the viewpoint of patient advocates and patient representatives

This article is 212 words and is an approximate 2-minute read.

The BBMRI-ERIC Stakeholder Forum – Patients and Citizens Pillar in collaboration with the BBMRI-ERIC team have published a position paper to provide recommendations on the implementation of the opt-out process/mechanism for secondary use under European Health Data Space (EHDS) regulation.

EHDS regulation guarantees citizens the right to opt out of the secondary use of their health data. This paper outlines the key recommendations and concerns raised by patient advocates and representatives regarding the implementation of the opt-out mechanism as defined in Article 71 of the EHDS regulation.

The key recommendations are:

1. Patients and citizens must be informed about the use of their health data for secondary purposes under EHDS regulation and their right to opt-out.
2. The opt-out system should go beyond a simple opt-out and allow for granularity. Patients and citizens want granular, flexible, and dynamic control over secondary use of their data.
3. Secondary use of data obtained through consent should only be allowed if patients/citizens have re-consented or if the data is anonymised.
4. Declaring opt-out should be easily accessible, transparent and through multi-channel systems.
5. Trust and transparency are the key aspects in creating an opt-out system.
6. Opt-out systems should consider patients and citizens’ needs. One-time investment in a transparent, fair and user-friendly system is desired and would be cost saving in the long run.

The recommendations presented are solely from the perspective of patient advocates and patient representatives to the implementation of the right to opt-out from secondary use of health data as outlined in Art. 71 of the EHDS Regulation.

The full position paper can be downloaded here.