In September 2025, under the umbrella of the Join Action CancerWatch – project, we gathered representatives from the European Network of Cancer Registries (ENCR), the Group for Cancer Epidemiology and Registration in Latin Language Countries (GRELL) and the Association of Nordic Cancer Registries (ANCR) to provide feedback to nine of the eleven guidelines and specifications of the second public consultation by TEHDAS2 (Second Joint Action Towards the European Health Data Space), covering topics like fees and penalties, making personal and non-personal electronic health data available for reuse, procedures and formats for data access, data minimization, pseudonymizsation, anonymisation and synthetic data, secure processing environments, opt-out and the obligation of notifying the natural person on a significant finding from the secondary use of health data.

Some of the highlights of our feedback is:  

•Opt-out under EHDS is different from current mechanisms. Citizens have the right to opt-out for secondary use of their data under EHDS. PBCR data requested via EHDS will need to exclude the citizens listed in the opt-out register. We recommend explicitly stating that the opt-out mechanism does not impact the data collection activities of the PBCRs.   

•The opt-out-based data access via HDAB may impact validity of population-based analyses. We recommend informing the data user of caveats in the data after opt-out is applied. We also recommend an analysis of the consequences of this mechanism. Current mechanisms may be more effective.   

•Data holders, including Cancer registries, are required to contact citizens in case of a “significant finding” while analysing the data. We recommend excluding PBCRs from this responsibility, as they do not have a treatment relation with the citizen. We  also recommend providing a better definition of a “significant finding”.   

•Data holders will get the opportunity to charge fees for data preparation activities (other than the actual collection of data). We recommend extending the list of eligible activities, including discussions with the data user to match data requests and (minimal) data set and to also include work done by data holders (close to the data) on anonymization, pseudonymisation and synthetization of data. We also recommend creating transparency in fees, so data users can be informed when budgeting activities, including the preparation of grant applications.  

•Data minimization is defined to be the responsibility of the HDAB. We recommend involving the data holders who hold relevant expertise, as data minimization requires domain knowledge. We recommend providing detailed workflows to describe the interactions between HDAB, data user and data holder.  

We would like to thank all our colleagues who were involved in this work, and a special thanks to Maria Carulla, Karima  Hammas, Jean Kelly, Lorena Estevez Iglesias, Nils Broeckx, Matthijs Sloep, Siri Larønningen and Gijs Geleijnse for the effort of drafting the responses on behalf of the PBCRs. We also wish to thank Tony O’Grady and David Asturiol from JRC for their collaboration, and the steering committees of ENCR, GRELL and ANCR for input.