Recommendation on the continued use of the Medical Informatics Initiative's Broad Consent after the Health Data Utilisation Act comes into force

The Health Data Utilisation Act (GDNG) allows data-processing healthcare facilities to use treatment data for research and quality assurance purposes, among other things, under certain conditions, even without patient consent. This concerns, among other things, the joint secondary use of treatment data by publicly funded associations of data-processing healthcare institutions, including collaborative research projects and research practice networks.

Important: This new option created by the legislator for the cross-site sharing of data does not replace broad consent or render it obsolete.

The GDNG regulation on freedom of consent by no means covers all requirements for the cross-site use of treatment data and biosamples. For this reason, the VUD, MFT, NUM, TMF and MII have drawn up an initial categorisation and recommendation (Annex) on the further use of broad consent. This indicates that every possible effort should continue to be made to obtain broad consent as comprehensively as possible.