🔭 #LegislativeObservatory
@NFDI has participated in the association hearing by @bmftr_bund regarding the planned Research Data Act (#FDG, #Forschungsdatengesetz). In its statement, NFDI

1. welcomes the establishment of a German Center for Microdata (#DZM),
2. demands standardization of secure processing environments (#SPE) and
3. encourages additional steps towards the more general availability of #metadata.

Read the full statement here:
🇩🇪 https://www.nfdi.de/wp-content/uploads/2026/02/NFDI-eV_Stellungnahme-Forschungsdatengesetz-FDG_2026-02-10.pdf

🔭 #LegislativeObservatory
Concluding our series on the status of the 🇩🇪 #Digitalstrategie (see previous post https://nfdi.social/@nfdi4immuno/111719260750940903):

Research Data Act (#FDG, #Forschungsdatengesetz) [Page 89; Q73] @bmbf_bund is evaluating how to address the demands identified in the public consultation conducted 04/2023, there are plans for another round of stakeholder involvement. A final draft of the @Bundesregierung is scheduled for Q4/2024.

🇩🇪 https://dserver.bundestag.de/btd/20/098/2009821.pdf

🔭 #LegislativeObservatory: The position of the #EUCouncil on the #EHDS (European Health #DataSpace) is now also available:

http://data.consilium.europa.eu/doc/document/ST-16048-2023-REV-1/EN/pdf

Key differences from the Parliament's position on secondary use of #HealthData are 1) no required opt-in for "genetic" data, but member states may impose additional restrictions [Art. 33 (5)]; 2) "other human molecular data" (Omics data) [Art. 33 (1) lit. ea] are treated equally to "genetic" data and need opt-in and 3) no opt-in for #Biobank data.

🔭 #LegislativeObservatory: #EuropeanParliament has just voted in favor of the #EHDS (European Health #DataSpace) compromise version of #ENVI and #LIBE , rejecting further amendments (ex. 555):

https://www.europarl.europa.eu/doceo/document/A-9-2023-0395_EN.html

Relevant changes for secondary use of #HealthData are 1) an opt-in requirement for sharing of genetic and #biobank data (Art. 33 (5a), Rec. 39a) and 2) allowing member states to impose further restrictions on data falling within Art. 9 #GDPR (Rec. 3a). #Trilog will start tomorrow!