Dear all,

The deadline for feedback on the EHDS electronic data guidelines is this Friday. Please complete these short surveys before our Thursday call. We can then discuss feedback at our regular call with the idea, that we as NFDI4Immuno may provide a collective feedback if needed.

Here are the links again:

Biobank Data

- Health data from biobanks: https://ec.europa.eu/eusurvey/runner/TEHDAS_Health_Cat6_2ndround

Genomic, Molecular and Pathogen Data

- Data on pathogens: https://ec.europa.eu/eusurvey/runner/TEHDAS_Health_Cat7_2ndround1

- Human genetic/genomic data: https://ec.europa.eu/eusurvey/runner/TEHDAS_Health_Cat7_2ndround2

- Other human molecular data: https://ec.europa.eu/eusurvey/runner/TEHDAS_Health_Cat7_2ndround3

Best,

Ulrik

Von: Stervbo,Ulrik
Gesendet: Dienstag, 18. Februar 2025 11:23
An: NFDI4Immuno All Members (nfdi4immuno-all@lists.nfdi.de) <nfdi4immuno-all@lists.nfdi.de>
Betreff: WG: Ihr Feedback ist gefragt: TEHDAS work on EHDS Article 51 health categories

Dear Colleagues,

Please find below a list of surveys from TEHDAS2, who are developing common guidelines and technical specifications for implementation of the European Health Data Space (EHDS).

Most relevant for us are probably the parts:

- Biobank Data

- health data from biobanks and associated databases: https://ec.europa.eu/eusurvey/runner/TEHDAS_Health_Cat6_2ndround

- Genomic, Molecular and Pathogen Data

- Data on pathogens that impact human health: https://ec.europa.eu/eusurvey/runner/TEHDAS_Health_Cat7_2ndround1

- Human genetic, epigenomic and genomic data: https://ec.europa.eu/eusurvey/runner/TEHDAS_Health_Cat7_2ndround2

- Other human molecular data such as proteomic, transcriptomic, metabolomic, lipidomic and other omic data: https://ec.europa.eu/eusurvey/runner/TEHDAS_Health_Cat7_2ndround3

The surveys close on February 28.

Best,

Ulrik

Von: healthdcat-ap <healthdcat-ap@bfarm.de>
Gesendet: Montag, 17. Februar 2025 10:00
An: healthdcat-ap <healthdcat-ap@bfarm.de>
Betreff: Ihr Feedback ist gefragt: TEHDAS work on EHDS Article 51 health categories

Sehr geehrte Damen und Herren,

wir möchten Sie darüber informieren, dass im Rahmen der TEHDAS-Workshopreihe zu den Kategorien von Gesundheitsdaten gemäß Artikel 51 EHDS die Definitionen auf der Grundlage Ihres Feedbacks aktualisiert wurden.

Sie sind nun herzlich eingeladen, an der zweiten Befragungsrunde teilzunehmen:

The Joint Action TEHDAS (second Joint Action Towards the European Health Data Space, www.tehdas.eu) Work Package 5 organised working groups to discuss the Minimum categories of electronic data for secondary use as listed in Article 51 of the EHDS Regulation. This work is designed to provide input for EHDS-guidelines for health data holders, focusing on clarification on the categories of health data in scope of the EHDS.

We have updated the full text definitions based on your input and would like you to review and provide examples through the surveys we have developed. The surveys stay open until February 28.

Date	Topic	Article 51 category	Survey link
November 19, 2024	Administrative Health Data	(c) aggregated data on healthcare needs, resources allocated to healthcare, the provision of and access to healthcare, healthcare expenditure and financing (e) healthcare-related administrative data, including dispensation, claims, and reimbursement data (j) data on professional status, and on the specialisation and institution of health professionals involved in the treatment of a natural person	https://ec.europa.eu/eusurvey/runner/TEHDAS_Health_Cat1_2ndround
November 26, 2024	Registries & Research Data	(k) data from population-based health data registries such as public health registries (l) data from medical registries and mortality registries (p) data from research cohorts, questionnaires and surveys related to health, after the first publication of the related results	https://ec.europa.eu/eusurvey/runner/TEHDAS_Health_Cat2_2ndround
November 29, 2024	Electronic Health Records & Clinical Data	(a) electronic health data from EHRs (m) data from clinical trials, clinical studies, clinical investigations and performance studies subject to Regulation (EU) No 536/2014, Regulation (EU) 2024/1938 of the European Parliament and of the Council, Regulation (EU) 2017/745 and Regulation (EU) 2017/746	https://ec.europa.eu/eusurvey/runner/TEHDAS_Health_Cat3_2ndround
January 7, 2025	Socio-Economic, Environment and Behavioural Determinants	(b) data on factors impacting on health, including socio-economic, environmental and behavioural determinants of health	https://ec.europa.eu/eusurvey/runner/TEHDAS_Health_Cat4_2ndround
January 10, 2025	Medicinal Products & Devices Registries	(h) personal electronic health data automatically generated through medical devices (i) data from wellness applications (n) other health data from medical devices (o) data from registries for medicinal products and medical devices	https://ec.europa.eu/eusurvey/runner/TEHDAS_Health_Cat5_2ndround
January 14, 2025	Biobank Data	(q) health data from biobanks and associated databases.	https://ec.europa.eu/eusurvey/runner/TEHDAS_Health_Cat6_2ndround
January 17, 2025	Genomic, Molecular and Pathogen Data	(d) data on pathogens that impact human health (f) human genetic, epigenomic and genomic data (g) other human molecular data such as proteomic, transcriptomic, metabolomic, lipidomic and other omic data	This survey is split for the different categories: d) Data on pathogens that impact human health f) Human genetic, epigenomic and genomic data g) Other human molecular data such as proteomic, transcriptomic, metabolomic, lipidomic and other omic data

Herzlichen Dank für Ihre Teilnahme!

Beste Grüße

Ihre

Datenzugangs- und Koordinierungsstelle

Abteilung 6, Innovationsmanagement, Geschäftsstellen
Bundesinstitut für Arzneimittel und Medizinprodukte
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn

Telefon: +49 (0)228-99307-0
Internet: https://www.bfarm.de

Wenn Sie möchten, können Sie jederzeit aus unserem Verteiler austreten. Dazu reicht eine formlose E-Mail an healthdcat-ap@bfarm.de