Public consultations

TEHDAS2 is seeking feedback on its draft guideline for HealthDCAT-AP, a metadata standard supporting the EHDS. This guideline aims to help health data holders comply with EHDS metadata description requirements, enhancing the discoverability, sharing and accessibility of health data across the EU.

The document outlines modifications to the baseline DCAT-AP specification to address the specific needs of health data and provides practical examples to guide metadata records creation.

Stakeholders, including health data holders and users, are invited to share their views on the usability of this standard for describing datasets within the EHDS framework.

TEHDAS2 invites feedback on its draft technical specification for a national health dataset catalogue that supports the EHDS. The specification defines a minimum set of capabilities member states need to adopt to achieve interoperability across national dataset catalogues.

The specification focuses on metadata input, management, export and access, ensuring a user-friendly system while meeting EU-level requirements and allowing national adaptability.

Stakeholders, including health data holders, health data users and health data access bodies, are invited to share their views on this specification to ensure it addresses key challenges in achieving interoperability and a unified EHDS.

TEHDAS2 is seeking input on its draft guideline for data users navigating the application process for accessing or requesting health data under the EHDS regulation. This guideline offers step-by-step instructions for identifying datasets, meeting regulatory requirements and adhering to access and usage conditions.

Designed for a wide range of users, including researchers, public authorities and private entities, the guideline aims to provide complementary document to the data application form, enabling clear understanding of what is needed to fill in the application and why. Data applicants will be able to work with the application form easily when reading the guidelines before stepping into the form itself. This will streamline the cross-border secondary use of health data, enhancing compliance and efficiency.

Stakeholders, including health data users, are invited to share their views on the content of this guideline to ensure it meets their needs.

TEHDAS2 invites feedback on its draft guideline for data users working with health data in a Secure Processing Environment (SPE) under the EHDS. The guideline aims at providing practical steps for choosing an SPE, accessing datasets in an SPE, conducting analyses and exporting results from the SPE, while safeguarding privacy and complying with EHDS standards. It also highlights best practices for secure and lawful secondary data use.

Stakeholders, including data users, are invited to share their views on the guideline to ensure it supports their needs.

1. Guideline for Health Data Access Bodies on fees and penalties for non-compliance regulated to the EHDS regulation 

2. Guideline for Health Data Access Bodies on minimum categories and limitations on the reuse of health data 

3. Guideline for data holders on making personal and non-personal electronic health data available for reuse 

4. Guideline for Health Data Access Bodies on the procedures and formats for data access  

5. Technical specification for Health Data Access Bodies on data minimisation and de-identification  

6. Technical specification for Health Data Access Bodies on the implementation of the common IT infrastructure 

7. Guideline for Health Data Access Bodies on linkage of health datasets 

8. Guideline for Health Data Access Bodies on obligations towards natural persons 

9. Guideline for Health Data Access Bodies on data altruism in health

1. Guideline for Health Data Access Bodies on collaboration with other parties 

2. Guideline for Health Data Access Bodies on international and third country access and transfer of electronic health data

3. Guideline for Health Data Access Bodies on enrichment of health datasets 

4. Data Access Application Management System (DAAMS) – Technical specification for health data access bodies 

5. Technical specification for Health Data Access Bodies on the implementation of secure processing environments

6. Guideline for Health Data Access Bodies on informing natural persons about the use of health data – “Citizen Information Point” 

7. Guideline for data users on handling research outcomes