TEHDAS2 opens public consultation on European Health Data Space implementation guidelines

Feedback is invited on draft guidelines and technical specifications essential for implementing the newly adopted European Health Data Space regulation.

Coinciding with the adoption of the European Health Data Space (EHDS) regulation, the TEHDAS2 (Towards European Health Data Space) joint action has announced the release of four draft guidelines and technical specifications centered on data discovery and dataset description. A 30-day public consultation is now open, with feedback invited until February 28, 2025.

Launched in May 2024, TEHDAS2 aims to support the effective secondary use of health data across Europe under the EHDS framework. Building on the work of its predecessor, TEHDAS, and other European initiatives, the project involves 29 European countries and is coordinated by the Finnish Innovation Fund, Sitra. TEHDAS2 is set to run until December 2026, focusing on fostering interoperability, governance, and secure health data use.

As noted by Markus Kalliola of Sitra in his recent interview with The Evidence Base, individual member states will require extensive guidance to ensure compliance with the EHDS regulation.

“Once the regulation is agreed and published in the official journal, the implementation period by Member States will begin. Each Member State will have their homework to do to adopt or amend their national legislation to ensure that it complies with the requirements of the EHDS regulation. Even the most digitally advanced Member States will have a lot of work to do to fulfil the requirements from the regulation.”

The first four guidelines developed by TEHDAS2 aim to address interoperability, governance, and secure handling of health data to ensure that the EHDS framework meets the needs of all stakeholders, including citizens, health professionals, innovators, and regulators. The guidelines include:

Draft guideline for data holders on data description

Introduces HealthDCAT-AP, a metadata standard developed under the HealthData@EU project to enhance dataset discoverability, accessibility, and sharing across EU Member States in line with the FAIR (findable, accessible, interoperable, and reusable) data principles. The guidelines provide advice to help health data holders—including healthcare providers, administrators, industry, and research institutions—accurately use HealthDCAT-AP to describe datasets to ensure interoperability and compliance with EHDS requirements.

Draft technical specification on the national metadata catalogue

Defines the minimum capabilities required for interoperability between national and European health data catalogues. The document outlines a minimum viable product for a national metadata catalogue, focusing on metadata input, management, export, and access to ensure a user-friendly yet adaptable system. Key objectives include guiding Member States on standardizing metadata collection and dissemination at the national level to enable integration into the EU-wide HealthData@EU platform using the HealthDCAT-AP standard.

Draft guideline for data users on good application practice for data access and data requests

Supports data applicants transitioning to data users under the EHDS Regulation, providing a comprehensive introduction from their perspective. It offers step-by-step instructions for identifying datasets, meeting regulatory requirements, and adhering to access conditions. Topics include selecting the appropriate application pathway (data access vs request), preparing required documentation, understanding timelines, and fulfilling obligations under the EHDS as well as the General Data Protection Regulation (GDPR).

Draft guideline for data users on how to use data in a secure processing environment

Provides guidance on securely accessing and using health data within a secure processing environment (SPE). The as-yet unpublished guidance aims to provide practical steps for selecting an SPE (also known as secure data environments [SDEs] or trusted research environments [TREs]), accessing datasets, conducting analyses, and exporting results while safeguarding privacy and ensuring compliance with EHDS standards. Additionally, it outlines best practices for secure and lawful secondary data use.