Results by user group

DOI: https://doi.org/10.5281/zenodo.20157049

This guideline aims to help data users understand how to use data in a secure processing environment (SPE) under the EHDS.

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DOI: https://doi.org/10.5281/zenodo.20157044

This guideline defines the best practices for data users on applying for and obtaining access to health data under the EHDS, including completing applications and complying with the legal, ethical and procedural requirements.

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DOI: https://doi.org/10.5281/zenodo.20133567

This guideline supports health data holders in complying with the EHDS Regulation by clarifying which electronic health datasets must be made available for secondary use and by providing practical instructions for describing them using the HealthDCAT‑AP common metadata model.

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DOI: https://doi.org/10.5281/zenodo.20199484

This guideline provides guidance for data holders on how to prepare, structure and make electronic health data (personal and non-personal) available for secondary use in line with EHDS requirements.

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DOI: https://doi.org/10.5281/zenodo.20267597

This guideline supports the implementation of the EHDS by health data access bodies and data holders in relation to fees and penalties for non-compliance. It aims to promote convergence of practices across the EU while reflecting diverse stakeholder perspectives.

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DOI: https://doi.org/10.5281/zenodo.20269996

This guideline provides reflections and recommendations for health data access bodies on allowed purposes and prohibited uses according to the EHDS.

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DOI: https://doi.org/10.5281/zenodo.20157235

This technical specification describes four main capabilities of the national metadata catalogue: metadata input, metadata management, metadata output and metadata access.

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DOI: https://doi.org/10.5281/zenodo.20199187

This guideline specifies procedures and standardised formats for health data access bodies to manage health data access applications, health data requests, data permits, health data request approvals and data handling processes under the EHDS.

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DOI: https://doi.org/10.5281/zenodo.20281197 

This guidance defines technical specifications for the Data Access Application
Management System (DAAMS) to support interoperable, efficient and harmonised processing of data access requests across Europe.

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DOI: https://doi.org/10.5281/zenodo.20269109

This document helps health data access bodies manage data protection considerations and requirements under the EHDS.

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DOI: https://doi.org/10.5281/zenodo.20266861

These technical specifications provide a policy-level overview and technical guidance to help Member States and health data access bodies connect to the secure, cross-border HealthData@EU infrastructure for the secondary use of health data.

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DOI: https://doi.org/10.5281/zenodo.20266473

These technical specifications define the core functional and security requirements for secure processing environments to enable safe secondary use of health data across the EU. It provides a harmonised framework for Member States to align their high-level design choices with the legal obligations of the EHDS.

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DOI: https://doi.org/10.5281/zenodo.20280387 

This guideline helps health data access bodies establish practical and legally compliant procedures for implementing individuals’ opt-out rights within the EHDS secondary use framework.

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DOI: https://doi.org/10.5281/zenodo.20281265 

This guideline helps health data access bodies manage the assessment and communication of clinically significant findings arising from the secondary use of health data.

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