Consulting services for the designation of AQuAS as a health data access body (HDAB) under the EHDS regulation
A project for: AQuAS (Agència de Qualitat i Avaluació Sanitàries de Catalunya)
BRIEF
The Challenge
Under the European Health Data Space (EHDS) Regulation, Member States must establish one or more Health Data Access Bodies (HDABs) to enable lawful secondary use of health data. In Catalonia, AQuAS is involved in a process of adapting to the EHDS requirements and operationalising and Office for Secondary Use Data Access (ODAS2), evolving from its existing PADRIS programme. The challenge is to translate regulatory obligations into an operating model, supporting in this transition and upscale of the secondary use of health data, providing processes and tooling that can: enable data discovery, manage access requests and data permits, ensure data minimisation and secure processing, publish transparency information, and support stakeholders with clear governance, sustainability and capability-building.
FOCUS
The Approach
The project delivers a technical office service to design, deploy and progressively operationalise ODAS2. Work starts with a short knowledge acquisition phase and a project master plan, followed by two execution phases:
1) Design and deployment of ODAS2 (organisation, governance, services and required procedures).
2) Evolutionary maintenance and improvement of the deployed results.
Core workstreams include: designing the ‘data user journey’ aligned to EHDS, defining and digitising the access-request and data-permit circuits (including a gap analysis between PADRIS and EHDS), establishing requirements for a secure processing environment (ETS), defining and publishing a HealthDCAT-AP aligned data catalogue, and implementing promotion/training and change management so that AQuAS staff, data holders and data users can adopt the new model.
CONCLUSIONS
The Envisioned Result
Expected outputs include:
1) An ODAS2 operating model and governance structure
2) Documented and standardised internal circuits and forms for access requests and data requests
3) Requirements for key EHDS-aligned components (catalogue, case-management portal, opt-out manager, monitoring/sanctions capability, transparency portal)
4) A secure processing environment design and operational setup approach
5) Internal governance and cataloguing tool that facilitates the management of data and its publication following HealthDCAT-AP
6) A sustainability and fees/taxes strategy
7) A change-management programme (branding, training pathways, communities of practice, and supporting digital portal) to promote secondary use across the SISCAT ecosystem.
PREDICTBY
Our Role
PredictBy is responsible for multiple tasks in this project as experts in EHDS / EEDS regulatory and governance expertise and Health data ecosystem monitoring, capacity building & stakeholder engagement
Our role in the project consists of conducting the following tasks:
Developing and digitalising the data‑access workflow, including application forms, user journeys and operational procedures.
Documenting and enriching metadata, including variables, definitions and glossary terms.
Implementing and configuring OpenMetadata as the cataloging platform, designing its governance and processes, and integrating it with the wider AQuAS ecosystem.
Defining and testing data‑quality metrics, providing early insights into dataset completeness, consistency and usability.
Contributing to the Community of Practice by creating and curating content that explains, promotes and supports the secondary use of health data.