“The European Health Data Space will help the EU to achieve a quantum leap forward in the way healthcare is provided to people across Europe. It will empower people to control and utilise their health data in their home country or in other Member States. It fosters a genuine single market for digital health services and products. And it offers a consistent, trustworthy and efficient framework to use health data for research, innovation, policy-making and regulatory activities, while ensuring full compliance with the EU's high data protection standards.” (EHDS Press Release, 3 May 2022)

All Member States will be required to participate. Analogue to the General Data Protection Regulation (GDPR) or Medical Device Regulation (MDR), this will be defined without a national legislation process but most likely delegating the detailed description on implementation strategies to the national levels. As this represents a true quantum leap for innovation in healthcare, this presents also challenges for data generating bodies such as hospitals, health insurance companies etc.

Our role in shaping health data spaces

Our team focuses on infrastructure-based topics to facilitate reproducible and high-qualitative secondary use of health data. Our related work over the past 20 years resulted in three categories of results directly related to activities in accordance with the EHDS.

1) Our extensive network of key stakeholders

We are in successful and continuous collaborations with all key stakeholders to shape future implementations of health data spaces, which includes academic institutions, public bodies, Austrian ministries, patient advocacy groups, cluster organisations and industry.

AIT is involved as key partner in leading national and international interest groups for data governance, data economy, interoperability etc., such as DIO, HL7, Gaia-X, EIT Health.

This enables us to get fist-hand updates on e.g., regulatory, and legal developments which serve as requirements for technical developments.

2) Our open technology framework

Our data nodes framework provides:

1. Pseudonymization and record linkage for master data records and free-text records (e.g., clinical notes).
2. Harmonization and Standardization. We build on a wide range of health standards including ISO11073, HL7 FHIR, the Clinical Data Architecture (CDA) and OMOP-CDM.
3. Data curation and annotation. We offer convenient services for smart data quality checks and auditable data editing and classification.
4. Collaborative data modelling. We offer collaborative work with networked data by providing an access-controlled model and feature store. Access can be managed by assigning different user-roles for different institutions.
5. Model/algorithm as a Service. We provide the hosing of data apps based on self-developed models/algorithms or third-party applications.