The European Health Data Space (EHDS) Regulation: Enabling Data Driven Innovation in Healthcare
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The field of public health has much to celebrate with the European Health Data Space (EHDS) regulation, which seeks to advance scientific research by making health data more accessible to researchers. In the same spirit as the EU Data Act, this regulation takes an egalitarian approach to data, in that it will require certain entities, such as pharmaceutical companies, health apps, hospitals, and those deemed “data holders,” to make certain data publicly accessible for secondary use. 

Once fully implemented, the EHDS will require data holders to report the health data they manage, including sensitive data contained in electronic health records, to a health data access body (HDAB) that will, in turn, make the data available in data catalogs, accessible to “data users,” such as researchers, through an HDAB managed platform.

The EHDS Vision  

One of the goals of the regulation is that data users would be able to run reports directly on the HDAB’s platform or download anonymous data sets for further analysis after receiving a permit. Reports generated using health data from the public repository would then be accessible to the public at large.  

In January 2024, the EU adopted working arrangements and formed Community of Practice (CoP) groups to facilitate the adoption and implementation of the EHDS between the different EU member states by 2027. CoPs are tasked with developing best-practices for establishing digital business capabilities, including:

  1. Data Access Application Systems: Specifying how data should be accessed and how sensitive data should be handled
  2. Health Datasets Metadata Cataloging and Data Quality and Utility Management: Specifying the effective cataloging of health datasets and ways to improve data quality and utility
  3. Secure Processing Environments: Specifying ways to provide secure processing environments for analytic and operational workloads using health datasets
  4. Cross-Border Gateways: Specifying how data should be shared across data sovereignty jurisdictions

Putting the EHDS into Action

The EHDS has an ambitious vision, but fortunately, a solution already exists that can deliver on the regulations’ goals. 

The Denodo Platform, a logical data management solution, provides unified views of data that is distributed across many data sources and environments, while facilitating the governance of these unified views for data quality, privacy, and ethical use. The Denodo Platform can implement the CoP’s digital business capabilities in the following ways:

  1. The Denodo Platform integrates, manages, and delivers data from many data sources without requiring the data to be copied or moved across borders. Instead, it provisions data “just in time,” as workloads require it, with fine-grained access control, data de-identification, and data usage monitoring features, so sensitive data is kept secure, mitigating the risks of leaks and misuse. 
  2. The Denodo Platform includes a powerful data catalog that captures both technical and business metadata, for easy self-service discoverability, data preparation, and provisioning by users who may not be technical data experts.  The catalog also supports embedded rules for measuring and controlling data quality in a consistent manner across all underlying data sources. 
  3. The Denodo Platform can be used as an interface for all workloads requiring health data, securely processing those workloads with  optimal performance. Additionally, it can monitor data usage, maintaining a log of which individuals  accessed what data and when, providing an auditable record. 
  4. The Denodo Platform can enable data access from across a globally distributed environment, including multiple countries and regions, without requiring data to be physically copied or moved across borders. Instead, it provides access only to de-identified datasets as required by data privacy regulations.

The AI Factor

Finally, many organizations are planning to use generative AI (GenAI) to further augment their collaborative research efforts. The Denodo Platform can also be used in support of GenAI-based analytics and applications. It quickly and safely implements retrieval augmented generation (RAG), the current best practice for providing large-language models with correct, accurate, and up-to-date data from all relevant data sources, another priority of the HDAB.

Contact us for more information about how the Denodo Platform can support the goals of the EHDS.

Maricela Lechuga
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Dominic Sartorio
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