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European Health Data Space (EHDS)

Last Updated on octubre 26, 2024

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The European Health Data Space (EHDS) is a health-specific data-sharing regulation that establishes clear rules, common standards, and a governance framework to ensure the effective use of electronic health data for both healthcare delivery (‘primary use’) and health research and policy-making (‘secondary use’). The EHDS legislative proposal was adopted by the European Commission in May 2022 as part of the EU’s broader “Strategy for Data” to allow the free flow of electronic health data across the EU. 

With regard to the EHDS enforcement timeline, the Parliament and Council negotiators reached an agreement on the text of the EHDS in March 2024. In April 2024, Members of the European Parliament (MEPs) voted to approve the inter-institutional agreement on establishing a European Health Data Space. Once officially approved by both Parliament and Council, the Regulation will enter into force twenty days after its publication in the Official Journal of the European Union.

The EHDS will be enforced by ​​the digital health authorities and health data access bodies at the national level regarding the access and transmission of electronic health data for primary and secondary use, respectively. Any breaches, violations, or non-compliance with the obligations under the EHDS will be subject to substantial penalties as provided for under the GDPR and other applicable EU data laws. 

Natural persons will gain extensive control over their electronic health data, with the rights to access, share, and manage it across the EU countries while also being able to opt out of their data being used for secondary purposes. This standardized approach aims to ensure innovation in the health sector while improving healthcare outcomes for natural persons and establishing the EU as a global leader in digital health governance. For a detailed understanding of EHDS, refer to our white paper.  

The Solution

Securiti enables organizations to comply with the European Health Data Space through AI-driven data mapping, DSR automation, documented accountability, and enhanced visibility into data processing activities.

The European Union’s Data Act

Request a demo today to learn how Securiti’s products and offerings can help your organization with its EHDS compliance efforts.

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Create customized web forms according to your brand image using the DSR request format to accept verified data subject rights requests. Automate the initiation of fulfillment workflows upon receiving verified requests with the help of pre-built response templates and notification extension templates, as per the EHDS. 

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Key Facts about the European Health Data Space

Here are some key facts to know about the EHDS:

1

The EHDS provides for two main uses of electronic health data, i.e., primary use (for healthcare delivery) and secondary use (for research, policy-making, and innovation);

2

The EHDS ensures that all natural persons are able to access their electronic health records across the EU;

3

Health professionals will have faster access to patient’s health records, including across borders, reducing the clinical and administrative burden. 

4

Secondary use of data, i.e., for research, policy-making, and innovation, is strictly restricted to instances where it would be used for legitimate research and policy purposes that benefit individuals and society;

5

Researchers will gain access to a broader and more diverse pool of healthcare data cost-effectively, provided it's for research purposes;

6

The EHDS will apply to organizations established within and outside the EU as long as they process the electronic health data of natural persons in the EU. 

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