European Union Health Data Space

In March 2024, after years of preparation, the Council of the European Union and the European Parliament reached a provisional agreement on a new regulation governing electronic health data. The regulation, known as the European Health Data Space, was first proposed in March 2022 and, when formally adopted, will apply to the primary use and secondary use of health data. This initiative is a key component of the broader EU data strategy and represents the first of nine sector– and domain–specific data spaces outlined in the European Commission’s 2020 communication on “A European strategy for data.”

The Council subsequently published the revised text for the EHDS, offering insights into the forthcoming regulation and its implications. Below is a review of the regulation, as it looks today.

EHDS: What’s in a Name?

The EHDS aims to create a unified infrastructure and governance framework for the “primary use” and “secondary use” of health data. It uses the following definitions.

• Primary use: This involves utilizing health data to enhance health care delivery and improve patient outcomes. Examples include patient treatment, prescription and dispensation of medicinal products and medical devices, and data related to social security, administrative, or
• Secondary Use: This primarily supports research and innovation by providing researchers with access to larger volumes of high-quality data more efficiently and cost-effectively. Secondary use also encompasses data applications that benefit society, such as policy-making and personalized.

Who Will be in Charge?

Each Member State will designate one or more digital health authorities to implement and enforce the primary use of health data under the EHDS at the national level. These authorities will handle various tasks, including serving as contact points for complaints from individuals regarding EHDS provisions. Additionally, data protection authorities will collaborate with digital health authorities to monitor and enforce data subject rights under the EHDS.

For the secondary use of health data, Member States will appoint a “health data access body” responsible for receiving, reviewing, and approving access requests. These bodies will also undertake monitoring and supervisory roles. Data protection authorities will oversee and enforce the right to object to the processing of personal electronic health data for secondary use.

A European Health Data Space Board will be established to facilitate cooperation and information exchange among Member States and the European Commission.

When Will the EHDS Come into Effect?

The exact implementation date is yet to be determined. However, it is anticipated that the provisional agreement will soon receive endorsement from the European Council and the European Parliament, leading to formal adoption. The EHDS will come into effect twenty days after its publication in the Official Journal of the European Union. Generally, the EHDS will apply two years after its entry into force, with specific provisions, such as those governing the secondary use of health data, coming into effect four- or six-years post-entry into force.

Conclusion

The EHDS is an ambitious initiative aimed at establishing a unified health data governance framework across the EU, facilitating seamless data exchange across borders. This initiative can create tremendous opportunities for business ventures, but it also adds exposure to regulatory scrutiny. To effectively implement and benefit from the EHDS provisions once they are adopted, businesses should consider taking steps to prepare for compliance now.