European Health Data Space’s implications for “Wellness Apps” & Medical Devices

The European Health Data Space is a health specific ecosystem comprised of rules, common standards and practices, infrastructures and a governance framework that aims at:

1. Empowering individuals through increased digital access to and control of their electronic personal health data, at national level and EU-wide.

2. Fostering a single market for electronic health record systems, relevant medical devices and high risk AI systems.

3. Providing a trustworthy and efficient set-up for the use of health datafor research, innovation, policy-making and regulatory activities.

The European Health Data Space is a key pillar of the European Health Union. It builds further on the General Data Protection Regulation (GDPR), and the NIS 2 Directive.

The European Union is building a strong European Health Union, in which all EU countries prepare and respond to health crises. EHDS provide available, affordable, innovative and adequate medical supplies, and member countries work together to improve prevention, treatment and aftercare for diseases.

Purpose:

• To increase citizens’ digital access to and control over their own health data.
• To support the free movement of citizens in the EU.
• To promote an EU market for electronic patient record systems, medical devices and high-risk systems with artificial intelligence (primary data use).
• To create a coherent, secure and efficient structure for the use of health data for research, innovation, policy-making and legislation (secondary data use).

History of European Health Data Space:

• 3 May 2022 – The European Commission launched the European Health Data Space (EHDS).
• 6 December 2023 – Agreement on the Council’s proposal for the European Health Data Space (EHDS).
• 15 March 2024 – political agreement reached between the European Parliament and the Council of the EU on the European Health Data Space (EHDS), one of the central building blocks of a strong European Health Union.
• 24 April 2024 – The Members of the European Parliament (MEPs) approved the creation of the European Health Data Space (EHDS).

The EHDS sets out a big list of covered electronic health data that should be made available for secondary use under the EHDS.  It includes, among others:

• Electronic health records;
• Human genetic data;
• Bio banks;
• Data from wellness applications;
• Clinical trial data – though according to the recitals, this only applies when the trial has ended;
• Medical device data;
• Data from registries; and

Data from research cohorts and surveys, after the first publication of the results – a qualifier that does not seem to apply for clinical trial data.

Implications for wellness applications:

Any appliance or software intended by the manufacturer to be used by a natural person for processing electronic health data specifically for providing information on the health of individual persons, or the delivery of care for other purposes than the provision of healthcare.

Wellness applications such as MyFitnessPal and Fitbit are having a growing influence on healthcare and have the potential to facilitate the shift from treatment to preventive healthcare. By allowing healthcare professionals and patients to monitor health data from wellness apps, the proposal will make it more possible to identify and treat potential illnesses before they have actually developed. The proposal facilitates this transition by encouraging the sharing of wellness app data between patients and healthcare professionals.

In order to promote the interoperability of wellness apps with EHR systems, a voluntary labelling scheme is proposed under which manufacturers of wellness apps will obtain a label that demonstrates compliance with the interoperability and security requirements. The voluntary labelling scheme will ensure transparency for users regarding compliance, and will also allow them to make more informed choices about the most suitable app for their needs.

Manufacturers of labelled wellness applications must register their application, including the results of the test environment, into and the EU database maintained and made public by the European Commission.

Implications for medical devices:

1. Interoperability

Medical devices and IVDs that claim interoperability with the harmonized components of EHR systems must “prove compliance with the essential requirements on the European interoperability component for EHR systems and the European logging component for EHR systems” laid down in Section 2, Annex II of the EHDS. The essential requirements on interoperability of the EHDS would only apply to the extent that the manufacturer of a medical device/IVD, which is providing electronic health data to be processed as part of the EHR system, claims interoperability with an EHR system. In such case, the provisions on “common specifications” for EHR systems should be applicable to those medical devices.

2. Conformity assessment

Medical device, IVD or high-risk AI systems should be certified in accordance with the MDR, IVDR and the AI Act, as applicable. The manufacturer will be required to conduct conformity assessments under (at least) three different EU Regulations which are the (1) MDR, the (2) AI Act and (3) the EHDS Regulation. EHR systems are subjected to other Union legislation in respect of aspects not covered by this Regulation, which also requires an EU declaration of conformity by the manufacturer. A single EU declaration of conformity shall be drawn up in respect of all Union acts applicable to the EHR system.

3. Registration

Article 32 (3) EHDS suggests that medical devices that also qualify as EHR systems or claim interoperability with EHR systems need to be registered in the new “EU database for registration of EHR systems and wellness applications” in addition to registration under medical devices rules.

For patients, EHDS gives them new rights over their electronic health data and imposes obligations for using that data in primary care. That will have to be satisfactorily reconciled with rights and obligations under GDPR.

Data holders will be subjected to new obligations to provide electronic health data for secondary use. Technology providers of electronic health record systems, some medical devices, and AI systems will face new obligations, including meeting premarket conformity assessment requirements, albeit self-certification.

Digital health services and wellness apps will also face new rules. The introduction of a new and harmonized scheme for giving access to electronic health data will add further complexity for providers and users. Therefore, outstanding questions include issues of definitions, rights, obligations, and technology.

Conclusion:

The European Health Data Space presents unprecedented opportunities for wellness applications and medical devices to leverage health data for improved healthcare delivery and patient outcomes. By embracing interoperability standards, ensuring data privacy and security, and fostering collaboration across the healthcare ecosystem, stakeholders can navigate the EHDS landscape effectively and unlock the full potential of digital health innovation in Europe.