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

European Health Data Space is a health specific ecosystem comprised of rules, common standards The European Health Data Space (EHDS) is a specialized health ecosystem built on shared rules, standards, infrastructures, and governance elements. Its primary objectives are:

1. Empowering individuals by enhancing digital access to and control over their personal electronic health data across the EU.
2. Supporting a unified market for electronic health record (EHR) systems, relevant medical devices, and high‑risk AI systems.
3. Establishing a secure and efficient framework for the secondary use of health data in research, innovation, policy development, and regulatory activities.

As a core component of the European Health Union, the EHDS expands on the foundations set by the General Data Protection Regulation (GDPR) and the NIS 2 Directive. It aims to ensure EU-wide preparedness for health crises, improve access to essential medical supplies, and promote coordinated action among Member States to enhance disease prevention, care, and recovery.

Purpose of the EHDS:

• To improve citizens’ access to and control over their health data. 
• To facilitate free movement of individuals across the EU by ensuring portability of health data. 
• To promote a unified market for EHR systems, medical devices, and high-risk AI systems (primary use of data). 
• To provide an efficient, secure system for health data use in research, innovation, regulation, and policymaking (secondary use). 

Key Milestones in the Development of EHDS:

• 3 May 2022 – The European Commission introduces the EHDS proposal. 

• 6 December 2023 – Council agreement on the EHDS framework. 

• 15 March 2024 – Political agreement reached between the European Parliament and the Council. 

• 24 April 2024 – European Parliament formally approves creation of the EHDS. 

Scope of Data Covered Under EHDS:

The regulation lists a comprehensive set of electronic health data categories available for secondary use, including:

• • EHR data 
• • Human genetic information 
• • Biobank data 
• • Data generated by wellness applications 
• • Clinical trial results (after trial completion) 
• • Medical device data 
• • Registry data 
• • Research cohort and survey data (after initial publication of results) 

Implications for Wellness Applications:

A wellness application is defined as any device or software designed to process electronic health data in order to provide information about a person’s health or to support care activities outside the scope of direct healthcare delivery.

Wellness apps such as Fitbit and MyFitnessPal increasingly influence healthcare by supporting preventive health measures. By encouraging the sharing of wellness app data between users and healthcare professionals, the EHDS aims to strengthen early detection and prevention strategies.

To support interoperability between wellness apps and EHR systems, a voluntary EU‑wide labelling scheme is proposed. Manufacturers that comply with the scheme’s interoperability and security requirements can obtain an EU label, helping users identify apps that meet defined standards. Labelled apps must also be registered, along with test environment results, in a publicly accessible EU database maintained by the European Commission.

Implications for Medical Devices:

1. Interoperability 

Medical devices and IVDs claiming interoperability with EHDS‑harmonized EHR components must demonstrate compliance with the essential interoperability and logging requirements outlined in Annex II of the EHDS. These requirements apply only to devices that provide electronic health data for processing within an EHR system and claim such interoperability. In these cases, common specifications for EHR systems also apply.

2. Conformity Assessment 

Devices, IVDs, and high-risk AI systems must undergo certification in accordance with the Medical Devices Regulation (MDR), the In Vitro Diagnostic Regulation (IVDR), and the AI Act. Manufacturers may therefore be required to undergo conformity assessments across three regulatory frameworks: 

• MDR 
• AI Act 
• EHDS Regulation 

A single EU declaration of conformity must cover all applicable Union legislation.

3. Registration Requirements 

Under Article 32(3) EHDS, medical devices that function as EHR systems or claim interoperability with them must be registered in a new EU database for EHR systems and wellness apps, in addition to existing device registration obligations.

Broader Impacts:

For patients, the EHDS grants new rights regarding their electronic health data and establishes responsibilities for how that data must be used in primary care, while also requiring alignment with GDPR protections.

Data holders will face new obligations to provide health data for secondary use. Likewise, providers of EHR systems, certain medical devices, and AI systems must comply with additional premarket and self‑certification requirements.

Digital health services and wellness app developers will encounter a harmonized but more complex regulatory environment governing access to electronic health data. Key outstanding questions remain around definitions, rights, obligations, and technical implementation.

Conclusion:

The European Health Data Space offers significant opportunities for wellness applications and medical devices to harness health data for better patient outcomes and more efficient healthcare delivery. By prioritizing interoperability, data protection, and collaboration across the healthcare ecosystem, stakeholders can navigate the evolving EHDS framework and unlock substantial potential for digital health innovation in Europe.e the EHDS landscape effectively and unlock the full potential of digital health innovation in Europe.