Brussels, 29 February 2024

COCIR, the European Trade Association representing the medical imaging, radiotherapy, health ICT and electromedical industries, expresses its full support to establishing a European Health Data Space (EHDS). The EHDS is a crucial initiative aimed at improving patients' control over their health data, advancing research, and enhancing health outcomes through the facilitation of data sharing ecosystems within the European Union. COCIR believes that these efforts are pivotal in ensuring the EU's continued competitiveness on the global stage.
As committed EU healthcare policy stakeholders, COCIR members acknowledge their responsibility towards end-users, particularly patients and healthcare professions and providers. Ensuring the availability of safe and effective products on the European market remains a top priority.
In response to the texts by the European Commission, Council of the EU, and European Parliament, COCIR offers comprehensive recommendations refining the proposed EHDS legislation to better serve its intended purpose and provide legal clarity.

Key Recommendations include:

• Refinement of Legal Framework for EHR Systems: COCIR advocates for a clear differentiation between 'EHR systems' and medical devices to mitigate legal uncertainty for manufacturers. A precise definition of 'EHR systems' is essential to streamline conformity assessment procedures and avoid overregulation.
• Specification of (Non-)Personal Electronic Health Data Scope: COCIR recommends a rewording of the definition to encompass personal electronic health data, anonymised data, and anonymous statistical data to enhance compliance and reduce uncertainty. Therefore, clarity is needed regarding the scope of electronic health data, particularly for secondary use.
• Protection of Intellectual Property (IP) and Trade Secrets: COCIR emphasizes the importance of safeguarding existing IP rights and trade secrets within the EHDS framework. Recommendations include consensual agreements between data users and holders and the incorporation of protective measures to uphold Intellectual Property Rights (IPR) and trade secrets.
• Mitigation of Risks in International Data Flows: COCIR recommends alignment with provisions of the General Data Protection Regulation (GDPR) to facilitate cross-border data transfers. Data localisation and sovereignty requirements should be avoided. Without alignment international data flows will be impeded and existing EU agreements, e.g. EU-Japan EPA, will be infringed.
• Consistency in Secondary Use of Data to Avoid Disruption: COCIR stresses the significance of ensuring consistency in the use of health data for secondary purposes, as provided for by the General Data Protection Regulation. Imposing diverging conditions at Member State level may lead to fragmentation and disrupt harmonization efforts.

COCIR remains committed to collaborating with policymakers to ensure that the EHDS Regulation reflects the industry's needs while upholding the highest standards of data protection, innovation, and competitiveness.

About COCIR
COCIR is the European Trade Association representing the medical imaging, radiotherapy, health ICT, and electromedical industries. Founded in 1959, COCIR is a non-profit association headquartered in Brussels (Belgium) with a China Desk based in Beijing since 2007. www.cocir.org

For more information, contact:

Annabel Seebohm
COCIR Secretary General        
Tel: +32 (0)2 706 8960
seebohm@cocir.org