Inception Impact Assessment – The European Health Data Space and the view from MedTech Europe

MedTech Europe welcomes the opportunity to provide the comments of the medical technology industry to the European Health Data Space Combined Evaluation Roadmap/Inception Impact Assessment. As indicated in its statement on the European data strategy of May 2020, MedTech Europe supports the project of the European Health Data Space (EHDS) and its corresponding initiatives.

The medtech industry is at the heart of the health data ecosystem. The industry’s digital health solutions annotate and enrich data to turn raw data into datasets of high value. Innovation in the development of new treatments and protocols is highly dependent on its ability to access and appropriately utilise health data.

The EHDS can accelerate the digital transformation of Europe’s healthcare systems and create the conditions for better use of health data by:

• Building a trustworthy health data ecosystem;
• Improving the quality of health data;
• Advancing the conditions for research and development by accelerating capabilities for the re-use of health data;
• Creating an institutional infrastructure for easy access to health data;
• Supporting the development of skills in the healthcare workforce and the optimal integration of AI systems in healthcare.

The EHDS can thus reinforce the competitiveness of European industry and new business opportunities.

BARRIERS

We would add the following factors to the problem description:

• Citizens should be empowered to access and manage their own health data. Electronic health record (“EHR”) systems and digital health tools should be improved to fully deliver on citizens’ right to portability of health data.
• The industry supports the voluntary European EHR Exchange Format as a critical means to overcome Europe’s digital health fragmentation.
• The industry shares the view that the fragmentation in GDPR implementation and inconsistent interpretation across the EU pose critical obstacles for health data use.
• The divergence in regulations and administrative practice at the national level often hinder the cross-border provision of health services.
• AI in healthcare has considerable potential. We would advise caution when considering introducing new generally applicable AI-specific legislation. Guidance may enable developers to navigate the EU regulatory environment more easily and efficiently

THE LEGAL BASIS OF THE EHDS

The MedTech industry believes that the EHDS should not be limited to the promotion of cross border services or data transfers. It should also address the broader issue of data access for permissible data use. Clarification or more consistent application of the GDPR across Europe is urgently needed.

We support the idea that, while assessing the need for new legislation, the application of existing legislation should be taken into account, to avoid overlapping and conflicting regulations. We favour an EU-wide alignment as opposed to Member State legislation.

RECOMMENDATIONS

• The EHDS needs to correspond to national and regional initiatives to create a trusted personal space for citizens to store and manage their health data safely.
• The health data governance framework must foster trust among citizens, patients, and healthcare professionals that their data benefits research and innovation, and it is used appropriately.
• MedTech Europe calls for more harmonisation of GDPR interpretation and application across the Member States.
• Companies accessing data should not be required to disclose the purposes of their project.
• The governance framework should prioritise standardisation needs and improve data interoperability.
• Cybersecurity needs to be a cornerstone of the EHDS.
• Applicable liability regimes regulating medical technologies continue to be fit for purpose.
• The EHDS should make it a priority to harness datasets for training and testing AI solutions in healthcare.
• Promoting professional education and training towards digital literacy for healthcare professionals should be an integral part of the policy agenda.