Digital health makes healthcare better, safer, and more efficient, and advances the delivery of high-quality care. For digital health to reach its full potential, we need to unlock the benefits of health data.
Medical technology companies need to process health data, both when developing new technologies and as part of their roll-out to healthcare systems. However, regulatory and legal challenges continue to limit access to health data by medical technology companies to develop new solutions for treating patients and advance personalised medicine and treatments. There is a need for clear rules under which the medical technology industry can collect, process, and share health data. The varied implementation and interpretation of the General Data Protection Regulation (GDPR) by national and local authorities create considerable legal uncertainties for industry, resulting in barriers to health data use.
MedTech Europe calls on European and national policymakers to make rules regarding health data use more consistent, with a specific focus on:
- rules for processing health data by medical technology companies for healthcare delivery and research and innovation;
- the legal basis for processing health data under the GDPR, and the interplay between the GDPR and the Medical Devices and In-Vitro Diagnostics Regulations;
- harmonised guidelines on anonymisation and pseudonymisation;
- exceptions for public interest and preventive medicine, in particular with regards to research conducted by medical technology companies;
- transfers of health data within and outside the European Economic Area.
The EU should take on a coordinating role to realise the full potential of health data. Aligning inconsistent national strategies through an EU-wide governance framework will enable the harnessing of health data in a resource- and cost-effective way.