On December 12, 2019, the European Parliament endorsed a non-binding resolution on enabling the digital transformation of health and care. The resolution calls on the European Commission to take a number of actions to foster the development of digital health systems in Europe to improve patient care and support research efforts — particularly those using innovative technologies such as AI.
In the resolution, the European Parliament recognizes the inherent tension between the importance of supporting innovative digital health solutions and pursuing scientific research and the sensitive issue of confidentiality of patient information. The Parliament stresses that patients’ personal data should be processed in accordance with the GDPR, and should be subject to strict ethical requirements and patients’ informed consent with regard to their collection, processing and storage.
In particular, the Parliament highlights the privacy and cybersecurity risks posed when organizations share and use patient health data — as well as the risk that digital health service providers may use such data in “inappropriate” ways. The Parliament calls on the Commission and Member States to clearly define responsibilities in relation to data governance, putting in place a new public-private paradigm. Furthermore, the Parliament calls on the Commission to support projects aimed at developing anonymization and pseudonymization techniques, as well as technologies needed to create synthetic data for AI algorithm training.
Recognizing also the importance of access to data for advancing scientific research, the Parliament calls on the Commission to develop guidance to promote the secondary use of data for research and exchange best practices on the sharing of health data. The Parliament also recognizes the potential of real-world data to be used for regulatory decisions on medicines to complement evidence from randomized-controlled clinical trials, and calls on the Commission and Member States to investigate this issue further. The Parliament also calls on the Commission to launch a broad European review of the ethical aspects of the digital transformation of health and care — particularly where AI is used — with a view to developing ethical standards and regulation that will protect patients’ rights as well as providing assurance to researchers and the medical technology industry.
In relation to medical devices, the Parliament stresses the importance of standardizing the regulation of mHealth and eHealth devices. The Parliament calls on the Commission to set up a platform for competent authorities, notified bodies and industry stakeholders to reach consensus on the application of the Medical Devices Regulation to digital health services.
The Parliament has called on the Commission to establish a clear timetable for the changes planned in order to foster the development of “digital health Europe”, and we expect to see the newly formed Commission’s plans in the coming weeks. Stay tuned for more updates in this space.