Digital medicine offers great opportunities. The European Commission is therefore presenting a bill this week setting out the rules for a European health data space.
The European Commission will unveil a bill on a “European health data area” on Tuesday, which could be a big step forward for digital medicine and access to patient data.
Digital laggard Germany has already reacted and presented in April a draft law on modernization of the registry, which will regulate how academic research groups, even without informed consent of patients, could access valuable patient data, which will be stored in the central database hosted by the German regulatory authority Bfarm. Access by authorized users – G-BA health technology evaluator, researchers, patient groups and health insurance companies to highly sensitive and encrypted personal health data will be coordinated by the TMF, which has been lobbying for research and research for several years. development based on biobanks. The TMF published an expert opinion last year, recommending funding of the central database by the pharmaceutical industry, to which companies so far have no access to this data.
The European Commission is officially talking about something completely different: Patients and service providers should have the right to access e-prescriptions, results, X-ray and MRI images, laboratory results, discharge reports or even vaccination records across Europe via a free access service using a smartphone or PC. “Creating a European data space – including in the health sector – is one of the Commission’s priorities for the period 2019-2025,” said the EU executive body. This means not only a primary use in actual health care, but also a secondary use in health research and policy.
A new “joint action on the European health data space” should support Member States and the Commission in exchanging health data for public health, treatment, research and innovation in Europe.
According to the bill, every EU citizen would have not only the right to digitally access their health data, but also the right to restrict access to third parties or share it with them for free, especially for research purposes. The approach is linked to the European Commission’s proposal to introduce a European digital identity (EUid), which is an EU-wide compatible online identification system that could play a central role in the secure exchange of cross-border data. Once again, Germany has taken pole position and in its registry modernization law has already proposed linking the personal tax number to link a person’s identity to their health data. Critics, however, warn that pseudonymisation could be overcome using artificial intelligence or, within the next 50 years, quantum computing.
Secondary use includes, in particular, health, social and administrative data, genetic and genomic data, public records, clinical studies, questionnaires for research purposes and biomedical data. From the Commission’s point of view, simpler and standardized access should allow for better policy making and promote research in different fields, from artificial intelligence to personalized medicine and epidemiology.
While critics argue that this move would violate the fundamental right to informational self-determination, the Commission presents the entire data system as transparent and, in accordance with Article 20 of the General Data Protection Regulation (GDPR). In contrast to Germany, the Commission argues, data should only be able to be transmitted on request and in “anonymised” form. The Commission also argues that even indirect identification of the delivering person will be impossible. The sale of health data, already carried out in the US by an entire industry, should also be banned in the EU. This move would make the whole EU a digital medicine island in a globalized world.
In Germany or Poland, whose health systems, unlike the Scandinavian countries, have delayed digitization, e-prescriptions, patient records and certificates of incapacity for work are still a dream in the future. According to the Commission’s plans, a standardized European-wide network should be available by 2025. However, the draft still needs the approval of the European Parliament and Member States.