Digital medicine holds great opportunities. The EU Commission is therefore presenting a draft law this week that defines rules for a European Health Data Space.
The EU Commission is set to present a draft law on a "European health data area" this Tuesday, which could be a big thing for digital medicine and access to patient data.
Digital latecomer Germany has already reacted and presented a draft Registry Modernisation Act in April, which will regulate how academic research groups – even without informed consent of patients – could get access to the valuable patient data, which are set to be stored in central database hosted by the German regulatory authority Bfarm. Access of authorised users- health technology assessor G-BA, researchers, patient groups and health insurance companies to the highly sensible, encrypted personal health data, will be coordinated by the TMF, which has lobbies for biobanking-based R&D for some years. The TMF published an expert opinion last year, in which it recommended funding of the central data base by the pharmaceutical industry, which companies so far are prohibited to access these data.
The EU Commission officially speaks of something quite different: Patients and service providers should be be given the right to access electronic prescriptions, findings, X-ray and MRI images, laboratory results, discharge reports or even vaccination records throughout Europe via a free access service using a smartphone or PC. "The creation of a European data space - also in the health sector - is one of the Commission's priorities for 2019 to 2025," the EU executive body said. This means not only primary use in actual health care, but also 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 draft law, every EU citizen would not only have the right to digitally access their own health data, but also the right to restrict access to it for third parties or share it with them free of charge - especially for research purposes. The approach is linked to the EU Commission's proposal to introduce a European Digital Identity (EUid), i.e. an EU-wide compatible online identification system that could play a central role in secure cross-border data exchange. Again, Germany has taken the pole position and in its Registry Modernisation Act has already proposed to link the personal tax identity number to link a person’s identity to its health data. Critics, however, warn that the pseudonymisation could be overcome using artificial intelligence or – within the next 50 years – by quantum computing.
Secondary use is to include, in particular, health, social and administrative data, genetic and genomic data, public registers, clinical studies, questionnaires for research purposes and biomedical data. From the Commission's point of view, easier, standardised access should enable better policy-making and boost research in several areas, from artificial intelligence to personalised medicine and epidemiology.
While critics say this move would violate the the basic right to informational self-determination, the Commission presents the entire data system to be transparent and, in accordance with Article 20 of the General Data Protection Regulation (GDPR). In contrast to Germany, the Commission say, data should only be able to be handed over on request and in "anonymised" form. The Commission also claims that even indirect identification of the surrendering person will be impossible. Also the sale of health data, which is already done in the US by an entire sector, should be prohibited in the EU. This move would make the entire EU a digital medicine island in a globalised world.
In Germany or Poland, whose healthcare systems in contrast to the Scandinavian countries have delayed digitalisation, electronic prescriptions, patient files and certificates of incapacity for work are still a dream of the future. According to plans of the Commission, a Europe-wide standardised network should be available by 2025. However, the draft still needs approval by the EU Parliament and the member states.