Digital medicine offers great opportunities. The European Commission is therefore presenting this week a bill defining the rules of a European health data area.
The European Commission is due to present a bill on a “European health data space” on Tuesday, which could be very important for digital medicine and access to patient data.
Germany, a digital laggard, has already reacted and in April presented a bill on the modernization of the register, which will regulate the way in which university research groups – even without the informed consent of patients – could have access to the valuable data of the patients, which must be stored in a central database hosted by the German regulatory authority Bfarm. Access by authorized users – the G-BA health technology assessor, researchers, patient groups and health insurance companies to highly sensitive encrypted personal health data, will be coordinated by the TMF, which has lobbies for R&D based on biobanks for a few years. The TMF published an expert opinion last year in which it recommended that the central database be funded by the pharmaceutical industry, to which companies have so far not had access.
The European Commission is officially talking about something quite different: patients and service providers should have the right to access electronic prescriptions, results, x-ray and MRI images, lab results, discharge reports or even to vaccination records throughout Europe via a free access service. using a smartphone or PC. “Creating a European data space – also in the health sector – is one of the Commission’s priorities for 2019 to 2025,” said the EU’s executive body. 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 Area” should help Member States and the Commission to exchange health data for public health, treatment, research and innovation in Europe.
According to the bill, 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 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), i.e. an EU-wide compatible online identification system which could play a central role in the secure cross-border exchange of data. Again, Germany has taken pole position and in its Registry Modernization Act has already proposed linking the personal tax identification number to link a person’s identity to their health data. Critics warn, however, that pseudonymization could be overcome by using artificial intelligence or – within the next 50 years – by quantum computing.
Secondary use includes 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, simplified and standardized access should enable better policy-making and stimulate research in several fields, from artificial intelligence to personalized medicine and epidemiology.
While critics say the move would violate the fundamental right to informational self-determination, the Commission portrays the entire data system as transparent and compliant with Article 20 of the General Data Protection Regulation (GDPR). Unlike Germany, according to the Commission, data should only be transmitted on request and in an “anonymised” form. The Commission also asserts that even the indirect identification of the person who surrenders will be impossible. Similarly, the sale of health data, which is already practiced in the United States by a whole sector, should be prohibited in the EU. This decision would make the entire EU an island of digital medicine in a globalized world.
In Germany or Poland, whose health systems unlike the Scandinavian countries have delayed digitization, electronic prescriptions, patient files and certificates of incapacity for work are still a dream of the future. According to the Commission’s plans, a European-wide standardized network should be available by 2025. However, the project still needs to be approved by the European Parliament and the Member States.
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