However, to establish this European system, all data must be harmonised and gathered in a single database. It is the case in France at the national level, because our health system is centralized and patient data is collected by a single agent, the Assurance Maladie, but this is not the case for all our European neighbours. For example, in Germany, it is not mandatory to subscribe to the public health insurance system; citizens can choose to subscribe to a private insurance system. In addition, medical records differ from one Länder to another. Therefore, the data are neither grouped in the same way nor centralised.
The challenge of confidentiality of health data
If a European medical data system were to see the light of day, it would have to be in full compliance with the General Data Protection Regulation (GDPS) which entered into force on 25 May 2018, protecting personal data while strengthening and unifying data protection for individuals within the European Union.
In the majority of countries that have introduced Shared Medical Records, the patient can choose who can or cannot access their data, which therefore remain protected. In addition, access and actions performed on the SMR are tracked, allowing the patient to verify who has accessed their file. If a health professional violates these rules, they would be sanctioned by the GDPS (financial sanctions or even criminal proceedings).
The European framework for health data exchange could therefore be based on the rules put in place in France, in order to protect data collected via electronic health records. The patient's medical data must remain confidential, in accordance with medical confidentiality, but they could be shared, in anonymity, between European hospitals for research purposes: indeed, with more data, professionals will be able to compare their practices and develop new innovations.
This system could lead to a "single market" for health data in Europe, which would benefit patients in terms of medical and therapeutic advances. To this end, a Europe-wide campaign to raise awareness is needed, as proposed by Institut Montaigne for the national SMR in 2010 in its study entitled Réussir le DMP, so that citizens are informed, and this system can be extended.
Finally, as also recommended by Institut Montaigne in the above-mentioned study, it seems necessary to provide financial incentives for European stakeholders to take part in this data exchange, through higher reimbursement rates for doctors or lower supplementary insurance contributions for patients.