Filenews 24 February 2024
Europe wants the medical records of patients in its countries to be shared across its territory. That is, if a Spaniard or a Greek on vacation in France starts feeling unwell and goes to the doctor, that professional will be able to access their data to treat them, which is known as primary data use.
It also aims that information about this patient can be used to develop new treatments or to open new lines of research for diseases (secondary use).
This is what the European Union has dubbed the European Health Data Space and which the Commission and the European Parliament have been preparing for a few months now.
However, although it is expected that the final text may be ready soon, many aspects raise doubts both about whether it will arrive on time and whether its implementation in various countries is viable.
At the European Parliament's headquarters in Madrid, the report "Making the European Health Data Space innovate: is it really possible?", produced by the think tank EIT Health Spain with the collaboration of experts in data, health systems, health innovation and patient organisations, among others, was presented.
According to ABC's response, the main conclusion is that Spain starts from an advantageous position to implement this plan, since it is among the top 5 countries in terms of digitization of medical data.
However, questions remain about when and how the plan could become a reality. "There are autonomous communities in which clinical records of Primary Care and Hospitals are not interoperable," recalled Joaquín Cayón, vice president of the European Health Law Association, as an example of the complexity of implementing a system of this type.
However, he argued that while "the interoperability of clinical records needs to be improved", the initiative is "an opportunity, a train we cannot miss".
The rule provides for the sharing of aggregated pathogen data, genetic data and information from the public health record, in the public interest
Family doctors also believe that the system still needs improvement. "Unfortunately, at the national level there are still many challenges to implement a fully interoperable system that enables the exchange of health data between all autonomous communities.
This is due, in addition to the systems used, to the organization and different regulations between communities that make this integration difficult.
The European target is "ambitious but achievable", although it will require close cooperation between member states and a shared commitment to overcome the technical, legal and administrative challenges that may arise.
But there is another aspect that worries professionals in the field. In the proposed regulation prepared by the European Commission, Parliament and the Council have tabled a number of amendments that may be problematic in achieving the main purpose of the project, which is none other than the free movement of data.
These amendments – currently only a proposal – require the explicit consent of the patient to be able to use certain data, meaning that the person can refuse to do so.
This, according to doctors, in addition to involving more bureaucracy, is an obstacle to progress, research and knowledge from which future patients will benefit. Some of the genetic data, however, would require explicit authorization from the patient.
The Commission wants the system to be ready as soon as possible. There are elections in early June, so if it is not closed and approved before May, the plan will be rejected.
Finland has almost completed its regulation in this regard. In Spain, according to Ministry of Health sources, steps are being taken in this direction, in addition to the interoperable clinical record, with other projects related to secondary data use, such as the launch of the Health Data Space of the National Health System.
