The European Parliament approved the Directive on open data and the reuse of public sector information, which substantially modifies the previous Directive. The legislative changes introduced have to do with the commitment to open formats, the provision of real-time access to dynamic data through application programming interfaces (APIs) and other mechanisms to increase the provision of valuable public data for its reuse by citizens and legal entities.

The new standard is part of the Strategy for the Digital Screen Advertising and is coherent with other sect oral initiatives, such as the Communication on the digital transformation of healthcare and healthcare services in the Digital Single Market, the training of citizens and the creation of a healthier society.

It also aligns with the OECD recommendations on the governance of health data. A recent report on the state of health in the European Union (EU) concluded that only through digital transformation processes can the future of health systems and healthcare be guaranteed.

Health data is one of the key components to enable this digital transformation. When we talk about health data we must distinguish between:

  • The administrative data of the health system: financial data of hospitals and other centers, personnel expenses, of sanitary material, etc.
  • The exclusive electronic medical record for each patient.
  • The registration of patients and diseases: the aggregate data of the group of patients and diseases.
  • Data from clinical trials, subject to a very specific data collection protocol.
  • Another type of data: those collected by applications for each user, surveys, legal, etc.

The barriers to reuse

An EU study on the transformation of healthcare and healthcare services in the Digital Marketing revealed problems in virtually all areas:

  • Lack of harmonization in the collection of administrative data, which prevents comparisons between health systems;
  • Diversity of standards and formats of electronic medical records, which prevents interoperability and that citizen, can take their electronic medical records from one hospital to another;
  • Limited access to data on patient records and diseases for research.

With this background, the European Council, in its Conclusions of December 2017 on health in the digital society, invited the EU Member States to:

  • Achieve interoperable information systems.
  • Promote the use of international and open standards, in order to avoid patented solutions that create dependence on a supplier.
  • Promote the use of data structures, coding systems and common terminologies to improve semantic interoperability, quality and comparison of data.
  • Study the creation of data networks and decentralized common platforms that allow the integration of data and its analysis in a secure environment.

Surprisingly, even among hospitals in the same country, researchers can add patient data to compare clinical values, digital images, diagnoses or treatment results to try to find patterns in the evolution or cure of diseases. Currently, only the summarized clinical history (patient summary) and the electronic prescription seem to move towards real interoperability.

The main barriers for researchers to share health data can be categorized into:

  • Ethical and legal problems. Doubts regarding the use of data ownership and privacy. Who owns the data? To the patient, to the hospital? And what do we collect with our apps? Can doctors add that data to other patients’ data? Can others make use of this data that I do not agree with?
  • Technical problems. The data is not collected with the quality that is required or is in a restricted format. In general, they are related to the lack of normalization and metadata. How reliable are the data generated by others?
  • Motivational problems preparing data to share takes a long time and, until now, you only get a reward for publishing the results of the research, not the data that can help other studies. How much time or money does it cost to prepare my data for others to use? What rewards do I get for sharing data?

How to overcome obstacles

All the studies coincide in pointing out the benefits of the reuse of information, especially in the field of health:

  • Accelerates innovation, because it improves access to research resources.
  • It improves the credibility of the investigations, because it facilitates the reproducibility of the investigations.
  • And promotes citizen science.

The research data are the pillars on which the research processes are based and the new directive urges the Member States to make it possible for data from publicly funded research to be fully accessible (open access policies), applying the principle of opening by default and compatibility with the FAIR principles (acronym for findable, accessible, interoperable and reusable, in, means that it can be found, is accessible, interoperable and reusable).

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