On the way to the “European Health Data Room”!

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Remember the acronym “EHDS”: European Health Data Space. The Commission has unveiled its proposal for a regulation with a view to creating a single European health data area. It is about harmonizing people’s practices and rights and offering the research sector and industry the (anonymous) information they need to take advantage of the growth potential of the healthcare market.

The creation of a European Data Space is one of the Commission’s priorities for the period 2019-2025.

In this context, health data occupy a significant place linked to their particular circumstances: on the one hand, they affect the person’s privacy and must therefore be strictly protected; on the other hand, they must to some extent be available to public authorities in order to be able to take decisions affecting public health; finally, they must also be able to be used by researchers and industry for the purpose of developing quality products, medicines and services.

At European level, an additional difficulty arises: rear end Health data informatics is still highly dependent on national special circumstances. The systems are not necessarily interconnected and interoperability is far from guaranteed. Many people have experienced the frustration of being on holiday in a foreign country and needing access to health data for a minor ailment or illness (x-ray, blood tests, prescription, etc.) in their country of origin. It is often difficult …

A proposal for a regulation on the European Health Data Area

Specifically, the answer takes the form of a draft European Commission regulation organized around three pillars:

  1. Enable citizens to check and use their health data, both in their home country and in other Member States.
  2. Promote the emergence of a genuine single market for digital healthcare products and services. It is about letting the data-driven economy unfold to its full potential and promoting a genuine single market for digital healthcare products and services.
  3. Set strict rules for the use of a person’s unidentifiable health data for research, innovation, policy making and regulatory purposes.

The initiators of the text promise: all this will be done, while guaranteeing full respect for the EU’s high data protection standards.

Paradoxically, it was the failure of European integration in the fight against coronavirus that acted as a catalyst. For the European Commission, the COVID-19 pandemic has indeed made it clear that “the complexity of the rules, structures and processes in force in the Member States hinders access to and data sharing of health data, in particular across borders.

The icing on the cake: the financial efforts are colossal. 5.5 billion euros in savings over 10 years are expected thanks to improved access to health data and the exchange of this data in the field of care. In addition, € 5.4 billion in savings over 10 years is expected thanks to the improved use of health data for research, innovation and policy making. The digital healthcare market will have a growth potential of up to 30%.

All this is worth a conciliation.

Empowering citizens to control their own health data, within their country and across borders.

The promoters of the text highlight the following benefits:

  • Thanks to EHDS, citizens will have instant, free and simplified access to their health data in electronic form. They will easily be able to share this data with other healthcare professionals within and between Member States to improve the delivery of healthcare.
  • Citizens will be able to exercise full control over their data and will be able to add information, correct erroneous data, restrict access to their data to others and obtain information on how their data is used and for what purposes.
  • Member States shall ensure that patient records, electronic prescriptions, medical imaging images and reports, laboratory results and hospital discharge letters are issued and accepted in a common European format.
  • Interoperability and security become mandatory. Manufacturers of electronic record systems must certify compliance with these standards.
  • To ensure the protection of citizens’ rights, all Member States must designate digital health authorities. These authorities will have to participate in a cross-border digital infrastructure ([email protected]), which will help patients share their data across borders.

Improving the use of health data for research, innovation and policy making

The promoters of the text highlight the following benefits:

  • EHDS creates a solid legal framework for the use of health data for research, innovation, public health, policy making and regulatory purposes. Under strict conditions, researchers, innovators, public institutions or companies will have access to large amounts of high-quality health data. These are essential for developing life-saving treatments, vaccines or medical devices and ensuring better access to health care and more robust health systems.
  • In order to access this data, researchers, companies or institutions must request the authorization of the body responsible for accessing health data to be set up in each Member State. Access will only be authorized if the requested data is used for specific purposes, in closed and secure environments and without revealing the identity of the persons. It will also be strictly forbidden to use the data for decisions that are harmful to citizens, for example to design harmful products or services or to increase the size of an insurance premium.
  • Organizations responsible for access to health data will be connected to the Union’s new decentralized infrastructure for the secondary use of data ([email protected]), which will be set up to support cross-border projects.

Questions anyway

The text arouses the enthusiasm of most observers, whether it is industry, researchers or consumer and patient associations.

However, there are some gray areas and questions left, especially:

The people in question fell completely? Is the accumulation and exchange of extremely sensitive data using advanced technologies compatible with the goal of increased control exercised by the data subject? Will people not validate a system that they do not understand / no longer understand because it is so complex?

The amplified digital divide? Is the project compatible with the fight against the digital divide? Isn’t there a risk of ignoring an elderly population (yet large consumers of healthcare) who drop out when asked about IT and dematerialization? Do we not risk abandoning a disadvantaged population that does not always have easy access to the Internet?

The jar of honey. Isn’t there a risk in creating what computer security specialists call a “honey pot”: The more honey you put in a pot, the more insects you attract. This is what is likely to happen if valuable data is concentrated in one place or if it is stored or managed using a single technology. The slightest mistake can be catastrophic. But given the sensitivity of health data, there is no doubt that hackers of all stripes will be happy to test the tightness of the system.

More information?

By consulting the documents available in the Annex, including the proposed settlement.

By consulting the commission’s website dedicated to the project.

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