Last year the European Commission presented a proposal for a regulation on the European Health Data Space, EHDS. This blog post will give you a high level understanding of what EHDS is, its purpose and the impact it can have on the European healthcare sector.

Sharing Health Data

Health data has always been an important part of medicine, not only in research but in the everyday life of a doctor, nurse or any other healthcare professional. Measuring vitals several times per day on a critically ill patient is both an important part of the clinical work as well as it is data gathering for the future.

The importance of sharing health data became very apparent during the recent pandemic. Sharing health data is important for both primary use, i.e. to facilitate the everyday work of the healthcare professionals, as well as for secondary use, i.e. for research, innovation and policy making on a societal level.

The reasons why it is so difficult to share health data today are complex and multifaceted. Legislations, security, privacy, different data standards and organisational challenges are to name a few.

The purpose with the European Health Data Space is to resolve a number of those challenges by creating “a health specific ecosystem of rules, common standards and practices, infrastructures and a governance framework”. This will:

• strengthen individuals control of their own health data

• promote reliability, security and interoperability by establishing rules for electronic health records (EHR) systems

• support the use of health data for better healthcare delivery, better research, innovation and policy making and

• enable a safe and secure cross-border exchange of health data, both for primary and secondary use

EHDS and GDPR

EHDS builds further on GDPR in terms of strengthening the individuals right to their own data. However, since EHDS also aims to facilitate health data exchange for secondary use there will be challenges to interplay the different rights between EHDS and GDPR.

Interoperability saves money

The European Commission estimates that the healthcare sector in Europe can save 11BN Euros in the coming 10 years by improving interoperability. This is based on that improved access to health data:

• improves patient safety

• improves diagnosis and treatment

• leads to less examinations

• improves overall efficiency in healthcare

• facilitates research and innovation

• facilitates policies and regulations

They also estimate that improved interoperability will increase the growth of digital health by 30% by facilitating companies to enter new markets for example.

EHDS and PSD2

The initiative of EHDS illustrates that the European Commission recognises and understands the importance of interoperability in the healthcare sector, including digital health, research and innovation. There are many challenges that need to be solved before the framework is in place by 2025, however, the first steps are taken towards a future where sharing health data is possible to a much greater extent than today.

Leyr’s unified approach is inspired by how interoperability has been solved in open banking. Thanks to the implementation of PSD2, the European banking sector was opened up to third parties and the fintech sector was enabled to innovate and disrupt.

We believe that even though EHDS is more complex and extensive than PSD2, it definitely has the same potential to unleash innovation and disruption in the healthcare sector. Leyr will be ready and in an excellent position to support the increased demand of health data infrastructure in Europe.

If you want to dig deeper into this topic, here are some useful links:

Summary and timeline from Ehälsomyndigheten

Study by European Commission

Recent article by Deloitte