What is the message?
The launch of the European Health Data Space (EHDS) represents a significant step towards creating a unified and interoperable health data ecosystem across Europe.
The proposal, unveiled by Commissioner Stella Kyriakides and Vice President Margaritis Schina, aims to provide patients with secure access to their health data while facilitating data-sharing for research and innovation.
EXECUTIVE SUMMARY
What are the key points?
Building Resilient Healthcare Systems: With Europe facing challenges such as an ageing population and a shrinking workforce, the EHDS is viewed as essential for shaping a sustainable and resilient healthcare system. The integration of telemedicine is highlighted as a key feature, allowing healthcare professionals’ expertise to support patient treatment remotely.
Secondary Use of Data for Research: The EHDS addresses the secondary use of patient data for research and innovation purposes. It aims to create a harmonized framework for accessing health data across multiple countries, facilitating research collaboration and innovation.
Interoperability Focus: The proposed regulation emphasizes interoperability and aims to strengthen patients’ rights while defining the roles of different stakeholders. However, alignment with existing and upcoming legislation such as the AI Act and Medical Devices regulation remains a challenge.
Challenges and Opportunities: Member states will need to invest in their capacity to implement the EHDS effectively. Currently, only a few countries have data hubs in place, highlighting the need for investment and infrastructure development.
Industry and Policy Perspectives: Industry leaders have welcomed the EHDS, emphasizing the need for a unified approach to address fragmented digital health markets and interoperability challenges. Policy-makers express optimism about the potential of digitalization and data utilization to improve healthcare services.
What are the key examples?
France, Germany, Finland, and the Netherlands are among the few countries that already have data hubs in place.
Industry leaders like Johannes Schildt, CEO of Kry, have stressed the importance of overcoming long-term health system pressures through European-level action.
The EHDS aims to connect data hubs across member states, requiring investment and capacity-building efforts from participating countries.
The proposal seeks to create a harmonized framework for accessing health data across Europe, promoting research, innovation, and improved healthcare services.
Conclusion
The launch of the European Health Data Space represents a significant milestone in efforts to create a unified and interoperable health data ecosystem in Europe.
While challenges remain, such as ensuring legal alignment and investing in infrastructure, stakeholders are optimistic about the potential for digitalization and data utilization to enhance healthcare delivery and patient outcomes.
DEEP DIVE
European Health Data Space launched: Can it achieve its goals?
“If we’re serious about overcoming the long-term pressures on our health systems and if we really want patients to benefit from new technologies, …
… we need to act now at a European level to tackle a fragmented digital health market and the lack of interoperability of health data.”
Healthcare IT News
May 04, 2022
Image: Pixabay/Pexels
The proposal of the European Health Data Space (EHDS) was unveiled yesterday (3 May) by Commissioner for Health and Food Safety, Stella Kyriakides and Commission Vice President Margaritis Schina.
Kyriakides said the EHDS will give patients safe access to their data and enable data-sharing for research and innovation. “It’s going to be a fundamental game changer,” she said.
… the European Health Data Space (EHDS) will give patients safe access to their data and enable data-sharing for research and innovation.
BUILDING A RESILIENT SYSTEM
Europe’s ageing population, a shrinking workforce and the rise in telehealth, make the EHDS a vital tool in shaping a sustainable and resilience healthcare system across the continent, according to Petra Wilson, managing director of Health Connect Partners and EU policy advisor to HIMSS.
“It allows for the know-how of healthcare professionals to travel, to support the treatment of patients without patients necessarily having to travel on their own. That’s because it foresees far higher integration of telemedicine than we had before.”
The proposal also addresses the secondary use of data-the deployment of patient data in research and innovation.
This will facilitate the study of all kinds of research questions, said Markus Kalliola, the coordinator of Towards a European Health Data Space (TEHDAS), a project supporting the development the EHDS involving 25 countries.
The EHDS will create a clearer and more coherent system, which will make it easier for researchers who want to access data from multiple countries to do so, he said.
“For the first time it will give us a harmonized framework for the legal groundwork for the secondary use of health data in the EU.”
The proposal also addresses the secondary use of data-the deployment of patient data in research and innovation.
In addition, the data space will yield information that can be used in public health policy.
“We have seen a lot of decision-making using health data to for example fight the epidemic,” Kalliola said.
“The EHDS will enable the secondary use of health data both for research and decision-making and also for innovation purposes.”
In addition, the data space will yield information that can be used in public health policy. “We have seen a lot of decision-making using health data to for example fight the epidemic …
INTEROPERABILITY FOCUS
The proposed regulation increases the legal certainty in Europe’s health data environment by defining the roles of different stakeholders and strengthening patients’ rights, said Anastasiya Kiseleva, a doctoral researcher at VUB and CY Cergy Paris University who published an last year on the legal obstacles facing the EHDS.
The proposed regulation increases the legal certainty in Europe’s health data environment by defining the roles of different stakeholders and strengthening patients’ rights
But as discussions continue, law-makers will need to ensure that the language in the regulation agrees with that of instruments like the AI Act, the Medical Devices regulation and other upcoming pieces of legislation, Wilson said.
“The proposed legislation has a heavy emphasis on the interoperability of electronic health records across the EU but we also need to make sure that European legislation in itself is properly interoperable.”
“The proposed legislation has a heavy emphasis on the interoperability of electronic health records across the EU but we also need to make sure that European legislation in itself is properly interoperable.”
It also poses a challenge to member states, which will need to invest in their capacity. The EHDS is designed to connect data hubs across member states, but currently just a few countries-like France, Germany, Finland and the Netherlands-have such hubs in place.
It also poses a challenge to member states, which will need to invest in their capacity.
The EHDS is designed to connect data hubs across member states, but currently just a few countries-like France, Germany, Finland and the Netherlands-have such hubs in place.
Industry leaders welcomed the new system, with Johannes Schildt, the CEO of Kry, a digital health company, stating,
“If we’re serious about overcoming the long-term pressures on our health systems and if we really want patients to benefit from new technologies, we need to act now at a European level to tackle a fragmented digital health market and the lack of interoperability of health data.”
“If we’re serious about overcoming the long-term pressures on our health systems and if we really want patients to benefit from new technologies, we need to act now at a European level to tackle a fragmented digital health market and the lack of interoperability of health data.”
And policy-makers are optimistic. “Ultimately the only way forward for us to improve our health systems and improve the services to citizens is through digitalization and using all the data out there,” Kyriakides said.
Originally published at https://www.healthcareitnews.com on May 4, 2022.
Names mentioned
Commissioner for Health and Food Safety, Stella Kyriakides
Commission Vice President Margaritis Schina.
Petra Wilson, managing director of Health Connect Partners and EU policy advisor to HIMSS.
Markus Kalliola, the coordinator of Towards a European Health Data Space (TEHDAS)
Anastasiya Kiseleva, a doctoral researcher at VUB and CY Cergy Paris University
Johannes Schildt, the CEO of Kry, a digital health company
