The European Union (EU) is in the middle of transformative efforts to digitalise healthcare systems across the continent, with initiatives focused on everything from electronic health record (EHR) interoperability to more comprehensive digital tools and services for patients.
To help support these ambitious projects, the EU has implemented a €20 billion, seven-year budget overseen by the new Health and Digital Executive Agency (HaDEA), under DG Santé, the organisation responsible for the EU Commission’s policies on health and food safety.
This budget includes €10.3 billion towards the Horizon Europe programe, established to foster research and innovation including health and key digital industries, and the €5.3 billion EU4Health program.
It also includes up to €1 billion for digitalising healthcare, including the creation of the European Health Data Space (EHDS) which is expected to be implemented in 2025, following the proposal for a regulation on the EHDS in May last year.
The EHDS is intended to enable citizens to control and share their health data with hospitals and doctors in their home country or other EU member states.
It will also provide wider access to up-to-date and reliable health data for healthcare professionals, while encouraging research into new and innovative lifesaving treatments.
A pivotal year
Jean-François Goglin, deputy CEO of Connective Santé, says the EHDS, a health-specific ecosystem of rules, common standards and practices, infrastructures and a governance framework, is a necessity for Europe to develop an ethical and secure framework, in accordance with the General Data Protection Regulation (GDPR).
“It will constitute a sovereign database of health data which cannot be plundered by the major planetary digital providers, and serve to develop its own innovative algorithms, especially in AI,” he explains. “2023 is a pivotal year in which we understand the strategic interest of developing and mastering the digital dimension.”
In France itself, Goglin explains with successive funding programs, the country has invested more than €2 billion to modernise the basic functionalities necessary for the proper functioning of a fair, ethical and sovereign health system.
These functionalities include the technical foundations, a national identifier, a secure shared national record, secure messaging, EMR for every healthcare provider, and a personal health space dedicated to each patient so that they are in control of their data and can actively participate in their own health journey.
“Despite this, interoperability and intermediation still require our full attention,” Goglin notes. “Without them, it will not be possible to effectively articulate the efforts of the various actors in the care pathways.”
Advancing research and innovation
Dr Peter Gocke, chief digital officer (CDO) and head of the digital transformation unit at Berlin’s Charité University Medical Centre, says an EU-wide initiative like the EHD is important for healthcare digitalisation as it addresses the challenges of fragmented healthcare systems and enables collaboration, innovation, and improved patient care across borders.
“By unlocking the potential of health data and promoting interoperability, the EHDS has the potential to significantly advance research, innovation, and healthcare outcomes throughout Europe,” Gocke explains.
He points out Germany has been traditionally considered to be lagging in digitalisation, including in healthcare, but there have been ongoing efforts to bridge the gap and implement digital initiatives. Most recent is the Hospital Future Act (KHZG) of 2021, which allocates €4.3 billion for the digitisation of public hospitals in Germany by 2024.
“There are still some critical areas where digitalisation should be prioritised in the healthcare sector, including EHRs, telemedicine and remote patient monitoring, interoperability and data exchange, and data analytics and AI in Healthcare,” he adds.
The challenge of interoperability
From Dr Gocke’s perspective, one of the challenges in healthcare digitalisation is the lack of interoperability among different systems and datasets.
“The EHDS seeks to establish common standards and technical specifications, promoting the harmonisation of health data across the EU,” he says.
This interoperability enables seamless exchange and integration of data, allowing healthcare providers and researchers to access comprehensive information regardless of geographic boundaries.
“It facilitates the development of digital health applications and tools that can be utilised across multiple countries,” Dr Gocke explains.
Petra Wilson, senior advisor, European Health Policy & EU Affairs, HIMSS, points to other initiatives underway in the world around digital health, including regulation on use of AI, which touches on digital health, and rules on security and cloud computing.
“It’s also important to mention the investment the European Commission is making to build out the core blocks of digital health, whether that’s digital twins in clinical research or the standardisation of prescribing so we can have cross-border distributed medicines,” she explains.
From Wilson’s perspective, programs like Horizon Europe and the EU4Health initiative have been instrumental on the social science and humanities side to helping understand how to support digitalisation in healthcare.
“The tools developed through those programs often leads to quicker progression in some of the smaller member states where there aren’t competing national programs,” Wilson concludes.
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