Will the European Health Data Space change the face of digital health?

In May 2022, the European Parliament and Council announced a proposal for the creation of a European Health Data Space, intended as a key pillar of the European Health Union. The main goal is to facilitate and enhance access to and use of health data for citizens, health professionals and researchers across the EU. This is a huge opportunity for the healthcare sector, as it enables companies to access anonymized electronic health data for innovation and research. So what do medtech and pharmaceutical companies need to do to prepare for this new situation? 

The challenge of health data in the European Union

Currently, European Union (EU) citizens wanting to access their personal health data face significant hurdles. In Germany, for example, insurers have, since 2022, been legally obliged to provide patients with an electronic patient record. Uptake among healthcare professions has, however, been slow, and apps for handling electronic patient records are not in widespread use, in part due to poor usability. 

One major reason for these difficulties is uneven implementation of the GDPR across member states. This creates uncertainty over what constitutes legitimate use of data. Differences in the degree of digitalization in different member states represent an additional obstacle to seamless cross-border access to data.

Regulations on secure use of health data have been in place for many years. The EU also explicitly states that every person in the EU has the right to their health data. In practice, many of us still carry health data from one health professional to another on paper, CD-ROM or DVD. Even at healthcare providers and insurers, the degree of digitalization is very low.

When Information is lost, diagnostic tests are unnecessarily (and wastefully) repeated, or an incorrect prescription results in treatment with multiple incompatible treatment regimes, patients are prevented from receiving effective or innovative treatments and face unnecessary obstacles on their patient journey.

But the problem also affects research and innovation. Access to patient data is a key problem for researchers at life science companies and universities. For emerging digital technologies like artificial intelligence, a lack of data is a major hurdle. This matters, because these technologies will be key to meeting the challenges facing today’s healthcare systems, from a lack of physicians in specific regions, to personalized medicine, to a range of challenges relating to our ageing society. 
 

The European Health Data Space

The European Health Data Space (EHDS) is a proposal for the creation of a domain specific data space for highly sensitive health information. It addresses challenges relating to digitalization and access to health-related data.

When implemented, individuals will have control over their electronic health data and be able to grant access to anyone, in particular medical professionals, in the European Union. There will also be major benefits for the healthcare sector. The EHDS will enable researchers, innovators and policymakers to use this electronic health data in a trusted and secure way that preserves privacy. 

Commonly referred to as secondary use of electronic health data, for research, innovation, regulatory support, and even personalized medicine, this represents an even greater opportunity for accelerating healthcare innovation than Germany’s planned PDSG law, scheduled to come into force in 2023, which allows patients to donate their health data to non-commercial users.

The Europe’s digital decade: digital targets for 2030 targets state that, by 2030, 100% of European citizens should have access to their digital medical records. The EHDS is a key pillar in achieving this ambitious target. 

New mandatory requirements and certifications

To achieve EU-wide standardization, a range of policy options have been proposed. The preferred option at present is for an EU framework that will be implemented on a national level.

The new regulatory framework will require electronic health record (EHR) vendors, medical device manufacturers and providers of high-risk AI systems to recertify their products. 

The new framework will include mandatory requirements for and certification of EHR systems and of medical devices claiming interoperability with EHR systems. An additional voluntary certification mark for wellness applications could provide transparency for users and providers, and reduce barriers to cross-border trade for manufacturers.

New Health Record exchange format

Under the proposed EHDS, primary uses of health data would include the following: 

1. patient medical records
2. electronic prescriptions
3. electronic dispensations
4. medical images and image reports
5. laboratory results
6. discharge reports

All vendors providing solutions for the above uses will have to adapt their solutions to comply with the new framework. Given that many countries are still struggling to implement nationwide digital health records, this is a far from trivial undertaking.

The European Electronic Health Record exchange format should ensure that data quality is sufficient for new use cases. Data quality covers data fields and groups, diagnostic coding systems, and technical specifications for data exchange.
For manufacturers reliant on qualitative data, standardization of data formats will ensure that models and solutions based on this data continue to meet the high standards required. For providers of the above solutions, this may mean significant additional work. 

Secondary uses of electronic health data

For the healthcare sector, it is the regulation of secondary uses of electronic health data that probably constitutes the most important part of the proposal.

For many organizations, lack of access to quality health data is a major barrier to creating value through digital innovation. A European standard which solves this problem by providing a solution which meets the highest ethical standards is therefore a game changer. This is the first time legislators have set out a concept for regulating the secondary use of health data.

The concept includes a detailed description of which categories of health data will be made available to researchers. These categories include, but are far from limited to, EHRs, genomics data, health data from clinical trials, and real world data (including data from medical devices and wellness applications). The proposal also includes regulations on the purposes for which secondary use of electronic health data would be permitted.

For the healthcare, life sciences and medical device sectors, the most important secondary uses are:

1. developing or improving products or services which promote public health or public safety 
2. training, testing and evaluating algorithms in medical devices, AI systems and digital health applications 
3. providing personalized healthcare in the sense of assessing, maintaining or restoring the state of health of natural persons, based on the health data of other natural persons.

Impact of the European Health Data Space

Implementation of the EHDS will impact nearly all parties involved in the healthcare ecosystem: 

• For EHR vendors, implementation of the EHDS will mean updating and certifying their existing products to comply with new EHDS data exchange standards. This will involve significant effort as they will need to update their products to meet both national and EU regulations.
• Manufacturers of critical AI applications that interact with and claim interoperability with EHR systems will face challenges similar to those faced by EHR vendors with respect to certification and compliance with the new regulations and compatibility with infrastructure.
• Medical device manufacturers will be impacted where devices interact with the above systems and where devices are intended to interact with EHDS applications or infrastructure. 
• A regulatory framework enabling the secondary use of data will also affect the life sciences sector. Life science companies will need to be aware of the opportunities and ensure they have the right strategies in place.
• The proposal also means significant changes for manufacturers of wellness devices (such as wearables). This implies a major shift in approach vis-à-vis the consumer healthcare market. Voluntary certification for wellness devices is currently under discussion. This could open up the possibility of wellness/fitness devices connecting to personal health records, potentially adding a useful dataset.

Steps to be considered right now

The EHDS is at present no more than a proposal for establishing a domain-specific data space. It is a proposal has been years in the making and draws on intensive research and analysis. It is therefore reasonable to assume that some, perhaps most, of it will have to be implemented at the national level.

For medtech and pharmaceutical companies, we have four recommendations for dealing with the challenges and opportunities posed by the EHDS: 

1. Establish or beef up your data strategy: 
   Whether you are an electronic health record system vendor, a medical device manufacturer or a pharmaceutical company, you will need to establish or beef up your data strategy to take account of the above developments. You should also ensure you have the skills and resources to take advantage of forthcoming access to health data. 
2. Adhere to proven best practices when applying AI in the pharmaceutical and life science sectors:
   Principles for applying AI in the pharmaceutical and life science sectors will become even more important, as greater availability of data will increase the demand for and validity of data and AI-based solutions.
3. Prepare your technology landscape to make use of upcoming data: 
   Companies should consider building data enablement expertise and evaluate the potential of digital health platforms for harnessing current and future data.
4. Evaluate the European market:
   Many EHDS standards and much EHDS infrastructure will be based on existing Myhealth@EU cross-border implementations. This means that those countries that are already taking part in this initiative will have a clear head start.

Summary

The EHDS proposal officially recognizes digitalization of health data as a key driver for improving healthcare delivery, innovation and management in the EU. This is an important step. Digitalization, in the form of digital and data driven solutions, is crucial for addressing a wide range of unmet medical needs in our society.

Developing these solutions requires high quality data. In this context, the EHDS proposal represents an opportunity to establish and ensure access to a harmonized cross-border health landscape.

The timeline is tight. Under the EU’s digital targets, the EHDS is scheduled for completion by 2030. Everyone involved in healthcare – providers, manufacturers and researchers – should start to prepare for this change without delay, and these preparations should cover both existing products and upcoming innovation projects.