10th November 2022
In the fourth instalment of the ‘Creating Impact’ series, we spotlight the European Commission’s legislative proposal for the European Health Data Space (EHDS).
Health innovators in the EU have long been calling for the harmonization of data sharing, processing, and reusing in the health sector, in order to foster digital services across Europe. EIT Health’s 2021 Think Tank Report ‘Learning from health data use cases’ outlined the need to create the right environment across Member States to allow digital health technologies to reach their full potential. Together with its partners, EIT Health identified several real-world challenges currently faced in bringing digital health solutions to market.
What are the challenges in bringing digital health solutions to market?
1. Roles and relationships
Bluemetrix, a data management provider that facilitates access to data in healthcare, pointed out how consent requests at each data collection point can be both confusing and irritating for patients, and time consuming for care providers.
“Due to the lack of a European Consent form patients need to be continually asked for the right to use their data.”
Furthermore, there are various challenges related to citizens’ rights, data quality and security.
2. Rules and regulations
There is a significant delay between the introduction of new EU regulations (e.g. GDPR and EU MDR) and national implementation of laws, followed by the organizational interpretation of those laws. These legal complexities have created various obstacles for digital health solution providers when it comes to working across borders or re-using data for research.
FibriCheck, a medically certified app which monitors patient’s heart rhythms on their smartphone, contributed “Our hospital partners are asking questions about using data for secondary research, but as there is often no clearcut legal answer regarding what is possible under which conditions, valuable data often remains unused.”
3. Policies and practices
DigiOnko, an app-based solution to support the digitization of the patient journey in cancer care, pointed out the issues they face with data interoperability and the conventional data collection practices still followed by many healthcare providers. “The reality is that many patients’ records are still paper, getting their data into a system like ours is complex and often not possible.”
This makes it harder to build trust between patients and care providers, as well as risk adversity and uptake hesitancy among healthcare professionals.
How could the European Health Data Space address these challenges?
In May 2022, the European Commission presented its European Health Data Space (EHDS) proposal, a health specific common governance framework combining rules, standards, practices and infrastructures. The proposal aims to make electronic health data more available and of a higher quality, so that patients can receive safe and continuous care regardless of where they are in Europe. It will also give patients more control over their own health data.
The development and implementation of EHDS would include action points such as:
- Incorporation of digital health solutions into everyday care of patients and disease prevention practices.
- Attention to new models of care reimbursement that account for care delivered remotely.
- New legal relationships set up between the providers of digital health solutions and traditional care providers. This will allow for new models of shared liability.
- Training on new data management competencies for clinical and other healthcare workers.
In EIT Health’s Flagships Programme, we advocate for the secondary use of data to be used in innovation, treatment development and public health.
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