Digitalization is becoming an increasingly more important part of the future of healthcare. It provides an unprecedented opportunity as recent developments in digital innovative technologies such as Artificial Intelligence (AI), machine learning (ML) in medical devices and algorithmic capabilities can potentially improve healthcare for delivering innovative and patient-centric care to EU citizens. It also ensures greater international resilience in the global health technology market and brings competitive advantages to European businesses. In this blog, EUCOPE’s Leander Vranken explains what the secondary use of health data in EHDS can offer to small and mid-sized biopharmaceutical companies.
The European Commission is determined to make this Europe’s ‘‘Digital Decade’’ and the digital transformation of Europe’s health sector is essential to improve the EU healthcare system. However, for European people and businesses to be able to benefit from these technological advances depends on how accessible and sustainable the use and re-use of European health data is going to be. In this context, the European Health Data Space (EHDS) might possibly be the most ambitious project ever undertaken and could transform healthcare as we know it.
The European Commission’s key priority with the creation of the EHDS is to promote Europe’s digital transformation by optimizing and widening the use of health data. In doing so, the EHDS provides a consistent, trustworthy and efficient set-up for the use of health data for research, innovation, policy-making and regulatory activities. A special focus is to include citizens as it is their data that will be reused under the EHDS framework, respecting their rights and high-security standards.
Europe is rich in digitalized health data, which is currently one of the most valuable resources in the modern world. However, there are still complex challenges to the wider use of health data hampering the full potential of digital health which include legal and interoperability barriers largely caused by fragmented approaches and diverging interpretations by EU Member States as to how health data can be lawfully shared. In our previous EHDS article we reviewed some of those legal and interoperability barriers that SMEs in Europe but also in 3rd countries such as the U.S. are facing. In this article, we will look at some of the opportunities that the EHDS can offer.
How does it work?
The secondary use of health data
Under the envisioned provisions of the EHDS, citizens can easily access and share their health data both nationally and across borders while also allowing health professionals to easily access patients’ medical records at home and abroad. This should increase the evidence base for decisions on treatment and diagnosis while also avoiding the duplication of tests.
At the same time, the EHDS allows for the secondary use of health data meaning that researchers but also the industry could obtain access to large numbers of high-quality health data sets for research and innovation activities. Essentially, the EHDS will establish a new electronic health data sharing mechanism for health research and innovation. This is crucial for the development of life-saving treatments, improve diagnosis and ensure equal access to healthcare. Small and mid-sized companies that heavily rely on innovation would especially benefit from an EU-wide single market for health data.
Following the envisioned set-up for secondary use in EHDS, industry innovators can now submit a request for access to health data pursuing the applicant complies with the intended purposes under the EHDS legislation. The system itself is built on ‘data holders’, ‘health data access bodies’ and ‘data users’. Data holders control and share health data, access bodies act as intermediaries and guardians giving access permission to data users who can request access to the health data. For example, a pharmaceutical company can request access as a data user from a data holder e.g. a hospital, even if there is a commercial purpose but as long as it aligns with the defined interests under EHDS like science, research and innovation. Requests are assessed by the access bodies who are responsible for giving access permits based on compatibility listed in the EHDS legislation. At the same time, a competitive marketplace is supported as data holders and access bodies can charge fees for making data available for secondary use.
Health data is by default particularly sensitive. Therefore, in order to reduce the risks on privacy rights, health data shall be anonymized. If personal data is required and justified, health data should be provided in a pseudonymized format with the encryption key held by only the health data access body.
More of a recommendation for pharmaceutical and biomedical companies, the EHDS framework should also provide clear safeguards to protect the forced disclosure of proprietary information and confidential datasets. IP protections play a crucial role in driving biomedical innovation. Thus, health data access bodies and data holders should be empowered to work together to ensure appropriate IP protections are maintained.
Why is it relevant?
Real-world evidence generation
Real-world evidence (RWE) generation requires robust research practices for the development of healthcare products. RWE is mainly derived from the routine collection and analysis of Real-world data (RWD) which requires access to large numbers of high-quality data sets with the ability to link different sources of health data. The EHDS shall establish a reliable health data ecosystem with EU-level data collection standards that accomplishes a basic level of quality, relevance and interoperability that allows access to these large and high-quality data sets to researchers and innovators, including the industry, and ensure that healthcare practices, innovative technologies and therapies meet a patient’s needs and lead to favorable health outcomes.
Small and mid-sized enterprises
The common network of health data sharing provided under the EHDS would also lower the barriers for small and mid-sized enterprises to use and reuse high-quality health data for research and innovation purposes that contribute to their competitiveness. An EU-wide single market for health data sharing with common EU-level collection standards enables SMEs to innovate and develop new therapies and products for patients across Europe and contribute to Europe’s competitiveness.
The group that has the potential to benefit the most from the EHDS is the rare disease community. By default, data for rare diseases is actually rare and clinical trial populations are limited. Rare disease data is scattered across different European countries and fragmented healthcare systems. The rare disease community has many unmet needs, and the rarity of diseases leads to scarse information and data. Thus, having a unique single market and a common access point for data on rare diseases, for both primary and secondary data usage, is essential to improve and foster research on rare diseases.
Rare disease patients also heavily rely on RWE for the development of innovative and personalized treatments. Greater availability to research data for the collection of RWD to produce RWE greatly enhances the production of innovative medical products and devices that offer better and more personalized care for rare disease patients.
All in all, the EHDS has the potential to truly transform the European health sector by linking health data sets and make them more accessible within the EU. Under the EHDS, a large number of high-quality data sets can be accessed and shared for research and innovative purposes that ultimately improve the lives of European patients.
EUCOPE’s Digital Health Working Group was created to respond to members’ needs and current political impetus on artificial intelligence (AI) and digital health. EUCOPE is also part of the eHealth Stakeholder Group, an expert group that provides advice and expertise to the European Commission on topics related to the digital transformation of health and care, such as health data, digital health services or the use of artificial intelligence.
For more information on EUCOPE’s Digital Health Working Group or how your organisation can contribute to it, please contact Leander Vranken firstname.lastname@example.org
July 26, 2023