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EuropaBio position on the European Health Data Space proposal

27/07/2022
OTHER
EuropaBio position on the European Health Data Space proposal

EuropaBio welcomes the European Commission’s bold ambition to make Europe the most competitive data economy globally. The power of data in the healthcare sphere is evident and realising the potential of healthcare data is a crucial step to ensure the EU is a leader in the development of next generational medicines. The biotechnology industry has stood at the forefront of using digital innovations for many years, having advanced alongside digital technologies.

The European Health Data Space (EHDS) marks a world first in providing federated access to important health data. Placing a central focus on citizens’ control over their data, the EHDS seeks to implement a framework through which data access for primary and secondary use is both clarified and simplified, improving the availability of data within a transparent and secure infrastructure. Data collection from across the EU will be valuable in addressing the health challenges facing Europeans, allowing for research and innovation, and collection of insights not possible when necessary data is fragmented.

While we encourage bold moves for the region, it is important to ensure gradual steps in building the EHDS avoid unintended consequences for a data-intensive research industry that operates globally. Data is a key asset for large and SME biotechnology companies alike in the healthcare sphere, supporting their ability to grow and sustaining their competitive advantage. Maintaining strong intellectual property protections is also necessary for a prospering data economy and vibrant innovation system for digital healthcare.

We outline our core priorities for the use of healthcare data in the development of novel biotechnology derived medicines, reflecting on the EHDS legislative proposal:

• EuropaBio encourage the EHDS initiatives that promote the rights and accessibility of citizens to the use of their electronic health data;
• To ensure trust and understanding of healthcare data use, the EHDS implementation should complement the overarching digital transformation;
Expansion of MyHealth@EU across Member States, and in terms of the services available, is a necessary step to support data portability;
• EuropaBio support standardisation of electronic health records to facilitate the core functioning of the EHDS and support a multi-stakeholder approach to establish relevant criteria;
A clear framework for the provision of telemedicine services within the context of the EHDS should be explored to enable appropriate access to these necessary services in each Member State, and for all citizens;
• National digital health authorities should receive clear operational guidelines to ensure a harmonised experience across the EU, in particular when dealing with relevant national contact points for digital health to avoid unnecessary fragmentation of data;
• Industry should play an appropriate role as part of the functioning of the European Health Data Space Board;
• Access to the EHDS for private scientific research, and to support development and innovation activities by industry is a welcome recognition of the role the private sector plays;
• Maintaining strong intellectual property protections is necessary for a prospering data economy and vibrant innovation system for digital healthcare;
• We encourage the ability for the EHDS to further our ability to use real world evidence (RWE) in regulation of medicines.

EuropaBio position on the European Health Data Space proposal


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EuropaBio position on the European Health Data Space - Factsheet


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Alexandra Simionca
Alexandra Simionca

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  • Unlocking the Potential of Biotechnology Innovation for Patients
  • Vision, clarity and enabling – the drivers for Europe’s biomanufacturing future

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