#VisionforEurope: Innovation, Investment, Excellence
EuropaBio position on the
European Health Data Space
The proposal for a European Health Data Space (EHDS) is part of the European
Commission’s efforts to harness the benefits of the data economy and unleash the
full potential of health data.
The EHDS will put citizens in control of their own health data, whether in their
country or cross-border, and held deliver the transformation of healthcare delivery.
The EHDS will also improve the use of health data for research, innovation, and
policymaking and create a strong, secure, and trustworthy legal framework for the
re-use of health data that will help deliver next-generation treatments.
The European Health Data Space (EHDS) marks a global 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.
The power of data in the healthcare sphere is evident. 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 EHDS will play a central role in 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.
Priorities
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 continue to complement the overarching digital
transformation (and relevant initiatives);
• 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;
• We encourage the ability for the EHDS to further our ability to use real world
evidence (RWE) in regulation of medicines;
• Maintaining strong intellectual property protections is necessary for a prospering
data economy and vibrant innovation system for digital healthcare.