Europaudvalget 2020-21
EUU Alm.del Bilag 720
Offentligt
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Holbergsgade 6
DK-1057 Copenhagen K
P +45 7226 9000
F +45 7226 9001
M [email protected]
W sum.dk
Minister for Health
European Commission
Date: 08-07-2021
Section: JURPEM
Case Officer: DEPAMHL
Case: 2110660
Doc.: 1798302
The Danish Government’s response to the public consultation
on European Health Data Space
The Danish Government would like to thank the European Commission for the
opportunity to comment on the consultation regarding the upcoming proposal for
The European Health Data Space.
The Danish Government welcomes the initiative on a European Health Data Space.
We share the goals of benefitting and making the most of digital health in providing
high-quality healthcare, reducing inequalities and promoting access to health data for
research and innovation on new preventive strategies, diagnosis and treatment. The
current COVID-19 pandemic has shown that health data is a crucial element for new
and innovative solutions in time of crisis. A shared European ambition in this regard
will be a central element in ensuring the future health care in Europe.
The Danish Government has just presented our new life science strategy in which we
have seven initiatives on better use of health data. The technological development
within health data is rapid, which creates new perspectives in regard of ensuring
more value and knowledge from health data. However, this creates new needs for
modern, clear defined and secure frameworks for the use of health data. In view of
the new life science strategy, the use of data is a central discussion in Denmark and
several different authorities and stakeholders are taken into account in the Danish
position on health data.Therefore, this consultation response, presents our
immediate and overall remarks and points of attention.
Access to and exchange of health data for healthcare
From a Danish perspective, we see potential in secure data sharing across Member
States, for the benefit of patients. It is essential that initiatives on sharing of health
data build upon federated models, and
Me er States atio al
organizations, such
as existing data infrastructure and national initiatives.
The Danish healthcare system has a long tradition of collecting and using healthcare
data for the benefit of patient treatment and care. The use of health data across
Member States ensures high standard patient treatment by facilitating that patients
staying in all Member States can receive data crucial for their treatment. Therefore,
Denmark welcomes that we in a European context support, that patients can be
treated in other countries and that it is possible to share relevant information for
patient treatment a cross borders.
However Denmark would like to state the importance that actions, within data
sharing, towards a European Health Data Space build upon EU and
Me er States
national regulation and principles. For sensitive personal data collected by the public
 EUU, Alm.del - 2020-21 - Bilag 720: Sundhedsministeriets notat samt dansk høringssvar vedrørende European Health Data Space
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sector, it is essential that the public authorities in Member States maintain control
over the use of data for the purpose of data security and citizens' trust.
Thus, when setting up the European Health Data Space it is important to strike a
balance between clearly defined roles, rules and criteria and at the same time make
room for innovation and quick responses to new technologies and market demands
that change over time. This need for flexibility calls for a decentralised infrastructure.
Therefore, The Danish Government encourages the development of data spaces as
soft i frastru tures ased o te h i al a d legal fra e orks rather tha a tual,
physical data pools. With this approach data sharing would become much easier for
member states to keep the data secure and to ensure control over who accesses
what data for what purposes.
Access and use of personal health data for research and innovation, policy-making
and regulatory decision
Denmark supports access to data for research, innovation, policy-making and regula-
tory decisions within the EU. There is great potential in being able to combine data
from the different Member States. Valuable research and innovation helps to create
good opportunities for new treatment methods and quality development for the ben-
efit of patients, as well as to ensure the future health care in Europe. The two data
spaces on genetics and cancer-images will be important in setting up pilots for how
the broader access and use of health data could look like.
Denmark's collection of health data is unique because many health registers and
databases cover the entire population over many years and can be combined across
data sources. The Danish population has confidence that their health data is
processed and stored securely. In this regard, it is important that new initiatives
within the European Health Data Space build upon and support the Member States'
local principles and organization, where the individual countries organizes access to
data, so that local conditions are taken into account. This is important because the
health data area varies with regulatory and administrative legacies among Member
States.
Digital Health services and products
Denmark is aware of the new possibilities for health data and the possibilities and
experiences that lie in common European solutions. Denmark has a well-developed
infrastructure where digital welfare solutions are deeply integrated in the health care
system. Therefore, we emphasize the need for continued voluntary action at national
level for Member States that have well-developed digital health services and thereby
ensuring that European solutions can integrate local national solutions.
Artificial Intelligence (AI) in healthcare
The development within technology creates new perspectives in relation to getting
even more value and knowledge out of European health data. At the same time,
however, it creates new needs for modern, clear and secure frameworks for the use
of health data. Denmark sees great potential in common European solutions to the
new challenges that come with artificial intelligence.
However, we would like to emphasize that there are a number of data protection
rules, with regard to artificial intelligence, where Denmark believes it is necessary to
take national conditions and rules into account.
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 EUU, Alm.del - 2020-21 - Bilag 720: Sundhedsministeriets notat samt dansk høringssvar vedrørende European Health Data Space
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Concluding remarks
In Denmark, health data and general use of data are an integral part of patient care
and health research. There is strong public and political attention towards that
Danish data are used responsibly and stored securely.
Therefore, Denmark finds it important that the use of health data and particularly
sensitive information about citizens' health is shared safely and securely. We
emphasise the importance that the European Health Data Space will be in
o plia e ith U io a d Me er States pri a y a d data prote tio rules, are
voluntary in nature and are in line with the division of competences between the
Union and the Member States.
Denmark sees great potential in a shared European strategy on health data for the
benefit of patients, research and innovation. Therefore, we welcome the cooperation
between Member States and the Commission in the work towards European Health
Data Space, to ensure continued development of a governance strategy for the use of
health data for health care and for the use of research.
In this view, it is essential that a European Health Data Space builds upon Member
States atio al regulatio s a d pri iples,
as well as upon local conditions, such as
existing data infrastructure and national initiatives, and fully respects Member State
competences and capacities. For sensitive personal data collected by the public
sector, it is essential that the public authorities in Member States maintain control
over the use of data to guarantee data security and public trust.
Denmark would again like to thank the Commission for the possibility of consultation.
We hope to have a close dialogue with the Commission, since we are currently
coordinating a Danish position on the upcoming proposal and would like to present
additional remarks and ideas on the European Health Data Space.
Yours sincerely,
Magnus Heunicke
Side 3