LS&HC Horizons 2023 - Flipbook - Page 61
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | Europe
61
EHDS initiative: early insights from the French and German systems
As a core part of the data strategy of the EU,
the European Commission (EC) aims to create
a single market for digital health services and
products, including a European Health Data
Space (EHDS). The EC published a proposal
for EHDS regulation in May 2022 (EHDS Draft
Reg), which is currently planned to become
law in June 2024.
The EHDS Draft Reg is intended to set up
cross-border infrastructure and governance
mechanisms to enable uses of electronic health
data for health care delivery (primary use
of data) and for research and policy making
purposes (secondary uses of data). Essentially,
the EHDS Draft Reg shall establish a healthspecific European ecosystem providing
rules, common standards and practices,
infrastructure and a governance framework
for access and control of electronic health
data. While the primary use of data is highly
relevant for actors in the health care system
and patients, getting and granting access
to health data for secondary purposes will
be of high interest for pharma and medical
device companies.
The EU and the member states have been
aware of the challenges resulting from the
EHDS Draft Reg. Thus, a pilot project under
French leadership is running, testing the
Patrice Navarro
Partner, Paris
interaction of different data platforms
brought together via prototype health data
access bodies.
Some practical implications can also be drawn
from the existing French Health Data Hub.
This Health Data Hub, formerly known as
the Système National des Données de Santé
(SNDS), is a national initiative in France
that aims to promote the sharing and use
of health data in the country. Thanks to the
high centralization of the French Health
system, the Health Data Hub manages huge
databases of public health data. It is designed
to facilitate collection, standardization, and
sharing of health data from various sources,
including hospitals, research institutions, and
patient organizations. The Health Data Hub
is a collaborative effort between the French
government, academic institutions, and
private sector partners. It is also aligned with
the EHDS initiative, which has drawn many
of its operating principles from it.
In Germany, a national act is expected soon
to foster a better scientific use in accordance
with the GDPR by establishing a decentralized
research data infrastructure.
Arne Thiermann
Partner, Hamburg
Dr. Karolin Hiller
Counsel, Munich, Berlin
