LS&HC Horizons 2023 - Flipbook - Page 20
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | Digital Health and AI
20
European Health Data Space: a revolution for electronic health records
Health data feeds the health care system
and is a fundamental tool for health care
professionals, pharmacists, researchers, and
regulators. The swift use and exchange of
information becomes of utmost importance
both for health care and other secondary
purposes (e.g., research, training, etc.).
However, there are still obstacles when sharing
and accessing data in the digital EU as there are
very often fragmented and non-interoperable
electronic health records (EHRs).
The Regulation on the European Health Data
Space (EHDS) (still a proposal) aims to solve
these issues by creating an interoperable
and common environment for EHRs in the
European Union, as well as enhancing citizens’
rights in relation to their data in this context.
In addition, the EHDS will also regulate
the secondary use of electronic health
data, enabling the reuse of data held by a
wide range of entities for purposes such as
research, innovation, policy making, training
of algorithms and patient safety. The EHDS
clarifies the conditions for secondary purposes,
including the concerned categories of data,
prohibited uses, and exchange process.
The EHDS will mean a revolution for the
handling and sharing of EHRs and the
reuse of health data, and will bring great
opportunities for the industry. Having said
this, it is still a work in progress and will
require further development to become
fully operational.
EHDS will translate into new obligations
for EHR systems manufacturers, importers,
and distributors; providers of medical
devices; health care professionals (HCPs);
and even wellness apps. Examples of these
include conformity declarations, technical
requirements, and marking.
Santiago De Ampuero
Castellanos
Senior Associate, Madrid
Juan Ramón Robles
Associate, Madrid
Joanna Rozanska
Associate, Madrid