LS&HC Horizons 2022 - Flipbook - Page 61
Hogan Lovells | 2022 Life Sciences and Health Care Horizons
61
Europe
Reimbursement of digital health applications in Europe
It is still a new development that digital health applications are becoming part of regular
health care services in some European countries. Not long ago medical apps were not
reimbursed by public – or private – health care insurance funds or other payors. Expedited
by the Covid-19 pandemic, reimbursement of digital health applications is slowly taking off
in European health care systems.
• I n Germany, certain digital health applications – so-called DiGAs – were added
as standard health care service of the German public health care system (SHI) in
2019/2020. Once evaluated and approved by the German authority BfArM in a Fast
Track Process, physicians are able to prescribe accredited DiGAs to patients which detect,
monitor, treat or alleviate diseases, injuries or disabilities. As of now, over 30 digital apps
have been accredited for reimbursement.
• I n UK, there is no specific national reimbursement pathway for digital health
applications and such applications do not fit easily within the existing public health
system reimbursement pathways. There are a number of initiatives to help address this,
such as the MedTech Funding Mandate policy which supports NHS uptake of selected
health technology assessed digital technologies, and on-going industry discussions to
develop a clearer reimbursement approach to digital health technologies.
• I n Spain, the Ministry of Health has recently launched a digital health strategy for the
National Healthcare System (SNS) which aims to help lay the necessary foundations
for reimbursement of digital health applications. The so-called ‘public procurement of
innovation’ (compra pública de innovación) is one of the first instruments for integrating
digital health solutions into the SNS. However, there is still a long way to go to develop a
regulatory framework for reimbursement.
• In Italy, to date, the following digital applications exist: telemedicine and
teleconsultation, e-prescription, health digital card, electronic health records and
digitalised reports. There is still much to do like medical app, cloud, AI, etc., but
especially in terms of reimbursability. As for now, in fact, there is no specific national
reimbursement pathway for digital health applications and such applications do not fit
easily within the existing public health system reimbursement pathways. Nevertheless,
the digitalization process has begun and is progressing rapidly as demonstrated by the
Government's development of the first National Telemedicine Platform, which could give
rise to rapid development of the sector.
• In France, the French government is planning to promote market access for medical
device innovations, particularly digital devices for therapeutic purposes (DTx). A €32
billion market in 2024 driven by chronic diseases (diabetes and obesity) has been
identified. The French Health Authorities (HTA) have adapted their methods to digital
devices and clarified the criteria for taking into account their therapeutic value as well
as the AI features. A derogatory reimbursement system has been created from 2022 for
digital innovations “presumed to be innovative” with precise requirements, particularly
in terms of data collection. The pricing authorities will also have to adapt their methods,
but this is underway.
Apart from Germany, reimbursement for digital health applications does not currently
exist in the major EU countries. Only France is about to introduce such a reimbursement
pathway. However, in the other EU countries similar developments are expected in the
coming years.
Charlotte Damiano
Partner, Paris
Jane Summerfield
Partner, London
Arne Thiermann
Álvaro Abad
Chiara Perolari
Karolin Hiller
Senior Associate, Madrid
Associate, Milan
Partner, Hamburg
Senior Associate, Munich, Berlin
Giuseppe Aminzade
Counsel, Milan
