Market study on telemedicine
Final Report
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interoperability and standardisation in eHealth
, but it still needs to develop a
uniform set of norms to regulate it. For now, Member States still have jurisdiction to
regulate this area.
Despite repeated initiatives from the EU to initiate coordination,
Member States have legal frameworks, approaches and levels of telemedicine
development that are too heterogeneous to hope for effective standardisation of practices
in the short term. Besides, countries sometimes adopt or adapt specific international
standards according to their own needs, which represents an additional barrier to
interoperability.
Through the eHealth Action Plan 2012-2020
, the European Commission aims to support
patients and healthcare workers, to connect devices and technologies, and to invest in
making medicine more personalised. In particular, by capitalising on tablet and
smartphone technology (mhealth) the Action Plan seeks to ensure the provision of
smarter, safer and patient-centred health services in the future.. In addition, digital
health is one sector of the Digital Single Market (DSM), which is one of the European
Commission's main priorities. In this direction, the European Commission adopted an
action plan in order to enable the digital transformation of health and care in the Digital
Single Market on April 2018. The aim of this action plant is to put EU citizens at the
centre of the healthcare system
. To allow EU wide deployment of developed solutions,
interoperability is high priority of the EU strategy in DSM. The eHealth European
Interoperability Framework references standards but Member States can choose to
approve open international standards. Therefore, non-interoperable solutions persist and
impede the scaling-up of telemedicine.
This lack of standards has mostly been felt in relation to data ownership and data
sharing. Indeed, countries have been struggling to implement regulations or
requirements related to cross-border sharing of patient data. Therefore, the need for EU-
wide harmonised standards and guidelines to ensure interoperability in data access and
processing has been explored in EU-funded projects (such as ESPOS and Antelope).
Data security
Because of the legal vacuum regarding data protection and security in most countries,
many fear a commercial or malicious use of patient data. The recent example of the
personal data misuse by Cambridge Analytica, which caught the public’s attention,
increased this fear. Determining the right of access to patient information is a difficult
question to solve.
How much patient information should be made available to hospitals?
Legal loopholes are persisting on these issues and responsibilities are not clearly
defined
. Sharp rise in hacker attacks and in medical identity theft has been noticed. Yet,
we underlined earlier that these concerns represent a major barrier to patients’
acceptance of telemedicine.
While policies are too permissive or non-existent in some countries, others have
adopted very stringent data protection laws, which impede any information sharing
between healthcare professionals. EU countries definitely need to strike a balance
https://ec.europa.eu/digital-single-market/en/interoperability-standardisation-connecting-ehealth-services
Vera Lúcia Raposo, Telemedicine: The legal framework (or the lack of it) in Europe, 2016
https://ec.europa.eu/digital-single-market/en/news/ehealth-action-plan-2012-2020-innovative-healthcare-
21st-century
https://www.covingtondigitalhealth.com/2018/05/summary-of-the-european-commissions-ehealth-strategy/
Professeur Hervé Dumez, Professeur Etienne Minvielle, Madame Laurie Marrauld, État des lieux de l’innovation
en santé numérique, November 2015
Topol E., The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care,
Basic Books, August 2013, p. 336