This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 6 “Maintaining an innovative, sustainable
and globally competitive health industry”. To that end, proposals under this topic should aim
for delivering results that are directed, tailored towards and contributing to all of the following
European suppliers of health technology and services benefit from enhanced single
market conditions for mHealth that facilitate economies of scale.
Health care systems and authorities are able to integrate mHealth solutions more rapidly
thanks to a European ‘mHealth label’.
Citizens, patients and health care professionals make more use of trusted mHealth
solutions for promoting their health and self-managing their health care needs.
European mHealth stakeholders build upon a digital ecosystem around a trusted mHealth
label, an EU-wide promotion and uptake of technical specifications for health and
Health systems and citizens benefit from the supply and use of health innovations
facilitated by the promotion of common pan-European principles for validation and
Scope: Europe is experiencing a fast growing market for health and wellness apps. At the
same time, concerns about the quality and reliability of apps have risen (for example, many
health and wellness apps are being published on app stores without clinical evidence
supporting the claimed benefits that they will deliver)188. CEN189, together with CEN/TC 251,
ISO and IEC, developed a new technical specification for ‘Quality and Reliability of Health
and Wellness Apps’ together with a CEN/ISO 82304-2 health app quality label (capturing
medical safety, usability, safety of personal data and technical quality of health apps).
The objective of the technical specification is to define quality and reliability criteria, which
support app developers to design and users of apps to select better apps.
The specification is intended for use by manufacturers of health apps as well as by app
checkers in order to communicate the quality and reliability of a health app.
Applicants should propose activities that bring together app developers, health care system
representatives, a diverse range of users (citizens/patients, health care providers), and
certification bodies in order to promote and stimulate the use and up-take of the health app
quality label, building a digital ecosystem around a trusted mHealth label to support the
integration and use of health and wellness apps in the health care system. Proposals should
encourage a people-centred approach that empowers citizens and patients, promotes a culture of dialogue and openness between health professionals, citizens, patients and their families,
and unleashes the potential of social innovation.
The proposals are expected to address all of the following:
Set up a structured dialogue on the uptake of the technical specifications between app
developers, health care system representatives, app stores, medical societies, patient
organisations, users (including health care professionals) and certification bodies,
building a digital ecosystem around a trustable mHealth label.
Co-create, develop and implement an action plan on the promotion of the mHealth label
in the health care system.
Implement concrete actions on the integration and use of secure and qualitative health
and wellness apps, using the new label, in specific health care settings, covering the
Ensure that the promoted health and wellness apps are bias-free and adequately address
the needs of different social groups, considering gender, age, ability and ethnicity, where
Support and set-up an inclusive dissemination strategy to promote the use of the
mHealth app quality label (cfr. EU energy labels and EU Nutri-Score nutrition label)
taking into account the different levels of digital health literacy among the actors
Interests of different age groups, sex and gender, as well as other categories like persons
with disability, ethnicity and the LGBTI+ community should be considered, where