Promoting a trusted mHealth label in Europe: uptake of technical specifications for quality and reliability of health and wellness apps

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)[[https://ec.europa.eu/digital-single-market/en/news/green-paper-mobile-health-mhealth]]. CEN[[http://www.ehealth-standards.eu/quality-reliability-for-health-and-wellness-apps/ due to be completed in 2020]], 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 entire EU.
• 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 relevant.
• 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 involved.
• 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 relevant.