Which entities accredit health apps in Europe?

There are currently 24 assessment bodies in Europe that can accredit Apps in the healthcare sector. These Apps can fall under the category of health products, or can be classified as wellness Apps. This is one of the services offered by the TIC Salut Social Foundation since 2015 and which is compiled by the European mHealth Hub in the report “D2.1 Knowledge Tool 1 – Health apps assessment frameworks”. The document provides an overview of active assessment organisations and repositories of applications related to mHealth, a term used to denote the practice of medicine and public health supported by mobile devices, sensors for monitoring patients and other solutions that provide remote digital assistance.

The objectives of the report are to help European countries and regions to develop, improve or adopt a large-scale health App assessment framework; to provide the foundations for a cross-border approach for the identification and implementation of common assessment measures; to highlight the specifics of the way the mHealth market works; and to share examples of patient organisations that have participated in the accreditation process to assess the quality of health apps.

The App Certification Service of the TIC Salut Social Foundation

One of the TIC Salut Social Foundation’s contributions towards the promotion of mHealth within the Catalan Health System is through its Mobile Health Apps Certification Service. This service focuses on the assessment of 4 main areas that are key factors in determining the quality and reliability of medical apps and devices: usability and accessibility, technology, security, and functionality and content. The assessment process is conducted by a multidisciplinary team made up of experts in medicine, infirmary, psychology, physical education, usability, data protection and technical development.

The service is aimed at health professionals, developers, political representatives, researchers and the general public who have or are developing an App within the health sector. To receive the certification guarantees that the solution complies with the highest quality standards. Moreover, it includes a seal of accreditation that is renewed annually.

List of assessing entities

Safety and Quality Strategy in Mobile Health Apps (Andalusian Agency for Healthcare Quality), Accreditation Service and TICSS guarantee certification (TIC Salut Social Foundation Generalitat de Catalunya), Digital Assessment Questions (NHS Digital), mHealthBelgium (Belgian Federal Government), MySNS Selecçao (SPMS – Shared Services of the Ministry of Health, EPE), Evidence Standards Framework for Digital Health Technologies (National Institute for Health and Care Excellence), Good practice guidelines on health apps and smart devices (High Health Authority), App Check -DiaDigital and PneumoDigital (Center for Telematics and Telemedicine (ZTG GmbH), Criteria catalogue for self-declaration of the quality of health apps (eHealth Suisse – Swiss Competence and Coordination Centre of the Confederation and the Cantons), MindApps.dk: apps for mental Health (Centre for Telepsychiatry, Region of Southern Denmark), PAS 277:2015 Health and wellness apps – Quality criteria across the life cycle – Code of practice (British Standards Institution i Innovate UK), AppKRI – meta-catalogue of criteria (Fraunhofer Institute for Open Communication Systems – Federal Ministry of Health), AppQ (Bertelsmann Stiftung- Federal Ministry of Health), BfArM DiGA-Fast-Track and Guidance Document (Federal Institute for Drugs and Medical Devices), GGD AppStore (Association of Regional Public Health Services and Regional Medical Emergency Preparedness and Planning), ORCHA Review process (Organisation for Review of Care and Health Apps ORCHA), My Health Apps (PatientView), ISO/TS 82304-2 Health and wellness apps – Quality and reliability (CEN/TC 251 and ISO/TC 215), iSYS score (iSYS Foundation), DEKRA Certification – MEDAPPCARE (Meddappcare – Dekra Group), Our Mobile Health (Our Mobile Health), cMHAFF: Consumer Mobile Health Application Functional Framework (Health Level Seven International), Continua Design Guidelines (Personal Connected Health Alliance), Report of the Working Group on mHealth Assessment Guidelines (European Commission).

About the mHealth Hub

The European mHealth Hub is a project created by the International Telecommunication Union, in collaboration with the World Health Organization and the Andalusian Ministry of Health, which is leading the project. The consortium is made up of 17 public and private entities from 12 European countries and is funded by the European Commission under the Horizon 2020 programme.