mHealthBelgium is the Belgian platform for mobile apps that are CE-marked as a medical device. This unique platform centralises all relevant and required information on mobile apps for patients, healthcare professionals and healthcare institutions in three language (Dutch, French and English). The information is related to CE marking, data protection, communication security, interoperability with other IT systems and the way in which the app is financed. mHealthBelgium consists of a validation pyramid with three levels. An app always enters at the lower level, M1, and can climb in hierarchy via M2 to the top level, M3.

mHealthBelgium is a joint initiative of the Belgian Federal Government and the Belgian (medical) technology industry, supported by the Ministry of Public Health.  As a consequence, it is a multistakeholder initiative. The criteria for each of the 3 levels of the validation pyramid are defined by the 3 corresponding national authorities:

The FAMHP (Federal Agency for Medicines and Health Products) is the competent authority for all things related to the quality, safety and efficacy of medicines and health products, including medical devices. Is responsible for level M1 within mHealthBelgium.

The eHealth Platform is a federal government institution with the mission to promote and support the providing of a well-organised, mutual electronic service and exchange of data between all healthcare stakeholders with safeguards in the areas of data security, the privacy of the patient and the caregiver, respecting medical professional confidentiality. Is responsible for level M2 within mHealthBelgium.

The NIHDI (National Institute for Health and Disability Insurance) is responsible for the refunding of medicines, medical devices and medical provisions. Is responsible for level M3 within mHealthBelgium.

The mHealthBelgium platform is managed by beMedTech (sector federation of industry of medical technologies) and Agoria (sector federation of technological industry).

Beyond the platform, the framework itself is a joint initiative between the Belgian Federal Government and the technology industry.

Platform management: non-for-profit non-governmental institution

Framework ownership: Joint initiative (gov institution + industry)

Today there is a lack of control with data security and an absence of common standards for quality, which is one of the major barriers for using apps in treatment for mental health.

MindApps helps users and therapist choose quality assured apps for mental health. At MindApps.dk you can:

• Search for apps for specific target groups and interventions
• Read reviews of apps for prevention, treatment, and recovery
• Get knowledge about opportunities and limitations using apps for mental health
• Get inspiration on how apps can be part of patient-to-therapist collaboration

MindApps.dk and the framework “The App Checker” ensure quality in apps.

Centre for Telepsychiatry in the Region of Southern Denmark, department in the Psychiatry in the Region of Southern Denmark.

Centre for Telepsychiatry, Heden 11, 1. og 3. Sal, 5000 Odense C

Email: telepsykiatriskcenter@rsyd.dk

Denmark

The aim is to establish national HTA criteria and process and that way support decision makers better.

https://www.has-sante.fr

France

BfArM offers a summary of the regulations that can be found in the German Social Code Book Five (Fünftes Buch Sozialgesetzbuch), in the Digital Health Applications Ordinance (DiGAV) and in the annexes to the DiGAV.

In the guidance document, the BfArM explains how it will regularly interpret the normative specifications of the Social Code Book Five, chapters 33a and 139e, and DiGAV within its assessment procedures. It thus offers transparency about the concrete requirements to be fulfilled in the procedure. At the same time, the guide is also designed in a way that all interested parties can have a comprehensive picture of the assessment bases and consequently of the (quality) characteristics of a Digital Health Application (DiGA) ^[1]. The Guidance will be continuously adapted, supplemented and further developed based on experience gained.

The BfArM also gives advice on the requirements for inclusion in the DiGA directory according to § 139e SGB V in order to ensure comprehensive support for applicants and to provide early assistance in generating meaningful documents and data for (final) inclusion, and on procedural issues as well as on questions concerning the notification of essential changes of a DiGA.

The procedure is designed as a fast track: The evaluation period for the BfArM is three months after receipt of the complete application. The core of the procedure is the examination of the manufacturer’s information on the required product characteristics – from data protection to user-friendliness – as well as the examination of evidence to be provided by the manufacturer for the positive care effects that can be achieved with DiGA.

https://www.bfarm.de/DE/Home/home_node.html

Germany

AppCheck serve as an information platform that reports everything important about apps and (digital) healthcare. DiaDigital helps users evaluate the quality and reliability of diabetes apps whereas PneumoDigital helps users evaluate the quality and reliability of Pneumological apps.

https://www.ztg-nrw.de/

Center for Telematics e Telemedicine GmbH (ZTG GmbH Universitätsstrasse 142

Germany

https://www.ztg-nrw.de/

Germany

Kooperation DiaDigital 2016/2017

PneumoDigital 2018/2019

https://www.fokus.fraunhofer.de/

Germany

The Bertelsmann Stiftung with the participation of Fraunhofer FOKUS has developed the APPQ set of quality criteria for digital health apps (DIGA). The development was funded by the German Federal Ministry of Health.   AppQ aims to serve as a tool for quality transparency through the collection of self-disclosures from developers of health apps. It builds on the knowledge gathered in APPKRI and other international efforts.

https://www.bertelsmann-stiftung.de/en/

Germany

The purpose of the GGD AppStore is to provide an understandable and transparent overview of relevant and reliable health apps and websites. Apps are included in the store after a careful, independent and transparent assessment by expert GGD professionals.

Creator

The Association of Regional Public Health Services (GGD) and Regional Medical Emergency Preparedness and Planning (GHOR)

Netherlands

https://ggdghor.nl/

MySNS Selecção is an app store which is part of the MySNS community. The objective of the framework is to facilitate the opportunity to share mobile applications developed by health institutions, companies, individuals who, according to European guidelines, have a significant role in bringing health closer to the citizen.

SPMS – Shared Services of the Ministry of Health, EPE (Portugal) is the entity responsible for the MYSNS Selecção creation and management.  SPMS has the nature of a legal person of public law of a business nature, endowed with legal personality, administrative and financial autonomy and its own assets, under the legal regime of the State’s business sector, approved by Decree-Law no. 133/2013, of October 3, being subject to the supervision of members of the Government responsible for the areas of finance and health.

Entity website: http://www.spms.min-saude.pt/

https://www.sspa.juntadeandalucia.es/agenciadecalidadsanitaria/en/

Spain

The framework was developed for the assessment of mobile apps and devices in health and social welfare environment by the TIC Salut Social Foundation, part of the Catalan Ministry of Health in Spain. The framework is based on four key criteria, which outline the essential requirements for quality and reliability of an app. Once the app has been validated, it will be published on the TIC Salut Social website in the Catalogue of Accredited apps, with the accreditation stamp. The corresponding accreditation certificate will also be delivered together with the detailed results report of the accreditation made.

https://ticsalutsocial.cat/en

Catalonia, Spain

In Switzerland, the cantons are responsible for the health care supply for their population. As people today move around, change doctors or travel to other regions, this means that the needed health information could be missing at the crucial moment. Therefore, eHealth Suisse has been coordinating the design and implementation of the Swiss Electronic Patient Record between the relevant stakeholders. Among these, there are in particular the federal government, cantons, care providers, physicians associations and so on. The Federal Act of 19 June 2015 on the Electronic Patient Record stipulates patients can upload their own data to their Electronic Patient Record (EPR).

The objectives of eHealth Suisse for the topic mHealth are:

·         In order to promote the digitalization in the health care system focusing on the introduction and dissemination of EPR, eHealth Suisse aims at making it possible to primarily patients and also to health professionals to upload data collected by apps into the Swiss EPR.

·         To contribute to the efficiency, quality and safety of the healthcare system.

To foster a secure use of apps in the context of the Swiss EPR, eHealth Suisse has edited the recommendations: “mHealth – Recommendations I”. In order to achieve these aims and based on the above mentioned recommendations, eHealth Suisse has elaborated the following products:

·         Guideline focused on the regulatory and legal situation in Switzerland and developed to help distinguish between lifestyle/wellness products and medical devices and to prepare and carry out the certification process.

·         Criteria catalogue for self-declaration of the quality of health apps created to establish more transparency with regard to the quality of health apps.

·         Recommendations for the use of technical norms and standards in the field of mHealth

·         Development of profiles for the technical connection of mHealth-apps to the Swiss EPR (ongoing activity).

Switzerland

Digital assessment Questions is an assessment framework developed by NHS Digital which aims to help users find trusted health and wellbeing apps that have been assessed to be clinically safe and secure. The apps are assessed against a range of NHS Standards. Once approved, the apps are published on the NHS Apps Library.

https://digital.nhs.uk/

UK

The purpose of the framework is to develop standards that ensure new technologies are clinically effective and offer economic value. The standards provide:

• advice to digital health innovators:
• about how the NHS makes decisions
• about the standards of evidence, they will be expected to produce for different types of digital technologies.

Help NHS commissioners:

• to make more informed and consistent decisions by providing a framework for the levels of evidence they should expect to see presented to them.
• Improve the approach to developing and commissioning digital health technologies:
• by making it more dynamic and value driven, with a focus on offering real value to patients.

The framework supports the relevant principles of the Department of Health and Social Care code of conduct for data-driven health and care technology^[1].

https://www.nice.org.uk/

United Kingdom (UK)

Non-departmental public body of the Department of Health in England

My Health Apps is a website which curates hundreds of health apps tried and recommended by patients and health consumers worldwide. Launched in 2013, it was created and currently being maintained by PatientView. PatientView was a member of the EU Working Group on mHealth Assessment Guidelines.

http://www.patient-view.com/

UK

The Publicly Available Specification (PAS) 277:2015 published by the British Standards Institution and sponsored by Innovate UK was mainly created for health and wellness app developers and it encourages the development of highly effective and safe apps. It contains quality criteria and covers the stages of the app life-cycle project, including development, testing, release, and update. The PAS does not contain requirements for apps that are classified as medical devices or are subject to other regulatory matters. PAS 277 is being used as a basis for developing an ISO Technical Specification (ISO/TS 82304-2 under ISO/TC 215).

www.bsigroup.com

UK