Assessment Frameworks

Initiated, led or supported by governmental institutions

BELGIUM

BELGIUM


mHealthBelgium

by Belgian Federal Government
(Multistakeholder initiative; platform operated by Agoria and beMedTech, in cooperation with FAMHP, NIHDI, eHealth Platform)

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.

Creator

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.

Owner Name

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.

Owner Type

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

Framework ownership: Joint initiative (gov institution + industry)

Year of Creation 2018, but platform only implemented and active since January 25 2019

https://mhealthbelgium.be/

FR / EN / NL

DENMARK

DENMARK


SOUTHERN DENMARK

MindApps.dk: apps for mental health

by Centre for Telepsychiatry in the Region os Southern Denmark

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.

Creator

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

Owner Name Centre for Telepsychiatry in the Region of Southern Denmark
Owner Type Governmental institution / state-run agency

 

Year of Creation 2017

https://mindapps.dk/en/vejledning-til-apptjekkeren/

Website currently under maintenance. They have decided to give mindapps.dk a short break so they can relaunch it in a new format around October 2021.

DA / EN

FINLAND

FINLAND


Digi-HTA

by the Finnish Coordination Centre for Health Technology Assessment (FinCCHTA) in collaboration with the University of Oulu

General purpose HTA framework for digital healthcare services. It can be used to assess various digital healthcare solutions with different degrees of maturity; it combines novel technologies like mHealth, AI and robotics in the same framework. Digi-HTA criteria and Digi-HTA recommendations have been published.

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

Creator FinCCHTA and University of Oulu
Owner Name FinCCHTA and University of Oulu
Owner Type Governmental institution / state-run agency
Year of Creation 2019

https://www.ppshp.fi/Tutkimus-ja-opetus/FinCCHTA/Sivut/Digi-HTA.aspx  

https://www.oulu.fi/cht/digihealthhub/digi-hta

https://journal.fi/finjehew/article/view/82538 

FI / EN

FRANCE

FRANCE


Good practice guidelines on health apps and smart devices

by High Health Authority (HAS)

The framework aims to provide guidance for, promote use of and increase confidence in health apps and smart devices, by supplying good practice guidelines for manufacturers and evaluators (evaluating bodies, consumer associations or medical professional organisations), who can use them for their own assessments. These guidelines cover apps and smart devices that have no stated medical purpose. In other words, they apply specifically to the “grey area” of apps or smart devices that have potential effects on health but are not medical devices. Medical devices, as defined by European Directive 93/42/EEC which leads to CE marking, are excluded. In 2021, they have realized an overview about the evolution of different approaches in the process of evaluation for apps in mHealth. A list of quality criteria of medical content is published and will be used for referencing digital services in the digital health space (mon espace santé) and in the professional service package (bouquet de services).
Creator Haute Autorité de Santé (HAS)

https://www.has-sante.fr

France

Owner Name Haute Autorité de Santé (HAS)
Owner Type Governmental institution / state-run agency
Year of Creation 2016

https://www.has-sante.fr/jcms/c_2681915/en/good-practice…

FR

GERMANY

GERMANY


BfArM DiGA-Fast-Track and Guidance Document

Federal Institute for Drugs and Medical Devices (BfArM)

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.

Creator Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) / Federal Institute for Drugs and Medical Devices (BfArM)

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

Germany

Owner Name Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) / Federal Institute for Drugs and Medical Devices (BfArM)
Owner Type Independent federal higher authority within the portfolio of the Federal Ministry of Health
Year of Creation 2020

[1] Digital Health Application (DIGA has a wide range of possibilities to support the detection and treatment of diseases and a self-determined, health-promoting lifestyle. It is a medical device with the following characteristic: 1. Medical device of risk class I or IIa (according to MDR or, within the framework of the transitional regulations, according to MDD); 2. The main function of DiGA is based on digital technologies; 3. The medical purpose is essentially achieved by the main digital function; 4. The DiGA supports the detection, monitoring, treatment or alleviation of diseases or the detection, treatment, alleviation or compensation of injuries or disabilities; 5. The DiGA is used by the patient or by the service provider and the patient together.

https://www.bfarm.de/EN/MedicalDevices/DiGA/_node.html

DE


App Check (DiaDigital and PneumoDigital)

by Center for Telematics and Telemedicine (ZTG GmBH)

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.

Creator Center for Telematics e Telemedicine GmbH (ZTG GmbH)

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

Center for Telematics e Telemedicine GmbH (ZTG GmbH Universitätsstrasse 142

Germany

Owner Name Center for Telematics e Telemedicine GmbH (ZTG GmbH)

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

Germany

Owner Type Non-governmental institution, for-profit (limited liability company [KOMM.]) [1]
Year of Creation AppCheck Website: 2012

Kooperation DiaDigital 2016/2017

PneumoDigital 2018/2019

[1]     AppCheck is integrated as an offer by ZTG GmbH in the state initiative eGesundheit.nrw, which is funded by the Ministry of Labor, Health and Social Affairs of the State of North Rhine-Westphalia.

https://appcheck.de/bewertung-durch-diadigital-und-pneumodigital/

DE


AppKRI (meta-catalogue of criteria)

Fraunhofer Institute for Open Communications
(Project funded by the Federal Ministry of Health)

The Fraunhofer Institute for Open Communication (FOKUS) has developed a comprehensive meta-catalogue of criteria for evaluating health apps. Stakeholders such as patient associations and medical associations are supported in the systematic evaluation and recommendation of health apps by offering a platform where criteria catalogues suitable for their target groups and objectives can be created. The catalogue can be easily exported from the online platform and further used as a basis for assessing health applications.
Creator Fraunhofer Institute for Open Communication Systems FOKUS

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

Germany

Owner Name Fraunhofer Institute for Open Communication Systems FOKUS
Owner Type Non-for-profit Non-governmental institution
Year of Creation 2018

DE


AppQ

Bertelsmann Stiftung (funded by the Federal Ministry of Health)

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.

Creator The Bertelsmann Stiftung

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

Germany

Owner Name The Bertelsmann Stiftung
Owner Type Private operating foundation

 

Year of Creation 2019

https://www.bertelsmann-stiftung.de/de/publikationen/publikation/did/appq/

DE


NETHERLANDS

NETHERLANDS


GGD AppStore

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

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/

Owner Name GGD-GHOR Netherlands
Owner Type Governmental institution / state-run organisation
Year of Creation 2016

https://www.ggdappstore.nl/Appstore/OverGGDappstore.

NL

PORTUGAL

PORTUGAL


MySNS Selecção

by SPMS – Shared Services of the Ministry of Health, EPE

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.

Creator

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/

Owner Name SPMS, EPE.
Owner Type Governmental institution / state-run agency
Year of Creation 2018

https://mysns.min-saude.pt/mysns-selecao/

PT

Spain

ANDALUSIA

Safety and Quality Strategy in Mobile Health Apps

by Andalusian Agency for Healthcare Quality (ACSA)

The Safety and Quality Strategy in Mobile Health Apps is a dynamic and integrated process which offers suggestions and advice for general citizenship and a list of recommendations is recognised with the granting of the AppSaludable Quality Seal. The Seal was created by the Andalusian Agency in Spain and it`s used to recognise reliable mobile applications. The process includes both the self-assessment of the app in accordance with recommendations included in the guide, and the assessment carried out by a committee of Agency’s experts to identify possible improvements. Once the seal is awarded, the app becomes part of a list of mobile health apps with remarkable safety and quality. The process is free and open to all public and private apps, both Spanish and from other countries.
Creator

 

The Andalusian Agency for Healthcare Quality

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

Spain

Owner Name

 

The Andalusian Agency for Healthcare Quality

 

Owner Type Governmental institution / state-run agency
Year of Creation 2012

https://www.sspa.juntadeandalucia.es/agenciadecalidadsanitaria/en/safety-and-quality-strategies-in-mobile-health-apps/

EN / ES


CATALONIA

Accreditation Service and TICSS guarantee certification

by TIC Salut Social Foundation

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.

Creator TIC Salut Social Foundation /Fundación TIC Salut Social / Fundació TIC Salut Social

https://ticsalutsocial.cat/en

Catalonia, Spain

Owner Name TIC Salut Social Foundation /Fundación TIC Salut Social / Fundació TIC Salut Social
Owner Type Governmental institution / state-run agency
Year of Creation 2015

https://ticsalutsocial.cat/en/serveis/mhealth-en/accreditation-service-and-ticss-guarantee-certification/

ES / CA

SWITZERLAND

SWITZERLAND


Criteria catalogue for self-declaration of the quality of health apps

by eHealth Suisse – Swiss Competence and Coordination Centre of the Confederation and the Cantons)

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).

Creator Swiss Competence and Coordination Centre of the Confederation and the Cantons.

Switzerland

Owner Name Swiss Competence and Coordination Centre of the Confederation and the Cantons.
Owner Type Governmental institution / state-run agency
Year of Creation 2019, not active yet

https://www.e-health-suisse.ch/gemeinschaften-umsetzung/ehealth-aktivitaeten/mhealth.html

UK

Digital Technology Assessment Criteria (DTAC)

by National Health Service (NHS Digital)

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.

Creator NHS Digital

https://digital.nhs.uk/

UK

Owner Name NHS Digital
Owner Type Governmental institution / state-run agency
Year of Creation 2017

https://www.nhsx.nhs.uk/key-tools-and-info/digital-technology-assessment-criteria-dtac/

EN


Evidence Standards Framework for Digital Health Technologies

by National Institute for Health and Care Excellence (NICE)

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].

Creator National Institute for Health and Care Excellence (NICE),

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

United Kingdom (UK)

Owner Name National Institute for Health and Care Excellence (NICE)
Owner Type Governmental institution /state-run agency

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

Year of Creation 2013

https://www.nice.org.uk/about/what-we-do/our-programmes/evidence-standards-framework-for-digital-health-technologies

EN


My Health Apps

PatientView

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.

Creator PatientView

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

UK

Owner Name PatientView

 

 

Owner Type For profit non-governmental institution
Year of Creation 2013

http://myhealthapps.net/app/details/584/patientview

EN


PAS 277:2015 Health and wellness apps

Quality criteria across the life cycle – Code of practice

by British Standards Institution (BSI) and sponsored by Innovate 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).

Creator The British Standards Institution / BSI Standards Limited

www.bsigroup.com

UK

Owner Name The British Standards Institution
Owner Type Governmental institution / state-run agency
Year of Creation 2015

https://shop.bsigroup.com/forms/PASs/PAS-2772015/

EN


Non governmental initiatives

European

Report of the Working Group on mHealth Assessment Guidelines

European Commission

The purpose of the mHealth app assessment guidelines is to establish a framework of safety, quality, reliability and effectiveness criteria to improve the use, development, recommendation and evaluation of mHealth apps and to facilitate prevention and an overall healthcare advancement through a controlled use of mobile technology.

Creator CONSARD Limited for European Commission

 

http://www.consard.co.uk

Owner Name European Commission

 

Year of Creation 2016

https://ec.europa.eu/digital-single-market/en/news/report-working-group-mhealth-assessment-guidelines

FRANCE

FRANCE


DEKRA Certification – MEDAPPCARE

by Meddappcare (Dekra Group)

Medappcare is the certifying body for connected well-being accredited by the French Accreditation Committee (COFRAC), the national accreditation body designated by the public authorities. Medappcare assesses and certifies mobile applications and websites in the areas of health, disability, loss of autonomy, and animal health. The certification highlights the quality of innovative services in these new sectors.

Creator Medappcare

France

https://www.dekra-certification.fr/certification-de-services/certification-applications-mobiles-et-sites-web-dekra-certification.html

Owner Name DEKRA Group

France

www.dekra-certification.fr

Owner Type Non for profit non-governmental institution
Year of Creation 2012

https://www.dekra-certification.fr/certification-de-services/certification-applications-mobiles-et-sites-web-dekra-certification.html

FR

Spain

CATALONIA

iSYS score

by iSYS Foundation

Isys Score is an evaluation framework for mobile health applications developed by the iSYS foundation, a Spanish organization which aims to promote projects related to health and technology. Evaluation focuses on three quality indicators: popular interest, trust, and utility.  The framework was created based on a systematic evidence approach, built with a Delphi process. The iSYS foundation publishes every year a catalogue as result of analysis approximately 300 medical Apps -that have a Spanish or Catalan version-, and they prepare a collection with the approximately 50 best apps according to the iSYS score.

Creator iSYS Foundation

Barcelona, Spain

https://www.fundacionisys.org/es/

Owner Name iSYS Foundation

 

Owner Type Non-profit non-governmental institution

https://www.fundacionisys.org/es/

ES / CA

UK

ORCHA Review process

Organisation for Review of Care and Health Apps ORCHA

Designed by clinicians, the ORCHA Review is an Intelligent platform to deliver robust, rapid and reliable accreditation for Digital Health worldwide.

Its baseline review assesses 260 criteria, looking for compliance across Clinical Assurance, Data Privacy and User Experience; covering many international policies, regulations and standards.

Each measure is responsive, personalised to the focus and functional capabilities of each app. Crucially the platform conducts automatic re-reviews of all app updates.

ORCHA’s framework can also deliver enhanced reviews, covering more than 500 criteria and 5 areas, including financial and commercial stability, and bespoke adaptations for a specific Country’s national programme requirements.

Because the platform is a smart solution driven by automation and AI, each review requires only 3-4 man days to conduct. ORCHA is able to conduct hundreds of reviews every week, across more than 180 condition and category areas. It has evaluated 6,000 apps to date.

ORCHA reviews its criteria with international experts every quarter. It is currently conducting a system-wide review with NeLL.

The app reviews are housed on a platform that can be intelligently searched to find apps against a range of criteria. The platform enables bespoke app libraries to be quick and easily built for clients. ORCHA also offers a range of products that can be added to a library, helping professionals to recommend and distribute apps safely to patients, and providing usage insights and measurement.

ORCHA conducts reviews for government organisations across Europe, the Middle East, and Australasia.

In the UK, ORCHA conducts reviews for NHS Digital and NHS providers in 50% of regions. NHS England is accelerating adoption across the NHS, placing ORCHA in its National Innovation Accelerator Programme.

Creator

Organisation for the Review of Care and Health Applications (ORCHA)

ORCHA Health Ltd

UK & the Netherlands

https://www.orcha.co.uk

Owner Name ORCHA

 

Owner Type For profit non-governmental institution
Year of Creation 2015

https://www.orcha.co.uk/our-solution/the-orcha-review/

EN


Our Mobile Health

by Our Mobile Health

Our Mobile Health is enabling healthcare professionals to recommend and deploy healthcare apps with confidence. Our Mobile Health (OMH) has helped develop an industry leading App Review Process which rigorously examines apps against ten key areas to identify the ‘best of the best’ apps which are then added to the OMH curated app library.

They focus on:

  • Providing access to mHealth apps that people can trust
  • Forming partnerships that maximise the reach of our curated digital health app library
  • Working with healthcare organisations to drive adoption of mHealth apps
  • Building up the evidence base for health app use
  • Influencing the mHealth policy environment to bring about sustainable change
Creator Our Mobile Health, London SW6 6NP

United Kingdom

https://www.ourmobilehealth.com/

Owner Name Our Mobile Health
Owner Type For-profit non-governmental institution
Year of Creation 2013

https://www.ourmobilehealth.com/

Website is not active

EN

Worldwide

cMHAFF: Consumer Mobile Health Application Functional Framework

Health Level Seven International (HL7)

The primary goals of cMHAFF are to provide a standard against which a mobile app’s foundational characteristics — including but not limited to security, privacy, data access, data export, and transparency/disclosure of conditions — can be assessed.

Target:

Quality Reporting Agencies

Regulatory Agency

Standards Development Organizations (SDOs)

Mobile Health App Developers

EHR, PHR Vendors

Health Care IT Vendors

Local and State Departments of Health

Healthcare Institutions (hospitals, long term care, home care, mental health)

Creator Health Level Seven International (HL7)

USA

http://www.hl7.org/index.cfm

Owner Name Health Level Seven International (HL7)

 

Owner Type Standards Development Organization (ANSI accredited);

Non-governmental institution: Non-for-profit

 

Year of Creation 2018

http://www.hl7.org/implement/standards/product_brief.cfm?product_id=476


Continua Design Guidelines (CDG)

Personal Connected Health Alliance (PCHA)

Continua Design Guidelines is the only secure end-to-end ICT framework for ensuring the interoperability of personal connected health and care using open standards, to create a secure and interoperable health data exchange in personal connected health world-wide.

Creator Personal Connected Health Alliance (PCHAlliance).

USA

https://www.pchalliance.org/

Owner Name Personal Connected Health Alliance (PCHAlliance).
Owner Type Non-governmental institution

Not-for-profit

Year of Creation 2008

https://www.pchalliance.org/continua-design-guidelines


SO/TS 82304-2 Health and wellness apps – Quality and reliability

CEN/TC 251 and ISO/TC 215

The Technical Specification for “Quality and reliability for health and wellness apps” aims to help establish a common international framework for evaluation of health and wellness apps. It defines quality and reliability criteria to support app developers to design better apps and provides users, including consumers, health professionals, payers and app stores, with a health app quality label inspired by the successful EU Energy label and first- and third-party quality requirements conformity assessment, to enable informed decisions. The scoring mechanism spans healthy and safe, easy to use, secure data and robust build. It builds upon existing international initiatives, ISO, IEC, HL7 and several other standards.

The Technical Specification is being developed by the European standardisation committee CEN/TC 251 Health Informatics in collaboration with ISO and IEC. The project team includes experts from 14 countries: Australia, Belgium, China, Finland, France, Germany, Ireland, Italy, Japan, Netherlands, Nigeria, Sweden, United Kingdom, and United States.

Creator

The Technical Specification is being developed by the European standardisation committee CEN/TC 251 Health Informatics in collaboration with ISO and IEC. The project team includes experts from 14 countries: Australia, Belgium, China, Finland, France, Germany, Ireland, Italy, Japan, Netherlands, Nigeria, Sweden, United Kingdom, and United States.

Owner Name

The European standardisation committee CEN/TC 251 Health Informatics CEN/TC 251 WG2.

The International Organization for Standardization’s Technical Committee on Health Informatics ISO/TC 215 JWG7.

Owner Type Standards organization
Year of Creation 2021

https://www.nen.nl/Standardization/Health-and-wellness-apps.htm

This is a non-exhaustive list of  health apps assessment frameworks in Europe. If you know of any other, please contact us at

Health apps repositories in Europe