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Adopting ISO 82304-2 and a trusted EU mHealth label for a single market that enables patients, citizens, health professionals, systems and authorities to benefit from a healthy supply of useful apps.

Objective

There is a growing recognition that health and wellness apps need to play a much stronger role in health care systems, self-care and health prevention than they do today. However, health care systems, health professionals, patients and citizens lack means to adequately assess the quality and reliability of the many apps to choose from, for every purpose, in each app store. Suppliers experience the varying national approval processes as confusing and unclear as to what is expected and the depth of evidence that is required by each approval body. We intend to break through the impasse by leveraging the golden opportunity of the publication in July 2021 of the ISO 82304?2 Technical Specification (TS) and its health app quality label. Work is now needed to turn this globally endorsed quality assessment and health app quality label into the EU assessment and EU mHealth label, embed it within the approval and reimbursement processes of European countries and foster cross-country alignment of these approval processes. The objective of Label2Enable is threefold: achieve trust, use and adoption. We will pursue: 1. trust with an EU certification scheme that results in consistent compliant inclusive app assessments 2. use with: - a more detailed health app quality report that enables health professionals to recommend apps and insurers to speed up decisions on reimbursements - supporting communication that enables all patients, citizens and carers to use the label in considering health apps - social experimentation to promote app stores, app libraries and other routinely used trusted sources that (seek to) offer health apps to effectively publish the label alongside them 3. adoption of the TS and cross-country recognition with pilots, use stories, advocacy, mass communication and targeted multi-stakeholder engagement, affordable app assessments and a sustainable non-profit entity that will maintain the scheme, accredit app assessors and promote the TS after the project.

Coordinator

ACADEMISCH ZIEKENHUIS LEIDEN
Net EU contribution
€ 710 957,00
Address
Albinusdreef 2
2333 ZA Leiden
Netherlands

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Region
West-Nederland Zuid-Holland Agglomeratie Leiden en Bollenstreek
Activity type
Higher or Secondary Education Establishments
Other funding
€ 710 957,00

Participants (13)

THE EUROPEAN INSTITUTE FOR INNOVATION THROUGH HEALTH DATA
Belgium
Net EU contribution
€ 224 000,00
Address
Oude Mechelsestraat 165
1853 Strombeek-bever

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Region
Vlaams Gewest Prov. Vlaams-Brabant Arr. Halle-Vilvoorde
Activity type
Research Organisations
Other funding
€ 224 000,00
ORCHA HEALTH BV
Netherlands
Net EU contribution
€ 229 000,00
Address
Stadsplateau 7
3521 AZ Utrecht

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
West-Nederland Utrecht Utrecht
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 229 000,00
FORUM DES PATIENTS EUROPEENS
Belgium
Net EU contribution
€ 121 000,00
Other funding
€ 121 000,00
EMPIRICA GESELLSCHAFT FUR KOMMUNIKATIONS UND TECHNOLOGIEFORSCHUNG MBH
Germany
Net EU contribution
€ 166 000,00
Address
Oxfordstrasse 2
53111 Bonn

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Nordrhein-Westfalen Köln Bonn, Kreisfreie Stadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 166 000,00
COMITE EUROPEEN DE COORDINATION DES INDUSTRIES RADIOLOGIQUES ELECTROMEDICALES ET D INFORMATIQUE DE SANTE AISBL
Belgium
Net EU contribution
€ 49 000,00
Address
Boulevard Auguste Reyers 80
1030 Bruxelles

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Region
Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad
Activity type
Other
Other funding
€ 49 000,00
HIMSS EUROPE GMBH
Germany
Net EU contribution
€ 89 000,00
Address
Bertha Benz Strase 5
10557 Berlin

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Region
Berlin Berlin Berlin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 89 000,00
EIT HEALTH EV
Germany
Net EU contribution
€ 31 000,00
Address
Mies-van-der-rohe-strasse 1 C
80807 Munchen

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Region
Bayern Oberbayern München, Kreisfreie Stadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 31 000,00
UNIVERSITEIT VAN AMSTERDAM
Netherlands
Net EU contribution
€ 90 000,00
Address
Spui 21
1012WX Amsterdam

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Region
West-Nederland Noord-Holland Groot-Amsterdam
Activity type
Higher or Secondary Education Establishments
Other funding
€ 90 000,00
EUROHEALTHNET ASBL
Belgium
Net EU contribution
€ 66 000,00
Address
Rue Royale 146
1000 Bruxelles

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Region
Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad
Activity type
Research Organisations
Other funding
€ 66 000,00
FUNDACIO TICSALUT
Spain
Net EU contribution
€ 46 000,00
Address
Carrer Roc Boronat 81
08005 Barcelona

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Region
Este Cataluña Barcelona
Activity type
Other
Other funding
€ 46 000,00
OPTIMIT DOO
Croatia
Net EU contribution
€ 27 000,00
Address
Planinska 13a
1000 Zagreb

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 27 000,00
ISTITUTO SUPERIORE DI SANITA
Italy
Net EU contribution
€ 50 000,00
Address
Viale Regina Elena 299
00161 Roma

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Region
Centro (IT) Lazio Roma
Activity type
Research Organisations
Other funding
€ 50 000,00
LIETUVOS SVEIKATOS MOKSLU UNIVERSITETO LIGONINE KAUNO KLINIKOS
Lithuania
Net EU contribution
€ 101 000,00
Address
Eiveniu 2
50009 Kaunas

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Region
Lietuva Vidurio ir vakarų Lietuvos regionas Kauno apskritis
Activity type
Research Organisations
Other funding
€ 101 000,00