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.

Project Information

Label2Enable

Grant agreement ID: 101057522

DOI

10.3030/101057522

Project closed

EC signature date 29 April 2022

Start date 1 May 2022

End date 30 June 2024

Funded under

• Health

Total cost

€ 1 999 957,50

EU contribution

€ 1 999 957,00

Coordinated by

ACADEMISCH ZIEKENHUIS LEIDEN
Netherlands

CORDIS provides links to public deliverables and publications of HORIZON projects.

Links to deliverables and publications from FP7 projects, as well as links to some specific result types such as dataset and software, are dynamically retrieved from OpenAIRE .

Deliverables

Documents, reports (14)

article healthcare professional survey

scientific article with the results of the survey performed in task 5.2

data management plan
evaluation label legislations

white paper with the results of task 2.3

final promotion dissemination report

final report on promotion and dissemination, the results of task 6.1, 6.2 and (joint) efforts with the WPs in promotion and dissemination

paper alignment EU law and values

white paper or scientific article with the results of task 2.2

analysis use stories

paper with an analysis of the use stories (use experiences) generated in task 7.1 that can guide future health authorities and systems and their adoption of ISO/TS 82304-2 and its label

article patient citizen carer survey

scientific article with the results of the survey performed in task 42

paper display apps

paper with the results of task 5.3 that guides app stores, app libraries and routinely used trusted sources and potentially in time a directive in how to effectively display the label

paper business model assessments

scientific article with the results of task 3.3

paper health app quality report

scientific article on the ISO/TS 82304-2 health app quality report and its future development, following the work done in tasks 5.1 and 2.1 with learnings from task 5.2 and 5.3

EU certification scheme

the publicly available part of the EU certification scheme, resulting from task 2.1

article test label

white paper or scientific article with the results of task 4.3

final report

Final report on the project as specified, reporting on task 1.1 and 1.2, including project results, project financial reporting, follow up and suggestions for impact beyond the project and the consortium

report use TS in reimbursement

white paper or scientific article with results of task 7.2

Websites, patent fillings, videos etc. (4)

communication patients citizens carers

the communication materials for patients, citizens, and carers resulting from task 4.4

promotion and dissemination plan

promotion and dissemination plan that guides further work in task 61 and 62 describes the KPIs and how to pursue them

communication suppliers

explanatory and engaging communication for suppliers on ISO/TS 82304-2 and the assessment process, using the results of task 3.2

website, PPT format, brochure

website PPT format brochure

Demonstrators, pilots, prototypes (1)

article consistency assessments

scientific article with the results of task 3.1

Other (1)

legal entity fully operational

a sustainable non-profit legal entity, that enables maintenance of the certification scheme and community of practice, accreditation of app checkers and promotion of the label, fully operational thanks to the work done in task 1.3, WP 2, 3 and 6, with increased demand thanks to the work done in WP 4, 5 and 7

Publications

Peer reviewed articles (1)

Value of a quality label and European healthcare professionals' willingness to recommend health apps: An experimental vignette study

Author(s): Biliunaite et al.
Published in: Journal of Health Psychology, 2024, ISSN 1359-1053
Publisher: Sage Journals
DOI: 10.1177/13591053241258205