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A health app developer’s guide to law and policy: a multi-sector policy analysis

BACKGROUND: Apps targeted at health and wellbeing sit in a rapidly growing industry associated with widespread optimism about their potential to deliver accessible and cost-effective healthcare. App developers might not be aware of all the regulatory requirements and best practice principles are eme...

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Autores principales: Parker, Lisa, Karliychuk, Tanya, Gillies, Donna, Mintzes, Barbara, Raven, Melissa, Grundy, Quinn
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5625720/
https://www.ncbi.nlm.nih.gov/pubmed/28969704
http://dx.doi.org/10.1186/s12911-017-0535-0
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author Parker, Lisa
Karliychuk, Tanya
Gillies, Donna
Mintzes, Barbara
Raven, Melissa
Grundy, Quinn
author_facet Parker, Lisa
Karliychuk, Tanya
Gillies, Donna
Mintzes, Barbara
Raven, Melissa
Grundy, Quinn
author_sort Parker, Lisa
collection PubMed
description BACKGROUND: Apps targeted at health and wellbeing sit in a rapidly growing industry associated with widespread optimism about their potential to deliver accessible and cost-effective healthcare. App developers might not be aware of all the regulatory requirements and best practice principles are emergent. Health apps are regulated in order to minimise their potential for harm due to, for example, loss of personal health privacy, financial costs, and health harms from delayed or unnecessary diagnosis, monitoring and treatment. We aimed to produce a comprehensive guide to assist app developers in producing health apps that are legally compliant and in keeping with high professional standards of user protection. METHODS: We conducted a case study analysis of the Australian and related international policy environment for mental health apps to identify relevant sectors, policy actors, and policy solutions. RESULTS: We identified 29 policies produced by governments and non-government organisations that provide oversight of health apps. In consultation with stakeholders, we developed an interactive tool targeted at app developers, summarising key features of the policy environment and highlighting legislative, industry and professional standards around seven relevant domains: privacy, security, content, promotion and advertising, consumer finances, medical device efficacy and safety, and professional ethics. We annotated this developer guidance tool with information about: the relevance of each domain; existing legislative and non-legislative guidance; critiques of existing policy; recommendations for developers; and suggestions for other key stakeholders. CONCLUSIONS: We anticipate that mental health apps developed in accordance with this tool will be more likely to conform to regulatory requirements, protect consumer privacy, protect consumer finances, and deliver health benefit; and less likely to attract regulatory penalties, offend consumers and communities, mislead consumers, or deliver health harms. We encourage government, industry and consumer organisations to use and publicise the tool. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12911-017-0535-0) contains supplementary material, which is available to authorized users.
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spelling pubmed-56257202017-10-12 A health app developer’s guide to law and policy: a multi-sector policy analysis Parker, Lisa Karliychuk, Tanya Gillies, Donna Mintzes, Barbara Raven, Melissa Grundy, Quinn BMC Med Inform Decis Mak Research Article BACKGROUND: Apps targeted at health and wellbeing sit in a rapidly growing industry associated with widespread optimism about their potential to deliver accessible and cost-effective healthcare. App developers might not be aware of all the regulatory requirements and best practice principles are emergent. Health apps are regulated in order to minimise their potential for harm due to, for example, loss of personal health privacy, financial costs, and health harms from delayed or unnecessary diagnosis, monitoring and treatment. We aimed to produce a comprehensive guide to assist app developers in producing health apps that are legally compliant and in keeping with high professional standards of user protection. METHODS: We conducted a case study analysis of the Australian and related international policy environment for mental health apps to identify relevant sectors, policy actors, and policy solutions. RESULTS: We identified 29 policies produced by governments and non-government organisations that provide oversight of health apps. In consultation with stakeholders, we developed an interactive tool targeted at app developers, summarising key features of the policy environment and highlighting legislative, industry and professional standards around seven relevant domains: privacy, security, content, promotion and advertising, consumer finances, medical device efficacy and safety, and professional ethics. We annotated this developer guidance tool with information about: the relevance of each domain; existing legislative and non-legislative guidance; critiques of existing policy; recommendations for developers; and suggestions for other key stakeholders. CONCLUSIONS: We anticipate that mental health apps developed in accordance with this tool will be more likely to conform to regulatory requirements, protect consumer privacy, protect consumer finances, and deliver health benefit; and less likely to attract regulatory penalties, offend consumers and communities, mislead consumers, or deliver health harms. We encourage government, industry and consumer organisations to use and publicise the tool. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12911-017-0535-0) contains supplementary material, which is available to authorized users. BioMed Central 2017-10-02 /pmc/articles/PMC5625720/ /pubmed/28969704 http://dx.doi.org/10.1186/s12911-017-0535-0 Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
Parker, Lisa
Karliychuk, Tanya
Gillies, Donna
Mintzes, Barbara
Raven, Melissa
Grundy, Quinn
A health app developer’s guide to law and policy: a multi-sector policy analysis
title A health app developer’s guide to law and policy: a multi-sector policy analysis
title_full A health app developer’s guide to law and policy: a multi-sector policy analysis
title_fullStr A health app developer’s guide to law and policy: a multi-sector policy analysis
title_full_unstemmed A health app developer’s guide to law and policy: a multi-sector policy analysis
title_short A health app developer’s guide to law and policy: a multi-sector policy analysis
title_sort health app developer’s guide to law and policy: a multi-sector policy analysis
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5625720/
https://www.ncbi.nlm.nih.gov/pubmed/28969704
http://dx.doi.org/10.1186/s12911-017-0535-0
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