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BMC Medical Informatics and Decision Making

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Open Access 01-12-2017 | Research article

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

Authors: Lisa Parker, Tanya Karliychuk, Donna Gillies, Barbara Mintzes, Melissa Raven, Quinn Grundy

Published in: BMC Medical Informatics and Decision Making | Issue 1/2017

Abstract

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.

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Title: A health app developer’s guide to law and policy: a multi-sector policy analysis
Authors: Lisa Parker
Tanya Karliychuk
Donna Gillies
Barbara Mintzes
Melissa Raven
Quinn Grundy
Publication date: 01-12-2017
Publisher: BioMed Central
Published in: BMC Medical Informatics and Decision Making / Issue 1/2017
Electronic ISSN: 1472-6947
DOI: https://doi.org/10.1186/s12911-017-0535-0

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

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