Evidence map›Paper›PMID 28969704›Full record

ArticleBMC medical informatics and decision making2017

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

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

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC medical informatics and decision making, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  3. The Internet, Apps, and the Anesthesiologist.Healthcare (Basel, Switzerland) · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Lisa ParkerCharles Perkins Centre, Faculty of Pharmacy, The University of Sydney, D17 6th floor, The Hub, Camperdown, Sydney, NSW, 2006, Australia. lisa.parker@sydney.edu.au.ORCID http://orcid.org/0000-0001-8635-6953
Tanya KarliychukAustralian Communications Consumer Action Network (ACCAN), Ultimo, NSW, Australia.
Donna GilliesMental Health, Western Sydney Local Health District, North Parramatta, NSW, Australia.
Barbara MintzesCharles Perkins Centre, Faculty of Pharmacy, The University of Sydney, D17 6th floor, The Hub, Camperdown, Sydney, NSW, 2006, Australia.
Melissa RavenCritical and Ethical Mental Health Research Group, The University of Adelaide, Adelaide, SA, Australia.
Quinn GrundyCharles Perkins Centre, Faculty of Pharmacy, The University of Sydney, D17 6th floor, The Hub, Camperdown, Sydney, NSW, 2006, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundApps 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.

methodsWe 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.

resultsWe 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.

conclusionsWe 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.

Indexed as

Policy MakingAustraliaEthics, MedicalHealth PolicyHumansMental HealthMobile ApplicationsPrivacyAdvertisementsHealth legislationHealth policyMedical device legislationMedical ethicsMedical informaticsMobile applicationsPrivacyProfessional ethics

Identifiers

PMID28969704
PMCPMC5625720

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.