Introduction There is currently a lack of clear and accepted standards for the development (planning, requirement analysis and research, design and application testing) of apps for medical and healthcare use which poses different risks to developers, providers, patients and the public. The aim of this work is to provide an overview of the current standards, frameworks, best practices and guidelines for the development of digital health apps. This review is a critical ’stepping stone’ for further work on producing appropriate standards that can help mitigate risks (eg, clinical, privacy and economic risks).
Methods and analysis A systematic review identifying criteria from applicable standards, guidelines, frameworks and best practices for the development of health apps. We will draw from standards for software for medical devices, clinical information systems and medicine because of their relatedness and hope to apply lessons learnt to apps. We will exclude other types of publications, and those published in languages other than English. We will search websites of relevant regulatory and professional organisations. For health apps, we will also search electronic research databases (eg, MEDLINE, Embase, SCOPUS, ProQuest Technology Collection and Engineering Index) because relevant publications may not be found on other websites. We will hand-search reference lists of included publications. The review will focus on international, USA, European and UK standards because these are the markets of primary interest to the majority of app developers currently. We will provide a narrative overview of findings and tabular summaries of extracted data. Also, we will examine the relationship between different standards and compare USA and European Union standards.
Ethics and dissemination No ethics approval is required. The review will be disseminated through peer-reviewed publications, conference presentations and inform efforts that aim to improve the quality of health apps through existing links with relevant organisations.
- Health Policy
- Quality In Health Care
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Contributors MHVV wrote the protocol. JS, DB and GW provided substantial comments for important intellectual input on the protocol.
Funding MHV is a Sir David Cooksey Fellow in Healthcare Translation at the University of Oxford and received no specific additional funding for this work. JS is supported by a UK Medical Research Council Studentship.
Disclaimer The funder had no role in writing this protocol.
Competing interests The author(s) declared the following potential competing interests with respect to the research, authorship, and/or publication of this article: This article represents the authors’ individual opinions and may not necessarily represent the viewpoints of their employers. MHV is the director of Dutches Consulting Ltd which provides digital health-related advice to clients in the life sciences. DB is a stockholder in Translation Ventures Ltd (Charlbury, Oxfordshire, UK) and IP Asset Ventures Ltd (Oxford, Oxfordshire, UK), companies that, among other services, provide cell therapy biomanufacturing, regulatory and financial advice to pharmaceutical clients. DB is also subject to the CFA Institute’s codes, standards and guidelines, so he must stress that this piece is provided for academic interest only and must not be construed in any way as an investment recommendation. Additionally, at the time of publication, DB and the organisations with which he is affiliated may or may not have agreed and/or have pending funding commitments from the organisations named here.
Patient consent Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Correction notice Since this paper was first published online the open access licence has changed from CC-BY-NC to CC-BY.
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