Why is it so difficult to govern mobile apps in healthcare?

• Published in: BMJ health & care informatics 2019-11, Vol.26 (1), p.e100006
• Main Authors: Magrabi, Farah, Habli, Ibrahim, Sujan, Mark, Wong, David, Thimbleby, Harold, Baker, Maureen, Coiera, Enrico
• Format: Article
• Language: English
• Subjects: Accountability; clinical governance; Commentary; Communication; Consumer health information; Consumers; Design; Government; Health informatics; Humans; Medical equipment; Medical Informatics - standards; Medical technology; mHealth; mobile applications; Mobile Applications - legislation & jurisprudence; Mobile Applications - standards; Patient safety; Preventive maintenance; Quality standards; Skills; Software engineering; Telemedicine
• ISSN: 2632-1009; 2632-1009
• DOI: 10.1136/bmjhci-2019-100006

Probable causes are the low entry barrier to app creation and absence of certification barrier to distribution to the public. [...]apps are ubiquitous, posing risks on a large-scale where traditional clinical governance approaches may be too slow.6 We show that the disparate contexts in which apps are developed are not uniformly conducive to assurance processes. While the functionality of apps, or any other software to support health services, should be based on clinical standards that provide evidence-based requirements for information and communication, the slow rate at which such standards are produced presents a challenge for clinical governance because without standardised use cases, apps are providing functionality where there is no clear understanding of risk. The lack of accountability is a serious issue because qualified engineers are professionals who can be held accountable for their actions while this may not be the case for clinicians and citizen developers (‘citizen developer’ is a new term implying a mix of skill and informality, even naivety compared with professional practice).8 Another rapid method for development is via mobile application frameworks which provide many pre-made components that can be used as building blocks for most health information and communication functions (eg, Ionic and React Native). With citizen developers, the informal context means that formal software development and clinical governance processes may altogether be absent. Because of a lack of skills and experience, citizen developers may be unaware of best-practice development methods and standards.