Mobile medical and health apps: state of the art, concerns, regulatory control and certification
English

Maged N. Kamel Boulos, Ann C. Brewer, Chante Karimkhani, David B. Buller, Robert P. Dellavalle
2014 Online Journal of Public Health Informatics  
This paper examines the state of the art in mobile clinical and health-related apps. A 2012 estimate puts the number of health-related apps at no fewer than 40,000, as healthcare professionals and consumers continue to express concerns about the quality of many apps, calling for some form of app regulatory control or certification to be put in place. We describe the range of apps on offer as of 2013, and then present a brief survey of evaluation studies of medical and health-related apps that
more » ... ve been conducted to date, covering a range of clinical disciplines and topics. Our survey includes studies that highlighted risks, negative issues and worrying deficiencies in existing apps. We discuss the concept of 'apps as a medical device' and the relevant regulatory controls that apply in USA and Europe, offering examples of apps that have been formally approved using these mechanisms. We describe the online Health Apps Library run by the National Health Service in England and the calls for a vetted medical and health app store. We discuss the ingredients for successful apps beyond the rather narrow definition of 'apps as a medical device'. These ingredients cover app content quality, usability, the need to match apps to consumers' general and health literacy levels, device connectivity standards (for apps that connect to glucometers, blood pressure monitors, etc.), as well as app security and user privacy. 'Happtique Health App Certification Program' (HACP), a voluntary app certification scheme, successfully captures most of these desiderata, but is solely focused on apps targeting the US market. HACP, while very welcome, is in ways reminiscent of the early days of the Web, when many "similar" quality benchmarking tools and codes of conduct for information publishers were proposed to appraise and rate online medical and health information. It is probably impossible to rate and police every app on offer today, much like in those early days of the Web, when people quickly realised the same regarding informational Web pages. The best first line of defence was, is, and will always be to educate consumers regarding the potentially harmful content of (some) apps. Mobile medical and health apps: state of the art, concerns, regulatory control and certification 2 Smartphones, the most common "personal computer" today, have revolutionised the communication landscape. Almost 'always on' and highly portable (carried by their users everywhere they go), smartphones provide real-time, on-demand communication, while their rich multimedia touch-displays operate with increasing speeds, delivering data services and computing power to document and improve the networked lives of their owners [1,2]. Communication via smartphones is personalised: smartphones store and exchange large amounts of personal information and users are able to customise their phones to suit their personal preferences and needs. A smartphone can record a large number of details about its user's current status and whereabouts. It can relay appropriate social support and enable realtime and asynchronous exchanges with other users via social networks and other forms of mobile communications. The latter include text messaging (Short Message Service-SMS), photography (still and video), location and other sensors (global positioning system [GPS], accelerometers, ambient light sensor, etc.), built-in applications or apps (e-mail, contacts, calendar, document readers and video players, etc.) and wireless data service [2] . ('App', short for 'application (program)', refers to a self-contained piece of software coded for a specific purpose and usually optimised to run on a mobile device.) Smartphones out-shipped feature phones worldwide for the first time in Q1 2013 [3, 4] . One of the main differences between smartphones and feature phones is that the latter, besides being less expensive than the former, offer very limited or no support for third-party, full-fledged apps. According to the 'Mobile Health 2012' report published by Pew Research Centre's Internet & American Life Project, 85% of US adults own a cell phone; of them, 53% own smartphones. Half of smartphone owners use their devices to get health information. Onefifth of smartphone owners have health apps on their devices [5] . The mobile revolution is offering an unprecedented opportunity to provide medical support when and where people need it. Large numbers and varieties of medical and health-related apps exist on the market today. A 2012 estimate puts the number of health-related apps at no fewer than 40,000 [6] . From basic apps composed of text message reminders to apply sunscreen, to sophisticated apps that coordinate the management of diabetes, apps play a multitude of functions in health and healthcare. Mobile technology has several potential advantages for providing actionable medical advice, but also has its own limitations and potential problems associated with it. These aspects of mobile technology will be the focus of the rest of this paper. Range of mobile applications Apps for medical providers Many apps are developed for a target audience of healthcare workers, including physicians, nurses and assistants. These apps are generally more sophisticated, with medical terminology and functions, and not easily navigable by non-health professionals. In a study published in
doi:10.5210/ojphi.v5i3.4814 pmid:24683442 pmcid:PMC3959919 fatcat:6kp6ehnffbgotp77wmciidujcy