Two decades ago, during the rapid emergence of the worldwide web as a popular source of health information, there was widespread anxiety among health practitioners, and especially the medical profession, that poor quality information on the internet could cause significant harm. Although there was never any consistent systematic evidence of harm beyond a few individual case reports, one response by many national health agencies was to call for, and in some cases develop, quality rating schemes. In 2000, an editorial in The BMJ by Tony Delamothe described these initiatives as ‘kitemarking the west wind’, referring to the difficulties in rating the quality of online health information and providing kitemarks for websites, and arguing that such schemes needed to demonstrate their benefit to population health before being pursued further. Just as the first generation of web technologies provided users with access to a vast quantity of online health information, now web2.0 interactivity and the rapid uptake of smartphones have led to an explosion in digital applications for health and wellbeing. An estimated 165,000 health apps were available in 2015 to the public, patients, health professionals and researchers. Health apps cover both ‘wellness’ apps, mostly for promoting healthy living (e.g. targeting physical activity, diet, sleep, stress), and ‘medical’ apps for diagnosing, self-managing, monitoring and treating conditions, providing decision-support and collecting healthrelated information. Regulation does exist for some health apps that are considered to be medical devices. In the United States, the Food and Drug Administration (FDA) launched a draft guidance on mobile medical apps in 2011, which was updated in 2015 and remains a work in progress. This guidance applies to health apps that meet the regulatory definition of a device, meaning those apps that are ‘intended to be used as an accessory to a regulated medical device, or transform a mobile platform into a regulated medical device’. In the United Kingdom (UK), the Medicines and Health Regulatory Agency (MHRA) published guidance in 2014 on health apps falling under their definition of medical devices and which should apply for CE marking (logo used in the European Union to confirm that a medical device is fit for purpose and adheres to safety legislation). While the exact number of health apps that have been registered as medical devices and FDA-cleared or received a CE mark is hard to determine, it is clear that so far only a very small proportion of health apps are regulated in this way (in 2013 there were approximately 100 FDAcleared apps in total, and in 2016 only 24 devices connected to health apps and 12 medical devices were cleared). However, most health apps are not medical devices by these definitions, and are therefore currently unregulated by organisations such as the FDA and MHRA, and freely available to the public, regardless of their efficacy and safety. Just as with the concerns over the quality of health websites, health policy makers in different countries around the world are now considering whether wider endorsement of health apps is required, as a result of concerns about risks to patient safety and privacy related to existing apps. 21 A recent review by the Commonwealth Fund showed that of 376 iOS apps and 569 Android apps for engaging patients with medical conditions, only 43% of iOS apps and 27% of Android apps appeared likely to be useful. Systematic assessments showed concerns about the clinical safety of several health apps. Concerns have also been expressed about selling data from health and wellness apps for commercial purposes. The European Commission, and national and regional governments, e.g. in the UK,, Catalonia and Andalusia, are therefore currently developing guidelines for assessing the quality of health apps that
[1]
A. Jadad,et al.
Analysis of cases of harm associated with use of health information on the internet.
,
2002,
JAMA.
[2]
A. Haines,et al.
The Effectiveness of Mobile-Health Technologies to Improve Health Care Service Delivery Processes: A Systematic Review and Meta-Analysis
,
2013,
PLoS medicine.
[3]
José Tomás Prieto,et al.
Smartphone apps for calculating insulin dose: a systematic assessment
,
2015,
BMC Medicine.
[4]
Stephen Armstrong,et al.
What happens to data gathered by health and wellness apps?
,
2016,
British Medical Journal.
[5]
Bárbara Vallespin,et al.
Ensuring Evidence-Based Safe and Effective mHealth Applications.
,
2016,
Studies in health technology and informatics.
[6]
Josip Car,et al.
Unaddressed privacy risks in accredited health and wellness apps: a cross-sectional systematic assessment
,
2015,
BMC Medicine.
[7]
J. Raftery,et al.
Health Technology Assessment in the UK
,
2013,
The Lancet.
[8]
R. Dellavalle,et al.
Mobile medical and health apps: state of the art, concerns, regulatory control and certification
,
2014,
Online journal of public health informatics.
[9]
Sasha Shepperd,et al.
A 5-star system for rating the quality of information based on DISCERN.
,
2002,
Health information and libraries journal.
[10]
T. L. Lewis,et al.
mHealth and Mobile Medical Apps: A Framework to Assess Risk and Promote Safer Use
,
2014,
Journal of medical Internet research.
[11]
Audie A Atienza,et al.
Mobile health technology evaluation: the mHealth evidence workshop.
,
2013,
American journal of preventive medicine.
[12]
Jaeho Lee,et al.
Developing a Framework for Evaluating the Patient Engagement, Quality, and Safety of Mobile Health Applications.
,
2016,
Issue brief.
[13]
Wanda Pratt,et al.
Healthcare in the pocket: Mapping the space of mobile-phone health interventions
,
2012,
J. Biomed. Informatics.
[14]
Cecily Morrison,et al.
The evolution of mobile apps for asthma: an updated systematic assessment of content and tools
,
2015,
BMC Medicine.
[15]
L. Swartz,et al.
Scaling Up mHealth: Where Is the Evidence?
,
2013,
PLoS medicine.
[16]
A. Haines,et al.
The Effectiveness of Mobile-Health Technology-Based Health Behaviour Change or Disease Management Interventions for Health Care Consumers: A Systematic Review
,
2013,
PLoS medicine.
[17]
Paul Heron,et al.
Assessing the quality of information to support people in making decisions about their health and healthcare
,
2006
.
[18]
P. Schulz,et al.
Mapping mHealth Research: A Decade of Evolution
,
2013,
Journal of medical Internet research.
[19]
Charles Abraham,et al.
A review and content analysis of engagement, functionality, aesthetics, information quality, and change techniques in the most popular commercial apps for weight management
,
2016,
International Journal of Behavioral Nutrition and Physical Activity.
[20]
T Delamothe,et al.
Quality of websites: kitemarking the west wind
,
2000,
BMJ : British Medical Journal.