How to Assess and Improve the Quality and Safety of Apps for Medicine and Health Promotion

Convenor: Jeremy Wyatt, chair in eHealth research, Leeds University, UK. Panel members: • Alain Labrique, Chair of WHO mHealth Technical Advisory Group; Johns Hopkins School of Medicine, Baltimore, USA • Kristina Curtis, Institute of Digital Healthcare, Warwick University, UK • Satish Misra, imedicalapps.org, USA • Tom Lewis, medical editor, imedicalapps.org, UK There have been several widely reported cases in which Apps were withdrawn (eg. Acne Cure [1]) or shown to be based on no evidence (eg. Smoking cessation Apps [2]) or be grossly inaccurate (eg. melanoma detection Apps [3]). This panel will therefore address a key question for clinicians, patients, regulators and App developers: how to ensure that an App is of reasonable quality and poses minimal risk to the public, professionals and organisations ? We will explore the pros and cons of a several approaches being adopted or proposed to assess and improve App quality and risks, including: • Formal regulation of medical Apps by the FTC [1], FDA [4], MHRA, EMEA, etc. • Informal attempts to promote best-of-breed Apps by review sites [5] • The use of a 23-item quality checklist for health promotion Apps based on Donabedian’s framework [6] • Mapping the intrinsic and extrinsic factors associated with App risk • Encouraging more rigorous evaluation of Apps and their impact on patient outcomes [7] Following short position statements by panel members, we anticipate vigorous debate by conference delegates around key issues such as: the trade-off between innovation and regulation, freedom of speech vs. safety, the need for truth in labelling [8], and why the public continue to download many health related Apps that are at best content free, and some that even cause harm. References 1. Federal Trades Commission. “Acne Cure” Mobile App Marketers Will Drop Baseless Claims Under FTC Settlements. http://www.ftc.gov/opa/2011/09/acnecure.shtm 2. Abroms LC, Padmanabhan N, Thaweethai L, Phillips T. iPhone Apps for smoking cessation: a content analysis. American Journal of Preventive Medicine. 2011 Mar;40(3):279–85. 3. Joel A. Wolf, BA; Jacqueline Moreau, BA; Oleg Akilov, MD; Timothy Patton, DO; Joseph C. English III, MD; Jonhan Ho, MD; Laura K. Ferris, MD, PhD. Diagnostic Inaccuracy of Smartphone Applications for Melanoma Detection. JAMA Dermatol. Published online January 16, 2013. doi:10.1001/jamadermatol.2013.2382 4. http://www.fda.gov/forconsumers/consumerupdates/ucm263332.htm 5. www.imedicalapps.com 6. Donabedian, A. Evaluating the Quality of Medical Care. The Milbank Memorial Fund Quarterly 1965; 44: 166-206 7. Friedman CP, Wyatt JC. Evaluation methods in biomedical informatics (2nd edition). New York: Springer, 2005. 8. Michael Rigby, Jari Forsstrom, Ruth Roberts, and Jeremy C Wyatt. Verifying quality and safety in health informatics services. BMJ 2001; 323: 552-6 []