‘Trust but verify’ – five approaches to ensure safe medical apps

BMC Medicine

Emil Chiauzzi¹  Paul Wicks¹ 

[1] 155 2nd Street, PatientsLikeMe, Cambridge 02141, MA, USA

关键词: Smartphone;    Mobile health;    Internet;    Insulin;    E-health;    Diabetes;    Asthma;    Apps;   

Others  :  1227190
DOI  :  10.1186/s12916-015-0451-z

 received in 2015-04-23, accepted in 2015-08-13,  发布年份 2015

【 摘 要 】

Mobile health apps are health and wellness programs available on mobile devices such as smartphones or tablets. In three systematic assessments published in BMC Medicine, Huckvale and colleagues demonstrate that widely available health apps meant to help patients calculate their appropriate insulin dosage, educate themselves about asthma, or perform other important functions are methodologically weak. Insulin dose calculators lacked user input validation and made inappropriate dose recommendations, with a lack of documentation throughout. Since 2011, asthma apps have become more interactive, but have not improved in quality; peak flow calculators have the same issues as the insulin calculators. A review of the accredited National Health Service Health Apps Library found poor and inconsistent implementation of privacy and security, with 28 % of apps lacking a privacy policy and one even transmitting personally identifying data the policy claimed would be anonymous. Ensuring patient safety might require a new approach, whether that be a consumer education program at one extreme or government regulation at the other. App store owners could ensure transparency of algorithms (whiteboxing), data sharing, and data quality. While a proper balance must be struck between innovation and caution, patient safety must be paramount.

Please see related articles: http://dx.doi.org/10.1186/s12916-015-0444-y, http://www.biomedcentral.com/1741-7015/13/106 and http://www.biomedcentral.com/1741-7015/13/58

【 授权许可】

   
2015 Wicks and Chiauzzi.

【 参考文献 】

• [1]research2guidance. Mobile Health Market Report 2013-2017: The commercialization of mHealth applications (Vol. 3). Berlin: research2guidance; 2013.
• [2]Huckvale K, Morrison C, Ouyang J, Ghaghda A, Car J. Smartphone apps for calculating insulin dose: a systematic assessment. BMC Med. 2015; 13:106. BioMed Central Full Text
• [3]Huckvale K, Morrison C, Ouyang J, Ghaghda A, Car J. The evolution of mobile apps for asthma: an updated systematic assessment of content and tools. BMC Med. 2015; 13:58. BioMed Central Full Text
• [4]Huckvale K, Prieto JT, Tilney M, Benghozi P, Car J. Unaddressed privacy and security risks in accredited health and wellness apps: lessons from a cross-sectional systematic assessment. BMC Med. 2015. doi:10.1186/s12916-015-0444-y.
• [5]Huckvale K, Car M, Morrison C, Car J. Apps for asthma self-management: a systematic assessment of content and tools. BMC Med. 2012; 10:144. BioMed Central Full Text
• [6]Ferrero NA, Morrell DS, Burkhart CN. Skin scan: a demonstration of the need for FDA regulation of medical apps on iPhone. J Am Acad Dermatol. 2013; 68:515-6.
• [7]van der Heijde DM, van 't Hof M, van Riel PL, van de Putte LB. Development of a disease activity score based on judgment in clinical practice by rheumatologists. J Rheumatol. 1993; 20:579-81.
• [8]Phillips B. “Pfizer rheumatology calculator” iPhone /Android application - important information. 2011. http://www.pharma-mkting.com/images/Pfizer_Rheum_BugLetter.pdf. Accessed 24 August 2015.
• [9]US Food and Drug Administration (FDA). Mobile medical applications. 2013. http://www.fda.gov/medicaldevices/productsandmedicalprocedures/connectedhealth/mobilemedicalapplications/default.htm. Accessed 21 March 2015.
• [10]Boulos MNK, Brewer AC, Karimkhani C, Buller DB, Dellavalle RP. Mobile medical and health apps: state of the art, concerns, regulatory control and certification. Online J Public Health Inform. 2014; 5:229.
• [11]Chan SR, Misra S. Certification of mobile apps for health care. JAMA. 2014; 312:1155-6.
• [12]Lewis TL. A systematic self-certification model for mobile medical apps. J Med Internet Res. 2013; 15: Article ID e89
• [13]Stoyanov SR, Hides L, Kavanagh DJ, Zelenko O, Tjondronegoro D, Mani M. Mobile app rating scale: a new tool for assessing the quality of health mobile apps. JMIR mHealth uHealth. 2015; 3: Article ID e27
• [14]Banerjee AK, Okun S, Edwards IR, Wicks P, Smith MY, Mayall SJ et al.. Patient-reported outcome measures in safety event reporting: PROSPER Consortium guidance. Drug Saf. 2013; 36:1129-49.
• [15]Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database--update and key issues. N Engl J Med. 2011; 364:852-60.
• [16]Apple. App store review guidelines. 2015. https://developer.apple.com/app-store/review/guidelines/. Accessed 21 March 2015.
• [17]Dave K. Apple’s App Store review process is hurting users, but we’re not allowed to talk about it. Medium. 2015. https://medium.com/@krave/apple-s-app-store-review-process-is-hurting-users-but-we-re-not-allowed-to-talk-about-it-55d791451b. Accessed 21 March 2015.