Regulating medical apps: Which ones and how much? The FDA has issued sensible guidance

BMJ (Online)

Volumn 347, Issue 7929, 2013, Pages

  Kamerow, Douglas ^a  

^a American Health Care   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

COMPUTER; COMPUTER PROGRAM; EXERCISE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE PERSONNEL; INTERNET; MEDICAL APPS; MEDICAL DEVICE; MOBILE PHONE; PRACTICE GUIDELINE; PRIORITY JOURNAL; SHORT SURVEY; SMOKING CESSATION; WEIGHT REDUCTION;

CELLULAR PHONE; HUMANS; SOFTWARE; TELEMEDICINE; UNITED STATES;

EID: 84886886610     PISSN: None     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.f6009     Document Type: Short Survey

References (5)

1. Jahns R-G. The market for mHealth app services will reach $26billion by 2017. Research 2 Guidance. 7 Mar. 2013. www.research2guidance.com/the-market-for-mhealthappservices-will-reach-26- billion-by-2017.
2. Associated Press. FDA lays out regulations for mobile device apps that work like medical devices. Washington Post 23Sep. 2013. www.washingtonpost.com/ politics/federal-government/fda-lays-out-regulations-for-mobile-device-apps- that-work-like-medicaldevices/2013/09/23/1a2aac06-2469-11e3-9372-92606241ae9c- story.html.
3. Tavernise S. FDA will apply its rules to only some health apps. New York Times 24 Sep. 2013:A12.
4. US Food and Drug Administration. Mobile medical applications: guidance for industry and Food and Drug Administration staff. 25 Sep. 2013. www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/UCM263366.pdf.
5. Abroms LC, Padmanabhan N, Thaweethai L, Phillips T. iPhone apps for smoking cessation: a content analysis. Am J Prev Med 2011;40:279-85.