FDA regulation of mobile medical apps

JAMA - Journal of the American Medical Association

Volumn 320, Issue 4, 2018, Pages 337-338

  Shuren, Jeffrey ^a   Patel, Bakul ^a   Gottlieb, Scott ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ATTITUDE TO HEALTH; CLINICAL DECISION MAKING; CLINICAL EFFECTIVENESS; CONCEPTUAL FRAMEWORK; ELECTRONIC HEALTH RECORD; FOOD AND DRUG ADMINISTRATION; HEALTH CARE ACCESS; HEALTH CARE NEED; HEALTH CARE POLICY; HEALTH CARE SYSTEM; HUMAN; LAW; MEDICAL SERVICE; MOBILE APPLICATION; PATIENT CARE; PERSONAL NEEDS; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; UNITED STATES; VALIDITY; DEVICE APPROVAL; GOVERNMENT REGULATION; LEGISLATION AND JURISPRUDENCE; SOFTWARE; SYSTEM ANALYSIS;

DEVICE APPROVAL; ELECTRONIC HEALTH RECORDS; GOVERNMENT REGULATION; MOBILE APPLICATIONS; SOFTWARE; SYSTEMS INTEGRATION; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85050961863     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2018.8832     Document Type: Review

References (7)

1. Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new digital health policies to encourage innovation, bring efficiency and modernization to regulation. FDA website. https://www.fda.gov/NewsEvents/Newsroom /PressAnnouncements/ucm587890.htm. Last updated December 17, 2017. Accessed May 22, 2018.
2. Mobile medical applications: guidance for industry and Food and Drug Administration staff. https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance /GuidanceDocuments/UCM263366.pdf. Published February 9, 2015. Accessed June 27, 2018.
3. Guidances with digital health content. FDA website. https://www.fda.gov/MedicalDevices/DigitalHealth/ucm562577.htm. Last updated March 8, 2018. Accessed June 3, 2018.
4. Digital Health. FDA website. https://www.fda.gov/medicaldevices/digitalhealth/. Last updated May 29, 2018. Accessed June 27, 2018.
5. Cybersecurity. FDA website. https://www.fda.gov/MedicalDevices/DigitalHealth/ucm373213.htm Last updated April 17, 2018. Accessed May 22, 2018.
6. International Medical Device Regulators Forum (IMDRF). FDA website. https://www.fda.gov/MedicalDevices/InternationalPrograms/IMDRF /default.htm. Last updated April 4, 2018. Accessed May 22, 2018.
7. Digital Health Innovation Action Plan. FDA website. https://www.fda.gov/downloads/MedicalDevices/DigitalHealth/UCM568735.pdf. Published April 26, 2018. Accessed May 22, 2018.