FDA Issues Final Guidance on Mobile Medical Apps


On September 23, 2013, the U.S. Food and Drug Administration (FDA) issued the long awaited final guidance (Guidance) on mobile medical apps. The FDA reaffirmed that it "intends to exercise enforcement discretion (meaning it will not enforce requirements under the Federal Drug & Cosmetic Act) for the majority of mobile apps as they pose minimal risk to consumers" and instead will "focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended."

There was significant concern from software developers, vendors, and other industry representatives regarding the regulatory position(s) the FDA would take and the resultant impact on the mobile app development market. The Guidance informs stakeholders how the FDA intends to apply (or decline to apply) its regulatory authorities to healthcare oriented mobile apps.

The FDA intends to regulate a subset of apps that it has labeled as "mobile medical apps," which must meet all of the requirements below:




Resources and Supporting Documents

December 2024
SuMoTuWeThFrSa
1234567
891011121314
15161718192021
22232425262728
293031

Blog Home  

Newest Blog Entries
7/23/15 Hospital Settles with OCR for $ 218,400 Over Cloud-Based File Sharing

6/8/15 Two California Privacy Bills to Watch in 2015

3/28/15 When Looking at Security, Consider Every Device

3/9/15 Alabama Board of Optometry Makes Final a Rule on Telemedicine

1/25/15 Indiana Court of Appeals Upholds $1.44 Million Jury Verdict Against Walgreen Co. in a Privacy Breach Case; Denies Rehearing

12/9/14 Malware Leads to a $150,000 OCR Settlement with a Behavioral Health Provider

11/30/14 Can a Board of Medicine Use the State’s Prescription Drug Database in Investigating Physician Actions?

11/29/14 Under the Florida Telemedicine Rule, Can a Physical be Conducted by Telemedicine?

11/19/14 Wearables and the Challenge for Consumer Device Makers

10/28/14 A Few Telemedicine Resources

10/27/14 FCC: The Newest Regulator to Throw its Hat into the Data Privacy and Security Ring

Blog Archives
December 2014 (1)
July 2014 (1)
August 2014 (4)
June 2015 (1)
June 2014 (3)
February 2014 (4)
April 2014 (6)
December 2013 (5)
October 2014 (2)
March 2015 (2)
March 2014 (3)
January 2014 (4)
September 2014 (1)
July 2015 (1)
November 2014 (3)
January 2015 (1)
October 2013 (9)
November 2013 (3)
May 2014 (6)

Blog Labels
HIPAA (3)
Employment (1)
Healthcare Competition (1)
Meaningful Use (4)
Mobile Apps FDA (2)
Dental (1)
Healthcare Fraud (1)
EHR (2)
Security (1)
Data Breach (10)
Privacy Litigation (3)
Marketing (1)
Financial Services (1)
Medical Marijuana (1)
FCC (1)
BYOD (2)
Mobile Apps (2)
Identity Theft (1)
Telemedicine (7)
FAQ (6)
Big Data (3)
Social Media (2)
Privacy (4)