FDA Issues Final Guidance on mHealth Apps | Healthcare Informatics Magazine | Health IT | Information Technology Skip to content Skip to navigation

FDA Issues Final Guidance on mHealth Apps

September 23, 2013
by Gabriel Perna
| Reprints

The U.S. Food and Drug Administration (FDA) has issued final guidance for developers of mobile health (mHealth) applications, with the agency saying it intends to exercise “enforcement discretion” for most apps because they pose minimal risk to consumers.

Instead, the FDA says it 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.” This includes mHealth apps intended to be used as an accessory to a regulated medical device. For example, an app that allows a healthcare provider to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet.

Another area of FDA oversight will be apps that transform a mobile platform into a regulated medical device. An example of that is an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack. The apps that do undergo FDA review will be assessed using the same regulatory standards and risk-based approach that the agency applies to other medical devices.

 “We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly,” Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, said in a statement.  “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”

The debate over mHealth app regulation was the focus of hearings in May, in front of The Energy and Commerce Subcommittee. In it, the FDA promised that its policy on mobile medical apps will not include the regulation of consumers’ smartphones or tablets. It is uncertain how the mHealth community will react to this guidance, as they had expressed concern on possible regulation of medical smartphone apps during those hearings.

Topics

News

Former Health IT Head in San Diego County Charged with Defrauding Provider out of $800K

The ex-health IT director at North County Health Services, a San Diego County-based healthcare service provider, has been charged with spearheading fraudulent operations that cost the organization $800,000.

Allscripts Touts 1 Billion API Shares in 2017

Officials from Chicago-based health IT vendor Allscripts have attested that the company has reached a new milestone— one billion application programming interface (API) data exchange transactions in 2017.

Dignity Health, CHI Merging to Form New Catholic Health System

Catholic Health Initiatives (CHI), based in Englewood, Colorado, and San Francisco-based Dignity Health officially announced they are merging and have signed a definitive agreement to combine ministries and create a new, nonprofit Catholic health system.

HHS Announces Winning Solutions in Opioid Code-a-Thon

The U.S. Department of Health and Human Services (HHS) hosted this week a first-of-its-kind two-day Code-a-Thon to use data and technology to develop new solutions to address the opioid epidemic.

In GAO Report, More Concern over VA VistA Modernization Project

A recent Government Accountability Office (GAO) report is calling into question the more than $1 billion that has been spent to modernize the Department of Veterans Affairs' (VA) health IT system.

Lawmakers Introduce Legislation Aimed at Improving Medicare ACO Program

U.S. Representatives Peter Welch (D-VT) and Rep. Diane Black (R-TN) have introduced H.R. 4580, the ACO Improvement Act of 2017 that makes changes to the Medicare accountable care organization (ACO) program.