FDA Releases Final Mobile Health App Guidance
The US Food and Drug Administration (FDA) will only exert its considerable oversight powers over mobile health applications and technologies that are likely to pose an adverse effect if used incorrectly, according to final guidance released by the agency on Monday, Sept. 23.
HIM professionals have long been waiting for the agency to publish such guidance, which have patient engagement implications and could impact the “meaningful use” EHR Incentive Program.
The guidance, titled “Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff” is aimed at developers and pertains to mobile medical applications (apps) or software that operates on mobile devices, such as smartphones or tablet computers, and performs the same functions as traditional medical devices.
“The agency 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,” a FDA press release accompanying the guidance states. “The FDA intends to 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.”
The FDA received over 130 comments to the draft guidance issued in July 2011. This final guidance updates those draft guidelines.
According to the agency, the FDA will seek oversight on mobile applications that:
- Are intended to be used as an accessory to a regulated medical device—for example, an application that allows a healthcare professional 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
- Transform a mobile platform into a regulated medical device—for example, 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.
“Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly. The FDA’s tailored policy protects patients while encouraging innovation,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in the press release.
Apps that could be subject to regulatory oversight could include, according to the guidance, “apps that use a sensor attached to the mobile platform or tools within the mobile platform itself to record, view, or analyze eye movements for use in the diagnosis of balance disorders (i.e., nystagmograph).”
Another example of an app that might be subject to regulatory oversight, and should therefore exercise discretion, is an app “that uses GPS location information to alert asthmatics of environmental conditions that may cause asthma symptoms or alert an addiction patient (substance abusers) when near a pre-identified, high-risk location.”
According to the FDA, medical apps that undergo FDA review will be assessed using the same regulatory standards and risk-based approach that the agency applies to other medical devices. Additionally, the agency will not regulate the sale or general consumer use of smartphones or tablets nor will it regulate mobile app distributors such as the iTunes App store or the Google Play store.
HIM professionals have been closely following mobile health, or mHealth, issues due to their potential impact on privacy and health records. HIM professionals worry about the accuracy of the information being collected through mHealth, and whether that information should be incorporated into a patient’s health record and used by physicians—or just used as an FYI for patients. The industry still awaits standards in mHealth that will better allow information collected via apps to be inputted into the electronic health record.
Click here to read the full FDA mobile health app guidance.