Within the past week or so, the FDA has issued draft guidelines concerning mobile medical applications or “apps,” as they are more commonly referred to. Medical apps are sold for devices such as Apple’s iPad and iPhone, Blackberry phones, and phones using Google’s Android software.
Dr. Jeffrey Shuren, Director of the FDA’s Center for Devices and Radiological Health, has explained the rationale for these guidelines, stating, “The use of mobile medical apps on smartphones and tablets is revolutionizing health care delivery,” and these guidelines seek to regulate “only those mobile medical apps that present the greatest risk to patients when they don’t work as intended.”
Therefore, only a select number of mobile medical apps shall be subject to FDA scrutiny under the new draft guidelines; and these fall into essentially two (2) categories: (i) apps that are used as an accessory to a medical device already regulated by the FDA (e.g., an app that allows a physician to make a diagnosis by viewing a medical image, such as MRI’s or x-rays, from a picture archiving and communication system (PACS) on a smartphone or mobile tablet); or (ii) apps that transform a mobile communication device into a regulated medical device by using attachments or sensors (e.g., an app that converts a smartphone into an ECG machine to detect abnormal heart rhythms or whether a patient is having a heart attack, or provides a way to use a smartphone like a stethoscope).
Examples of other apps that are to be regulated by the FDA include:
- Apps that enable a physician from a remote location to see a patient’s vital signs displayed on such patient’s bedside monitor.
- Apps that work in concert with an insulin pump to monitor and control the delivery of the proper insulin dose;
- Apps that analyze patient-specific data to assist in the care of a patient or to recommend a specific treatment action;
- Apps that allow the user to input patient-specific information and uses algorithms to obtain patient-specific results or diagnosis (e.g., apps that collect patient-specific data and compute the prognosis of a particular disease).
According to Bakul Patel, an FDA policy advisor, the FDA is seeking to “strike that fine balance between promoting innovation and assuring safety and effectiveness” of those medical apps to be regulated. Two (2) concerns are that (a) the mobile device’s smaller screen size and lesser contrast ratio could adversely affect the quality of images appearing on such a device; and (b) a portion of the apps perform tasks that mimic the work of medical devices, but could cause harm if such apps fail to perform as promised.
Under the new FDA guidelines, software developers would, in some cases, have to show that their apps worked as well as non-mobile devices for the same use, and the FDA would have to provide clearance for such apps before they could be sold. In fact, the FDA has already approved several medical apps in response to requests from certain software developers. For example, within the past six (6) months, the FDA has approved a smartphone-based ultrasound and an app that enables physicians to view CT, MRI and other scans on Apple’s iPhone or iPad.
However, the FDA’s draft guidelines make clear that mobile apps that count calories, provide medical reference materials, assist with electronic medical records, are used to make decisions regarding general health and wellness, or automate general office operations, such as billing and scheduling, are not mobile medical apps and, therefore, shall not be subject to FDA regulation.
Still, the FDA intends to require general controls for all mobile medical apps, such as registration, listing, manufacturing quality systems, and adverse event reporting. However, if the app performs functions similar to those of currently-regulated medical devices, or involves functions that are critical to diagnosis or treatment decisions, the FDA may require greater oversight, such as pre-market review or pre-market application, together with such other controls as the FDA deems necessary to assure the safety and effectiveness of a particular app.
The FDA has signaled in the new draft guidelines that they will not use a heavy regulatory hand and, instead, permit the market and software innovation as it relates to mobile medical apps to continue to develop. However, the FDA has indicated that it intends to “monitor” other mobile apps in order to “determine whether additional or different actions are necessary to protect the public health,” thereby leaving the door open to further regulation of other medical apps in the future. But, the new guidelines should provide a certain level of comfort to physicians that use those apps that are the subject of such guidelines, knowing that such apps have been scrutinized and tested as part of the regulatory process.
The FDA is accepting public input and comments on the draft guidelines for 90 days, and such comments may be submitted online at http://www.regulations.gov. The FDA intends to update the guidelines based upon the feedback it receives.