Mobile Apps in Healthcare – FDA Issues “Final Guidance”

Back in September the FDA issued what it is referring to as “Final Guidance” concerning how medical device regulations will be applied to mobile medical applications. The push has been on to firm up how these will be regulated within the context of existing rules, primarily due to the focus on pro-active healthcare via technology. With the Affordable Care Act still struggling the healthcare industry is wasting no time in looking forward to how they can begin to drive better patient results now that they drive the system, a complete turnaround from when it was the insurance companies that set the standards.

Multiple organizations now exist for the sole purpose of promoting more communications technology solutions for patient care. Many of these were started by the insurance providers, particularly those in the category of known as “provider of last resort”. Non-profit companies like the Blue Cross Blue Shield Network were among the early supporters of efforts like this.

This focus on using application development on devices that have historically not been used in patient care made it necessary for the FDA to give the firms a framework. The “guidance”, which is available here, is described as containing “nonbinding recommendations”. It is very detailed in what parameters you will need to consider when developing patient targeted apps.

Despite the fact that it is described as “nonbinding” it will be taken by most in healthcare seriously nonetheless, particularly as “not following” the guidance could expose them to legal problems if a patient suggests they have been adversely affected by an applications use.

The guidance covers both the device and the platforms that exist to support the app.

In the FDA’s press announcement concerning the final guidance, the first draft of which was issued in 2011, suggests a focused enforcement plan stating “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. 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.

Mobile apps have the potential to transform health care by allowing doctors to diagnose patients with potentially life-threatening conditions outside of traditional health care settings, help consumers manage their own health and wellness, and also gain access to useful information whenever and wherever they need it.”

The FDA is focused on mobile medical apps:

  • That are intended to be used as an accessory to a regulated medical device – for example, an application that allows a health care 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.
  • Or 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.

As the director of the FDA’s Center for Devices and Radiological Health Jeffery Shuren, M.D., J.D., says “Some mobile apps carry minimal risks to the 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,”

One thing is for sure. Mobile apps will have a big role in healthcare worldwide going forward. As consumer mobile devices become more and more integrated into our everyday lives it is only a matter of time until physicians start tapping into their power. Developing these applications will take a combination of healthcare expertise, firm knowledge of the FDA’s guidance and development experts who can translate that into useful mobile medical applications.

Outsourcing the development will always be a strong option for larger organizations like existing medical data companies, large physician practices, hospitals, and a myriad of yet to be innovated new patient solutions. The issues and complexities involved in developing fool proof apps that work well on a broad spectrum of patient devices require expertise often not available in-house. Low cost outsourced development may well be a way for innovative healthcare companies to begin to take advantage of the rush to capitalize on the power of mobile smart devices to better care for their patients.

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