The App Will See You Now – Regulating Mobile Medical Apps

Cathy Betz
Written by Cathy Betz
on August 05, 2011

Want to learn how to interpret an electrocardiogram? Track your calories and exercise? Monitor your blood pressure? Find the nearest emergency room? Say it with me: There’s an app for that.

 The ever-growing number of health-related software applications, or apps, for smartphones, tablets, and personal digital assistants has caught the eye of the U.S. Food and Drug Administration (FDA). Earlier this month, the agency proposed guidelines for certain mobile applications specific to medicine or health care. Only a small number would be covered. And the industry is all atwitter about it.

The Mobile R(evolution)
As technology has evolved in both the medical and communications arenas, innovators have begun to develop mobile apps of increasing complexity to leverage the portability mobile platforms can offer. This has culminated in an explosion of software applications for mobile platforms that assist both individuals in wellness management and healthcare providers in patient care.

Today, mobile medical apps include a variety of functions, ranging from monitoring calorie intake, helping people maintain a healthy weight, and allowing doctors to view a patient’s radiology images on their mobile communications device.

 Scope of the guidance
“The use of mobile medical apps on smart phones and tablets is revolutionizing health care delivery,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health in a release. “Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended.”

Only a small number of the thousands of mobile apps would face FDA scrutiny under the new draft guidelines. They fall into two categories: apps that serve as an accessory to an FDA-regulated device, and apps that turn a mobile platform into a medical device. Examples are apps that allow a doctor to view X-ray or MRI images on a smartphone or tablet computer, or see vital signs displayed on a patient’s bedside monitor from another location. Others may allow connection of heart sensors on a patient’s chest to a mobile device, or provide a way to use a smartphone like a stethoscope.

The agency is not planning to regulate apps that are aimed directly at consumers to help them in activities such as recording caloric intake or physical activity that pose little risk to patient health.

Future forward
There can be little doubt that mobile devices will increasingly serve medical purposes, even functioning as medical monitoring devices. The concept of the phone as “pocket doctor” may still be questionable for some people, since there are only limited applications in this space so far, but the concept holds much promise. After all, our phones and mobile devices are with us much more constantly than doctors are.

 Consumers are ready to use mobile apps, text messaging, and even payment services to make health decisions and communicate with their healthcare providers. A certain level of regulation is needed to ensure that consumers have tools they can trust. 

The questions and comments are pouring in over the FDA’s guidance, making it obvious that the government’s first attempt to clarify its regulatory authority over this fast-growing field won’t be the last. The FDA is wise to extend its oversight to mobile medical apps.

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There have been made comments on this article

  1. Dena Rosko on at

    Hi, Thank you for this post. I like your blog. I hesitate to agree with your conclusion given conflicts of interest in the FDA. To me the Food & Drug Administration is ill-equipped to handle and justly manage the magnitude to which the medical industry has grown. Off the cuff I recommend a task force related to health reform.

  2. […] guidance from the Food and Drug Administration (FDA) for mobile medical applications. This year the FDA clarified its regulatory authority over this fast growing field. These applications will offer physicians the chance to view medical […]

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