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FDA Opens the Door to Rapid Growth in Health Apps for Smart Phones

Seniors may take greater interest in smart phones that help them manage their health

Jeffrey Shuren, M.D., J.D., Director of FDA’s Center for Devices and Radiological Health, blogs about mobile health care apps below main story.

Sept. 24, 2013 – Senior citizens, the biggest consumers of health care, have a new reason to get a smart phone. The Food and Drug Administration announced yesterday meaning it will not enforce requirements under the Federal Drug & Cosmetic Act for the majority of medical applications, or apps, which are software programs that run on mobile communication devices and perform the same functions as traditional medical devices.

The FDA announcement of the final guidance for developers of mobile apps says 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.

The agency called it a tailored approach to mobile apps.

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.

 

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Mobile medical apps currently on the market can, for example, diagnose abnormal heart rhythms, transform smart phones into a mobile ultrasound device, or function as the “central command” for a glucose meter used by a person with insulin-dependent diabetes.

“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, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

FDA Says Most Smartphone Health Apps Won't Get Regulatory Scrutiny

The federal agency will reserve its attention for apps that function like medical devices. Below is a roundup of other media reports on the FDA action by Kaiser Health News

The Associated Press: FDA Lays Out Rules For Some Smartphone Health Apps
Food and Drug Administration officials say they will begin regulating a new wave of applications and gadgets that work with smartphones to take medical readings and help users monitor their health. With the rise of the iPhone, Android and other mobile devices has come a flood of applications designed to help people stay healthy. Industry analysts estimate there are already more than 17,000 medical applications available, ranging from calorie counters to high-tech heart monitors (9/23).

New York Times: F.D.A. To Regulate Some Health Apps
The Food and Drug Administration said Monday that it would regulate only a small portion of the rapidly expanding universe of mobile health applications, software programs that run on smartphones and tablets and perform the same functions as medical devices (Tavernise, 9/23).

CQ HealthBeat: FDA Guidance On Medical Apps Targets Highest-Risk Programs
The Food and Drug Administration said Monday that it would not add new regulatory requirements for most smartphone medical applications but will target the relatively small number of apps that pose a greater risk to patients if they don’t work (Adams, 9/24).

This is part of Kaiser Health News' Daily Report - a summary of health policy coverage from more than 300 news organizations. The full summary of the day's news can be found here and you can sign up for e-mail subscriptions to the Daily Report. In addition, KHN’s staff of reporters and correspondents file original stories each day, which you can find on their home page.

The FDA is focusing its oversight 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.

Mobile 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.

The agency does not regulate the sale or general consumer use of smartphones or tablets nor does it regulate mobile app distributors such as the ‘iTunes App store” or the “Google Play store.”

The FDA received more than 130 comments on the draft guidance issued in July 2011. Respondents overwhelmingly supported the FDA’s tailored, risk-based approach.

“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,” said Shuren. “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”

The agency has cleared about 100 mobile medical applications over the past decade; about 40 of those were cleared in the past two years.

For more information:

   Mobile Medical Applications Final Guidance1

   Consumer Update: Keeping Up with Progress in Mobile Medical Apps2

   Mobile Medical Applications Web Page3

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

   Read FDA Blog: FDA Voice

   Visit FDA on Facebook, Flickr, YouTube and Twitter


Identifying Medical Devices Will Strengthen Safety

By Jeffrey Shuren, M.D., J.D. 

Medical devices are an important part of everyday life for many people. Some are used to diagnose, others to treat patients. Some are implanted in the body. Some are used by doctors in hospitals, while others are used by patients in their home or at work. 

Nevertheless, it may surprise you that unlike consumer products and medications, many medical devices do not have a unique identifier that unambiguously distinguishes one product from another. 

This is about to change. FDA is implementing a new system that will provide a consistent and standard way to identify medical devices throughout their distribution and use. 

It is called the Unique Device Identification (UDI) system. Most devices may be required to have a code on their label and packaging, and for certain devices, on the product itself, in plain text and a machine-readable format, like a bar code. This code will correspond to the specific model or version of a device and will include production information, such as the lot number and expiration date. 

Features for Senior Citizens

Jitterbug Mobile Phones for Seniors Get New Plans for Better Mobile Health, Safety

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Sept. 24, 2013 – The Jitterbug cell phone, designed for senior citizens and their families, has new service plans offering unlimited access to medical alert services, medical professionals, and other exclusive health management tools, all combined with minutes for a flat monthly fee. GreatCall, Inc., creator of the phone, announced the new plans last week. Read more...

It will also provide a link to a publicly available database – called the Global Unique Device Identification Database – where you can find information about some of the devices’ key characteristics, such as model and brand – but no identifying patient information will be stored there. 

FDA worked with the health care community and the device industry to develop a system that will provide a clear way of documenting device use in electronic health records and clinical information systems. 

Companies, health care professionals and patients will be able to report medical device adverse events more accurately. And recalls will be faster and more effective. When there are critical issues with a medical device, the UDI could be specified in safety alerts and recall notices. Health care professionals would be able to rapidly identify patients who have or are using the recalled device. At the same time, similar devices not implicated would not be taken out of use in a broad attempt to remove potential hazards. 

Implementation of the UDI system will take place over several years, beginning with devices that pose higher risks to patients – such as heart valves and hip prostheses (also known as artificial hips). Other devices, such as powered wheelchairs and blood glucose meters, will follow. 

This is a landmark step for FDA. UDI may be an acronym for Unique Device Identification, but what it really stands for is better patient health. 

Jeffrey Shuren, M.D., J.D., is the Director of FDA’s Center for Devices and Radiological Health 

Posted on September 20, 2013 by FDA Voice

Some of this information is reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives and sign up for email delivery. © Henry J. Kaiser Family Foundation. All rights reserved.

 

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