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
The agency called it a tailored approach to mobile
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.
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
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,
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
The FDA is focusing its oversight on mobile medical
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.
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.
Identifying Medical Devices Will Strengthen Safety
By Jeffrey Shuren,
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.
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
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.
5Star, included in all new GoPlans for Jitterbug,
transforms the phone into a personal medical alert device, company says
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.
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.
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
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.
You may be eligible for money damages if you owned or leased one of these VW, Porsche or Audi vehicles.
In the major scandal of 2015, Volkswagen cheated you and the world. They rigged diesel emission controls so you, nor regulators, would know how much pollution their cars were adding to our environment.
They were caught and have reserved $7.3 billion to help "make it right" with victims.
If you owned or leased one of these vehicles, contact us now.
Janicek Law attorneys are actively pursuing these cases against VW. Do Not Wait...