The
U.S. Food and Drug Administration has released guidance
on mobile medical applications to inform manufacturers and distributors which
applications would require review and approval by the agency. It seeks public
comment on the document through Oct. 19.
According
to its draft guidelines made public on July 19, the agency would regulate a
small group of medical apps for smartphones that directly affect a patient's
health. The FDA will not regulate the sale of mobile devices themselves,
however.
A
separate FDA rule regarding medical device data systems took
effect on April 18 requiring IT companies to register health care hardware
and software that transfers, stores, converts or displays health care data.
The
FDA's Center for Devices and Radiological Health oversees regulations for
companies manufacturing, repacking, relabeling or importing medical devices in
the United States.
The
Federal Communications Commission governs smartphone airwave signals, while the
FDA regulates medical devices that provide treatment or therapy.
The
smartphone platforms for which medical apps would be regulated under the draft
guidelines include Android, BlackBerry and iPhone. Mobile apps in question
would reside directly on a smartphone or on the Web.
"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,"
Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological
Health, said in a statement.
The
apps that will require regulations are those that work as an accessory to an
FDA-regulated device and those that turn a smartphone into a medical device to
monitor health conditions. Apps that could turn phones into a stethoscope or
ECG machine to look for abnormal heart rhythms will fall under the regulations.
An
app that allows a physician to monitor a heartbeat or other vital signs such as
blood glucose readings would also need FDA approval. Other medical apps that
would be regulated might generate signals to check a patient's hearing or use a
smartphone's light to treat skin conditions.
Apps
that connect to medical imaging servers to allow doctors to view X-rays on
smartphones to make diagnoses would also fall under the guidelines. In
addition, screen size, contract ratio or inadequate ambient lighting could
affect the quality of medical images and impact patients' health, the FDA
reports.
The
agency's guidelines would not include medical reference, physician-managed EHR
(electronic health record) and patients' PHR
(personal health record) applications.
Practice-management
applications that allow doctors' offices to track billing, inventory and
appointments would also be unaffected by the regulations.
"If
it is marketed as a medical solution, the FDA has jurisdiction, and these
guidelines are actually a bit late," Rob Enderle, principal analyst at the
Enderle Group, wrote in an email to eWEEK.
At
UnitedHealth Group's Mobile Health and Technology panel discussion attended by
eWEEK on June 10 in New York City, Tom Marchioro, solutions architect,
fitness, for GPS manufacturer Garmin, mentioned that the company is
working on wellness apps for smartphones, but won't be developing those that
require FDA approval.
"We're
probably going to draw the line for the foreseeable future on things that
require FDA approval," Marchioro said, noting the long procurement and
approval cycles. "FDA approval slows everything down," he explained.
FDA
spokesman Dick Thompson had told eWEEK back in September
that the FDA would seek public input before issuing a final document. The
agency will issue an updated guidance following the end of the comments period
on Oct. 19.
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