The FDA is evaluating if medical smartphone apps require additional federal regulation, according to reports.
Food and Drug Administration is looking into whether smartphone apps that allow
patients to monitor their vital signs wirelessly should earn FDA approval
Bradley Merrill Thompson, an attorney with law
firm Epstein, Becker & Green, who studies health care issues, told GigaOM
that the FDA is keeping an eye on app stores
to see which medical applications
for smartphones might require regulation.
"The FDA is actively engaged in surveillance of various app stores
to see if apps should trigger their involvement," Thompson told GigaOM
for an Aug. 31 report. "Applications where a smartphone is connected in
any way to imaging are under scrutiny, in particular. Any app that is
used to transmit images to a medical facility requires FDA approval."
GigaOM notes that the iStethoscope
iPhone application and the Instant Heart Rate
tool for Android could warrant FDA regulation.
"We are developing draft guidance that will
help clarify an appropriate policy and role for the FDA regarding the
regulation of mobile applications, including those on smartphones," FDA
spokesperson Dick Thompson wrote in a Sept. 8 e-mail to eWEEK. "Some mobile
applications are very similar to traditional software applications that the FDA
has already classified or regulated, but we believe that further clarifications
on mobile applications would be helpful."
Thompson added that the FDA plans to seek public input before issuing a final
On July 26, the FDA and Federal Communications Commission held public meetings
to explore the extent to which wireless medical devices should be regulated.
"Innovation in broadband and wireless-enabled medical devices holds
significant promise for enhancing health and reducing the costs of health care
for all Americans," FCC Chairman Julius Genachowski and FDA Commissioner
Margaret Hamburg wrote in a joint statement.
The two officials cited heart
rhythm monitors and glucose monitoring systems as examples.
and integrating wireless and broadband communications technology with medical
devices and applications requires agencies to assure that such devices operate
in a safe, reliable and secure manner," Genachowski and Hamburg added.
the joint meeting, Genachowski and Hamburg signed a Joint Statement of
Principles and Memorandum of Understanding on the agencies' commitment to both
innovation and patient safety.
medical devices allow patients to transmit vital information to patients over
the Web to allow doctors to make decisions on care remotely.
glucose monitors, insulin pumps and heart monitors as well as patch fetal
sensors for pregnant women, according to a joint statement by the FDA and FCC.
The FCC regulates smartphone airwave signals, while the FDA
regulates medical devices that provide treatment or therapy, according
to the two agencies.
Meanwhile, software companies may be hesitant to enter the medical app
market due to fear of FDA regulation.
degree of fear of the FDA regulations is putting established companies off from
coming into that market," U.K.-based wireless technology analyst Nick Hunn
"It's causing concern for startups, and perhaps most worrying of all, it's
making investors wary of putting money in a company if they have to go through
a protracted approval process."
Editor's Note: This article has been updated to include additional information from an FDA spokesman.