The Journal of mHealth Vol 1 Issue 1 (Feb 2014) | Page 22

FDA Issues Final Guidance on Mobile Medical Apps
Continued from page 19

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specifically intended for medical purposes);
Provide maps and turn-by-turn directions to
medical facilities.

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Examples of mobile apps for which FDA intends
to exercise enforcement discretion
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This extract provides examples of mobile apps that
MAY meet the definition of medical device but for
which FDA intends to exercise enforcement discretion.
These mobile apps may be intended for use in the diagnosis of disease or other conditions, or in the cure,
mitigation, treatment, or prevention of disease. Even
though these mobile apps MAY meet the definition of
medical device, FDA intends to exercise enforcement
discretion for these mobile apps because they pose lower risk to the public.

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The FDA understands that there may be other unique
and innovative mobile apps that may not be covered in
this list that may also constitute healthcare related mobile apps. This list is not exhaustive; it is only intended
to provide clarity and assistance in identifying the mobile apps that will not be subject to regulatory requirements at this time:

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Mobile apps that help patients with diagnosed
psychiatric conditions (e.g., post-traumatic stress
disorder (PTSD), depression, anxiety, obsessive
compulsive disorder) maintain their behavioral
coping skills by providing a “Skill of the Day”
behavioral technique or audio messages that the
user can access when experiencing increased anxiety;
Mobile apps that provide periodic educational
information, reminders, or motivational guidance
to smokers trying to quit, patients recovering
from addiction, or pregnant women;
Mobile apps that use GPS location information
to alert asthmatics of environmental conditions
that may cause asthma symptoms or alert an addiction patient (substance abusers) when near a
pre-identified, high-risk location;
Mobile apps that use video and video games to
motivate patients to do their physical therapy exercises at home;
Mobile apps that prompt a user to enter which

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February 2014

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herb and drug they would like to take concurrently and provide information about whether interactions have been seen in the literature and a summary of what type of interaction was reported;
Mobile apps that help asthmatics track inhaler
usage, asthma episodes experienced, location of
user at the time of an attack, or environmental
triggers of asthma attacks;
Mobile apps that prompt the user to manually
enter symptomatic, behavioral or environmental information, the specifics of which are predefined by a health care provider, and store the
information for later review;
Mobile apps that use patient characteristics such
as age, sex, and behavioral risk factors to provide
patient-specific screening, counseling and preventive recommendations from well-known and
established authorities;
Mobile apps that use a checklist of common
signs and symptoms to provide a list of possible
medical conditions and advice on when to consult a health care provider;
Mobile apps that guide a user through a questionnaire of signs and symptoms to provide a recommendation for the type of health care facility
most appropriate to their needs;
Mobile apps that record the clinical conversation
a clinician has with a patient and sends it (or a
link) to the patient to access after the visit;
Mobile apps that are intended to allow a user to
initiate a pre-specified nur