The Journal of mHealth Vol 1 Issue 1 (Feb 2014) | Page 21

FDA Issues Final Guidance on Mobile Medical Apps
replacing the judgment of clinical personnel, or performing any clinical assessment. Examples include mobile apps that are:
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Medical flash cards with medical images, pictures,
graphs, etc.;
Question/Answer quiz apps;
Interactive anatomy diagrams or videos;
Surgical training videos;
Medical board certification or recertification
preparation apps;
Games that simulate various cardiac arrest scenarios to train health professionals in advanced
CPR skills.

3. Mobile apps that are intended for general patient education and facilitate patient access to commonly used
reference information. These apps can be patient-specific (i.e., filters information to patient-specific characteristics), but are intended for increased patient awareness, education, and empowerment, and ultimately
support patient-centered health care. These are not devices because they are intended generally for patient education, and are not intended for use in the diagnosis of
disease or other conditions, or in the cure, mitigation,
treatment, or prevention of disease by aiding clinical
decision-making (i.e., to facilitate a health professional’s
assessment of a specific patient, replace the judgment
of a health professional, or perform any clinical assessment). Examples include mobile apps that:
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Provide a portal for healthcare providers to distribute educational information (e.g., interactive
diagrams, useful links and resources) to their
patients regarding their disease, condition, treatmen Ё