Syrian regime forces have allegedly targeted hospitals as a weapon of war, and doctors and nurses have fled the fighting. Telemedicine offers a way to guide treatment of patients in intensive care.
For the past decade, Mercy Health has explored telemedicine and its ability to deliver well-coordinated, state-of-the-art care to its patients in both rural and urban areas.
This list 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.
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.
These guidelines cover the provision of direct-to-patient, primary and urgent care services delivered by licensed health care providers using real-time, two-way videoconferencing and telephonic technologies. Such technologies include mobile devices such smart phones, laptops, or tablets where regulatory conditions permit.