Category Archives: TeleHealth

Telehealth is the use of electronic information and telecommunications technologies to support long-distance clinical health care, patient and professional health-related education, public health and health administration

Examples of Mobile Apps For Which the FDA Will Exercise Enforcement Discretion

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.

FDA Examples of Mobile Apps

ATA wants to launch telemedicine accreditation program for primary, urgent care this fall

 

Medcity News

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.

ATA Guidelines