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.
The American Telemedicine Association (ATA) will host its annual Fall Forum in Palm Desert, Calif., on Sept. 6-9, 2014. The forum will consist of two full days of program related to telehealth in chronic care, a full-day forum focused on telemedicine opportunities in China, and an executive leadership retreat for CEO’s of the world’s leading healthcare technology companies and institutions.
“We believe that a patient-physician relationship must be established to ensure proper diagnoses and appropriate follow up care,” said AMA President Robert M. Wah, M.D. “This new policy establishes a foundation for physicians to utilize telemedicine to help maintain an ongoing relationship with their patients, and as a means to enhance follow-up care, better coordinate care and manage chronic conditions.”
TeleHealth Solutions is now offering “Migration Services” for existing telehealth/telemedicine systems. If your current system is no longer meeting the needs of your providers or the technology is failing to grow with your business, TeleHealth Solutions can help. Our team will evaluate your existing system technology, features, and functionality – offer a replacement strategy – develop a migration plan – implement the new solution.
If an ensuing six-month feasibility study is successful, project coordinator Dr. Paul Porter envisions an ambulance crew someday responding to a stroke victim, using the eyeglass technology to provide real-time video and audio to a neurologist back at the hospital who could then order a clot-busting, brain-saving drug immediately.
