mHealth, also known as mobile health, is a form of telemedicine using wireless devices and cell phone technologies
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “General Wellness: Policy for Low Risk Devices.” FDA is issuing this draft guidance to provide clarity to industry and FDA staff on the Center for Devices and Radiological Health’s (CDRH’s) compliance policy for low risk products that promote a healthy lifestyle (general wellness products). This draft guidance is not final nor is it in effect at this time.
Physicians are under increased pressure to save money while not cutting into patient care. Mobile apps have evolved and are doing a better job of helping physicians do this by offering tools that allow physicians to do complex calculations and quickly search for information.
Research firm Kalorama Information, for instance, named telemedicine one of its top 5 health trends for the year that was, while IDC Health Insights gazed ahead in its annual predictions, projecting that some 65 percent of transactions with healthcare organizations will be mobile by 2018, a reality that would fuel telehealth encounters as part of an omni-channel strategy.
Samsung has just announced at the Samsung Developer’s Conference that the open reference version of it will be available to be ordered by developers today.
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.
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