The face of medical education and practice has changed dramatically with the Internet and mobile applications. Now it is less likely medical students and doctors will make mistakes when they can instananeously check out information online on their PC or on their mobile device when on the road. Bill Gates, the founder of Microsoft, hit the impact of this revolution in learning and practice right on target in his book "Business @ The Speed of Thought: Using a Digital Nervous System." With this new technology minds have the capacity to simply move faster and in health care this can save lives.
However, caution is necessary in dealing with some types of Medical Apps in the new digital revolution and so the FDA is moving in with regulatory guidelines. Matthew Coleman has reported for Emergency Medicine News "FDA to Regulate Mobile Medical Apps." Numerous medical apps for doctors with smartphones and tablets have appeared. Now the Food and Drug Administration has said it will subject certain medical apps to strict class regulations.
An FDA spokesperson has told Emergency Medicine News in an interview “The use of mobile medical applications on smartphones, tablets, and other communication devices by health care professionals to diagnose and treat patients is revolutionizing health care. The FDA has a public health responsibility to oversee the safety and effectiveness of a small subset of mobile medical applications that present a potential risk to patients if they do not work as intended.”
The FDA will be scrutinizing medical apps that act as an accessory to a medical device and medical apps that transform the mobile device into a medical device. Some examples of apps that fall under the regulatory oversight are applications which allow the user to view medical images, such as digital mammography or digital images of potentially cancerous lesions on a mobile platform.
The FDA will also be regulating those medical apps that perform a health analysis or provide a diagnosis by trained health care professionals, applications which allow the user to view patient-specific lab results, and applications that connect to a home use diagnostic medical device to collect historical data, or to receive, transmit, store, analyze, and display measurements from connected devices. Although the majority of mobile apps will not fall under this proposed FDA oversight, the apps in this subset are seen as presenting a potential risk to patients.
Photographer : Ambro
