As more iPhone apps are released for medical purposes such as diagnosis and treatment of symptoms, Electronic Medical Records (EMR), and other health-related purposes, Apple‘s mobile device is garnering more attention from the FDA.
Don Witters of the FDA Center for Devices and Radiological Health (CDRH) said the agency’s goal is to achieve safe, secure, and reliable deployments of wireless technology in health care. As a result, the FDA more interested in the iPhone use by licensed medical professionals. Mobihealthnews.com reports that Witters has defined a medical device as:
“…an implementation, product, apparatus or other component or accessory, which is used in the diagnosis, cure, mitigation, treatment, prevention of disease or effects any structure of the body–that could actually include some information technologies and performance technologies–but usually something that is performed on the patient, touches the patient or is performed between physician and patient.”
Can an iPhone achieve many or all of these uses and purposes? Yes. It appears that an iPhone loaded with the proper apps is indeed a medical device of some sort.
If that’s the case, how should the FDA get involved in regulating the device? Witters said the FDA’s role is “to provide some reasonable assurance of safety and effectiveness in medical devices marketed in the U.S.”
mHealth apps developers as well as wireless medical device makers should contact the FDA to provide their views about how this emerging industry should be regulated. For questions on this subject, or to provide an opinion, contact the FDA’s CDRH. As regulations and roles are defined and categorized, so too will laws emerge regarding mobile devices and their medical use.