Medical applications have played a significant role in the rapid adoption of smartphones and tablets, but to date, we’ve only covered two apps which were reviewed by the FDA prior to their public release (Mobile MIM, pictured, and AirStrip). However, the FDA announced yesterday that it plans to regulate mobile apps which would be used by doctors to diagnose or monitor their patients. The FDA released draft guidelines on its website and will be taking comments for the next 3 months.
More from the FDA:
A growing number of software applications are being developed for use on mobile platforms, which include smart phones, tablet computers, and personal digital assistants. As these mobile platforms become more user friendly, computationally powerful, and readily available, innovators have begun to develop mobile apps of increasing complexity to leverage the portability mobile platforms can offer. Some of these new mobile apps are specifically targeted to assisting individuals in their own health and wellness management. Other mobile apps are targeted to healthcare providers as tools to improve and facilitate the delivery of patient care.
As is the case with traditional medical devices, mobile medical apps can pose potential risks to public health. Moreover, mobile medical apps may pose additional or different risks due to the unique characteristics of the platform. For example, the interpretation of radiological images on a mobile device could be adversely affected by the smaller screen size, lower contrast ratio, and uncontrolled ambient light of the mobile platform; FDA intends to take these limitations into account in assessing the appropriate regulatory oversight for these products.
Press release: FDA outlines oversight of mobile medical applications