If you have a pulse and are familiar with Apple’s iPhone, you’ve heard the slogan “there’s an app for that.” With the number of apps exceeding 350,000 for just the iPhone and iPod Touch iOS platform, and ten of thousands of apps for the Android, BlackBerry and other smartphones, there are countless medical apps available. And just like Apple’s well known modern slogan, there is also another phase which is much older, scientia potentia est or “knowledge is power” – this is the phase that worries the Food and Drug Administration (FDA). The FDA is now proposing guidelines to regulate a small number of medical apps and oversee those that they deem could be dangerous to the general public if the information presented is wrong. All of these apps are medical related and will only be regulated if the information presented could put an individual at risk if the apps does not work as intended.
The policy advisor to the FDA, Bakul Patel, states that some of the apps have a simple goal of helping consumers manage their own health and wellness, for example the National Institutes of Health’s LactMed app, which gives nursing mothers information about the effects of medicines on breast milk and nursing infants. While there are other apps help health care providers improve and facilitate patient care – the Radiation Emergency Medical Management (REMM) app gives health care providers guidance on diagnosing and treating radiation injuries.
“There are advantages to using medical apps, but consumers and health care professionals should have a balanced awareness of the benefits and risks,” said Patel. “Apps can give consumers valuable health information in seconds and are opening innovative ways for technology to improve health care. However, the small group of mobile medical apps FDA proposes to oversee present a potential risk—these apps may impact how a currently regulated medical device (such as an ultrasound) performs.”
Patel added that the FDA wants to hear from as many consumers, advocacy groups, health care professionals, and software creators and distributors as possible to help finalize the proposed guidelines.
The FDA is open to hear public comment on the new guidelines, but you need to act fast as that period ends October 19th.
There are already a number of FDA ‘cleared’ apps including ultrasound and an apps for the iPhone and iPad which allow doctors to view medical images and X-rays.
FDA is proposing to oversee mobile medical apps that:
• Are used as an accessory to an FDA-regulated medical device. For example, an app could enable a health care professional to view medical images on an iPad and make a diagnosis;
• Transform a mobile platform into a regulated medical device. For example, an app that turns a smartphone into an electrocardiography, or ECG, machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.
If you feel that you have valuable input on the proposed FDA regulations, submit your comments online or in writing to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
There maybe “an app for that“, but the FDA wants to make sure that there isn’t a medical app that puts you six feet under.