Drug regulators are taking a look at smartphone and tablet applications that help patients monitor their health and connect with doctors remotely.
On Monday, the Food and Drug Administration released formal guidance for creators of medical apps, laying out which programs it thinks need to be regulated to protect patient safety.
The apps allow doctors to check an X-ray, perform an ultrasound or help someone with diabetes easily monitor their blood sugar from a distance. But if they malfunction, those apps could recommend an unnecessary medical treatment or unsafe prescription dosage, potentially posing a threat to patients.
“Mobile apps are unleashing amazing creativity, and we intend to encourage these exciting innovations,” Bakul Patel, senior policy adviser for the FDA’s device center, said in a statement. “At the same time, we have set risk-based priorities and are focusing FDA’s oversight on mobile apps that are devices for which safety and effectiveness are critical.”
To promote the growth of medical apps, the agency said that it would not enforce standards for most apps that log and track health data, since they “pose minimal risk to consumers.” Instead, those programs could likely empower Americans to better monitor their health.
However, the FDA will target apps that are intended to be used along with another medical device, or those that turn a user’s smartphone or tablet into a device that would be regulated under normal conditions.
Those devices can pose a threat if they don’t work as intended, the FDA said. For instance, an app that calculates dosage of a drug or radiation therapy could malfunction and lead to a patient receiving the wrong dose.
To make sure the tools are up to snuff, the FDA will treat those apps like any other medical device.
The 43-page guidance document released on Monday finalizes a 2011 draft that received largely positive comments from the public.
So far, the FDA has cleared almost 100 mobile medical apps, including blood pressure monitors and tools for doctors to monitor heart rate.
