This is completely fiscally irresponsible. Larger proportions of our medical devices are in greater risk yet resources are being driven away from regulation them.
Part of the reason why this isn???t a good idea has to do with financials. 50% of our medical devices and 80% of our pharmaceuticals are imported according to the FDA themselves in their report Pathway to Global Product Safety and Quality. They also said themselves that ???The safety of America???s food and medical products remains under serious threat??? it would take 9 years just to inspect every high-priority pharmaceutical facility alone, let alone those of lower priority.???
You know all those apps for that? Well, the Food and Drug Administration wants to regulate some of those that offer you health or medical guidance.
While they do want to encourage the development of new apps, they also want oversight. Especially on those that “present the greatest risk to patients when they don’t work as intended,” the agency announced on Tuesday. And they want your input on their proposed guideline.
By 2015, about 500 million smartphone users worldwide will be using a healthcare application. These apps can help fight obesity, diagnose diseases like malaria, and allow you to participate in clinical trials from your house.
The agency’s draft guidance defines only a small subset of mobile medical apps that “impact or may impact the performance or functionality of currently regulated medical devices.” This subset includes any app that mimics or substitutes the real thing:
- Apps that are used as an accessory to an FDA-regulated medical device. For example, one that allows doctors to make specific diagnoses by viewing medical images on a smartphone.
- Apps that transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices. For example, one that turns a smartphone into an electrocardiography (ECG or EKG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.
This means that most of the 17,000 health apps currently available to consumers won’t fall under the guidelines, like those that track exercise regimens or help you quit smoking.
“The use of mobile medical apps on smartphones and tablets is revolutionizing healthcare delivery,” says FDA’s devices director Jeffrey Shuren. “There are advantages to using medical apps, but consumers and healthcare professionals should have a balanced awareness of the benefits and risks,” adds FDA policy adviser Bakul Patel.
According to the agency, the guidelines will provide a “roadmap for software developers” who want to know the regulatory bounds of their industry. However, the ultimate responsibility for an app’s safety and effectiveness still falls to the manufacturer.
At the moment, the FDA does bestow its approval on some apps, PopSci reports, including a radiology tool called Mobiel MIM. But that approval at the moment is both pretty scarce and totally optional – that is, it’s a nice bonus if your app is FDA-approved.
Weigh in on the 30-page Draft Guidance.
Image: x-rays of iPhones by Eloise Claire via Flickr
