As the mobile health industry continues to rapidly expand with no signs of slowing down, FDA regulation of health apps has evolved too.
Today, there are more than 100,000 mobile health apps on the market for Apple and android devices, with mobile health revenues projected to jump to $26 billion by 2017, according to Mobile Health Economics.
In February 2015, the FDA announced plans to review mobile medical apps that interpret data and act like medical devices. (We include examples of companies the FDA warned about this at the end of this post.)
The agency is basically making a call on the safety and effectiveness of certain apps. “Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly. The FDA’s tailored policy protects patients while encouraging innovation,” said Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, in a statement.
The agency does not intend to regulate apps that track a person’s daily steps, enable patients to refill prescriptions or search medical references. Nor will they oversee the mobile devices, such as iPhones and tablets, which can run medical apps.
It’s important to know which apps are worth your precious time and money. Therefore, PYP updated our popular 2013 list of the best FDA approved health apps and devices:
AirStrip ONE evolved from a diagnostic aid that delivers patient data from medical devices, electronic medical records and patient monitors to clinicians – to a platform that enables mobile interoperability. AirStrip Technologies’ platform intends to connect clinicians with patient data and with other providers to share data and promote care collaboration.
AliveCor Mobile ECG turns your smartphone into an electrocardiogram by snapping on the back of an iPhone. To take cardiac measurements, a person presses the device against the skin over the heart. A new feature allows people to keep a digital journal and track their symptoms, activity and diet.
This device captures blood-glucose information and transmits it in real-time. WellDoc’s system offers a personalized coach to help patients manage their medication and treatment. WellDoc now calls its device BlueStar, and offers a commercial model that also engages a healthcare team in the management of type 2 diabetes.
Welch Allyn designed its iExaminer app and ophthalmoscope to help with detection of conditions like glaucoma or retinopathy of prematurity. The ophthalmoscope connects to an iPhone 4 or 4S and allows providers to store the pictures to a patient file or email and print them.
The first medical app ever offered through iTunes, MIM Software designed the Mobile MIM to share images from radiation oncology, radiology, nuclear medicine, neuroimaging and cardiac imaging. The company intends this health app to enhance physician access to image scans to help them consult with peers on challenging cases, reduce image distribution delays and share images with referring physicians, partner institutions and patients.
ResolutionMD diagnostic medical imaging software from Calgary Scientific allows providers to securely access patient images and reports across a single practice or large enterprise healthcare system. Providers can securely review and collaborate from web and mobile devices without downloading any sensitive data.
Triton iPad App
In March 2015, the FDA cleared the Triton iPad App for estimating blood loss during surgery. This app takes a photo of a blood collection container using an iPad camera, and then analyzes it in the cloud. In 2012, the FDA cleared the Pixel app, also from Gauss Surgical. Pixel estimates blood loss during surgery by scanning blood filled sponges in an operating room.
So there you have our recommendations for the most useful, not to mention coolest, FDA-approved health apps on the market for physicians.
Apps the FDA Snagged in the Past
In 2013, the FDA sent an official warning letter to Biosense Technologies Private Limited about their uChek Urine Analyzer. Although the app connects a smartphone to FDA cleared reagent strips, because it allows a phone to analyze the results, it’s considered a medical device.
The FDA might also block importation of a mobile device if a company doesn’t first secure 501(k) clearance. This was the case for EPI Mobile Health Solutions of Singapore, whose Bluetooth-enabled mobile ECG device the FDA prevented from entering the U.S. for nearly one year.
Xavier E. Martinez contributed to this post.
Have you used one or more of these FDA approved health apps? If so, leave your opinion for colleagues below.