Health industry is now Mobile! And we know that there is no looking back, since the use of mobile in the health industry is set to increase and the FDA has put regulations in place for health apps to suit the changes.
The use of mobile apps is so popular that the number of health apps has exceeded 100,000 especially for Android and Apple devices. In February 2015, FDA declared that mobile medical apps that act like medical devices and interpret information will be reviewed. It also warned companies that gave misleading information through health apps. Through regulations, FDA is making call on the effectiveness and safety of certain apps. Though some health apps come with minimal risk for patients and consumers, there are other apps that carry risks if not used correctly. The regulation has tailored policy to protect patients and it also encourages innovation in this field.
Some of the basic information such as apps that tract an individual’s daily steps, or one that enable patients to search medical reference or refill prescriptions will not be regulated. The type (tablets, iPhones, etc) of mobile devices that run a medical app will not be scrutinized.
As a customer, it is important to use apps that worth your money and time. Following is the list of FDA approved health devices and apps:
AliveCor Mobile ECG is a health app that turns your smartphone into an ECG device just by snapping the back of the phone. You can take cardiac measurement by pressing the phone against the skin over the heart. It has a feature that helps people to make a digital journal to track their activity, symptoms and diet.
AirStrip Technologies is a platform that connects clinicians with patient information and with other medical providers to share electronic medical record and improve care collaboration. The app was developed from a diagnostic aid that gives patient data from electronic medical records, medical devices and patient monitors to clinical practitioners – a platform that promotes EMR interoperability.
WellDoc’s device captures blood-glucose data and transmits it in realtime. The system serves as a personalized coach to assist patients manage their treatment and medication. The device is now called BlueStar and comes in a commercial model that engages a healthcare team to help patients manage type 2 diabetes.
iExaminer app and Ophthalmoscope was developed by Welch Allyn to detect conditions like retinopathy or glaucoma. The device is connected to an iPhone and allows providers to save the pictures to an email or patient file and print them.
It is the first medical app that can be used through iTunes. Mobile MIM was designed by MIM software to share images from radiology, radiation oncology, neuroimaging, nuclear medicine and cardiac imaging. The intention of this app is to improve physician access to scanned images to help them consult with colleagues on challenging medical cases and thereby decrease the time taken for image distribution. This app can be used to share images with referring physicians, patients and partner institutions.
ResolutionMD is diagnostic medical imaging software developed by Calgary Scientific. It allows providers to access patient reports and images across an individual medical practice or a large healthcare organization. Medical providers can securely review and consult from mobile and web devices without downloading the medical data.
Triton iPad App is a recently approved app to estimate the amount of blood loss during surgery. The app takes a picture of the blood collected in a container with the iPad camera and analyzes the amount in the cloud. The app was approved by FDA in March 2015. Similar app called Pixel app had been cleared by FDA in 2012. Both these apps are developed by Gauss Surgical. Pixel analyses blood loss by scanning the blood filled in sponges.
The above are FDA approved health app for physicians available in the market.
FDA Warned Apps in the Past
FDA has sent official warning letter to Biosense Technologies in 2013 for their Chek Urine Analyzer. Though the app works with smartphone using a FDA cleared reagent strip, it is snagged because the phone is used to analyze the result and so it is considered a medical device.
FDA is also likely to block import of a mobile device if the company does not secure the 501(k) clearance first. This was the reason why FDA prevented the import of Bluetooth enabled mobile ECD device from EPI Mobile Health Solutions, Singapore for almost a year.