Take this app and call me in the morning. A new wave of medical treatments are coming to your phone.

The development of mobile technologies create new opportunities to improve health and streamline communication between doctors and patients. Mobile medical applications (apps) can promote wellness programs, remind patients to take medications or schedule appointments, and even track vitals.

In September 2018, the FDA cleared two new apps for the Apple Watch Series 4, classifying the apps as class II medical products. These apps were reviewed separately from the watch itself. The watch is not a medical device, but the software is.

The first app is, ECG, (also known as EKG). This software-only electrocardiogram detects atrial fibrillation (AFib), an irregular heart rate that often leads to heart failure and stroke. The watch has built-in sensors so that when users open the app, the sensors perform an ECG. The ECG data is stored within the Apple Health app and can be transferred to third-party apps and shared with physicians. This is the first time that FDA has approved an ECG to users without first requiring a doctor’s review.

The second app, referred to as the Irregular Rhythm Notification Feature, is software that analyzes the user’s pulse rate by photoplethysmography (PPG), a technique that utilizes light to measure blood flow. If an irregular rhythm is detected, the app sends the user an alert.  

Apple has also teamed up with medical device company Zimmer Biomet, to enhance how patients communicate with their surgical care teams after hip and knee replacement surgery. Their app is enhancing the way patients recover from hip and knee replacement surgery by sending activity data to their surgeons and receiving messages about exercise videos and therapy reminders. The goal of the partnership is to connect patients with their doctors continuously, before and after surgery.  

Digital medical managers

Apple is not the only company promoting mobile medical apps. Google Play Store launched CareZone, an app that helps patients manage their medications and doctor instructions. Features include medication lists, doses, and additional doctor instructions if needed. It also includes a calendar to create and manage medication schedules.

Doctor on Demand is another Google app which connects you to a board-certified doctor in your area. This app does not provide comprehensive diagnosis, but it does provide quick help for things like the flu, depression, skin irritations, heartburn, anxiety, and other non-life-threatening issues.

In addition to CareZone and Doctor on Demand, Google has developed a “peer-to-peer” app called Figure 1, a knowledge sharing app for medical professionals. The app’s purpose is to host discussions on topics such as rare diseases, medical procedures, and picture sharing. Figure 1 helps healthcare professionals stay up to date on various diseases and therapies and promotes continuous learning throughout the healthcare industry.  

FDA oversight

As convenient and exciting as mobile medical apps are, they can also pose a health risk if they fail to perform as intended or give the user unreliable data. The FDA has a public health responsibility to oversee the safety and effectiveness of medical devices, including mobile medical apps. To this end, the FDA published the Mobile Medical Applications Guidance for Industry and Food and Drug Administration which explains the agency’s oversight of apps as medical devices.

The FDA focuses both on apps that present risks to patients if they fail to work as intended and on apps that could impact the functionality or performance of traditional medical devices. For mobile apps that meet the regulatory definition of a “device” but have minimal risk to patients, the FDA will determine enforcement discretion and will not expect manufacturers to submit premarket review applications or register their apps with the FDA.  

The FDA established classifications for medical devices based on the risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. The three classifications are; Class I, Class II, or Class III

Class I is defined as a device that poses the lowest risk to the user. Class II is defined as devices that has a moderate to high risk to the user. Class III are devices that pose a potential risk of illness or injury. Device classification depends on the intended use of the device and upon indications for use. The classification is viewed as “risk based”, so the risk the device poses to the user is a major factor in the determination of the class it is assigned to.  

These new digital advances allow users to take control of their health and set the stage for competing companies. If software in a smart watch can become a medical device, what’s next? Perhaps a video game to treat ADHD, or music apps that treat epilepsy. Is big pharma ready to compete with technology companies?

For a list of mobile medical apps that have been cleared or approved by the FDA visit the mobile medical apps example page .

Additional Resource:

https://www.globenewswire.com/news-release/2019/01/24/1704860/0/en/Global-mHealth-Apps-Market-Will-Reach-USD-111-1-Billion-By-2025-Zion-Market-Research.html