I grew up with a phone that had to be plugged into a wall, with a cassette tape for taking messages. I got my first mobile phone in 2007 - a flip phone that could take grainy photos and could barely (and painfully slowly) connect to an internet browser. Fast forward 15 years, and my (already outdated) 2019 iPhone 11 boasts face ID, an accelerometer, a compass, a barometer, video chat and streaming, access to high-speed internet, etc.
Smartphones are ubiquitous nowadays. In fact, 67% of the entire world uses mobile phones, and 92.4% of those users use their phones to access the internet. Due to the rise of smartphone apps, people can use their phones for just about anything, and medical care is no exception. Most major American hospitals offer Mobile Medical Device Apps. About 90% of physicians use mobile phones at work to access electronic health records (EHR), communicate with each other, and handle scheduling. And studies show that patients who use Mobile Medical Apps to access patient portals prefer them to older systems and cite significant benefits.
So what is a mobile medical device app, and what are some examples? What is it about them that makes them so widely used, and what are some possible downsides to consider? That’s what we will discuss in this blog.
What Is a Mobile Medical Device App?
According to the FDA, Mobile Medical Apps (MMA) are “medical devices that are mobile apps, that incorporate device software functionality that meet the [FDA’s] definition of a device… and are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device.” In other words, they are apps that use a mobile device’s hardware to perform medical functions, while abiding by the FDA’s terms and regulations for medical devices. This can be an app or an accessory attached to a device. For more information on what it means for an app to be a device itself, see our blog on SaMD.
“Mobile Medical” apps are often and easily confused with “Mobile Health” apps. Health apps are typically open to the general public and address general lifestyle and health conditions (nutrition, weight loss, sleep cycle, meditation, menstrual cycle tracking, etc.). As long as they don’t make specific claims on medical evidence, they don’t have to go through the rigorous regulation process that medical apps do. On the other hand, Medical Apps are mostly used and prescribed by medical professionals and have to comply with medical evidence, meaning that they undergo rigorous testing and must adhere to regulation and policies. Functions include chronic disease management, diagnostics and treatment, and remote monitoring and data collection.
Types of Mobile Medical Apps
Here are some categories of Mobile Medical Apps:
Display: This would be an app that functions as the screen and/or interface for a separate (or attached) medical device. It may fall under some of the other categories as well.
Medication Apps: These apps help patients and professionals measure patients' activity, food intake, and vitals to provide dosage information for a prescription drug, such as insulin.
Diagnostic App: These apps may use the mobile camera to take a picture of a test result, or a patient's condition, and provide an assessment.
Risk Assessment: These apps can integrate with health-monitoring devices to offer real-time monitoring for things like blood glucose, blood pressure, and arrhythmias.
Telehealth: Within a medical device app, patients can request and attend a video or audio appointment with a professional. These apps may also include EHR, messaging, virtual waiting rooms, and payment portals.
Accessories: These include physical attachments to the phone, such as stethoscopes, otoscopes, and EKG’s that perform a physical function then display the results on the mobile screen.
Pros and Cons of Mobile Medical Apps
There are many advantages to using a mobile phone as a medical device:
Easy to Get and Afford: Mobile devices start at affordable prices and are easy to access or acquire at a neighborhood store. This is cost and time effective for developers as well, as the need to produce a device to host their software is negated.
Easy to Use: Mobile devices are easy to operate, and most people already know how to use them. They can also typically go a whole day (depending on use) with a full charge.
Easy to Carry: It’s literally in the name “mobile.” Most are lightweight and can fit in any given pocket, hand, or handbag.
Connectivity: Mobile devices are made to easily connect to networks and to communicate with other devices. This is crucial for communication between people, devices, and/or databases.
Photo, Video, and Sound: Mobile devices typically can take pictures (and good ones, as of the last few years) and can record and display high-resolution video and sound, which can aid in telemedicine, recording data, and diagnosis of conditions.
Display: With high-definition screens, patients can easily view the information relayed to them, professionals can clearly see images taken of and/or by their patients, and video quality is clear during telemedicine visits.
Other Advanced Hardware Features: Mobile devices have embedded sensors and ports that allow for a multitude of treatment benefits, such as vital readings, and movement monitoring. They are also set up to accommodate accessories.
Apps: Mobile devices are built to host a variety of software apps, not excluding medical ones, and are regularly updated with new features and security measures.
Computing Power: The memory, power, and speeds of mobile devices are strong enough to accommodate the complex processes performed by many medical apps.
Increased Efficiency and Cost Effectiveness: This pro is multi-layered. Storing information and running payments digitally saves paper costs, time, and human resources. Apps that help patients stay current and accountable with at-home care (ex. medicine intake) reduce the need for minor check-ups, which allows medical professionals to put more focus on more urgent cases. This also potentially saves the patient time and money, as it reduces the need to take off work, find childcare, etc. or pay out-of-pocket expenses for minor visits. Another plus for professionals and facilities: many of these conveniences can also build patient loyalty. Finally, apps made to monitor the upkeep of equipment can also help hospitals save on repair and replacement costs.
There are however, also downsides to using a mobile device as a medical device:
Battery consumption: While it is certainly a “pro” that batteries allow a device to be transported without the need to be constantly plugged in, it is necessary to acknowledge that battery life isn’t perpetual. Some of the aforementioned complex processes run by medical devices can be particularly battery-draining. Even without that added risk, it can be dangerous if a patient is without a charger or an outlet for an extended period of time (ex. camping, car broken down, power outages, forgetting to bring a charger).
Unsatisfactory Audio and Visual Environments: Patients aren’t always guaranteed quiet spaces for telemedicine visits, making recordings, leaving messages, or listening to audio. Likewise, they aren’t always guaranteed proper lighting. This can affect a professional’s ability to examine and/or diagnose, but it can also affect the effectiveness of sensors (ex. a heart rate monitor that functions by detecting light reflection from a user’s skin). These are things that need to be addressed in future developments.
Security: Cybersecurity is always of concern when it comes to devices that can connect to the internet. Other security concerns include regular device updates; they technically invalidate apps and could potentially affect the function if the developer doesn’t keep up with the updates.
User Error: “To err is human.” Any of the cons listed so far have the potential to be worsened by human error (forgetting a charger, choosing a poor environment for audio or visual capture, connecting to an unsecure network, not protecting the device, etc.), and there are countless other mistakes that could be made. Additionally, users who did not grow up around technology (whether because of age or other circumstances) may struggle more than others.
The rapid development of mobile technology plus the ongoing developments in healthcare research have proven to be a super significant marriage. It puts patient treatment (literally) in the palm of their hands, while increasing communication between them and their providers. The life-saving, time-saving, and money-saving convenience of Mobile Medical Devices is only marred by a few (though not insignificant) drawbacks. I look forward to what breakthroughs the near future will bring!