Picture this. You wake up in the morning and your Google calendar reminds you that you have an appointment with your doctor at 10 am for a checkup. You get ready, head to your computer and check in to your appointment via video chat software directly with your doctor. He asks the usual questions, and has you use your phone to do routine checkup procedures (e.g. checking your heartbeat, general health, etc.). At the completion of your checkup, he sends you a virtual prescription through an iPhone app. In addition, you use this same app to download your health records and to keep track of specific health status metrics that keeps him informed of your current health status and its progression.
There are no waiting lines, no driving to your appointment in a rush, your health is managed in the privacy and convenience of your own home. The mobile health (mHealth) application market is headed for explosive growth, according to a new report by Research and Markets, which has projected the market will swell 61 percent by 2017, reaching $26 billion. This is where our future is headed, and if you are in app development you are going to need to understand 3 key factors in this space prior to starting any mHealth project.
1. Consider your user groups and healthcare environment early and throughout the entire development process
It is extremely important to understand the target groups and environments that your app is being designed for. As an mHealth app developer you want to think about it early on in the design process and revisit it throughout the life cycle of the project. Essentially, stakeholders who are involved need to understand if their needs are going to be met when using your product.
Think about the obvious questions such as how you can monetize, is there a demand, etc., but also be aware of who and what environments the app is being designed for. It may be that certain facility policies will not allow for the app to be implemented, and therefore it is much better to know this before continuing with the idea and app creation. There are some tools you can use to employ such as work domain analysis, functional analysis, risk assessment, and usability testing (an approach which can encompass a lot of those lingering questions).
Some questions that will help mobile app developers in the development process for mHealth include:
Will your product be replacing an already existing product or will it be a new technology being introduced to the environment?
Will patients, healthcare providers, or both use it?
How will this product fit with other technology in the intended healthcare environment? For example, if it’s suppose to provide an alarm, what other systems are also in place that could possibly present conflicting alarms simultaneously?
Will it add interruptions or distractions to the healthcare personnel?
Will the healthcare system’s policy even allow for the use of mobile devices? (This is dependent on the hospital/facility itself.)
2. Will the FDA deem your product a mobile medical application?
There are a lot of apps coming out that are focused, simple, and not too complex in the self-health management and dietary arena. However, when you get into the apps that help diagnose or replace a medical device you will fall into FDA territory. For example, an app that allows you to take a picture of a wound and that generates a treatment plan for the wound would fall under FDA regulations. That’s where our team has been focused – helping companies navigate whether they need to get FDA approval or not, and if so how to go about the process with regards to human factors and usability testing.
The FDA has guidance in this area available for everyone (FDA: Medical Mobile Apps)
It can be a bit overwhelming to go through all of the information, but here are the key points taken from the FDA’s regulations that you should understand.
“A “mobile medical app” is a mobile app that meets the definition of “device” in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)4; and either:
· is used as an accessory to a regulated medical device; or
· transforms a mobile platform into a regulated medical device.
The intended use of a mobile app determines whether it meets the definition of a “device.” As stated in 21 CFR 801.4,5 intended use may be shown by labeling claims, advertising materials, or oral or written statements by manufacturers or their representatives. When the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man, the mobile app is a device.”
As stated in the regulations, the application’s intended use and how it is marketed to the public is a large factor that determines whether it falls under regulation.
Here is a good example (one that is mentioned in the FDA guidance): If you have an app with an LED light on your phone and you market it to assist in helping to find your keys or for use in the dark, then it is not subject to FDA approval.
Now, if you market it as a light that is specifically designed to help you examine a wound to aid in providing care or treatment guidance to a patient, then it may very well be subject to regulation.
3. HIPAA Compliance
HIPAA is privacy and security standards that were developed with 2 main purposes:
To implement appropriate security safeguards that protects electronic health information that may be at risk
To protect individuals health information while permitting the appropriate access and use of that information. This ultimately promotes the use of electronic health info in the industry.
HIPAA compliance is a bit novel with regards to the cloud-based arena, but it is definitely feasible and already being demonstrated with new apps already on the market. It is not difficult to attain compliance, but is an important topic to understand. A great option is to bring somebody in with a HIPAA compliance background to look at the design and data at an early stage to make sure your app meets all requirements and is good to go.
If you carefully examine all three points listed above, your medical mobile application will be ahead of the game and will have a much better chance of having success in the industry.