Levine and his team are certainly not shying away from the effort. Their study intends to start with a survey of stroke patients and health providers to find out what features they would like in an app, and take into account gender and cultural differences found in device use.
For instance, how will stroke victims use these devices if their mobility and dexterity are reduced after a stroke event? And what will they use them for? Active monitoring of vital signs is one use, but an app that finds local stroke support groups or online forums might be just as effective in the long term in preventing another stroke. These are the kinds of questions Levine wants to have answered before ideally moving on to another funded project: actually building an app that reflects the results of the current study.
Levine doesn't see a lot of sense in not approaching medical app development in this manner, and holds little regard for the currently more prevalent approach of building apps and getting them to market as fast as possible. He believes this attitude is already prevalent in the pharmaceutical industry, which has led to products that are less than optimal. "Why be the first to market if you're not the best?" Levine argues.
Additionally, Levine sees a danger in just building any apps without complete research. For some apps, the content handled by the application will require the app to be compliant with the law. An app that tracks blood pressure or blood sugars is handling patient-specific data, and therefore must be HIPAA compliant. This is not something an app developer will want to get wrong.
Medical apps, stat!
Put any three doctors in a room together, though, and you're likely to get three different opinions.
Dr. Kurian Thott has an almost diametrically opposite approach to medical app development than Levine. Thott, Women's Health and Surgery Center physician and Chief of Women's and Children's Services at Stafford Hospital in Northern Virginia, is a firm believer in letting the market sort out which medical apps will succeed.
Adding regulations from the FDA "will be amazingly difficult," Thott said. "It will put a monkey wrench into the app development process."
And Thott knows a thing or two about app development. He's the originator of the aforementioned iRounds app, a tool that helps a group of physicians communicate better when one doctor hands off their on-call status to the next doctor in the rounds rotation.
The need for such an app was great for Thott, because patient hand-off is a critical point in a patient's care, and any communication error there can potentially lead to problems when the next doctor has to make decisions about the patient. Charting (on paper or electronically) can communicate basic information, but Thott wanted a tool that would deliver the nuances of what was happening with a hospitalized patient at any given time. Plus, a mobile app would be more convenient, since patient records are usually at the hospital, whereas an on-call physician might be at home or in their private office.
It was this pain point that led Thott to begin working with a team of software engineers to build iRounds. It's this kind of need that Thott believes will continue to drive innovation in the medical app sector. It's not that apps should be built without thought about patient care or the app's practicality; Thott just believes that, as practitioners, health care providers should be able to figure out how apps will work best for them.
"Eventually the market will dictate what's successful and what's not," Thott emphasized.
Filling the prescription
Ultimately, it may come down to a balance between these disparate views.
In this kind of scenario, applications are screened and filtered by peers and an insurance provider to ensure quality, without government regulations. Reed sees solutions like Happtique as portals where doctors could trust an app well enough to actually prescribe it for patient use.
"This would be a really revolutionary way of dealing with apps," Reed said. Delivery of apps in this nature would ensure better app quality and keep the doctor aware of what apps the patient was using to improve their health.
Whether public or privately regulated, it's clear that some sort of management of medical apps is coming soon. But is it too late to regulate such an exploding industry?
That's a diagnosis that may have to wait.