In Star Trek: The Motion Picture, the humanoid crew members of the Enterprise wore little boxes near the waistlines of their pajama-like uniforms. While their purpose wasn't explained in the film's dialogue, these were supposed to be medical telemetry devices that would periodically scan each crew member and report back to sickbay if something were remiss.
For many things in Star Trek, such as cell phones and voice-activated computers, art became reality -- and it's happening again. In this case, our "medical telemetry devices" are devices that are with us as much as those fictional Starfleet scanners were with Admiral Kirk and his crew: the near-ubiquitous smartphone.
The explosive rise of medical applications that run on smartphones and tablets has been noted by the medical profession for some time. Indeed, health care professionals are behind much of the innovation occurring with medical apps, as they seize the opportunity to build tools they can use on their iOS and Android devices.
But just as all new waves of technology bring with them room for growth and innovation, there are also risks that must be mitigated as well. And with medical apps, the risk isn't just a crashed app or lost data -- it can also be a human life.
Who's in the waiting room?
Wading into the medical application sector is a complicated business. Just ask Morgan Reed, a programmer on the advisory council of mHIMSS. mHIMSS is the mobile group of the larger Healthcare Information and Management Systems Society (HIMSS) non-profit, an organization that works on improving IT systems for the healthcare industry.
Reed can paint a broad picture of the state of healthcare IT these days. Right now, healthcare IT is undergoing a major retooling of its own: there's a government-mandated shift to convert all healthcare records into electronic format, not to mention the need to comply with new regulations coming into effect as part of the Affordable Care Act.
"Last year, the government invested $38.7 billion into converting to electronic records," Reed said, emphasizing some of the churn that's going on in medical IT right now. Into that mix, Reed added, you have all these new health and medical apps jockeying for the attention of consumers and health care providers.
These apps fall into two categories. There are consumer-facing apps such as MapMyRide, Glucose Buddy, and even Weight Watchers. These can be referred to as "health and fitness apps." There are even dedicated health and fitness devices, such as FitBit.
Then there are what can be described as the medical applications: apps that are used by health care providers to help clinically treat or manage information about patients. Apps within this category include iRounds, 10 Second EM, or Gas Guide.
Though they're proliferating rapidly, many of these medical apps face some strong challenges for health care providers and the hospitals in which much of the patient care is concentrated.
Hospitals, Reed explained, are very interested in adopting tablets for their medical staffs. But they also must figure out the best way for health care providers to not only access all these newly electronic medical records but interact with and update those records, too.
Clinical apps have additional hurdles.
"How do I take the data and put it into something that has clinical application?" Reed rhetorically asked, hypothetically describing an app where a physician might have to enter an order for additional morphine for a patient in need of pain management. In such an app, entering 5 picograms of the medication versus 5 micrograms (a million times more) is a huge difference, and not something you would want to get wrong due to a simple data entry error.
"This goes beyond 'look at me I lost five pounds' apps," Reed said. "We have to make sure we get this right. That means we have to embrace and work with the FDA."
Apps need a full workup
The idea of government regulations of some kind for medical apps is one that Dr. Steven Levine, professor of neurology and of emergency medicine at SUNY Downstate Medical Center, embraces wholeheartedly.
Levine is the principal scientific investigator on a study to develop mobile apps for stroke patients and their caregivers. The two-year study is funded by a grant from the federally funded Patient-Centered Outcomes Research Institute (PCORI).
Levine's team is approaching the creation of these stroke apps with a great deal of research methodology and academic rigor. The ultimate goal of these apps will be to give stroke survivors and their health care providers a way to monitor and manage the patient's life after a stroke event -- and to help keep another stroke from occurring. Since strokes are the number one combined killer globally, it's a challenge that Levine wants to get absolutely right.
This level of research is not something Levine sees much of in the medical app sector. In fact, he was surprised how few peer-reviewed papers there were measuring the effectiveness and usability of applications.
"People aren't taking the time and devoting the energy to apply the research methodology," Levine said.
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.