In digital medicine, there is often overlap between “medical necessity” and “interesting novelty.” Unfortunately, in some cases, devices that fall more in line with medical necessity haven’t caught up with the user-friendly data displays of more novel devices.
Anna McCollister-Slipp is the co-founder of Galileo Analytics, which creates visualizations and analytics of healthcare data. She also advocates for policies and technology to streamline and improve diabetes management. She has coped with type 1 diabetes for almost 30 years, and she sees the potential for more cohesive monitoring and treatment of her condition.
She has a continuous glucose monitor and an insulin pump attached to her body. Before meals, she uses an injector pen to administer Symlin (pramlintide acetate), a synthetic version of a hormone that is critical in controlling glucose levels. And she uses a pinprick digital glucose monitor about 10 times a day for more precise moment-in-time readings. These devices don’t talk to each other. They don’t have user-friendly apps or software to track progress.
McCollister-Slipp also uses a fitness tracker, digital scale, and blood pressure monitor. Plus, the tracker helps her determine correlations between glucose levels and exercise when she cross-references the data.
While tracking and controlling her diabetes is a cumbersome and time-consuming process, even the devices without streamline data displays make her life easier. “It’s a life changer,” she says of her array of devices. “I just wish they’d invest a lot more in making the data more usable.”
Since her diagnosis, McCollister-Slipp has seen the slow evolution of diabetes treatment. While digital medicine is having a general growth spurt, she warns, “As someone who lives with a disease that’s on the cutting edge of digital health, I’m also skeptical of the hype.
“It’s pretty easy to predict that things are coming fast when you see them in early stages, but complex diseases are complex to solve,” she says. At the same time, she’s “incredibly excited” at the possibilities within digital medicine, and she plans to continue advocating for expedient changes.
So what, exactly, is digital medicine?
“Boy, that’s a good question,” says Steven Steinhubl, the director of digital medicine at Scripps Health, a leader in medical technology research, study, and mobilization. “True digital medicine is really understanding the individual and what is unique about all of us. … It’s combining a much greater understanding of each individual’s distinctive response to the changing environment around them using mobile health technologies with, when possible, their digital genomic data.”
Eric Topol, the director of the Scripps Translational Science Institute and a member of Genome’s advisory board, explored the impact of the “digital revolution” on healthcare in his book The Creative Destruction of Medicine: “This is a new era of medicine, in which each person can be near fully defined at the individual level, instead of how we practice medicine at a population level, with mass screening policies for such conditions as breast or prostate cancer and use of the same medication and dosage for a diagnosis rather than for a patient.”
Steinhubl offers the example of high blood pressure, a common chronic condition. “There’s going to be dozens, if not more, genetic conditions that may be contributing,” he says. Digital medicine helps to identify and track certain genetic factors that can be determined through blood samples and linked to important physiological variations in continuous blood pressure records identified through smartphone-linked blood pressure monitors.
As Steinhubl’s and Topol’s comments show, it is impossible to separate digital medicine from genomics. Both aim at a more detailed understanding of the human body, both are too all-encompassing to apply a narrow definition, both try to collect as much information as possible, and, perhaps most notably, both focus on the individual.
One mobile information system called BaseHealth compiles genetic, medical, and personal information into one platform to provide doctors and patients a comprehensive view of the individual. It is among the best examples of digital medicine as the physiological chronicling of the individual. If information is power, BaseHealth shows that the packaging of that information can hold that much more power. With this application, genetic, clinical, and lifestyle data are compiled into a nuanced picture of an individual’s health, allowing for preventive care.
“I strongly believe there is a lot we can do about preventable diseases,” says Hossein Fakhrai-Rad, co-founder, CEO, and president of BaseHealth. “Our focus is mainly on common complex diseases. We want to deal with diseases that you can do something about,” he says.
At Scripps, a third of clinical trials originate from device developers who need to test their products. The other two-thirds are aimed at integrating digital medicine as a method of gathering information to treat a specific patient population.
Scripps is conducting one study that uses a wireless device to track atrial fibrillation, which is an abnormal heartbeat, and collecting patient blood samples to cross-reference genetic patterns and determine markers that may contribute to the condition. Studies like this can provide useful information about risk factors to enable preventive medicine. Scripps is also testing a handheld ultrasound machine that could be used in addition to, or eventually instead of, a stethoscope. Instead of listening to the heart and blood vessels to determine a problem, doctors could see blockages and leaks for a more verifiable diagnosis.
Scientists at Scripps are also conducting a study called Wired for Health that uses a wireless glucometer, blood pressure cuff, and ECG device (AliveCor) to test the management of certain chronic conditions. The study aims to determine if the use of such devices reduces the number of doctor and emergency room visits and saves on healthcare resources while improving patient care.
Mobile medical devices and apps are regulated primarily by the FDA, which classifies them according to patient risk if something should malfunction. The higher the risk, the more stringent the regulation. No risk, no regulation. While it sounds simple, there are still gray areas as to what qualifies as a medical device and what constitutes a greater risk.
“Devices that are more intrusive or where the level of resolution matters to the physician’s decision, those are the things that are edging toward more potential harm to the patient,” says Darrell West, the vice president and director of Governance Studies and the founding director of the Center for Technology Innovation at The Brookings Institution. At the same time, he says, “the regulatory situation has been complicated for device manufacturers because they have not been sure what devices are subject to regulation and which ones require FDA approval.”
The FDA released a guidance document for device developers last year, but in an industry so new and fast-paced, the kinks are still being worked out, according to several people involved in development.
Additionally, the FDA process is long, and the testing required is expensive, says Alisa Chestler, an attorney at Baker Donelson in Washington, D.C., who handles healthcare cases and represents physician practice groups that are integrating digital components into their care. There is also uncertainty about how digital medical devices affect legal risk to doctors and manufacturers. For example, what if a physician is monitoring a patient’s vital signs remotely but doesn’t see a negative sign quickly enough to address it before a related decline in that patient’s health? Is the doctor legally at fault? This remains unclear.
With the inherent legal land mines and regulatory snafus, Chestler offers simple advice: “If it’s done the right way, it’s done the right way.” In other words, with due diligence from everyone involved, technology will progress. As for what that “right way” is, it’s impossible to nail down an answer. “Unfortunately, it’s a consult-your-attorney kind of answer,” she says.
While there are many hurdles and unanswered questions in bringing these devices to the marketplace, pioneering companies are smoothing the paths for companies that will follow, says Matt Hendricks, a partner at Pharmica Consulting, which advises device creators. “Once those initial companies get through,” he says, “they really set the standards for what’s to follow. … In my opinion, the benefit to be gained is far greater than some of the potential liabilities.”
In the current healthcare system, doctors are reimbursed by insurance companies when they send a patient to labs for testing. Though digital medicine carries the potential for healthcare savings, the economics would have to shift to make much of the technology work out financially.
“All of mobile health is going to be hamstrung until the [shift of] financial incentives, which right now incentivize us to do more,” Scripps’ Steinhubl says. “Mobile health is really designed around the idea of: Let’s make this more convenient for individuals. Let’s get real-world information from their homes instead of having them come into the office.”
Healthcare systems are designed around “sick care,” he says, rather than health maintenance, which is the goal of devices from the Jawbone UP fitness tracker to the breast cancer-screening bra.
Recently, however, there has been a shift toward reimbursing healthcare providers for preventive measures that limit patients’ visits to the hospital. It’s the bud of the sweeping changes Steinhubl deems necessary for digital medicine to become an integral part of mainstream care.
“A lot of the stuff that we do in our office visits now is no different than in the 1930s,” he says. A nurse directs patients to hop on a scale, then fastens the blood pressure cuff around their arm. Next, the doctor enters with a stethoscope to check the heart and lungs. Breathe in, breathe out. Your grandma had the same checkup. “The difference was in the 1930s, about 40 percent of healthcare was in the individual’s home,” Steinhubl says. “I think what mobile healthcare allows us to do is to bring healthcare back to the home. … It’s not the same as the horse and buggy or the doc going to the house, but it’s going to feel that way.”
Digital medicine not only brings healthcare back into the home, but it also brings technology into the body. Its outgrowths range from devices that make healthcare more convenient to devices that make the human body function better from the inside out.
The following is not science fiction, though it may read that way. Fiorenzo Omenetto, David Kaplan, and Hu Tao, all bioengineers at Tufts University, and Michael McAlpine, a Princeton nanoscientist, created a bacteria-sensing “tooth tattoo” made of electrodes and chemical sensors mounted on a thin layer of engineered silk.
The silk is made to dissolve within 15 to 20 minutes of application, leaving behind the sensor, which is read and powered by a tiny attached antenna that communicates with a handheld device.
The device can detect bacteria that cause periodontal disease. Because of its size (slightly too big for a human tooth), it was tested on cows. More work must be done before the device can undergo clinical testing, but because so much about humans’ overall health can be determined from saliva, which contains biomarkers for many diseases, the implications are vast. If the sensor could be adapted to red-flag those biomarkers, it could be the beginning of a semi-permanent health monitor — like a fitness tracker for your insides.
It’s not a stretch to imagine that these “tattoos” could be applied on the skin to track other measures of wellness.
“If you think of all the body monitoring that is happening right now with exercise monitors, it’s very interesting to think about how these are becoming so popular, but they don’t really tell you much, if anything, physiologically. Imagine if you had that information,” Omenetto says. For example, a simple skin-mounted device could constantly monitor glucose levels to help people make better food choices.
Omenetto and his colleagues are collaborating with John Rogers at the University of Illinois at Urbana-Champaign on dissolvable bioelectronics mounted on silk. In 2010, they tested a silk-mounted brain-monitoring device on a cat. The material molded closely to the brain, as it does to teeth, fruit, and other materials. Devices like this have the long-term potential to both monitor activity and well-being and administer treatment targeted from the inside. A group of scientists, including Omenetto, are also developing small edible sensors that can be applied to perishable foods to alert consumers when they are going bad.
While the future could hold an app that tracks the freshness of the contents of your fridge, other devices are likely to change healthcare and wellness tracking in the short term. Breath analytics is among the next frontiers. While we generally know breathalyzers as the gold standard in field sobriety testing, similar devices could be used to screen patients for certain types of cancer and other diseases.
Steinhubl at Scripps plans to launch a trial of an “electronic nose” that works with a smartphone app to diagnose lung cancer. The device is made by Vantage Health, a company associated with Nanobeak Inc.
“You can imagine, if it progresses to where we’re good enough, every time you talk on your cellphone, you could potentially be screening for cancer,” Steinhubl says. “A device like this, refined over time, could potentially eliminate the need for mammograms or colonoscopies.” It could even put the cancer-screening bra out of business.
Still, there’s a long road ahead before digital medical devices become ingrained in mainstream care. There are obstacles — not everyone has a smartphone, not everyone is tech-savvy, and for those who are, healthcare in general must become more innovative and adaptable before these devices will be the norm.
Roadblocks aside, it seems that the pace of technological development is largely determining the pace of implementation. Institutions like Scripps aim to clear the path of regulations and policies by way of research and testing. In other words, they gather more knowledge about the devices that generate more knowledge about patients.
“It’s one of these rare changes in medicine that individuals, the healthcare consumers, can get behind and enthusiastic about, that providers can look at and say, ‘I can see this as something that’s going to help me care for my patients better,’ and for payers — any definition of payer, but especially the government as a large payer — to be able to say, ‘This is actually going to not only improve outcomes, it’s going to be a lot less expensive for me in the long run, too.’ It has the potential and will; we just have to show people,” Steinhubl says.
The way healthcare providers address medicine, from diagnostics to chronic-condition management, will continue to change rapidly. “We are on the very flat part of the exponential curve, the very earliest,” Steinhubl says. “It’s really going to be remarkable.”
In other words, “What we believe today is science fiction will tomorrow be science,” says Albert of AliveCor. This digitally enhanced future will inevitably focus more on the individual. It’s the doctor’s return to the home, though the patient may see him even less.