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Is there any hope for what some call the “siloed, episodic, reactive nature of U.S. healthcare, whereby patients seek care only after potentially costly health complications occur, and physicians are only reimbursed for expensive in-person office visits that may not reflect the day-to-day reality of the patient experience of living with complex chronic conditions”?
It’s a pretty grim assessment. And may seem even more so when you consider the source. That’s how FDA commissioner Scott Gottlieb, MD, and FDA lieutenants Jeffrey Shuren, MD, and Bakul Patel, writing in the Journal of the American Medical Association, characterize the obstacles involved in transitioning from volume to value.
But those FDA bigwigs also see a potential bright light in the darkness: Mobile medical apps, they say, could be at least part of the answer.
With a proven ability to influence behavior, software-based digital therapy is increasingly being seen as a bridge to value-based healthcare, especially when it comes to managing chronic diseases that account for seven of 10 deaths and 86% of healthcare costs in the U.S.
A recent Wall Street Journal article cites studies showing that a combination of “remote monitoring, behavior modification and personalized intervention overseen by the patients’ own doctors” has demonstrated improved outcomes in diabetes, heart disease, and lung disease.
Another study found that a mobile phone-based “health coaching intervention” helped patients lose weight and lower blood pressure.
Digital interactions can also be targeted toward improving medication adherence. As Anthony Perry, MD, vice president for population health and ambulatory services at Rush University Medical Center, tells the Journal, “We know there is a mismatch between the prescriptions we write and the prescriptions that get taken by patients.”
To address the mismatch, Rush is working with a tiny sensor that patients actually swallow. The sensor, which is about the size of a grain of sand, automatically records when medications are taken (along with other data) and transmits the information to a smartphone or other device. When patients miss a dose, the system reminds them to take their meds.
Who needs pills?
In fact, maybe, eventually, patients won’t even need all those pills. Digital therapy, some suggest, has the potential to help “curb our country’s dependence on prescription drugs and find better, more effective options for treatment.”
Others go even farther. “I’m confident that 10–20 years from now, when we look back on this phase of medicine, it’s going to seem backwards and even barbaric that our solution to everything was just giving out pills,” says a partner in an investment firm that’s betting on what it calls, digital therapeutics.
The firm sees digital therapy as the inevitable “third phase” of medicine, providing therapy and cures that are much less expensive to develop and produce than the chemical and protein drugs we rely on now.
How to regulate?
The fact that the game is fairly inexpensive to break into leads to another challenge for providers. Suddenly, hundreds of thousands of mobile health apps have become available, and quite possibly more by the time you finish reading this sentence.
How do we know which ones work (and how well they work) and which ones don’t? That’s the question the FDA’s top brass mentioned above were trying to address. The agency, the authors say, needs to “create a regulatory framework … that recognizes the distinctive aspects of digital health technology, including its clinical promise, unique user interface, and compressed commercial cycles for new product introductions and modifications.”
One way to do that is with a “precertification program” under which the FDA or accredited third parties would assess developers for the “quality of their software design, testing, and other appropriate capabilities.”
Not all apps are subject to FDA regulation, however. The FDA oversees apps intended to treat, diagnose, cure, mitigate, or prevent disease or other conditions. Policies must, say the authors, empower patients and clinicians, and facilitate innovation within a framework that provides confidence in a given app’s performance and reliability.
Digital healthcare technology can also improve value propositions by making it much easier for providers to connect and communicate with patients. Consumers currently spend two and a half hours a day on messaging apps, and that number is bound to grow. Smartphones have become an indispensable tool.
New AI-assisted technology helps providers communicate via smart phones and other mobile devices, and have been shown to both deepen patient engagement and help providers deliver outcomes that surpass expectations. These tools make it easy to connect with patients and their family members, send appointment reminders, and address concerns, thus improving patient experiences while reducing costs.