The IoT, or Internet of Things, refers to the growing trend of tracking and controlling everyday objects using the internet. Now, anything with an on/off switch and a special sensor — from coffee makers to lamps and washing machines — can send and receive data via the web. In this article, we’re going to focus on the IoT in healthcare.
Best intentions, unintended consequences
In late 2017, the U.S. Food & Drug Administration (FDA) approved the first digital pill for general human consumption. The product is part medication delivery system and part IoT device. The medication component is Abilify (aripiprazole), an antipsychotic used to treat bipolar disorder, schizophrenia and other mental health diseases.
Inserted within the tablet is an ingestible sensor that tracks the exact moment the pill hits the stomach, pinging an external patch worn by the patient and delivering that data through the cloud to a web portal or caregiver’s digital device. This astonishing feat brings with it a plethora of medical and ethical ramifications for patients and their healthcare providers.
What does the digital pill really mean for medication compliance, patient rights and the IoT in healthcare?
IoT devices are innovating healthcare by reducing invasive procedures, improving communications and streamlining workflows. But the new digital pill could have some unexpected negative ramifications for patient privacy and hospital reimbursement that could shift the clinical axis of “first, do no harm,” to “do this, or suffer harm.”
The IoT in healthcare: patient compliance
The IoT in healthcare represents a new wave of digital disruption. Abilify MyCite, the world’s first FDA-approved electronic pill, is only the latest. Today, smart beds have been linked to improved outcomes in pressure ulcers, and in-home medical devices can be monitored remotely by patient caregivers. From heart attack detection to transcranial direct current stimulation, the future of the IoT in healthcare is in the implantable device.
If you’re still skeptical, just follow the money. Globally, the use of IoT devices in healthcare was valued at 58.4 billion in 2014, with projections doubling by 2022.
Like the Greek God Proteus, the digital pill has the potential to change medicine — particularly in the area of patient compliance, which remains one of the most difficult outcomes to control. Earlier this year, The New York Times codified the problem of patient non-compliance:
- 20 to 30 percent of patient prescriptions are never filled.
- 50 percent of medications for chronic diseases are not taken as prescribed.
- Typically, only one-half of a full prescription is consumed by the patient.
- Non-compliance causes approximately 125,000 deaths annually and 10 percent of all hospitalizations.
- This costs U.S. hospitals somewhere between $100 and $289 billion annually.
The manufacturers of the digital pill suggest that it will help doctors address non-compliance by creating a record of when, how and if the patient consumed the medication. Caregivers could increase compliance by reminding patients who are overdue to take their medication. This could be particularly valuable in the area of mental health, where most studies suggest non-compliance is much higher. Nonadherence is, in fact, part of the disease itself. Many schizophrenics fail to recognize their illness, which leads to a cyclic behavioral pattern of refusing to take the medication that stabilizes their disorder.
A slippery slope?
While the Abilify digital pill might help doctors put these patients on the path to recovery, mental health patients are in fact some of the more vulnerable in the healthcare paradigm. That’s because of the stigma attached to these disorders. From public perception and movie portrayals of “crazy” to insurance parity, mental health is the slippery slope that can turn public opinion from sympathy to blame and judgment. This could open the door to coercive or punitive responses for medication non-compliance.
For example, could the digital pill become a requisite for release from an inpatient mental health facility? Could it also be tied to population health models in healthcare, signaling a drop in reimbursement for hospitals that fail to use digital compliance tracking?
What’s next for the IoT ingestibles
It’s clear that Abilify MyCite is the beginning of an entirely new service line for the IoT in healthcare. But as healthcare organizations are shifting their clinical care models toward the proactive treatment methods found in population health, is the digital pill the right way to encourage the non-compliant patient?
Some value-based hospital reimbursement is already linked to patient education and ultimately, compliance with treatment modalities. These new reimbursement models reward hospitals for patient compliance that reduces ER visits. Could creating a verifiable record of patient compliance cause CMS or other payers to further erode reimbursement if medication non-compliance correlates with an inpatient admission? Could a side effect of the digital pill be that insurers will increase policy rates based on the risk of individual non-compliance?
While many believe this additional pressure could improve patient compliance (and therefore health outcomes), it also forces doctors into the role of digital arm twister. The New York Times quotes a psychiatrist who calls it, “packaging a medication with a tattletale.”
There are important ethical considerations to these new devices that will likely be worked out in the American judicial system. It’s expected that the pharmaceutical industry will widely adopt treatments incorporating medication and IoT devices. How will these devices affect the individual medical providers, such as the frontline clinical teams who might challenge how the digital pill is being mandated? 2017 already saw nurses being arrested for refusing to draw blood on a patient. How will the digital pill affect not only clinical outcomes but the ethical ramifications of advocating for vulnerable patient populations?
The jury’s out
It should be noted at this stage that no clinical studies on the digital pill and its ability to increase patient adherence to medication schedules have been conducted. Abilify hasn’t even been released to the public yet, so our best insight into the effect of these tools is simply conjecture.
No matter what the outcome of the technology and its impact on treatment, one thing is very clear — this Fantastic Voyage into the ingestible world of IoT devices is just getting started.