Last updated: 9/25/18
Designing and deploying devices like the Apple Watch Series 4 is the easy part. The hard part is building systems of care that actually improve health based on the information supplied by technology.
Years ago, when I was a medical student, one of my mentors regularly told us to order a test on a patient only if we knew how the result would change the plan of care. This was his way of teaching us the difference between data and actionable information. I was reminded of this foundational wisdom as I read reports about the new Apple Watch Series 4 with fall-detection and electrical heart-rate sensor capabilities. It’s clear the Series 4 will generate new data. It’s less clear how that data can be harnessed to improve health outcomes in the real world.
Health IT has been “Data-Rich, Information Poor” (DRIP) for decades. It’s essential that data from devices like the Series 4 be turned into useful, actionable information. So, hoping to gain some insights on some possible practical applications of the Series 4, I called up my old friend and colleague Deepak Talreja, M.D., F.A.C.C., a practicing interventional cardiologist and experienced medical informaticist.
There is exciting potential in devices like the Series 4. They represent a significant step on the journey towards the Internet of Things (IoT) for health care. As Talreja noted, “Similar innovations have already reached the marketplace—with step-counting and biometrics of ‘Fitbit’-type wearable devices, CardioMEMS™ for heart failure, and the Alivecor Kardia portable phone peripheral that also offers an optional e-cardiology ‘over-read’ for an additional monthly fee.”
Talreja and I agree that the world will inevitably see the widespread deployment of a diverse array of devices that connect, communicate and collaborate to promote better health. While this vision is full of promise for the long run, it will face many challenges and limitations in the near term, however. Ultimately the “Iron Triad” of people, process, and technology will determine the success of these efforts so, it’s worth thinking about the Series 4 from this perspective.
“The competition between consumer-driven wearables and medical-grade devices will test the limits of HIPAA privacy laws, medical-provider and subspecialist access, the willingness of providers to evaluate nontraditional data streams both during scheduled visits and after hours, and medicolegal laws and precedents,” Talreja said. For devices like the Series 4, he concluded, “One key will be to ferret out what measurables are both useful and interpretable by consumers.” They will also test the reimbursement system since someone will have to cover the cost of all of this. The devices aren’t free. Providers are rightly reluctant to give their services away. It is unclear at this time who will pay for the device or services. Sure, some patients will pay out of pocket, but that’s not a scalable or sustainable approach.
The Limits of Technology
It’s important to be precise about capabilities when it comes to functions like electrocardiogram (ECG) production and analysis. The Series 4 is FDA-cleared to identify normal heart rhythms or signs of Atrial Fibrillation (AFib). It does not address other important, common and lethal cardiac arrhythmias like Ventricular Fibrillation. Essentially, the Series 4 can tell if you are “fine” or should “get checked out for possible AFib.” This may be useful but is also very limited.
AFib can be benign or lethal. Analysis based on the available FDA data suggests the Series 4 will have a positive predictive value of around 45%. This means more than half the time the ECG app flags a problem, it will be wrong. Throw in the expectation that the population of Series 4 owners is likely to skew towards younger and healthier and the number of false positives will be even higher.
This raises the real possibility of needlessly scaring a lot of people and wastefully taxing an already overburdened health care system. Based on his experience with remote monitoring and consumer devices, Talreja points to the “important implications of increasing utilization of primary care and subspecialty medical services, additional medical testing, and emergency room and urgent care visits by anxious patients who in some cases will be responding to monitoring artifacts.”
Interoperability with the rest of the health IT ecosystem is another big challenge. The Series 4 “interoperability” appears to be limited to production of a PDF. This will be highly limiting and potentially counter-productive. How will that PDF flow into the system of care in a timely and reliable manner? EHRs are already overstuffed with PDFs which can be hard to find and are unstructured. Will this PDF be one more “needle” in that “haystack”? And who, exactly, is supposed to read and act upon these reports?
People and Process: Who is Watching the Watch?
It does no good to have devices like the Series 4 generating data if we don’t know what to do with it or don’t have processes in place to reliably respond. Designing and deploying devices like Series 4 is the easy part. Building the systems of care that can act upon the information they supply will be much harder and essential if they are to have a significant impact on health.
And, this is a consumer-facing device so an effective system of care is highly likely to include the patient, their family, other caregivers in addition to traditional health care providers. It will not be easy to sort this all out into a reliable, scalable system. The Series 4’s fall-detection function provides an excellent window into these kinds of people and process challenges.
The Series 4 app can detect when the wearer has fallen and send an alert. I’m a member of the sandwich generation. The idea that I could support my elderly mom in her efforts to live independently and safely by having her watch tell me if she has “fallen and can’t get up” is appealing.
But I have concerns about process and making the info actionable. What if I am out of range, busy, asleep or incapacitated in some way? Who is “watching the watch” and able to act if I can’t? Those concerns are magnified if there are issues with sensitivity, specificity or if the device is prone to user error. There are also very basic “people” questions like, “Will Mom consistently wear the watch?”
The Cure for DRIP: A Population Health – AI Mash-up
Talreja believes it’s feasible to build “a reliable, scalable and useful IoT for health care out of devices like the Series 4, but this will ultimately require a combination of population health and advanced analytics.” He’s right, of course. As the number and variety of devices grows, the tidal wave of data they generate will have to be filtered for human consumption and action. If we don’t, we will just make DRIP worse.
For patients, there is the promise of AI-assisted interpretation and decision support that empowers them to better sort out what’s going on and what they should do. For providers, it is the promise of automated monitoring and notification – air traffic control as it were – to help them find and focus on the individual patients with serious problems. The addition of automated protocols for routine care will further reduce the burden on human providers while advanced decision support will assist them in dealing with complex situations even more effectively.
The Best Day or the Worst?
Upon hearing about the Series 4, Ethan Weiss, M.D., a University of California, San Francisco cardiologist, tweeted:
I can’t figure out whether today is the best day in the history of Cardiology or the worst
— Ethan Weiss (@ethanjweiss) September 12, 2018
Talreja and I agree the answer to Dr. Weiss’s question is “Yes.” It will be some of both. Eventually, a well-designed IoT for health care comprised of many such devices will be a boon to better heath at lower cost. However, the combination of limited functionality, weak interoperability, low positive predictive value and lack of well-defined care process points to a rocky start and limited benefits at first. Achieving meaningful success will be a challenge with many ups and downs and frequent reminders that turning data into actionable information requires serious attention to people, process and technology. Otherwise, it’s just more DRIP, DRIP, DRIP.
Dave Levin, MD is the Chief Medical Officer for Sansoro Health where he focuses on bringing true interoperability to health care. Dave is a nationally recognized speaker, author and the former CMIO for the Cleveland Clinic. He has served in a variety of leadership and advisory roles for health IT companies, health systems and investors. You can follow him @DaveLevinMD or email Dave.Levin@SansoroHealth.com
Deepak R. Talreja, M.D., F.A.C.C. is a practicing interventional cardiologist and medical informaticist. You can follow email him at firstname.lastname@example.org.