So Far, Little Proof That Digital Health Is Healthy. Does It Matter?

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outcome-based data,” says AliveCor interim CEO Euan Thompson, the company’s third chief executive in two years. “We’re not claiming that the patient will therefore do better, we’re just detecting atrial fibrillation.”

Still, detecting A-fib is theoretically a very good thing. The National Stroke Association says it makes a person five times as likely to have a stroke, and 75 percent of A-fib related strokes are preventable. Thompson says AliveCor’s algorithm analyzes 100,000 heartbeats a month. It identifies A-fib correctly 100 percent of the time, he says, but still has a slight false-positive rate. (“We err on the side of caution.”)

That’s not yet good enough for Aetna, however. In the same policy bulletin that gives Zio a green light for reimbursement, the insurer writes this: “Aetna considers the AliveCor Heart Monitor (iPhoneECG) experimental and investigational because its clinical value has not been established.”

Thompson says AliveCor is in a different product category: episodic monitoring, not continuous monitoring. The product is in clinical studies, and the company would love insurance companies to tie the app’s use to the cost savings of preventing stroke, but “we are not supporting these clinical studies for the purpose of building a reimbursement case,” he says.

One effect of the new wave of heart monitors could be that more patients will be confirmed to have A-fib and wind up being treated with a drug regimen or a surgical correction called ablation. But much of the new health-related technology is about keeping patients away from surgeries, drugs, and other costly interventions. That’s an excellent goal.

On the other hand, keeping people away from expensive products is usually a terrible way to attract venture capitalists. But in the Obamacare era, fueled by widespread consensus that healthcare spending needs to drop, capitalists hope prevention has its rewards, as well.

One pilot study to watch is happening in Wyoming, where the state’s Medicaid program this year began using a smartphone app for pregnant women called Due Date Plus from Wildflower Health of San Francisco. It’s centered on a calendar, with reminders about prenatal checkups and milestones, and a checklist of symptoms that prompt women to call a health hotline. By the end of the year, Wyoming should be able to compare the first Due Date Plus group to years of baseline data: Are Due Date Plus mothers having fewer preterm babies, low-weight babies, and C-sections, for example?

Wyoming is not a populous state, of course, so the pilot data won’t be statistically significant. Neonatal intensive care unit admission [NICU] rate is normally 9 to 10 percent, says Wildflower CEO Leah Sparks, and the goal is to reduce that rate. “It will likely take at least a couple years to get sufficient data that we feel like the outcomes analysis has some level of statistical quality,” she says.

But she also puts weight on Wildflower’s ability to make Due Date Plus—and any other family-health app it develops—a brand-booster. “Everyone assumes that health plans only care about reducing medical costs, and we’re certainly tracking that for maternity,” she says. “But in a world where health plans are more competitive, with exchanges and new markets, they’ll be focused on other metrics like ‘how well am I retaining members,’ how well am I converting them to new products,’ ‘how well am I getting new enrollments,’ ‘what’s my brand level.’ That’s an easier metric on a year to year basis than certain types of medical outcomes.”

Sparks says two Silicon Valley companies who fund employee healthcare themselves have also put Due Date Plus into practice, with a third going live in November. “For those companies, one pregnancy that goes to the NICU and costs a couple hundred thousand dollars can really blow out your benefits for the year,” she says. “They also see maternity about recruitment, retention, and talent war. They have a lot of reasons to knock it out of the park with their prospective parents.”

Other app makers want their products to be so cheap and easy to implement, potential users won’t wait around for iron-clad proof. That’s happening in many U.S. municipalities with PulsePoint, the brainchild of Richard Price, a former fire chief in the San Francisco Bay Area town of San Ramon. Downloaded onto a smartphone, PulsePoint alerts users if they’re near somebody who’s made a 911 call for cardiac arrest. It also maps the nearest automated external defibrillator. The idea is that bystanders can start CPR and even apply the defibrillator before the first responders arrive. Years of public health data show bystander intervention saves lives. But there’s no proof PulsePoint works better than luck.

Nine hundred locations, with San Diego County one of the largest, don’t care. They’ve already integrated the PulsePoint software into their 911 call centers for $10,000, plus an annual license fee that goes from $5,000 to $25,000 based on population.

Steven Brooks, a Canadian researcher at Queen’s University in Toronto, wants to do a randomized clinical trial, but his first attempt … Next Page »

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2 responses to “So Far, Little Proof That Digital Health Is Healthy. Does It Matter?”

  1. Rob McCray says:

    Alex – this is a very good review of the issues. Within the 15 years of my experience in the field the conversation has moved from health and tech companies not understanding why they should work together to our current situation with tens of thousands of products and apps making mostly unvalidated health claims. We need to apply the discipline of science and clinical validation to the field which otherwise could end up like nutritional supplements – unregulated, generally lacking both validation and quality systems, and financially small $30 Billion compared to about $3 Trillion in health care spending). The problem is that traditional approaches are expensive and slow. They also are ill-equipped to validate tech-enabled services to a population of subjects whose environmental and behavioral inputs are constantly changing. Drs. Steinhubl and Kvedar are key thought leaders who are conscious of these matters. The challenge which my organization is undertaking is to move to a validation/regulatory model that is more dynamic and utilizes the technologies of connected health to assess both risk factors and effectiveness associated with medical products in real world conditions and within the context of the services that support them. In this dynamic approach, both the manner of use of these products and their software components can be modified to improve the safety/outcomes profile. The validation process thus becomes one that is continuous. We have done much better at regulating automobiles than medical products. With the tools at hand, it is possible to move (cautiously) toward a an Open Outcomes Based Regulatory model for medical products.

  2. Josh Trent says:

    The article has a negligible stance towards fitness wearables. It is important to remember that in order for behavioral intervention and/or fitness wearable technology to make dramatic impact leading to a tipping point in adoption, companies must be patient and give the market what it is asking for. As stated by Joseph Kvedar: ”…stay lean, pivot when it doesn’t work, and assume when people adopt it it’ll be right.” Very well put!