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

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to set one up, in collaboration with Toronto’s emergency medical services, fell apart because of Canadian privacy concerns, Brooks says.

In Seattle, the fire department’s associate medical director, Michael Sayre, says he wants King County, which includes Seattle, to adopt PulsePoint, even though the county already has what could be the nation’s highest survival rate for cardiac arrests in public, about 60 percent.

“I think it could make a difference and further boost the bystander CPR rate,” says Sayre. “That would be an experiment, I could be wrong, but it’s not a lot of money in the big picture. It’s more about getting this project on list of things that need to be done. That’s the major barrier.”

PulsePoint is the product of a nonprofit foundation, with the engineering work donated by a big Bay Area software company. But for-profit companies are using a similar strategy: Build upon bodies of evidence that the medical community already trusts, and don’t scare customers away with high prices.

With $28 million in venture funding, Omada Health in San Francisco has designed an online program, inspired by social networks and augmented by coaches only a phone call away, that aims to keep people in danger of developing Type 2 diabetes from crossing the threshold into disease. It’s based on the U.S. government-funded Diabetes Prevention Program, a set of guidelines tested in real-world settings for 15 years and considered the gold standard in behavioral intervention for Type 2 diabetes.

A series of new design ideas for Omada's online Prevent program, posted in Omada's conference room in San Francisco. (Photo by Alex Lash.)

New design ideas in progress for Omada’s online Prevent program, posted in Omada’s conference room in San Francisco. (Photo by Alex Lash.)

According to a metastudy, those attempts at real world practice have shown average weight loss of 2.4 percent after 12 months. Omada’s Prevent program, in a study the company did with two outside investigators, achieved an average 4.8 percent weight loss after 12 months.

It also reduced A1C levels—a proxy of average blood sugar level in the previous three months—nearly 0.4 percent, which Omada medical director Cameron Sepah says took the average participant from prediabetic to normal glycemic range.

Those data are important to Omada. CEO Sean Duffy says, “We’ve gotten payer traction with that trial plus our commercial data,” which remains unpublished. Omada only charges its customers—Blue Cross/Blue Shield of Louisiana, HealthNet, and Kaiser are a few examples—if Prevent users hit the promised outcomes. More data could be coming soon from a current U.S. Veterans Administration study.

Omada now wants to use the same DPP guidelines and apply it to other diseases like hypertension and high cholesterol. It’s encouraged in no small part by an influential U.S. health task force’s recommendation that the intervention techniques would be beneficial to people with other metabolic or cardiovascular risks, says Duffy. “That guidance is influential to the payer community, especially after the Affordable Care Act.”

In a sense, Omada is doing the same as biopharma startups that spin out NIH-funded academic research: build a for-profit venture upon years of taxpayer-funded work. But it’s not spending years toiling in labs and running tests on mice, monkeys, and humans. Omada is building online apps that nudge people to eat better and exercise more, basically—or that get them to nudge each other, through the ever-more acceptable environment of a social network.

Another company involved in diabetes care is WellDoc of Baltimore, MD, although it has started with disease management, not prevention. Like Omada, it has passed the two levels of evaluation that Kvedar says firms need to sell into the healthcare sector: clinical and economic verification. It’s no surprise both have started with Type 2 diabetes. “If someone’s A1C level is above 7, and I lower it a point,” says Kvedar, someone—probably an insurance company—will save on average $4,000 a year. “The return on investment is relatively short-term for diabetes.”

The big challenge, he says, comes with behavior intervention that might not pay off for years. Smoking is bad, and stopping is good. But when? Those ex-smokers might “pay off” by not having major health problems 15 years down the line, when they’re probably in a different health plan. “The question is,” says Kvedar, “who cares enough about that to write a check right now? That’s why so many companies say they’d rather make a cute thing to put on your wrist, make some money, sell it, and move on to the next thing.”

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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!