MIT to launch nonprofit focused on empirical evaluation of digital health products

MIT's Hacking Medicine program, which studies digital health and medicine, is set to become a nonprofit institute devoted to empirically evaluating the real-world effectiveness of the latest medical gadgets, gizmos, smartphone apps and the like.

Proving effectiveness is critical to gaining insurance reimbursement and "staying power" in the fast changing world of technology, where new products are being launched on a daily basis.

"There's so much hype now," Zen Chu, MIT faculty director of Hacking Medicine, told the The Wall Street Journal. "It's great, in a way. It's early stages, and there are so many startup companies. But they're all having the same trouble. What's actually working, and how do you prove that?"

Clinical trials aren't as effective for evaluating new-era, consumer-oriented devices that utilize technology because they don't tend to improve outcomes through chemical or even mechanical means, but by changing behavior. Any behavioral changes observed in a clinical trial--where subjects are being closely observed and monitored--won't necessarily carry over into the real-world.

"Clinical trials can show efficacy," Malay Gandhi of San Francisco VC and incubator Rock Health told the WSJ. "For digital health, you need to show effectiveness. That's different. The people who pay for things, like insurers, they want to see effectiveness."

Previously, utilization may have been enough to secure reimbursement, but the health economics paradigm is designed to judge devices based on outcomes, not volume of use. "The country is moving to value-based care," Gandhi told the WSJ. "So [digital-health products] need to be able to prove they are valuable."

One way for a health technology product to demonstrate value is by producing cost-savings for hospitals and technology. For example, Propeller Health's sensors are an attempt to solve the classic medical problem of non-adherence by providing and collecting information about real-life usage of inhalers. Its app gives personalized advice and coaching; other technology enables doctors to track inhaler usage in realtime so that they can optimize therapy.

Questions like whether those efforts reduce the $300 billion per year in spending attributed to medication nonadherence (and by how much) will be tackled by the MIT Hacking Medicine nonprofit. It will also create guidelines on evaluating digital health products.

According to the WSJ, the institute hopes to create working groups in October.

- read the story in the WSJ (sub. req.)