Investment in digital medicine has exploded in the past few years, with mobile apps and wearables unfurling vast amounts of previously unknown data to consumers, providers and health plans. But experts worry that a lack of standardized measures could slow provider adoption of digital tools.
“I can’t imagine purchasing a piece of biomedical equipment without proof of validation,” said Dr. Edmondo Robinson, senior vice president and chief digital officer at Moffitt Cancer Center in Tampa, Florida. “I would never unleash that on a patient, right? It would be wrong. So why would I do that with digital tools?”
Clinically validated digital endpoints—sensor-generated data collected from patients at home or other non-clinical settings—could help manage conditions that are costly and pervasive. However, few digital tools on the market have been formally approved like medical devices. While clinical labs and device makers must follow strict guidelines to ensure that test results and measurements are comparable, there are no similar standards for digital endpoints.
“The absence of clinical validation reduces the motivation for the parties to use these tools,” said Dr. Kaveh Safavi, a consultant at Accenture.
Moreover, few vendors have strong evidence that their solutions deliver the results they promise because their investors don’t require it, leaving it up to healthcare executives to separate fact from fiction.
“The big venture capital firms will give you hundreds of millions of dollars with no evidence, so long as you show some kind of engagement or you’re selling your product,” Robinson said.