Insights

Reimagining digital health regulation

An agile model for regulating software in health care

A digital revolution in health care

Over the last decade, software has begun to permeate and transform virtually every industry—and health care is no exception.

The software that drives market disruptors, including smartphones, social media, and the sharing economy, has fundamentally changed the way we live, work, and play. It's also powering game-changing developments in exponential medicine, including 3D printing, point-of-care diagnostics, robotics, bioinformatics, synthetic biology, genomics, and more.

Software is changing how clinicians practice medicine, how consumers manage their own health, and how patients and providers interact. One revolutionary development in digital health technology is software that can perform complex medical functions— software as a medical device (SaMD). SaMD can diagnose conditions, suggest treatments, and inform clinical management.

Reimagining digital heath regulation

What is SaMD?

SaMD is software that performs one or more medical functions. While the software may be embedded in a piece of hardware (as is often the case) it’s the software itself that performs the medical function.

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