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With the speed and impact of innovation increasing rapidly, our institutions have struggled to keep up. For better or worse, rules and regulations have typically lagged behind the innovation frontier, responding only when a crisis or particular incident highlights a new challenge to be managed or risk to be mitigated. This dynamic isn’t specific to healthcare—just think back on all of the questions raised in the last few years with Tesla’s autopilot car crashes to see the parallels. Regardless of industry, for those innovators on the cutting edge, this creates an environment of regulatory uncertainly that is inherently risky for the companies that blaze forward assuming a specific regulatory approach will be adopted by the relevant authorities. The more disruptive the technology, the more likely it is that such an environment will exist.

With cutting-edge medical technologies today—including AI-based algorithms that theoretically can reduce HCP involvement in various aspects of patient care—there often isn’t a go-to approval process laid out, an existing CPT code or a well-understood assignment of liability. Let’s look at a recent example of how one medtech innovator is pushing through the ambiguity.