Digital Diagnostics created the first FDA-cleared artificial intelligence to diagnose diabetic retinopathy — a potentially blinding eye condition linked to diabetes — without a doctor’s input. So John Bertrand, co-founder and CEO of the Iowa-based company, is well positioned to evaluate the business and regulatory challenges facing AI developers in health care. He spoke with Daniel about how the market — and the government — are receiving new artificial intelligence products. This interview has been edited for length and clarity. How is AI shaping the health care landscape? We’ve really crossed over from a novel technology mindset to one of validated use cases. We’re at a point where providers are ready to adopt AI. There are signals that things have gone mainstream. But many of the old conversations are still there, around bias, ethics and validation. Many of the principles from before still matter and will be discussed for some time. Are investors driving innovation? There’s a higher level of sophistication around AI from investors. Two years ago, if you said “AI” and waved your hands, someone would write you a check. Now you have investors asking really smart questions. I’d say we’re in inning two of the game, and people are now starting to understand some fundamentals: What is your revenue model? Are you going to be a reimbursed product? I find that to be good for the industry as a whole because we’re going to start to see products that deliver real value in the way health care needs it delivered. Will regulation affect what products succeed? We haven’t seen any major changes on the regulatory side, honestly. In the last few years, there’s been some forward-looking directional statements made by the White House and the FDA. There hasn’t been a ton of revolutionary change in how they’re approaching it. These regulatory bodies have done a good job of collaborating with the early technologists, getting the first several products through and getting feedback. But we’re at a point where there’s more innovation out there than there’s capacity to regulate. So I think more streamlining and cross-agency work is necessary.
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