Ben Scharfe, Executive VP of AI at Altera Digital Health, addresses the evolving regulatory landscape for AI in healthcare, emphasizing AI developers' primary responsibility to ensure transparency so clinicians can understand and verify AI-generated outputs. AI is positioned to be a supportive tool for providers, not as an autonomous decision-maker, with emerging regulations beginning to codify the human-in-the-loop requirement. Ben warns of setting higher standards for AI than physicians and automation complacency, in which clinicians might over-rely on AI.

Ben explains, "Altera provides electronic health records predominantly as well as interoperability solutions for hospitals, health systems, and ambulatory systems. We predominantly serve the US, but we're also present in Canada, in Europe, and in the Asia Pacific region. So we have a global presence, but we do a lot of our work in the US."

"I think the regulatory landscape around the division of responsibilities is really something that is evolving. And so last year, at one point, there was a proposed federal moratorium on state-level legislation, with little, I would say, federal regulation to counterbalance."

"Maybe fortunately, it didn't pass, but since then, there's been a patchwork of state regulation. So I'd say the responsibilities are not entirely defined because they vary by state, and some of those regulations are somewhat contradictory. But recently, the FDA did put out some new guidance and essentially where the responsibility lies for builders. I'd say the primary responsibility is around transparency and enabling clinicians and care providers to understand the reasoning behind any output from an AI system. To be able to review the citations, the evidence used, and the data points the AI may have ingested or consulted in creating some sort of output, so the provider can still have ownership of the care. And essentially, I'd say the core theme there is not having AI that is really acting autonomously on a patient, but rather AI that supports providers who know what they're doing and are licensed."

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