Leading Successful Change, Revised and Updated Edition by Gregory P. Shea

Author:Gregory P. Shea
Language: eng
Format: epub
Publisher: Wharton School Press

The case of IDx-DR illustrates the changes that will need to take place to leverage AI-enabled tools like IDx-DR. How will these devices be approved and regulated? How will providers be reimbursed? Aided by the FDA’s Breakthrough Devices Program that designated IDx-DR for priority review, Abramoff created a pathway for other autonomous AI in medtech to achieve FDA acceptance and approval. He had many discussions with the FDA over eight years to codevelop the principles for evaluating AI, ensuring it is safe, efficient, and equitable. Abramoff explains, “They used a lot of resources to work with us because autonomous AI was entirely new for them.”45

Additionally, autonomous AI poses unique legal liability questions, Mark Levy, partner at Eckert Seamans Cherin & Mellott, said at the Food and Drug Law Institute conference in May 2019.46 Abramoff explains that “autonomous AI is something very specific. It assumes medical liability. It makes a clinical decision without a physician.”47 IDx-DR has made it very clear that the company has legal liability for its screening decisions and so pulled the Rewards Lever to support the desired change. In its 2018 AI policy, the American Medical Association advocates for companies that develop autonomous AI to assume liability.48

Finally, Abramoff has worked to create an entirely new payment system for medical AI, another example of pulling the Rewards Lever.49 This is now mostly complete with the new CPT code.50

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