The FDA is looking at new rules to govern AI, but is the rulebook outdated?

by Sean Ruck, Contributing Editor | October 08, 2019
From the October 2019 issue of HealthCare Business News magazine

From 2011 (the year of Snapchat’s introduction) we jump back to the 1960s and 1970s. In 1962, sci-fi author Arthur C. Clarke’s first adage was published that would become known as Clarke’s Three Laws. By 1973 the third in the trio saw the light of day. Primo explains that the first law has to do with “when a distinguished and elderly scientist states that something is possible, he is almost certainly right. When he states that something is impossible, he is very probably wrong.”

Primo says the second law states that the only way to discover the limits of a possibility is to venture a little bit past them into the impossible. “The third law, any sufficiently advanced technology is indistinguishable from magic, is where we are today. We see it with Snapchat, where the application does seemingly impossible things with images. AI has come a long way and where it will end is probably never,” he says.

The final leap takes us back to present day. The FDA faces a regulatory challenge with medical devices based on software only, Primo says. These devices are actually software applications and better-known under the term “Software as a Medical Device” (SaMD). This terminology was defined by the International Medical Device Regulators Forum and these devices don’t necessarily involve hardware. To be effective, the FDA needs to be in step with those developing medical devices and software based on AI. When a manufacturer has developed the AI-based SaMD, the manufacturer’s organization needs formal FDA approval before marketing and commercializing this SaMD application. The FDA will make the determination about whether this specific SaMD is performing as safe and effective, as proposed. Is it safe for the healthcare provider and patients? Under which risk classification should the SaMD be categorized. Class I, II or III?

HCBN will cover these topics in the second installment, coming next month!

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