By Lauren J.F. Barta and Timothy E. Grimsrud
Innovative medical and healthcare applications of artificial intelligence (AI) are everywhere:
The potential legal implications of these innovations are numerous, and lawmakers are trying to adapt existing laws and regulations—or create new ones—to keep up.
The Food and Drug Administration (FDA) is actively working to account for AI-enabled medical devices in its regulatory framework.
This year, the FDA piloted its Digital Health Software Precertification Program, which is a more streamlined and efficient regulatory framework for software-based medical devices.
Significantly, the framework focuses more on the manufacturer’s track record for quality and monitoring and responding to the real-world performance of its devices, as opposed to the device itself.
“Because software products can be adapted to respond to glitches, adverse events, and other safety concerns quickly, the FDA is working to establish a regulatory framework that is equally responsive when issues arise to help ensure consumers continue to have access to safe and effective products,” the FDA explained on the program’s website.
Intellectual property law has not been as responsive.
While the law has remained virtually unchanged with respect to AI, earlier this year, Andrei Iancu, Director of the U.S. Patent and Trademark Office, explained that policymakers will need to consider AI’s impact on the legal concepts of “inventor” and “author,” ownership of inventions created with AI, use of copyrighted materials to “train” AI systems, and patentability of AI systems or inventions that otherwise incorporate AI.
Iancu’s list is likely the tip of the iceberg.
There also does not appear to be any significant legislation proposed or case law in place to specifically account for liability allocation in the event of harm caused by AI-enabled medical devices or diagnostics.
Indeed, none of the few state and federal cases that even mention “artificial intelligence” or “machine learning” have addressed liability when AI is the “actor.”
AI innovation is everywhere in the medical and healthcare industries, and the law is likely to continue developing significantly to account for it. Medical device companies and healthcare providers are likely already mitigating their risk of exposure through indemnification and other contractual provisions with AI developers, but this will almost certainly be an important and developing area of law.