“FDA’s Proposed Regulatory Framework for Modifications to AI-Based Software as a Medical Device (SaMD): IP Review and Strategy Guide”February 9, 2022
Partner Ryan Phelan co-authored a white paper with members of the Intellectual Property Owners Association's software-related inventions and artificial intelligence (AI) and other emerging technologies committees discussing implications of the Food and Drug Administration's (FDA) proposed regulatory framework for modifications to AI software as a medical device (SaMD).
The committee report, announced in IPO.org's Daily News on Feb. 9, 2022, details patent, trade secret, and Freedom of Information Act (FOIA) request considerations and notes key disclosure questions for AI patents. The report also analyzes the FDA's processes and SaMD examples provided for public comment.
In the report, the authors caution that while "the FDA's labeling requirements for software do not differ substantially from the requirements for tangible medical devices," there are unique challenges concerning AI/machine-learning based SaMD "that are not present in conventional software." The report also addresses quality control issues related to data ownership and apparent conflicts between the FDA's need to inspect a manufacturer's data management practices to promote transparency for the public and its need to maintain manufacturers' interests in complying with data collection and disclosure rules.
The report, titled, "FDA's Proposed Regulatory Framework for Modifications to AI-Based Software as a Medical Device (SaMD): IP Review and Strategy Guide," is available online to IPO members.