Oversight and Investigations Informer – October 6, 2022
FDA guidance hikes oversight of clinical decision support software
What We Are Watching:
The FDA is expected to significantly expand its oversight of software that helps clinicians make decisions about patients’ treatment, according to guidance the agency issued on Tuesday. In its guidance, the FDA stated it will consider software that gives providers specific recommendations about treatment to be a medical device, as well as software that provides more medical information about a patient than what could be disclosed in a conversation. ( InsideHealthPolicy)
Key Insights:
The recent FDA guidance updates on mobile medical applications and artificial intelligence (AI) driven clinical support tools indicate that the regulatory body is stepping up efforts to treat specific health-related software as medical devices. The moves, taken into account with the agency’s plans to regulate AI-based clinical decision tools as medical devices, indicate that developers of such software systems and the clinical practices that utilize them may be subject to future FDA scrutiny. Developers and clinical facilities may benefit from additional analysis to ensure that the software in place is compliant with the newly updated guidance. The FDA approval processes for medical devices, both the PMA and 510(k), have been the subject of scrutiny in recent years as illustrated in the 2018 Netflix Documentary, The Bleeding Edge.
For more information, contact Frederick Hill.
What We Are Watching:
Former Nintendo worker Mackenzie Clifton, who filed a labor complaint against the company earlier this year, alleged in an interview with Axios that Nintendo engaged in “union busting.” Clifton claims that they were fired after asking a question about unions in an online company meeting in January, which Clifton claims interfered with their federally protected rights to discuss unionization without fear of retaliation. Additional allegations of Nintendo mistreating workers have come out since Clifton filed their complaint. ( Axios)
Key Insights:
Unionization efforts by employees and petitions filed with the National Labor Relations Board in 2021/22 for union recognition are approximately 60% higher than they were the previous year, according to public reports. It’s expected that strong union interest will continue as employees seek greater influence regarding company operations. This includes pushing for more diversity, equity and inclusion within management; ESG goals; flexibility in remote versus office; work-life balance; pay and healthcare benefits.
For more information, contact Robert Josephson.
What We Are Watching:
The Federal Reserve has tapped six major banks – JPMorgan Chase, Citigroup, Bank of America, Goldman Sachs, Morgan Stanley, and Wells Fargo – to participate in the regulator’s pilot climate scenario analysis exercise. The exploratory effort will test the banks’ resilience to climate-related stress scenarios. (American Banker)
Key Insights:
While the initial pilot program, which will begin in 2023, does not have capital or supervisory requirements, the banking industry and some Republicans are already skeptical. The Bank Policy Institute, a trade group representing large banks, issued a report suggesting climate-related risks do not threaten the financial stability of large banks and Senate Banking Committee Ranking Member Pat Toomey (R-PA) argued the program is intended to discourage investment and lending in the energy industry and will lead to increased regulation.
For more information, contact Cheyenne Hopkins.
What We Are Watching:
The Brooking Institute released a report on Thursday scrutinizing the EPA for its “lax regulation” of the pesticide industry. The report claims that research shows that there has been “significant decline in the health-protective actions taken by the EPA’s pesticide office over the years,” citing specific chemicals such as chlorothalonil, atrazine, 2,2-D, acephate, and aldicarb as “extremely hazardous” to human health. (Brookings Institute)
Key Insights:
The Brookings Institute, a prestigious and generally centrist think tank, has released a report suggesting that the Environmental Protection Agency Office of Pesticides is taking a too relaxed approach to regulating pesticides, such as glyphosate, paraquat, dicamba, and others, falling behind other world regulators in their restrictions. The author suggests that failing to keep pace with world restrictions is creating a costly barrier to trade, negatively impacting both our farmers and our trade balance.
For more information, contact Kristina Moore.
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