New paper from Gerke: FDA needs to develop labeling standards for AI-powered medical devices

The regulatory framework for artificial intelligence-based medical devices needs to be improved to ensure transparency and protect patients’ health, says Sara Gerke, the Richard W. & Marie L. Corman Scholar at the University of Illinois Urbana-Champaign and expert in the ethical and legal challenges of artificial intelligence for health care. Gerke argues that the Food and Drug Administration should prioritize the development of labeling standards for AI-powered medical devices in much the same way that there are nutrition facts labels on packaged food. 

Gerke spoke to the Illinois News Bureau about her new paper, recently published in the Emory Law Journal, “A comprehensive labeling framework for AI/ML-based medical devices: From AI Facts labels to a front-of-package AI labeling system — Lessons learned from food labeling.”

The College of Law welcomes Eric Baudry and Sarah Lawsky to faculty

The University of Illinois College of Law is proud to welcome Eric Baudry and Sarah Lawsky as new faculty members this fall. Baudry joins as an assistant professor of law with a specialty in tax law, poverty, and redistribution; Lawsky will serve as the L.B. Lall and Sumitra Devi Lall Professor of Law and the co-director of the Innovation Law and Technology Program.

“I’m really excited about joining the law school here because of the vibrant intellectual life among the faculty,” Lawsky said. “The University of Illinois is such an incredible institution, and the opportunity to do interdisciplinary work here at the law school with the other parts of this university is really exciting.”

Lawsky comes to Illinois having previously taught at George Washington University Law School, UC Irvine School of Law, and, most recently, at Northwestern Pritzker School of Law. Her work focuses on computational law, with a focus on formal methods and the formalization of tax law. As part of the Innovation Law and Technology Program, she hopes to continue her work in conjunction with experts from the Siebel School of Computing and Data Science and the School of Information Sciences as well as others. At the College of Law, Lawsky will be teaching contracts and federal income tax courses, aiming to meet the existing high standards of the law school.

“Illinois has an amazing tax professor in Dick Kaplan, who’s terrific. My goal is to try to match the very high level of quality of tax instruction that he has established,” she said.

Also an expert in tax law, Baudry comes to Illinois Law with experience as a clerk in the Eastern District of Michigan and the Ninth Circuit, a Skadden Fellow at Mid-Minnesota Legal Aid, and a faculty fellow at the University of Michigan Law School. He will teach income taxation, corporate taxation, and a seminar on the intersections of taxation and poverty.

“I’m interested in planting roots in this community, both as a person who lives in Champaign and as a tax scholar who cares about inequality in our community. Specifically, I’m interested in how residents experience impoverishment and how our local and state governments can use tax law as a vehicle to help improve the lives of their citizens” Baudry said. “My long-term goal as a professor would be to bring that work into the law school.”

Both Lawsky, who has spent the last nine years at Northwestern, and Baudry, a native Minnesotan, expressed their excitement to be a part of Illinois Law and the local community. Having a son in the state university system gave Lawsky an idea what to expect, and she says she’s eager to “learn what it means to be a part of the University of Illinois system.” Baudry shared his enthusiasm to talk to students, alumni, and faculty about his professional expertise as well as his personal passion for games.

“Getting to know the faculty and the staff and the spaces at Illinois Law, I immediately felt like this is a place that would push me to be my best, while also offering fantastic resources and supports for my journey to get there,” he said.

The College of Law is pleased to welcome Baudry and Lawsky to the faculty and looks forward to their accomplishments as part of the University of Illinois.

Lawless publishes new book on debt in the United States

Over the almost 45 years the Consumer Bankruptcy Project has been collecting data, the landscape of debt in the United States has shifted significantly. Updating that work is “Debt’s Grip,” a new book by Professor Robert Lawless and his fellow principal investigators telling the story of financial struggle in the United States in the words of bankruptcy filers themselves.

“It was time to document the many ways things have changed, but also the way things have not,” Lawless said. “One of the sad things is American households continue to struggle for many of the same reasons they did 35 years ago.”

“Debt’s Grip,” which is available everywhere now, provides an update on the Consumer Bankruptcy Project, started by Teresa Sullivan, Elizabeth Warren, and Jay Westbrook. Their work, dating back to the 1980s, provided novel insight by combining bankruptcy court records and surveys that asked individuals to tell their story in their own words.

Lawless joined the Consumer Bankruptcy Project in 2001 and later became one of its principal investigators. Along with many student research assistants from the College of Law, Lawless and co-authors Pamela Foohey (who served as a visiting assistant professor at Illinois from 2012–14) and Deborah Thorne have been doing continuous data collection for the project since 2013 and publishing in law reviews and sociology journals. This intensive effort, along with greater access to technology, has helped the group provide new insights into debt in the U.S and provided the foundation for “Debt’s Grip.”

“We lean more into the demographics of bankruptcy in this book because the last book was written with data before the internet,” Lawless said. “There’s a lot more we know now about the demographics of who files bankruptcy…. We have a nationally representative picture of who files bankruptcy.”

This book is the first Lawless has written for a broader audience. As with textbooks, the goal of “Debt’s Grip” is to share his expertise and teach the reader, but Lawless hopes this book can inform decision makers like lawyers, judges, other policy leaders in the field of bankruptcy.

“We put some context into what it means to live at the financial edge. People have stories of going without medicine, without food, or sacrifices to keep a car running so they can get to work or they can get their children to school. The book, I hope, details and lays out what that really means,” he said.

“Debt’s Grip” is published by the University of California Press and available now. For more information on Professor Lawless, visit his faculty page on our website.

Sherkow cited extensively in blog post on drug labels

In an analysis of a brief expected to be filed in the fall, the Patently-O blog cites the work of Professor Jacob Sherkow extensively in examining the ‘label-plus’ theory of inducement. This framework establishes that a generic drug’s label by itself cannot violate patent protections because of a congressionally authorized regulatory scheme. Sherkow’s work, in particular, helps illuminate the distinction between regulatory and factual speech in the particulars of the case at issue.

Sherkow presents at ATRIP Congress in Copenhagen

In June, Professor Jacob Sherkow traveled to Denmark to present his work, “Patent Eligibility, Secure Computing, and Genomic Data Sharing,” at the ATRIP Congress at the University of Copenhagen. His presentation took place on Monday, June 23, as part of the Intellectual Property & Justice: Balancing Frameworks in Patent Law portion of the conference.

New paper from Kaplan examines SECURE 2.0

The SECURE 2.0 Act of 2022 included six major changes pertaining to current plan participants in retirement plans. In a new article published in The Elder Law Journal, Professor Richard Kaplan examines and analyzes each of those changes and how they address some of the deficiencies in the present tax-subsidized matrix of employer-provided retirement savings plans.

Amar and Mazzone revisit core principles of Federalism

In response to protests in Los Angeles and the subsequent responses by local and federal officials, Professors Vikram Amar and Jason Mazzone put their constitutional law expertise to work to take another look at the principles of federalism and why they matter. “To conclude states must agree with the President before any kind of federalized military forces could be used would be to place the safety of federal personnel and federal property at the mercy of state government. As American history suggests, that could be a very dangerous scenario,” they write.

Read the full article on Justia Verdict.

Finkin compares the Trump administration and German National Socialists in Justia article

In an article adapted from a lecture given in London, Professor Matthew Finkin lays out a case comparing the actions of the Trump administration today to those of the German National Socialist party in the 1930s. The unprecedented actions of the current United States president have been foreshadowed by the early actions of the Third Reich, he explains. “What ensued there resonates here,” Finkin states.

Sherkow quoted in article on polygenic testing startups

Polygenic testing startups offer consumers the chance of a “superbaby” by screening for genetic disorders and allowing parents to select certain embryos for fertilization; however, the ethics and the science of this practice are very controversial. Speaking to The San Francisco Standard, Professor Jacob Sherkow added his expertise on the issue. “[These companies] claim to have a proprietary algorithm, which, in reality, is a total black box,” he said. “If they are not completely accurate, consumers may make adverse health choices on the basis of misinformation.”

News-Gazette quotes Aronson and Mazzone on student visa restrictions

The Trump administrations stated plans to “aggressively revoke visas for Chinese students” would have an immense impact on the University of Illinois, as the school hosted more than 6,000 individuals from China last year. In a wide-ranging examination of faculty opinions on how damaging this policy may be, the News-Gazette spoke to law professors Lauren Aronson and Jason Mazzone. “I take all threats from this administration seriously,” Aronson, director of the Immigration Law Clinic, said.

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