Medical Error & AI: Who Is Liable?

"Locating Liability for Medical AI" [SSRN Download (requires subscription)]
DePaul Law Review, Forthcoming

W. NICHOLSON PRICE II, University of Michigan Law School
Email: wnp@umich.edu

I. GLENN COHEN, Harvard Law School
Email: igcohen@law.harvard.edu

Abstract:

When medical AI systems fail, who should be responsible, and how? We argue that various features of medical AI complicate the application of existing tort doctrines and render them ineffective at creating incentives for the safe and effective use of medical AI. In addition to complexity and opacity, the problem of contextual bias, where medical AI systems vary substantially in performance from place to place, hampers traditional doctrines. We suggest instead the application of enterprise liability to hospitals—making them broadly liable for negligent injuries occurring within the hospital system—with an important caveat: hospitals must have access to the information needed for adaptation and monitoring. If that information is unavailable, we suggest that liability should shift from hospitals to the developers keeping information secret.

Hot Topics in Health Law from AHLA's Annual Meeting

The American Health Law Association (AHLA) wrapped up its annual meeting on June 28 with a presentation on hot topics. Speakers were from DHHS/OIG (Susan Edwards), DOJ (Kelley Hauser), and private practice (Scott Hasselman, Reed Smith).

Take-aways:

• According to Edwards, OIG plans to release a general Compliance Program Guidance (CPG) by the end of this year that will help providers develop and maintain an effective compliance program. OIG will then issue by the end of next year managed care and nursing facility CPGs, Edwards said.
• The informative session also covered fraud issues related to the end of the COVID-19 public health emergency. Hauser, noting that fraud enforcement always lags behind implementation of new reimbursement, assured the audience that more enforcement actions would be coming. Hauser also said that given the sensitivity of the emergency funds, DOJ would likely look harder at use of the funds and will pursue enforcement actions even if the recovery is not a big dollar amount.
• Edwards also mentioned the OIG final rule on information blocking that was released early on June 27 and noted that a separate rule that will apply to providers will list “disincentives” for information blocking.
• Hauser reviewed recent fraud case law, such as the SuperValu case on scienter—if there’s evidence that a defendant is questioning the accuracy of certain statements or billing, you’re probably going to hear from DOJ.
• The speakers also discussed the use of AI and questioned whether it could be used to create clinical notes. Hauser noted that the government is generally in favor of any technology that could improve accuracy and predicted that more widespread use of AI will likely lead to a certification process of some sort to ensure that such programs work as intended.
• Each speaker then chose an emerging topic to discuss. Hauser picked parallel criminal and civil investigations, highlighting that such investigations are advantageous to the government and he has seen a steady increase in them during his tenure at DOJ.
• Edwards talked about managed care oversight and its increasing importance amid explosive growth in managed care. And Hasselman highlighted the corporate practice of medicine doctrine (and here) and urged lawyers to be aware of it while structuring transactions.