W. Nicholson Price II (University of Michigan Law School), Rachel Sachs (Washington University in Saint Louis – School of Law), and Rebecca S. Eisenberg (University of Michigan Law School) have posted “New Innovation Models in Medical AI” on SSRN. Here is the abstract:
In recent years, scientists and researchers have devoted considerable resources to developing medical artificial intelligence (AI) technologies. Many of these technologies—particularly those which resemble traditional medical devices in their functions—have received substantial attention in the legal and policy literature. But other types of novel AI technologies, such as those that relate to quality improvement and optimizing use of scarce facilities, have been largely absent from the discussion thus far. These AI innovations have the potential to shed light on important aspects of health innovation policy. First, these AI innovations interact less with the legal regimes that scholars traditionally conceive of as shaping medical innovation: patent law, FDA regulation, and health insurance reimbursement. Second, and perhaps related, a different set of innovation stakeholders, including health systems and insurers, are conducting their own research and development in these areas without waiting for commercial product developers to innovate for them. Third and finally, the activities of these innovators have implications for health innovation policy and scholarship. Perhaps most notably, data possession and control play a larger role in determining capacity to innovate in this space, while ability to satisfy the quality standards of regulators and payers plays a smaller role, relative to more familiar biomedical innovations such as new drugs and devices.