The initiative, leveraging its network of leading academics and industry leaders in the healthcare insurance sector, is dedicated to addressing the pronounced regulatory gap concerning the oversight of artificial intelligence tools within the health insurance sector. While the integration of AI software as medical devices (SaMD) into clinical practice has garnered considerable attention, the inadequate supervision of AI tools employed by major insurers remains a pressing concern.
The US Food and Drug Administration (FDA) has advanced an “Action Plan” for clinical AI (CAI) governance. However, the US healthcare system remains threatened by the unregulated application of insurance AI (IAI).
Justification for the lack of regulatory oversight surrounding IAI may arise from the mistaken assumption that IAI harbors no direct impact on patient care. However, the use of IAI in the Medicare Advantage (MA) prior authorization pathway, for example, may directly determine the treatment coverage to which a patient is entitled.
Furthermore, the use of AI-SaMD to improve efficiency will likely keep growing, given the burden placed upon the U.S. healthcare system by an increasingly elderly, multi-morbid population. When novel technologies can save lives or improve patient outcomes, it is ethically imperative to investigate their potential and eventually invest in their development and deployment.
The initiative is committed to fostering dialogue and disseminating knowledge on the regulatory challenges associated with AI in health insurance. It is dedicated to advancing actionable recommendations for regulatory agencies, advocating for the integration of IAI within the framework of healthcare services regulations and establishing robust oversight mechanisms to ensure ethical and equitable outcomes for all stakeholders.
This initiative and introductory text were inspired by the paper Artificial intelligence for health insurance: A proposed framework for FDA oversight
For more information please mail to: AI4healthinsurance.initiative@ai4people.org
