Clinical Decision Support: Elements of a Sensible Legal Framework
47 Pages Posted: 22 Oct 2019 Last revised: 19 Nov 2019
Date Written: 2018
Clinical decision support (“CDS”) systems are computer programs that are designed to assist patients and health care professionals. A key segment of the CDS market encompasses software that utilizes sophisticated algorithms that combine biomedical knowledge, clinical practice guidelines, and patient-specific data to offer treatment recommendations for individual patients. If developed and used properly, such software can enhance health care decision-making, reduce health care costs, and improve health outcomes. Yet, the quality of CDS programs varies considerably, and CDS recommendations have led to medical errors and adverse health events. This article examines the legal and regulatory landscape governing CDS. I begin by unpacking the regulatory regime and analyzing regulatory ambiguities. I then highlight the limits of regulation, and discuss the proper role of tort law for CDS-related harms. I conclude by arguing that, when structured sensibly, laws and regulations can serve as important levers that incentivize safe and effective CDS systems.
Keywords: FDA, medical software, clinical decision support
JEL Classification: I12, I18, K13, K23
Suggested Citation: Suggested Citation