Liability, Regulation and Policy in Surgical Innovation: The Cutting Edge of Research and Therapy

Abstract:     
Serious patient safety concerns are raised by limited oversight and the risks borne by patients as surgeons develop and refine novel procedures. These concerns must be balanced with the encouragement of medical progress. Surgical innovation can currently follow alternate legal pathways: (1) medical practice, involving tort liability and retrospective judgment of alleged medical malpractice, and (2) human subjects research, allowing prospective review and retrospective imposition of liability. Analysis of these pathways and a case study of surgical innovation leads to a recommendation for a tailored policy approach, including monitoring, local institutional oversight, and educational initiatives.

Number of Pages in PDF File: 92

Keywords: surgery, patient safety, health law, medical malpractice, human subjects research, innovation

Accepted Paper Series