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

92 Pages Posted: 20 Feb 2009

See all articles by Anna C. Mastroianni

Anna C. Mastroianni

University of Washington - School of Law; University of Washington, Dept. of Health Services, School of Public Health; University of Washington, Dept. of Pediatrics and Department of Bioethics and Humanities, School of Medicine

Date Written: February 10, 2009

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.

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

Suggested Citation

Mastroianni, Anna C., Liability, Regulation and Policy in Surgical Innovation: The Cutting Edge of Research and Therapy (February 10, 2009). Journal of Law-Medicine, Vol. 16, No. 2, 2006, Available at SSRN: https://ssrn.com/abstract=1340719

Anna C. Mastroianni (Contact Author)

University of Washington - School of Law ( email )

William H. Gates Hall
Box 353020
Seattle, WA 98105-3020
United States

HOME PAGE: https://www.law.washington.edu/directory/profile.aspx?ID=144

University of Washington, Dept. of Health Services, School of Public Health ( email )

Seattle, WA 98103
United States

University of Washington, Dept. of Pediatrics and Department of Bioethics and Humanities, School of Medicine ( email )

Seattle, WA 98195
United States

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