Legal issues related to medical decision support systems.

The use of computer-based decision support programs in medicine will result in litigation when adverse health care outcomes affect patients. This paper reviews how the United States legal system is likely to handle such cases. To date, there is minimal direct experience with such cases in the American legal system. Medical decision support systems are more likely to be viewed as tools used by physicians in providing a service to patients than as products owned by patients. Therefore, it is fairly certain that the negligence principles applied in medical malpractice cases will also be applied in cases involving computer-based medical decision support systems. Only under special circumstances will principles of strict product liability apply. As there are no existing standards, and medical decision support programs are hybrids having characteristics of both services and products, future litigation will be handled on a case by case basis.