Published online by Cambridge University Press: 27 April 2021
The question of how and when a novel medical procedure becomes accepted as standard practice has important legal implications. It may in certain situations be determinative of whether third-party reimbursement is available for such procedures. It may also affect the standard used in determining a physician’s liability for negligence. This article discusses several innovative medical procedures and the process of their acceptance by the medical community. It will be seen that none of these examples effectively delineates the process by which an innovative procedure becomes the accepted standard of care. Finally, the article suggests a system based upon consensus among recognized medical experts, and recommends that this system supplant the traditional cost-benefit analysis which is currently used to determine the accepted standard of care.
No formal mechanism currently exists for the introduction of innovative medical technologies, in contrast to the complicated procedures developed for the orderly introduction of new drugs into the marketplace.