Legal liability in the development and use of medical expert systems

The application of medical expert systems is likely in some instances to result in patient injury litigation. Such legal action will be based on the same principles now applicable to medical practice and products liability. These principles define legally wrongful acts, product defects, and theories of recovery: negligence, breach of warranty and strict liability. The resolution of such litigation will depend on whether the clinician should have relied on the advice of the expert system when the advice and patient treatment is alleged to have been wrong, as well as the overall quality of the expert system, its functional design, and claims made for it. Clinical engineers who become involved with expert system development, selection or implementation should understand the risk management implications of this technology.