Desiderata for product labeling of medical expert systems.

Abstract

The proliferation and increasing complexity of medical expert systems raise ethical and legal concerns about the ability of practitioners to protect their patients from defective or misused software. Appropriate product labeling of expert systems can help clinical users to understand software indications and limitations. Mechanisms of action and knowledge representation schema should be explained in layperson's terminology. User qualifications and resources available for acquiring the skills necessary to understand and critique the system output should be listed. The processes used for building and maintaining the system's knowledge base are key determinants of the product's quality, and should be carefully documented. To meet these desiderata, a printed label is insufficient. The authors suggest a new, more active, model of product labeling for medical expert systems that involves embedding 'knowledge of the knowledge base', creating user-specific data, and sharing global information using the Internet.