Computer-assisted detection in clinical practice: medical legal considerations.

The integration of new technology into medical practice reflectsaprocessthatinvolvessafety,efficacy,andadded value. The extent to which any given device or procedure impacts standards of practice is often difficult to predict. Clinical trial validation, outcomes analyses, and regular use by a large percentage of practitioners often serve as a benchmark for accepted practice patterns, conditioned by alternative approaches which have also satisfied similar criteria. In the field of breast imaging, many new approaches are being proposed that not only modify previous concepts and clinical practice, but also purport to change the basic paradigms that have been historically accepted. Each presents its own practical dilemmas. For example, screening for breast cancer in high-risk patients as an application of magnetic resonance imaging (MRI) has been raised, given the modality’s generally observed increased sensitivity compared with mammography. However, because risk stratification as well as MRI techniques vary, widespread agreement regarding the specific implementation of this approach as a “standard” pattern of care has not been reached. Similarly, the potential improvement in outcomes of full-field digital mammography (FFDM) for those with dense breasts raises issues in clinical practice concerning the triaging of patients to one type of mammography versus another, especially in an environment where both analog and FFDM capabilities exist within a single facility and where analog machines predominate in most communities. As deliberate, and sometimes slow, as the transformation of “standard forms of practice” may be, the legal implications concerning the determination of “standard of care” may lag behind even this pace. Guidelines established by courts and rules of evidence permit some latitude in reckoning whether agivenapproachcomportswithreasonablepractice.Thetwo areas just described—MRI and FFDM—represent new technologies that may be subject in the future to such determinations. One new technology—computer-assisted detection (CAD)—also represents a potential shift in a clinical practice paradigm. In contrast to the other techniques, the introduction of CAD as a potentially reliable standard of practice has invited legal commentary as of the present time. Therefore, this technology serves to illustrate the issues germane to the determination of standard of care not only for CAD, but also for other applications. The current discussion will therefore focus on the introduction of CAD into clinical practice and the legal considerations attendant to such proposed use, with an analysis that may be used for any new technology. In 2003, an Ohio appellate court agreed to review a case involving the allegation of delay in diagnosis of breast cancer, where the results of a CAD device was introduced during the trialtosupportadefendantexpert’sopinionthatthefailureto identifyagroupoffaintmicrocalcificationswasnotbelowthe standard of care. In permitting, as a matter of law, the introduction of a CAD analysis of the films in question in Gray v Fairview General Hospital, 1 the court—under the circumstances of the case—indicated that a sufficient degree of scientific reliability existed to permit a jury to consider the information from the CAD test. Parameters for determining admission of scientific evidence have been established by both the Federal Rules of Evidence and the United States Supreme Court. 2,3