s Point-of-Care Genetic Tests for Infectious Disease: Legal Considerations

Personalized medicine will play an important role in the treatment of infectious diseases. Molecular microbiology diagnostics have the potential to identify pathogens with great accuracy and rapidity. The speed of identification is particularly crucial to effective clinical management of many infections. An important complement to precision diagnostic techniques is moving towards point-of-care application, to avoid the costly diagnostic delays associated with transport and laboratory analysis. Point-of-care molecular diagnostics are expected to have a significant impact in combatting hospital acquired infections (‘HAIs’). HAIs are a major cause of increased morbidity and death among patients in health care settings globally. These infections are often antibiotic resistant, and affect already weakened patients. It is hoped that molecular diagnostics will eventually allow for the rapid identification of a particular strain of pathogen(s), even for unculturable and polymicrobial infections. This article considers how the existing legal and normative framework governing hospitals’ responses to HAIs may affect the introduction of rapid, point-of-care molecular diagnostics. To this end, we carried out a review of international, national, and institutional guidelines addressing hospital duties to prevent, control, and rapidly diagnose HAIs. We also reviewed relevant legislation and case law in Canada and the United States. In particular, we consider if the complex normative framework governing hospitals helps or hinders the adoption and implementation of precision diagnostic tools. We conclude that health-care institutions are likely to come under increasing pressure – both ethical and legal – to adopt rapid molecular diagnostics as part of their response to HAIs.