title: Legal liability and the uncertain nature of risk prediction: the case of breast cancer risk prediction models.
abstract: BACKGROUND
  The rapidity of technological change in genetics is not always matched by the uptake of this new knowledge into practice. Increasing genetic knowledge has already led to legal liability for those who have not used it properly, such as not informing patients or their families of potential genetic risk. A similar outcome is also of concern in the case of risk prediction models used for hereditary breast cancer.
  
  
  RESULTS
  No legal case has directly addressed the use of risk prediction models. However, as genetic medicine and risk prediction models become more widely used, the prospect of a lawsuit will also increase. Current case law is instructive on the circumstances under which medical liability actions could be pursued and circumstances under which liability is unlikely, such as the provision of faulty family history information by a patient.
  
  
  CONCLUSIONS
  There is existing case law on family history and genetics that parallels in many respects the use of risk prediction models. However, the idea of a bad 'prediction' is a difficult legal concept. Outside of a plain misuse or failure to use a risk prediction model when circumstances clearly required it, there is little legal guidance presently available to determine the risk for medical liability.
authors.affiliation: Centre of Genomics and Policy, McGill University, Montreal, Que., Canada. lee.black@mcgill.ca
authors.forename: L
authors.initials: L
authors.lastname: Black
authors.forename: B M
authors.initials: BM
authors.lastname: Knoppers
authors.forename: D
authors.initials: D
authors.lastname: Avard
authors.forename: J
authors.initials: J
authors.lastname: Simard
mesh_terms: D001943:Breast Neoplasms / Q000175:diagnosis* / Q000235:genetics; D005260:Female; D006801:Humans; D016365:Liability, Legal; D015233:Models, Statistical; D018570:Risk Assessment; D014342:Truth Disclosure