title: The legal and ethical concerns that arise from using complex predictive analytics in health care.
abstract: Predictive analytics, or the use of electronic algorithms to forecast future events in real time, makes it possible to harness the power of big data to improve the health of patients and lower the cost of health care. However, this opportunity raises policy, ethical, and legal challenges. In this article we analyze the major challenges to implementing predictive analytics in health care settings and make broad recommendations for overcoming challenges raised in the four phases of the life cycle of a predictive analytics model: acquiring data to build the model, building and validating it, testing it in real-world settings, and disseminating and using it more broadly. For instance, we recommend that model developers implement governance structures that include patients and other stakeholders starting in the earliest phases of development. In addition, developers should be allowed to use already collected patient data without explicit consent, provided that they comply with federal regulations regarding research on human subjects and the privacy of health information.
authors.affiliation: I. Glenn Cohen (igcohen@law.harvard.edu) is a professor of law and director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, both at Harvard Law School, in Cambridge, Massachusetts.
authors.forename: I Glenn
authors.initials: IG
authors.lastname: Cohen
authors.affiliation: Ruben Amarasingham is president and CEO of PCCI, a nonprofit research and development corporation, and an associate professor in the Departments of Internal Medicine and of Clinical Sciences at the University of Texas Southwestern Medical Center, both in Dallas.
authors.forename: Ruben
authors.initials: R
authors.lastname: Amarasingham
authors.affiliation: Anand Shah is vice president of clinical services at PCCI.
authors.forename: Anand
authors.initials: A
authors.lastname: Shah
authors.affiliation: Bin Xie is a health services manager at PCCI.
authors.forename: Bin
authors.initials: B
authors.lastname: Xie
authors.affiliation: Bernard Lo is president of the Greenwall Foundation and professor emeritus of medicine and director emeritus of the Program in Medical Ethics, both at the University of California, San Francisco.
authors.forename: Bernard
authors.initials: B
authors.lastname: Lo
mesh_terms: D000465:Algorithms; D035843:Biomedical Research / Q000941:ethics; D003627:Data Interpretation, Statistical; D057225:Data Mining / Q000941:ethics / Q000331:legislation & jurisprudence; D066264:Datasets as Topic / Q000941:ethics / Q000331:legislation & jurisprudence; D003695:Delivery of Health Care / Q000941:ethics* / Q000331:legislation & jurisprudence*; D006801:Humans; D015233:Models, Statistical
keywords: Ethical Issues; Information Technology; Medicine/Clinical Issues; Research And Technology