TY - JOUR

T1 - Liability (and) Rules for Health Information

AU - Contreras, Jorge

AU - Nordfalk, Francisca

PY - 2019

Y1 - 2019

N2 - The recent trend toward propertization of health data could posesignificant challenges to biomedical research and public health.Property rule systems can result in sizable up-front costs in theacquisition of consent from individual data subjects, as well as theongoing risk that data subjects will retract consent or object tounanticipated data uses, thus compromising existing data resources andanalyses. Instead, we propose that research using individual health datashould be subject to a regulatory regime, enforceable bygovernment/public repositories, while at the same time permittingprivate enforcement actions to address particularized individual injury.Thus, while the physical collection of human tissue would continue tobe subject to existing rules regarding informed consent, ex ante consentwould not be required for the use of information derived from physicalsamples. Rather, rules regarding permissible research use and handlingof health information would be put in place, and violations of thoserules would be dealt with on an ex post basis, both through regulatorypenalties and private liability actions. These recommendations aresupported by two cases studies: the Utah Population Database andStatistics Denmark, both of which provide examples of successful healthdata repositories that are governed by regulatory systems. While theseexamples are drawn from governmental data resources, the approachthat they exemplify can be extended to academic and other researchenvironments. These case studies suggest that regulatory and liability models should be considered more broadly for the governance ofresearch using human health data in lieu of property-based systems.

AB - The recent trend toward propertization of health data could posesignificant challenges to biomedical research and public health.Property rule systems can result in sizable up-front costs in theacquisition of consent from individual data subjects, as well as theongoing risk that data subjects will retract consent or object tounanticipated data uses, thus compromising existing data resources andanalyses. Instead, we propose that research using individual health datashould be subject to a regulatory regime, enforceable bygovernment/public repositories, while at the same time permittingprivate enforcement actions to address particularized individual injury.Thus, while the physical collection of human tissue would continue tobe subject to existing rules regarding informed consent, ex ante consentwould not be required for the use of information derived from physicalsamples. Rather, rules regarding permissible research use and handlingof health information would be put in place, and violations of thoserules would be dealt with on an ex post basis, both through regulatorypenalties and private liability actions. These recommendations aresupported by two cases studies: the Utah Population Database andStatistics Denmark, both of which provide examples of successful healthdata repositories that are governed by regulatory systems. While theseexamples are drawn from governmental data resources, the approachthat they exemplify can be extended to academic and other researchenvironments. These case studies suggest that regulatory and liability models should be considered more broadly for the governance ofresearch using human health data in lieu of property-based systems.

M3 - Journal article

VL - 29

SP - 179

EP - 223

JO - Health matrix (Cleveland, Ohio : 1991)

JF - Health matrix (Cleveland, Ohio : 1991)

SN - 0748-383X

IS - 1

ER -