Abstract
The recent trend toward propertization of health data could pose
significant challenges to biomedical research and public health.
Property rule systems can result in sizable up-front costs in the
acquisition of consent from individual data subjects, as well as the
ongoing risk that data subjects will retract consent or object to
unanticipated data uses, thus compromising existing data resources and
analyses. Instead, we propose that research using individual health data
should be subject to a regulatory regime, enforceable by
government/public repositories, while at the same time permitting
private enforcement actions to address particularized individual injury.
Thus, while the physical collection of human tissue would continue to
be subject to existing rules regarding informed consent, ex ante consent
would not be required for the use of information derived from physical
samples. Rather, rules regarding permissible research use and handling
of health information would be put in place, and violations of those
rules would be dealt with on an ex post basis, both through regulatory
penalties and private liability actions. These recommendations are
supported by two cases studies: the Utah Population Database and
Statistics Denmark, both of which provide examples of successful health
data repositories that are governed by regulatory systems. While these
examples are drawn from governmental data resources, the approach
that they exemplify can be extended to academic and other research
environments. These case studies suggest that regulatory and liability models should be considered more broadly for the governance of
research using human health data in lieu of property-based systems.
significant challenges to biomedical research and public health.
Property rule systems can result in sizable up-front costs in the
acquisition of consent from individual data subjects, as well as the
ongoing risk that data subjects will retract consent or object to
unanticipated data uses, thus compromising existing data resources and
analyses. Instead, we propose that research using individual health data
should be subject to a regulatory regime, enforceable by
government/public repositories, while at the same time permitting
private enforcement actions to address particularized individual injury.
Thus, while the physical collection of human tissue would continue to
be subject to existing rules regarding informed consent, ex ante consent
would not be required for the use of information derived from physical
samples. Rather, rules regarding permissible research use and handling
of health information would be put in place, and violations of those
rules would be dealt with on an ex post basis, both through regulatory
penalties and private liability actions. These recommendations are
supported by two cases studies: the Utah Population Database and
Statistics Denmark, both of which provide examples of successful health
data repositories that are governed by regulatory systems. While these
examples are drawn from governmental data resources, the approach
that they exemplify can be extended to academic and other research
environments. These case studies suggest that regulatory and liability models should be considered more broadly for the governance of
research using human health data in lieu of property-based systems.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Health matrix (Cleveland, Ohio : 1991) |
| Vol/bind | 29 |
| Udgave nummer | 1 |
| Sider (fra-til) | 179-223 |
| Antal sider | 44 |
| ISSN | 0748-383X |
| Status | Udgivet - 2019 |