Risks and Legal Protections in the World of Big-Data
0
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
The development of large electronic data sets, whether from electronic health records, health registries, or large-scale gene-environment interaction studies, offer an unparalleled, innovative opportunities to learn more about human health and disease. However, because these data may be used in unexpected ways, without the knowledge or consent of individuals whose data are being used, they also raise critical concerns about protections of individuals against risks. Traditional approaches to protecting research participants and patients may not address new or heightened risks in the “big data” era. My research colleagues and I conducted legal research to elucidate the web of legal protections afforded research participants in genomic research, including laws governing human subjects research, privacy, consent, discrimination, and use of research participants’ genetic information. It has revealed substantial regulatory activity and variation across the 50 states that may fill known gaps in federal protections. For example, some states go further than the Genetic Nondiscrimination Act (GINA) by extending genetic antidiscrimination statutes to life and disability insurers or to employers with less than 15 employees. In addition, states explicitly provide remedies, such as statutory damages, attorneys’ fees, and costs that can facilitate enforcement of legal rights not afforded in federal laws. This research has broader implications for data use in other research or in health care settings. In this paper, I suggest how this research can inform approaches to data privacy law in the United States and beyond to provide appropriate protections as health systems and scientists seek to harness the promise of big data while respecting individuals’ interests in their data.
Abstract
The development of large electronic data sets, whether from electronic health records, health registries, or large-scale gene-environment interaction studies, offer an unparalleled, innovative opportunities to learn more about human health and disease. However, because these data may be used in unexpected ways, without the knowledge or consent of individuals whose data are being used, they also raise critical concerns about protections of individuals against risks. Traditional approaches to protecting research participants and patients may not address new or heightened risks in the “big data” era. My research colleagues and I conducted legal research to elucidate the web of legal protections afforded research participants in genomic research, including laws governing human subjects research, privacy, consent, discrimination, and use of research participants’ genetic information. It has revealed substantial regulatory activity and variation across the 50 states that may fill known gaps in federal protections. For example, some states go further than the Genetic Nondiscrimination Act (GINA) by extending genetic antidiscrimination statutes to life and disability insurers or to employers with less than 15 employees. In addition, states explicitly provide remedies, such as statutory damages, attorneys’ fees, and costs that can facilitate enforcement of legal rights not afforded in federal laws. This research has broader implications for data use in other research or in health care settings. In this paper, I suggest how this research can inform approaches to data privacy law in the United States and beyond to provide appropriate protections as health systems and scientists seek to harness the promise of big data while respecting individuals’ interests in their data.
참고문헌 (29)
- S. J. Nass, "Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health through Research" (2009), National Academies Press
- Laura M. Beskow, "Lessons from HeLa Cells: The Ethics and Policy of Biospecimens", Annual Review of Genomics and Human Genetics, 17, pp.395~417 (2016)
- Michelle M. Mello, "The Havasupai Indian Tribe Case—Lessons for Research Involving Stored Biological Samples", New England Journal of Medicine, 363(3), pp.204~207 (2010)
- "Newborn Blood Spot Litigation: 70 Days to Destroy 5+ Million Samples, Genomics Law Report, February 2, 2010" (2010)[URL]
- Allison M. Whalen, "That’s My Baby: Why the State’s Interest in Promoting Public Health Does Not Justify Residual Newborn Blood Spot Research Without Parental Consent", Minnesota Law Review, 98, pp.419~453 (2013)
- U.S. Department of Health and Human Services, "Federal Policy for the Protection of Human Subjects; Final Rule, 82(12) Fed. Reg. 7149 (2017)", ~ (2017)
- "Did Facebook and PNAS Violate Human Research Protections in an Unethical Experiment?, Science-based Medicine, June 30, 2014" (2014)[URL]
- John Kleinsman, "Facebook Study: A Little Bit Unethical But Worth It?", Journal of Bioethical Inquiry, 12(2), pp.179~182 (2015)
- Timothy Stoltzfus Jost, "Improving the Quality of Health Care for Mental and Substance-Use Conditions: Quality Chasm Series" (2006), Institute of Medicine Committee on Crossing the Quality Chasm
- Jim Pyles, "The Right to Obtain Restrictions under the HIPAA", HITECH Rule: A Return to Ethical Practice of Medicine, 2013, pp.9(9), ~
- "Data on Man’s Pacemaker Led to his Arrest on Arson Charges, ABA Journal, February 6, 2017" (2017)[URL]
- "Family DNA Searches Seen as Crime-Solving Tool, and Intrusion on Rights, New York Times, January 27, 2017" (2017)[URL]
- Leslie E. Wolf, "Certificates of Confidentiality: Protecting Human Subject Research Data in Law and Practice", Minnesota Journal of Law, Science & Technology, 14(1), pp.11~87 (2013)
- Leslie E. Wolf, "Advancing Research on Stored Biological Materials: Reconciling Law, Ethics, and Practice", Minnesota Journal of Law, Science & Technology, 11(1), pp.99~156 (2010)
- James Swann, "FBI Committed to Helping Health-Care Industry Fight Cybercrime", BNA’s Health Care Daily Report, May 9, 2017, ~ (2017)
- "FDA, Industry Fear Wave of Medical-Device Hacks, The Hill, April 10, 2017" (2017)[URL]
- "Ransom-Seeking Hackers Targeting Hospital Data, U.S. News and World Report, May 12, 2017" (2017)[URL]
- "The text of the Nuremberg Code"[URL]
- Ruth R. Faden, "Informed Consent, Comparative Effectiveness, and Learning Health Care", New England Journal of Medicine, 370, pp.766~768 (2014)
- Leslie E. Wolf, "Advancing Research on Stored Biological Materials: Reconciling Law, Ethics, and Practice", Minnesota Journal of Law, Science & Technology, 11(1), pp.127~133 (2010)
- U.S. Department of Health and Human Services, "Federal Policy for the Protection of Human Subjects, 82(12) Fed. Reg. 7149 (2017)", ~ (2017)
- "Trump Administration Seen Unlikely to Change Human Research Rule, Health Care on Bloomberg Law, May 26, 2017" (2017)[URL]
- Perry W. Payne Jr., "Health Insurance and the Genetic Information Nondiscrimination Act of 2008: Implications for Public Health Policy and Practice", Public Health Rep, 124(2), pp.328~331 (2009)
- "Genetic Information Nondiscrimination Act (GINA) of 2008, Pub. L. 110-233, 122 Stat. 881 (2008)", ~ (2008)
- Leslie E. Wolf, "Certificates of Confidentiality: Protecting human subject research data in law and practice", Minnesota Journal of Law, Science & Technology, 14(1), pp.11~87 (2013)
- Ruth R. Faden, "Informed Consent, Comparative Effectiveness, and Learning Health Care", New England Journal of Medicine, 370, pp.766~768 (2014)
- James P. Evans, "Genetic Exceptionalism. Too much of a good thing?", Genetics in Medicine, 10, pp.500~501 (2008)
- "Your Rights under HIPAA"[URL]
- "Debate over Blood Samples from Babies, USA Today, February 8, 2010" (2010)[URL]