Risks and Legal Protections in the World of Big-Data

• 영문명: Risks and Legal Protections in the World of Big-Data
• 발행기관: 이화여자대학교 생명의료법연구소
• 저자명: Leslie E. Wolf
• 간행물 정보: 『생명윤리정책연구(Asia Pacific Journal of Health Law & Ethics)』Vol.11 No.2, 1~15쪽, 전체 15쪽
• 주제분류: 법학 > 법학
• 파일형태: PDF
• 발행일자: 2018.03.30

영문 초록

The development of large electronic data sets, whether from electronic health records, health registries, or largescale 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.

목차

Ⅰ. Introduction

Ⅱ. Types of Risks

Ⅲ. Corresponding Types of Protection

Ⅳ. Lessons for data-driven health care

키워드

Human Subjets Research Ethics Genetic Information Legal Protections Data Privacy Health Information Privacy Confidentiality