“Research” in the Information Age
July 01, 2002
Beth Rubin co-authored this publication by the American Health Lawyers Association. The article details the increased regulatory scrutiny of health data collection and access, which has resulted from changes in technology, including electronic health records and data repositories. While that technology allows for more extensive assessments of public health risks, changes in biotechnology research methodologies, and a new means of coordinating care and health care costs, these advances must be balanced with the risks to individuals’ privacy interests. The article orients attorneys, their health care clients, and the health care industry to the continuing regulation of the use of data in human “research.” It discusses the difference between “research” and non-research uses of data, and addresses the regulation of data mining and the important role of deidentified data and the HIPAA deidentification standards. The authors conclude with a discussion of the legal issues that relate to the use of the Internet for research-related activities. Some of the critical areas of research addressed in this important work include: - Basic stages in clinical trials - The federal policy for the protection of human subjects - The role of the Institutional Review Board (IRB) as well as coverage of recent case law developments. To purchase the publication, you can call the American Health Lawyers Association at +1.202.833.0766 or go to its web site at www.healthlawyers.org.