Issue 6 : November/December 2002
Privacy and Liability Issues
November/December 2002
Subscription Information
FDLI members receive Update as part of membership.
Additional
copies or back issues are available at $15 each.
HIPAA-Related Liability for Employers?
by Mark Barnes, Partner in the Health Care Group in the law firm of
Ropes & Gray, NY
Patrik S. Florencio, Associate in the Health Care Group in the law firm
of Ropes & Gray, NY
and Brian M. Wyatt, Associate in the Health Care Group in the law firm
of Ropes & Gray, NY
Privacy Rule Creates New Compliance Obligations for Research
Involving Human Subjects
by Jennifer Kulynych, J.D., Ph.D., Attorney in the law firm of Ropes
& Gray, Washington, D.C. Formerly, she was Director, Division of
Biomedical and Health Sciences Research with the Association of American
Medical Colleges.
Implications of DHHS Medical Privacy Rule for Pharmaceutical
and Medical Device Manufacturers
by Naomi J.L. Halpern, Associate with the law firm of Olsson, Frank
& Weeda, P.C., Washington, D.C.
Reconciling Privacy Rights and Technological Advances:
The Unique Health Identifier
by Wendy J. Netter, Third-year law student at Harvard Law School.
This article is an abbreviated version of Ms. Netter's submission to
FDLI's 2001-2002 H. Thomas Austern Memorial Writing Awards Competition,
in which her entry won third place. A version of the full paper will
appear in 43 JURIMETRICS J. (2003).
HIPAA's Impact on Informed Consent
by Mark Hochhauser, Ph.D., Readability Consultant, Golden Valley, MN
Acrylamide in FoodsA Developing Issue
by Matthew Weinberg, Chief Executive Officer of THE WEINBERG GROUP,
INC., Washington, D.C.
Product Price: Making The Strategic Choice
by John B. Reiss, Ph.D., J.D., Partner and Co-Chair of the Health Law
Practice Group and of the Life Sciences Practice Group in the law firm
of Saul Ewing LLP, Philadelphia, PA
Risk Assessment in Medical Device Software Regulation
by Sherman Eagles, Technical Fellow at Medtronic, Inc., Minneapolis,
MN and Co-Chair of the Medical Device Software Committee of the Association
for the Advancement of Medical Instrumentation, Arlington, VA
and Kenneth Jensen, Principal Regulatory Manager at Medtronic, Inc.,
Minneapolis, MN
Endocrine DisruptionHistory, Fact, and Fantasy of Gender
Bending Chemicals
by Raphael J. Witorsch, Ph.D., Professor of Physiology at the School
of Medicine, Medical College of Virginia, Virginia Commonwealth University,
Richmond, VA
From the President's Desk
FDLI FY 2002 Annual Report
by Jerome A. Halperin, President and Chief Executive Officer of the
Food and Drug Law Institute, Washington, D.C.
Making History
Biologics Centennial: 100 Years of Biologics Regulation
by Suzanne White Junod, Ph.D., Historian with the Food and Drug Administration,
Rockville, MD
Enforcement Corner
Clinical Trials and Tribulations: Expanding Scrutiny and Jeopardy
by Steven M. Kowal, Partner in the law firm of Bell, Boyd & Lloyd,
LLC, Chicago, IL
Global Corner
Product Safety and Liability
by Matthew Weinberg, Chief Executive Officer of THE WEINBERG GROUP,
INC., Washington, D.C.
Associates' Corner
Privacy of Employee RecordsThe Scope of DEA's Inspection Authority
by Mark D. Learn, Associate with the law firm of Hogan & Hartson
L.L.P., Washington, D.C.
Note: All author affiliations are current as of the date of publication of the issue.
(Note: All author affiliations are current as of the date of publication of the issue.)

