Archive for September, 2013

OHRP Clarification on Compensating Subjects

OHRP has revised its response to the Frequently Asked Question (FAQ) “When does compensating subjects undermine informed consent or parental permission?” (http://www.hhs.gov/ohrp/policy/consentfaqsmar2011.pdf). Human subjects often are provided payment for their time, inconvenience, and out-of-pocket...

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HIPAA Guide for Law Enforcement

The Office for Civil Rights (OCR) of the Department of Health and Human Services added a planning resource to its website to assist law enforcement and emergency planners when addressing information sharing situations where...

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Model Notices of Privacy Practices

The Office for Civil Rights and Office of the National Coordinator for Health Information Technology have collaborated to develop model Notices of Privacy Practices for health care providers and health plans to use to...

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NON-COMPETE CASES NOT SUBJECT TO DEMURRER

Demurrer cannot be used to decide on the merits an employee’s challenge to the enforceability of the restraints on competition. ASSURANCE DATA, INC. v. JOHN MALYEVAC Record No. 121989 SEPTEMBER 12, 2013     “Because “[a] demurrer does...

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The Congressional War on Contractors

  Jessica Tillipman The George Washington University Law School 2013 George Washington International Law Review, Vol. 45, p. 235, 2013 GWU Legal Studies Research Paper No. 2013-110 GWU Law School Public Law Research Paper...

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Gene Patenting — The Supreme Court Finally Speaks

Gene Patenting — The Supreme Court Finally Speaks Aaron S. Kesselheim, M.D., J.D., Robert M. Cook-Deegan, M.D., David E. Winickoff, J.D., and Michelle M. Mello, J.D., Ph.D. N Engl J Med 2013; 369:869-875August 29,...

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Patenting the PKU Test — Federally Funded Research and Intellectual Property

NEJM Patenting the PKU Test — Federally Funded Research and Intellectual Property Diane B. Paul, Ph.D., and Rachel A. Ankeny, Ph.D. N Engl J Med 2013; 369:792-794August 29, 2013DOI: 10.1056/NEJMp1306755 http://www.nejm.org/doi/full/10.1056/NEJMp1306755?query=TOC “Aggressive commercialization of...

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Patents, Profits, and the American People — The Bayh–Dole Act of 1980

NEJM Patents, Profits, and the American People — The Bayh–Dole Act of 1980 Howard Markel, M.D., Ph.D. N Engl J Med 2013; 369:794-796August 29, 2013DOI: 10.1056/NEJMp1306553 “It’s time for Congress to recalibrate Bayh–Dole. Profits...

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Risks (and Benefits) in Comparative Effectiveness Research Trials

NEJM Chris Feudtner, M.D., Ph.D., M.P.H., Mark Schreiner, M.D., and John D. Lantos, M.D. August 21, 2013DOI: 10.1056/NEJMp1309322 “The enmeshment of research and standard clinical care makes evaluation of the risks posed by a...

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Solutions to Keep Teaming Agreements Valid and Enforceable – Learning from the Cyberlock Decision August 28, 2013 by Kevin Hilferty

© 2012 Integrity Management Consulting, Inc. All rights reserved. “A Federal court recently struck a great blow to the validity of Teaming Agreements.  Some Teaming Agreements, arrangements of understanding between Prime and Sub contractors,...

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