Thursday, June 30, 2011

Sorrell v. IMS Health Inc. : SCOTUSblog

Sorrell v. IMS Health Inc. : SCOTUSblog
Vermont’s Prescription Confidentiality Law, which – absent the prescriber’s consent – prohibits the sale of prescriber-identifying information, as well as the disclosure or use of that information for marketing purposes, is subject to heightened judicial scrutiny because it imposes content- and speaker-based burdens on protected expression. Vermont’s justifications for the prohibition cannot withstand such heightened scrutiny.

PLIVA, Inc. v. Mensing : SCOTUSblog

PLIVA, Inc. v. Mensing : SCOTUSblog

Federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus preempt, state-law tort claims alleging a failure to provide adequate warning label

Home | Costs of War

Home | Costs of War

The Eisenhower Research Project based at Brown University assembled a team that includes economists, anthropologists, political scientists, legal experts, and a physician to do this analysis.

We asked:

  • What have been the wars’ costs in human and economic terms?
  • How have these wars changed the social and political landscape of the United States and the countries where the wars have been waged?
  • What will be the long term legacy of these conflicts for veterans?
  • What is the long term economic effect of these wars likely to be?
  • Were and are there alternative less costly and more effective ways to prevent further terror attacks?

Study looks at worker burnout - Health News - NHS Choices

Study looks at worker burnout - Health News - NHS Choices
If you have more than 16 years in, this is you (and me).

A Model Health Care Delivery System for Medicaid — NEJM

A Model Health Care Delivery System for Medicaid — NEJM

Access to Safety Data — Stockholders versus Prescribers | Health Policy and Reform

Access to Safety Data — Stockholders versus Prescribers | Health Policy and Reform
Just out from NEJM

Wednesday, June 29, 2011

Medical News: Spine Journal Takes Aim at Infuse Research - in Orthopedics, Orthopedics from MedPage Today

Medical News: Spine Journal Takes Aim at Infuse Research - in Orthopedics, Orthopedics from MedPage Today

Female guards need training to avoid sexual trysts with male prisoners: study | Posted | National Post

Female guards need training to avoid sexual trysts with male prisoners: study | Posted | National Post

A new Canadian study says female guards need training on “boundary violations” to avoid the dangers of sexual trysts with male inmates.

The article in the Journal of the American Academy of Psychiatry and the Law concludes long-term interaction between female guards and other workers and inmates, conniving by the convicts, and “lovesick” emotional vulnerability on the part of both parties can set the stage for inappropriate relationships.

The paper sets out a checklist of rules for female workers, including keeping front of mind why inmates are behind bars, seeking counselling for any feelings of sexual attraction to them and not using work as a means to satisfy personal needs.

How about training on staying on the opposite side of the bars?

Biologist spared jail for grant fraud : Nature News

Biologist spared jail for grant fraud : Nature News
discussion of leniency based on quick response

Federal Register | Defense Federal Acquisition Regulation Supplement; Safeguarding Unclassified DoD Information (DFARS Case 2011-D039)

Federal Register | Defense Federal Acquisition Regulation Supplement; Safeguarding Unclassified DoD Information (DFARS Case 2011-D039)

The DFARS does not presently address the safeguarding of unclassified DoD information within industry, nor does it address cyber intrusion reporting for that information. DoD published an Advance Notice of Proposed Rulemaking (ANPR), and notice of public meeting in the Federal Register at 75 FR 9563 on March 3, 2010, to provide the public an opportunity for input into the initial rulemaking process. The ANPR addressed basic and enhanced safeguarding procedures for the protection of DoD information.Show citation box

The purpose of this proposed DFARS rule is to implement adequate security measures to safeguard unclassified DoD information within contractor information systems from unauthorized access and disclosure, and to prescribe reporting to DoD with regard to certain cyber intrusion events that affect DoD information resident on or transiting through contractor unclassified information systems. This rule addresses the safeguarding requirements specified in Executive Order 13556, Controlled Unclassified Information. On-going efforts, currently being led by the National Archives and Records Administration regarding controlled unclassified information, may also require future DFARS revisions in this area. This case does not address procedures for Government sharing of cyber security threat information with industry; this issue will be addressed separately through follow-on rulemaking procedures as appropriate.Show citation box

This proposed rule addresses basic and enhanced safeguarding requirements, including cyber incident reporting,

Federal Register | HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health Act

Federal Register | HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health Act

The Department of Health and Human Services (HHS or “the Department”) is issuing this notice of proposed rulemaking to modify the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule's standard for accounting of disclosures of protected health information. The purpose of these modifications is, in part, to implement the statutory requirement under the Health Information Technology for Economic and Clinical Health Act (“the HITECH Act” or “the Act”) to require covered entities and business associates to account for disclosures of protected health information to carry out treatment, payment, and health care operations if such disclosures are through an electronic health record. Pursuant to both the HITECH Act and its more general authority under HIPAA, the Department proposes to expand the accounting provision to provide individuals with the right to receive an access report indicating who has accessed electronic protected health information in a designated record set. Under its more general authority under HIPAA, the Department also proposes changes to the existing accounting requirements to improve their workability and effectiveness.

DoD IG Report on Audit of Boeing Spare Parts Contracts (May 2011)

DoD IG Report on Audit of Boeing Spare Parts Contracts (May 2011)

Boeing found to have overcharged Army for helicopter parts -- GovExec.com

Boeing found to have overcharged Army for helicopter parts -- GovExec.com
Back to the Eighties. $1700 for a part worth a few bucks

Tuesday, June 28, 2011

Federal Register | HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health Act

Federal Register | HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health Act

Guidances Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology

Guidances Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology

Monday, June 27, 2011

Texas Supreme court on non-competes

 "... whether a covenant not to compete signed by a valued employee in
consideration for stock options, designed to give the employee a greater stake in the company’s performance,
is unenforceable as a matter of law because the stock options did not give rise to an interest in restraining
competition. We hold that, under the terms of the Covenants Not to Compete Act (Act), the consideration for
the noncompete agreement (stock options) is reasonably related to the company’s interest in protecting its
goodwill, a business interest the Act recognizes as worthy of protection."

Reverses the lower Court decision.

Friday, June 17, 2011

Legislative History Research: A Basic Guide

CRS guide on how to do Legislative History research

Thursday, June 16, 2011

The Clause |

The Clause |: "- Sent using Google Toolbar"
reprints:
“Is It Public, or Is It Not?”
What to Watch for When Public and Private Become Entwined,
and Why It Matters
by
Roland Nikles*
[Note: © The American Bar Association, The Procurement Lawyer, Vol. 46, No. 3, Spring
2011. Reprinted with permission. All rights reserved.]

good for ARRA issues in particular

Controversial climate study retracted | The Scientist

Controversial climate study retracted | The Scientist: "- Sent using Google Toolbar"

Major OOPS for the climate change deniers.
Wikipedia as a source!

DNA-RNA mismatch | The Scientist

DNA-RNA mismatch | The Scientist: "- Sent using Google Toolbar"

Could be a significant new factor in genetic transmission.

HUMANA MEDICAL PLAN, INC. et al v. GLAXOSMITHKLINE, L.L.C. et al Document 26 - :: Justia Docs

HUMANA MEDICAL PLAN, INC. et al v. GLAXOSMITHKLINE, L.L.C. et al Document 26 - :: Justia Docs

Secondary payer case, but also perhaps of interest as a Subject Injury case of sorts.

Wednesday, June 15, 2011

Vedder Price: Ajay A. Jagtiani and Marc W. Butler Publish "The Perils Of One Wrong Word In A Contract" in Law360

Vedder Price: Ajay A. Jagtiani and Marc W. Butler Publish "The Perils Of One Wrong Word In A Contract" in Law360: "- Sent using Google Toolbar"

Government officials can't hide when they failed to treat a company fairly and honestly

06/14/2011Miller, G.DEFENSE TECHNOLOGY, INC. V. THE UNITED STATES [11-111C]


Court refuses to allow Government to hide Government officials names in a protest case that shows government  in bad light.

Friday, June 10, 2011

Draft FDA Nanotechnology

Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications ofNanotechnology and Nanomaterials

Thursday, June 9, 2011

FDA rule on safety reporting NEJM article

New FDA Regulation to Improve Safety Reporting in Clinical Trials

NEJM | June 8, 2011 | Topics: Drugs, Devices, and the FDA

Wednesday, June 8, 2011

Whistle-blower claims his accusations cost him his job

Retaliation or not?
"... a postdoc at the University of Wisconsin–Madison's zoology department was presented with three options. The department's chairman said he could wait to be fired, resign voluntarily or accept a "gracious exit strategy" that would give him time to prepare a paper for publication, if he dropped his "scientific misconduct issues"."

Tuesday, June 7, 2011

New rules for transfers to non-US persons of ITAR-governed items and data


International Traffic in Arms Regulations: Dual Nationals and 
Third-Country Nationals Employed by End-Users

Monday, June 6, 2011

Stanford Bayh-Dole case handed down by Sup. Ct. today

BOARD OF TRUSTEES OF THE LELAND STANFORD
JUNIOR UNIVERSITY v. ROCHE MOLECULAR
SYSTEMS, INC., ET AL.
Syllabus:
The Bayh-Dole Act does not automatically vest title to federally-funded inventions in federal contractors or authorize contractors to unilaterally take title to such inventions.
The Court’s construction of the Act is also reflected in the common practice of contractors, who generally obtain assignments from their employees, and of agencies that fund federal contractors, who typically expect those contractors to obtain assignments. With effective assignments, federally funded inventions become “subject inventions” and the Act as a practical matter works pretty much the way Stan-ford says it should. The only significant difference is that it does so without violence to the basic patent law principle that inventors own their inventions.

NAS books now downloadable free.

National Academies Press Makes All PDF Books Free to Download
 
As of June 2 all PDF versions of books published by the National Academies Press will be downloadable to anyone free of charge. This includes a current catalog of more than 4,000 books plus all future reports printed by NAP. "Our business model has evolved so that is now financially viable to put this content out to the entire world for free," said NAP executive director Barbara Kline Pope. "This is a wonderful opportunity to make a positive impact by more effectively sharing our knowledge and analysis."

Representation Relating to Compensation of Former DoD Officials

Defense Federal Acquisition Regulation Supplements: Representation Relating to Compensation of Former DoD Officials
New proposed rule that will make DoD contractors enforce post employment restrictions on ex-DoD employees working for the contractor.

Thursday, June 2, 2011

New case on FCA rejects limits on scope of law

The First Circuit, in
2011/06/01 10-1505P.01A 10-1505  U.S. ex rel. Hutcheson v. Blackstone Medical, Inc.
    District of Massachusetts, Boston

rejected two purported limitations on FCA liability.The Court rejects the argument that, in the absence of an express legal representation or factual misstatement, a claim can only be false or fraudulent if it fails to comply with a precondition of payment expressly stated in a statute or regulation. Second, the Court allows the argument that a submitting entity's representations about its own legal compliance CAN incorporate an implied representation concerning the behavior of non-submitting entities.