Links

European Union Negotiations Reach Agreement On New Clinical Trials Regulation

Article by Mark Barnes, Eve M. Brunts and Albert F. Cacozza, Jr. Ropes & Gray LLP “The European Union (“EU”) has cleared the way for adoption of a new clinical trials regulation within the EU. On December 20,...

Read More

NEJM Fully Transparent Medical Records

Forty years ago, Shenkin and Warner argued that giving patients their medical records “would lead to more appropriate utilization of physicians and a greater ability of patients to participate in their own care.”1 At that...

Read More

Preliminary Cybersecurity Framework for improving critical infrastructure cybersecurity

Executive Order “Improving Critical Infrastructure Cybersecurity” directed NIST to work with stakeholders to develop a voluntary framework for reducing cyber risks to critical infrastructure. Preliminary Cybersecurity Framework On October 29, 2013, NIST announced a...

Read More

CMS Issues New Guidance on 2-Midnight Rule

AAMC Washington Highlights  CMS Issues New Guidance on 2-Midnight Rule November 8, 2013—The Centers for Medicare and Medicaid Services (CMS) Nov. 1 issued three new documents about the “2-Midnight Rule.” The new documents include additional guidance, ...

Read More

Good article on patenting post Mayo

The future of prenatal molecular diagnostics: impact of the changing patent landscape Tara L Rachinsky Pharmaceutical Patent Analyst January 2014, Vol. 3, No. 1, Pages 1-3 , DOI 10.4155/ppa.13.76 (doi:10.4155/ppa.13.76) http://www.future-science.com/doi/full/10.4155/ppa.13.76

Read More

THE OFFICE FOR CIVIL RIGHTS DID NOT MEET ALL FEDERAL REQUIREMENTS IN ITS OVERSIGHT AND ENFORCEMENT OF THE HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT SECURITY RULE

OCR did not meet Federal requirements critical to the oversight and enforcement of the Security Rule: Although OCR made available to covered entities guidance that promoted compliance with the Security Rule, it had not...

Read More

Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics

This draft guidance is intended to describe FDA’s current thinking about how manufacturers, packers,  and distributors (firms), that may either be the applicant or acting on behalf of the applicant, of prescription human and...

Read More

Hospital Industry Consolidation — Still More to Come?

New England Journal of Medicine Leemore Dafny, Ph.D. N Engl J Med 2014; 370:198-199January 16, 2014DOI: 10.1056/NEJMp1313948 The Affordable Care Act (ACA) has unleashed a merger frenzy, with hospitals scrambling to shore up their...

Read More

How Many Scientists Fabricate and Falsify Research?

by Daniele Fanelli  “The image of scientists as objective seekers of truth is periodically jeopardized by the discovery of a major scientific fraud. Recent scandals like Hwang Woo-Suk’s fake stem-cell lines or Jan Hendrik...

Read More

Doing good science- Scientific American

Don’t be evil: Obligations of scientists (part 3) By Janet D. Stemwedel | December 19, 2013 “… a bit more about scientists’ negative duties (i.e., duties to refrain from doing particular kinds of things).” How plagiarism hurts knowledge-building: Obligations...

Read More