Medical Research

Controversial U.S. Medical Study Raises Informed Consent Questions

by Michael Werner | Holland & Knight LLP on 5/10/2013

The recent controversy surrounding a study of newborn babies in universities across the United States demonstrates the importance of compliance with human subject protection regulations in medical research....more

White House Unveils BRAIN Initiative

by Donald Zuhn | McDonnell Boehnen Hulbert & Berghoff LLP on 4/10/2013

Last week, President Obama announced a new research initiative designed to advance our understanding of the human brain. It is hoped that the new initiative, dubbed the BRAIN (Brain Research through Advancing Innovative...more

Research Initiatives Hope To Unlock Complexity Of Brain Injuries

by Johnston, Moore & Thompson, Huntsville... on 4/3/2013

Traumatic brain injuries can manifest themselves in a vast array of symptoms. Victims can be made to struggle with any combinations of memory difficulties, motor difficulties, personality changes and emotional struggles....more

Time to Take Advantage of HIPAA Omnibus Rule's "Good News": Fundraising, Research, and Student Immunization Records

by Kristen Blanchette, Adam H. Greene | Davis Wright Tremaine LLP on 4/3/2013

The Omnibus Rule went into effect on March 26, 2013. While covered entities and business associates have until Sept. 23, 2013, to comply with new restrictions and obligations, they can take advantage of the rule’s benefits...more

Sharing an Umbrella

by MoFo Tech on 3/26/2013

Big Pharma and academia cement big deals in the quest for bigger prizes - With the patents of many highly profitable blockbuster drugs expiring over the course of a few years, the search is on for new drugs to fill...more

New from Abroad: Broadening of UK Bolar Defence

by McDonnell Boehnen Hulbert & Berghoff LLP on 3/6/2013

Originally published in WP Thompson & Co. on March 4, 2013. On 26 February 2013, the UK government announced a proposed change to the Patents Act to exempt clinical and field trials, as well as "health technology...more

Physician Payment Sunshine Rule is Finalized

by Christopher P. Dean, Joshua Freemire, William Mathias | Ober|Kaler on 2/15/2013

The Final Rule implementing the Physician Payment Sunshine Act was announced on February 1st and published in the Federal Register on February 8th. The Final Rule establishes procedures for drug and device manufacturers to...more

CMS Issues Final Rule for Implementing Sunshine Act

by Wilson Sonsini Goodrich & Rosati on 2/14/2013

On February 8, 2013, 16 months after the statutory deadline, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register the final regulation implementing the physician payment transparency...more

CMS Issues Final Rule to Implement Physician Payments Sunshine Act

by King & Spalding on 2/7/2013

On Friday, February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) released the highly anticipated final rule to implement the federal Physician Payments Sunshine Act (the “Sunshine Act”). The final rule will...more

CMS Issues Final Physician Payment Sunshine Rule

by Michael Werner | Holland & Knight LLP on 2/5/2013

In an action that will have broad implications for drug and device manufacturers, researchers, distributors, teaching hospitals and physicians, on February 1, the Centers for Medicare and Medicaid Services (CMS) publicly...more

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