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2012
Date Title
January 11, 2012

Privacy and Data Protection 2011 Year in Review

Type: White Papers
 

2011
Date Title
October 14, 2011

OCR’s Proposed Revisions to Accounting for Disclosures Standard Produces Strong Opposition from Many Covered Entities

Type: White Papers
September 1, 2011

HHS Finalizes New Financial Conflicts of Interest Regulations

Type: On the Subject
July 27, 2011

HHS Proposes Overhaul of Human Subject Protections for Domestic Clinical Trials

Type: On the Subject
July 11, 2011

New FDA Draft Guidance Regarding Financial Disclosures by Clinical Investigators

Type: White Papers
July 7, 2011

OHRP Revises Federalwide Assurance

Type: On the Subject
 

2010
Date Title
September 21, 2010

Navigating the Government’s Final Rules for Earning Incentive Dollars Through “Meaningful Use” of E-Health Record Technology

Type: White Papers
August 2, 2010

AAMC Task Force Releases New Guidance on Managing Conflicts of Interest in Clinical Care

Type: White Papers
July 27, 2010

OCR Issues Proposed Modifications to HIPAA Privacy and Security Rules to Implement HITECH Act

Type: White Papers
March 9, 2010

FDA Proposes New Regulation to Require Sponsors to Report Suspected Data Falsification

Type: On the Subject
February 4, 2010

HHS Establishes the Initial Pathway for Qualifying for HITECH Act Incentives Dollars for Meaningful Use of Certified Electronic Health Record Technology

Type: White Papers
 

2009
Date Title
October 15, 2009

GINA & HIPAA: Interim Final Rules and Privacy Proposed Rule Published

Type: White Papers
August 27, 2009

Regulatory Update: HITECH’s HHS and FTC Security Breach Notification Requirements

Type: White Papers
 

2008
Date Title
November 3, 2008

Developments in Medicare Payment for Services in Clinical Trials

Type: On the Subject
September 16, 2008

Top 10 Intellectual Property and Regulatory Legal Issues for Biotech Start-Ups

Type: On the Subject
April 29, 2008

FDA Issues Draft Guidance on Certification Requirements Under New Clinical Trial Registration and Posting Provisions

Type: On the Subject
February 28, 2008

AAMC/AAU Joint Advisory Committee Issues New Guidelines on Managing Conflicts of Interest

Type: On the Subject
February 21, 2008

Ownership of Biological Samples and Clinical Data II: U.S. Supreme Court Denies Certiorari in the Catalona Decision

Type: On the Subject
 

2007
Date Title
October 15, 2007

FDA Oversight of Clinical Trials

Type: On the Subject
July 11, 2007

CMS final decision on reconsideration of the Clinical Trials NCD: Maintains status quo.

Type: On the Subject
May 31, 2007

May 2007 FDA Draft Guidance for Industry: Protecting the Rights, Safety, and Welfare of Study Subjects—Supervisory Responsibilities of Investigators

Type: On the Subject
 

2006
Date Title
July 25, 2006

CMS Announces Reconsideration of Clinical Trial Billing Policy

Type: On the Subject
May 1, 2006

Ownership of Biological Samples and Clinical Data: Catalona Decision Announced

Type: On the Subject
 

2005
Date Title
September 30, 2005

U.S. Congress Announces New Investigations into University Spending on Clinical Research

Type: On the Subject
August 11, 2005

New Federal Requirements for Investigating and Managing Allegations of Research Misconduct

Type: On the Subject
 

2004
Date Title
November 4, 2004

Increasing FDA Oversight Over Clinical Research

Type: On the Subject
April 28, 2004

Law of Tissue Banks and Stem Cells in Flux

Type: On the Subject
April 7, 2004

Massachusetts Appeals Court Decision Casts Doubt on the Tax-Exempt Status of Hospital Affiliated Medical Practices

Type: On the Subject

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