HIPAA/HITECH Requirement Changes and Enforcement: For Research Centers March 2011

Mar 4, 2011
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 Course Description 

The stimulus package brought with it the HITECH Rule, February 2009, effective February 17, 2010, that resulted in some changes to concepts and definitions within the Privacy and Security Rules impacting covered entities’ responsibilities. The impact of noncompliance has increased a great deal, and the impact of noncompliance has intensified. Come learn the expanded definitions of covered entity, business associate, unauthorized disclosures, penalties, and more. We will also discuss corrective action planning, and preparing for the increased amount of CE inspections, both routine and complaint driven.



Learning Objectives 

  • Apply the latest regulatory changes and notices impacting to the HIPAA Privacy & Security Rules specific to medical practices
  • Examine covered entities compliance and the need to prepare for inspections from OCR
  • Develop and respond to a gap analysis of current systems for compliance
  • Implement best practices that do not contradict with FDA and other regulatory authorities outside of research
  • Examine the Enforcement Rule updates and implications

Who Should Attend 

  • Privacy Officers
  • Site Managers
  • CRCs/Research Nurses
  • Investigators
  • Project Managers
  • CRA Mangers
  • CRAs
  • QA
  • Regulatory


Sandra "SAM" Sather, MS, BSN, CCRA, CCRC

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Course Length Time 

1.5 hours; 12:00 - 1:30 p.m. Eastern

Course Dates 

March 4, 2011                          

Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471. 


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