HIPAA Compliance Monitoring and Auditing

We’ll use real-world examples to help explain the Privacy Rule, which governs patient rights and disclosure of protected health information (PHI), We’ll explain what’s meant by covered entities (CE), business associates (BA), and many other relationships within the health care industry impacted by HIPAA.

Since computer systems currently are an integral part of health care and clinical research, we’ll see how they fit into the Security Rule. We’ll also examine administrative safeguards, physical safeguards, technical safeguards, and policy and procedure creation—all of which are crucial components of the Security Rule.

Last, but not least, we’ll focus on the Office for Civil Rights (OCR), HIPAA’s “watchdog” organization, and learn about the civil and criminal penalties for non-compliance.

At completion of this session, you’ll be confident and capable of implementing HIPAA’s Administrative Simplification rules, develop understanding of laws impacting it and be able to conduct effective HIPAA compliance audits, in your own organization.

Why You Should Attend:

In this session, we’ll review the compliance process and focus specifically on the Administrative Simplification portion of HIPAA, starting by defining the lingo of HIPAA, ARRA/HITECH, ASCA, ACA, and the OMNIBUS rules.

Next, we’ll focus in on the Administrative Simplification rules of HIPAA, starting with transactions, code sets, and identifiers, which are all key elements in the HIPAA-mandated electronic health care transmissions.

Areas Covered in the Session :

  • Discuss current HIPAA laws and regulations as it pertains to clinical research
  • Describe key elements of HIPAA compliance program
  • Privacy and confidentiality protection in clinical research
  • Overview current best practices in HIPAA compliance
  • Discuss practical aspects of HIPAA compliance program implementation
  • Develop effective HIPAA compliance monitoring and auditing practices
Who Should Attend:

  • HIPAA professionals
  • Compliance Officers
  • Clinical Research Associates
  • Project/Program Managers
  • Directors of Compliance and QC/QA
  • Research nurses
  • Clinical research coordinators
  • Clinical research associates


Marina Malikova

Dr. Malikova has over twenty years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology.

Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She also holds a Master’s Degree in Clinical Investigation and Project Management Certification from Boston University.

In her current role as Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations, quality assurance, risk management, safety monitoring, strategic planning, and macro-management of research programs. She provides guidance and oversight to the Project Managers, Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), and laboratory staff. She advises faculty/staff on protocol and informed consent writing; assists with BU IRB applications and submissions; provides oversight for data user agreements, cost coverage analysis and budgets development, contracts and licensing for clinical research; and ensures compliance.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance