For health care and clinical research professionals it's mandatory to understand the compliance requirements of HIPAA, and subsequent rules and laws that affect HIPAA, including ARRA/HITECH, the Affordable Care Act (ACA), Administrative Simplification Compliance Act (ASCA), the Patient Safety and Quality Improvement Act (PSQIA), and the OMNIBUS rules. These laws require all health care and clinical research professionals to take careful steps to protect protected health information (PHI).
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.
Why Should You Attend:
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.
• 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
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• 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, Executive Director, Boston University School of Medic
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.