HIPAA & Source Data Access: Dispelling the Myths
Since updates to HIPAA security requirements for use and disclosure of patient health information, the sponsor challenges to accessing pertinent source documentation related to clinical trials has increased. Allowing sponsors access to original source documents creates a risk of unauthorized disclosure of protected health information outside the covered entity. Nothing has changed regarding the FDAs requirements related to source documentation at sites, except guidance from the agency supporting remote access to source documentation for remote monitoring when possible under the new paradigm of centralized remote monitoring. With the proper systems in place and proper training of both site and sponsor staff, this can be supported. The two set of requirements can work well together!
This course will help you navigate confusing HIPAA requirements and provide solutions to ensure patient data security. Through instruction and value-added documentation, you will walk away with actionable knowledge to keep your efforts compliant, and have the ability to separate fact and fiction.
Come to this interactive live session and you will be able to:
- Recognize the differences between confidentiality in clinical research and de-identification under the HIPAA Privacy Rule
- Understand the requirements of the Privacy Rule relating to research sites’ disclosure of patient protected health information to sponsors
- Recognize the requirements of HIPAA HITECH security and privacy requirements specifically impacting sponsor review and collection of subject source data
- Identify acceptable practices related to monitoring original source documents that are in line with FDA and HIPAA Security and Privacy Rule requirements
This course will be of benefit to anyone responsible for running or managing clinical trials at sites, including site managers, investigators and study coordinators. Additionally, this course will be of particular interest to those that select, monitor or audit research sites.
Sandra “SAM” Sather’s current focus of consulting is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions. She has over 25 years of clinical experience: Bachelor of Science in Nursing and a Master of Science in Education with a Specialization in Training and Performance Improvement. SAM is the vice-president of Clinical Pathways, a consulting firm located in the Research Triangle Park area in North Carolina, USA. Clinical Pathways’ services include development and updates to clinical monitoring operations, compliance and auditing services, GCP subject matter expert, training management and development, mentoring, performance improvement systems analysis, staff management and more. SAM is dual certified by the Association for Clinical Research Professionals (ACRP) for over 10 years (CCRA and CCRC) and current member of the ACRP Academy Board of Trustees and Regulatory Affairs Committee (RAC); She is a frequent speaker for industry conferences and has authored dozens of courses for clinical research in various functional areas (e.g., monitoring, safety, HIPAA, and vendor management).