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.
At the conclusion of this 90-minute session, participants 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