Evaluate the Implications of Amendments to the HIPAA Privacy Rule & CLIA Regulations for Laboratories Offering Clinical Sequencing

Project Dates
08/01/2014 to 03/31/2015
Principal Investigator

Gail P. Jarvik, MD, PhD (University of Washington)

This project addressed recent regulatory amendments that require CLIA-certified and -exempt laboratories that are subject to the HIPAA Privacy Rule to comply with new individual data-access requirements. The general aim of this work was to:

  • provide a preliminary analysis to aid Clinical Sequencing Exploratory Research (CSER) investigators in their efforts to understand factors that affect whether their laboratories engaged in genomic sequencing are subject to the new requirements;
  • identify specific issues that may need to be addressed in their laboratories’ compliance programs; and
  • highlight unresolved bioethical and compliance concerns that may require further attention.

Role: Susan M. Wolf, JD, Consultant

Project outcomes

Publication of consensus analyses from the working group.