title: 2013 HIPAA Changes Provide Opportunities and Challenges for Researchers: Perspectives from a Cancer Center.
abstract: In 2013, the U.S. Department of Health and Human Services modified the Health Insurance Portability and Accountability Act Privacy Rule to "strengthen privacy and security protections" while "improving workability and effectiveness to increase flexibility for and decrease burden on regulated entities." In this article, we attempt to translate these generalized goals into the real-world implications of these changes. Under the new rules, researchers can obtain participants' permission to use their protected health information for more research activities with a single, upfront authorization (thereby reducing paperwork for participants, researchers, and institutional review boards) while providing potential participants with more information upon which to base their decisions about participation. The combined authorizations can be used in clinical trials and their optional substudies and in stand-alone biospecimen-banking research that includes authorization to permit future research use. We also suggest best practices for taking advantage of the flexibility offered by the new rules while maintaining strong privacy protections for human subjects.
authors.affiliation: Department of Gynecologic Oncologic and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas. rfreedma@mdanderson.org.
authors.forename: Ralph S
authors.initials: RS
authors.lastname: Freedman
authors.affiliation: Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Scott B
authors.initials: SB
authors.lastname: Cantor
authors.affiliation: Tumor Registry, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Kelly W
authors.initials: KW
authors.lastname: Merriman
authors.affiliation: Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Mary E
authors.initials: ME
authors.lastname: Edgerton
mesh_terms: D000046:Academic Medical Centers; D035843:Biomedical Research / Q000331:legislation & jurisprudence; D002173:Cancer Care Facilities; D020408:Health Insurance Portability and Accountability Act / Q000331:legislation & jurisprudence*; D006801:Humans; D012108:Research Personnel; D014481:United States