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. Clin Cancer Res; 22(3); 533-9. Ó2016 AACR. Disclosure of Potential Conflicts of InterestNo potential conflicts of interest were disclosed. Editor's DisclosuresThe following editor(s) reported relevant financial relationships: J.L. Abbruzzese is a consultant/advisory board member for Celgene and Halozyme. CME Staff Planners' DisclosuresThe members of the planning committee have no real or apparent conflicts of interests to disclose. Learning ObjectivesUpon completion of this activity, the participant should have a better understanding of recent changes to the Health Insurance Portability and Accountability Act regulations and how researchers could potentially benefit from their application. The participant should also have a better understanding of institutional review board processes related to protected health information and certain best practices for privacy protection involving biospecimens maintained in biodata repositories and data from tumor registries utilized in research.

Reproducibility and Reuse of Adaptive Immune Receptor Repertoire Data

“…Access to health information is regulated by national and international laws, such as the Health Insurance Portability and Accountability Act in the United States or the EU Regulation 2016/679 in the European Union, which requires medical information and personal identifiers to be safeguarded. For studies using AIRR-seq data from human subjects, data must be collected following a protocol that has been approved by the researcher’s Institutional Review Board, which oversees human subjects’ protections and ensures that all studies are performed in a legal and ethical manner ( 63 ). Human subjects must provide informed consent, and there should be broad agreement in the consent language regarding the confidentiality of medical information and the use of AIRR-seq data and metadata for future research.…”