On January 25, 2013, the Federal Register published the Department of Health and Human Services omnibus amendments to the Health Insurance Portability and Accountability Act Privacy, Security, Enforcement, and Breach Notification Rules. These modifications also include the final versions of the HIPAA regulation amendments mandated by the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act. Although the amended rules were effective on March 26, 2013, covered entities and their business associates have a compliance (...) date of September 23, 2013.It has been 10 years since the April 14, 2003 compliance date for the original HIPAA Privacy Rule. Despite HHS’ clarification of some issues by posting answers to frequently asked questions, there have been no significant amendments to the Privacy Rule since 2003. (shrink)

Genomic research results and incidental findings with health implications for a research participant are of potential interest not only to the participant, but also to the participant's family. Yet investigators lack guidance on return of results to relatives, including after the participant's death. In this paper, a national working group offers consensus analysis and recommendations, including an ethical framework to guide investigators in managing this challenging issue, before and after the participant's death.

On January 25, 2013, theFederal Registerpublished the Department of Health and Human Services omnibus amendments to the Health Insurance Portability and Accountability Act Privacy, Security, Enforcement, and Breach Notification Rules. These modifications also include the final versions of the HIPAA regulation amendments mandated by the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act. Although the amended rules were effective on March 26, 2013, covered entities and their business associates have a compliance date of (...) September 23, 2013.It has been 10 years since the April 14, 2003 compliance date for the original HIPAA Privacy Rule. Despite HHS’ clarification of some issues by posting answers to frequently asked questions, there have been no significant amendments to the Privacy Rule since 2003. (shrink)

The death of a research participant raises numerous ethical and legal issues regarding the return of research results to related family members. This question is particularly acute in the context of genetic research since the research results from an individual may be relevant to each of the biological relatives. This paper first investigates the ethical and legal frameworks governing the return of a deceased participant's individual research results to his or her related family members. Then, it weighs the rights and (...) interests of both the deceased individual and related family members in an attempt to identify key ethical considerations underlying the return of such results. This analysis of international guidelines and national laws and regulations reveals that though the legal framework regarding privacy and confidentiality of clinical and research information is well established (albeit not homogenous), guidelines are generally absent in the post-mortem context. Nevertheless, a brief analysis of this issue through two ethical perspectives (principlism and consequentialism) allows us to identify six key elements to be taken into consideration when returning a deceased participant's research results. (shrink)