As reported in my January 24th, 2013 post, the Office for Civil Rights of the U.S. Department of Health and Human Services (HHS) issued an omnibus final rule (the Rule) implementing changes in current regulations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), pursuant to the Health Information Technology for Economic and Clinical Health Act (HITECH Act). In addition to finalizing proposed regulations set forth in a proposed rule dated July 14, 2010, it also addressed other HIPAA provisions. It also finalized a proposed rule issued in 2009 that implements the HIPAA-related genetic privacy provisions of the Genetic Information Nondiscrimination Act (GINA). Continue reading this entry
The application of medical technology in the pediatric setting must serve the best interest of the child. Genetic testing of children and infants presents unique challenges. In contrast to the testing of adult patients, most children cannot understand the risks and benefits or provide informed consent. The American Academy of Pediatrics (AAP) and the American College of Medical Genetics and Genomics (ACMG) recently issued recommendations regarding genetic testing or screening of infants and children. In Ethical and Policy Issues in Genetic Testing and Screening of Children (“Report”), the AAP and ACMG review the scenarios in which genetic testing or screening of minors may occur and recommend best practices for such testing.Continue reading this entry
On January 17, 2013, the Office for Civil Rights of the U.S. Department of Health and Human Services (HHS) issued the long-awaited omnibus final rule (the Rule) implementing changes in current regulations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), pursuant to the Health Information Technology for Economic and Clinical Health Act (HITECH Act). Most of the Rule finalizes numerous proposed regulations set forth in a proposed rule dated July 14, 2010 (the Proposed Rule), which focused on the HITECH Act but also addressed other HIPAA provisions. The Rule also finalizes a proposed rule issued in 2009 that implements the HIPAA-related genetic privacy provisions of the Genetic Information Nondiscrimination Act (GINA).
Foley & Lardner, LLP provides an Executive Summary of the Rule and recommendations for preparing to comply. To learn more click here.
On November 24, 2009, President Obama established the Presidential Commission for the Study of Bioethical Issues (Commission) to advise him on bioethical issues generated by novel and emerging research in biomedical and related areas of science and technology. As part of this initiative, the Commission issued a Notice on March 27, 2012 (Federal Register) seeking comments on the ethical issues raised by the ready availability of large-scale human genome sequencing data.
Privacy And Access
Tremendous technological advances have reduced the cost of sequencing to the point where relatively inexpensive, rapid sequencing of whole genomes is not only likely but imminent. The emergence of this new technology raises, for the Commission, issues how this information can and ought to be collected, used, and governed. Of particular initial interest are issues relating to the privacy of and access to this information by patients, researchers, and medical professionals.
The Commission is particularly interested in comments informing policies, practices, research, and perspective on issues of privacy and data access as they relate to the integration of large scale human genome sequencing into research and clinical care. Of additional interest are models and mechanisms for protecting privacy in both genetic/genomic databases of sensitive information and the sharing and management of information and access to large-scale human genomic data.
To Submit Comments
Individuals, groups, and organizations interested in commenting may submit comments by email to email@example.com or by mail to the following address:
Public Commentary, The Presidential Commission for the Study of Bioethical Issues, 1425 New York Ave. NW., Suite C-100, Washington, DC 20005.
To assure consideration, comments must be received by May 25, 2012.
For additional insight into the Commission’s thinking on the issues concerning genetic testing, see the Commission’s blog.