Privacy And Progress In Whole Genome Sequencing

The delivery of health care is in a period of intense transition as information garnered from the sequencing of complete genomes is being integrated into the development and delivery of clinical care. This information is necessary for the advancement and continued development of personalized medicine. As many parties touch this data, e.g., the laboratory technician, the research hospital, the drug developer and the clinician, the patient and her family is vulnerable to unauthorized access to and misuse of that information.

Earlier this month the Presidential Commission for the Study of Bioethical Issues (the Commission) issued guidelines to address ethical and legal issues that arise as a result of whole genome sequencing. Privacy and Progress in Whole Genome Sequencing, Presidential Commission for the Study of Bioethical Issues, attached here as the "Report." The Commission recognized that current U.S. governance and oversight of genomic data do not fully protect individuals from the risks associated with sharing their whole genome sequence data and information, which sharing is necessary to advance the technology and realize its full potential. Presently, privacy regulation varies greatly from state to state. After reviewing any present regulations and considering their limitations and possible future use of the technology and ethical obligations concerning the use of this information, the Commission recommends strong baseline protections for whole genome sequence data to protect individual privacy and data security while also leaving ample room for data sharing opportunities that propel scientific and medical progress. The Commission recommends the following:

Strong Baseline Protections While Promoting Data Access and Sharing. Clear policies defining acceptable access to and permissible uses of whole genome sequence data are necessary. The policies should promote opportunities for models of data sharing by individuals who want to do so. A consistent floor of privacy protections covering whole genome sequence data is necessary regardless of how the data were obtained. The policies must protect individual privacy and prohibit the unauthorized use of data without individual consent. Data Security and Access to Databases. Accessible whole genome sequence data should be stripped of traditional identifiers whenever possible to inhibit recognition or re-identification. Only in exceptional circumstances should entities such as law enforcement or...