Nov
04
2011
In September, Secretary of the U.S. Department of Health and Human Services Kathleen Sebelius proposed rules to give patients direct access to their clinical laboratory results. We believe that giving people access to their lab results will trigger more engagement by patients and better dialogue between patients and their doctors. Your comments may help make a difference between whether the proposed rules become reality.
Tags: CLIA, direct access, HIPAA, laboratory testing, legislation, regulation
Jul
20
2010
The FDA/CDRH Public Meeting on Oversight of Laboratory Developed Tests (LDTs) took place yesterday and today (July 19 and 20) in Washington, DC. Webcasts of both days will be available from the FDA for the next year. 23andMe’s President and Co-Founder Anne Wojcicki spoke about the promise and power of direct-to-consumer genetic testing at the [...]
Tags: 23andMe, Anne Wojcicki, Ashley Gould, FDA
Jul
15
2010
On Wednesday July 14, 23andMe and California State Senator Alex Padilla co-hosted a day-long policy forum entitled “Genomics and the Consumer: The Present and Future of Personalized Medicine.” The approximately 150 people in attendance—lawyers, scientists, ethicists, business people, elected officials and consumers themselves—were treated to a day of stimulating panel discussions, plus lunch breakout sessions [...]
Tags: Genomics and the Consumer, policy forum
Jun
24
2010
Today, 23andMe is pleased to announce that we have received institutional review board (IRB) approval for our research protocol and an accompanying revised Consent Document. This approval reaffirms that all 23andMe research efforts intended for publication protect the interests of our customers. Our absolute commitment to privacy has not changed. An IRB is an independent [...]
Tags: 23andMe, consent, Consent Document, IRB, Privacy Statement, research, Terms of Service
Jun
10
2010
The Genetic Information Nondiscrimination Act, or GINA, is U.S. federal legislation that protects Americans from discrimination (in health insurance and employment decisions) on the basis of genetic information. GINA was signed into law by President George W. Bush on May 21, 2008. The Genetic Alliance, the Genetics and Public Policy Center at the Johns Hopkins [...]
Tags: Genetic Alliance, Genetic Information Nondiscrimination Act, Genetics and Public Policy Center, GINA, NCHPEG
Oct
05
2009
Dan Vorhaus at Genomics Law Report has launched “What ELSI is new?”, a series of guest posts on the most pressing ethical, legal, and social issues (ELSI) relating to genomics. (You gotta love the name.) The contributor list is a who’s who of voices in the ELSI, policy, and blog worlds. I’m honored to be [...]