Federal regulators have published a final rule for implementation of the Genetic Information Nondiscrimination Act of 2008 (Pub. L. 110-233). GINA, which was signed in May 2008 by President Bush, restricts the collection and use of genetic information in a number of ways. GINA prohibits health insurance providers and employers from requiring genetic testing. Genetic data cannot be used to determine insurance premiums, eligibility for insurance, or employment.

GINA Title I’s health coverage provisions apply to group health plans sponsored by private employers, unions, and state and local government employers; issuers in the group and individual health insurance markets; and issuers of Medicare supplemental (Medigap) insurance. [...] Title II of GINA prohibits use of genetic information in the employment context, restricts employers and other entities covered by Title II from requesting, requiring, or purchasing genetic information, and strictly limits such entities from disclosing genetic information. [...]

The Commission published a proposed rule to implement Title II of GINA on March 2, 2009, and asked for public comment on the proposed rule, the discussion in the preamble, and other Title II issues not addressed in either document. See 74 FR 9056 (March 2, 2009).

The regulation report includes a section-by-section analysis of the rule. I suggest reading this part first and then looking more closely at the regulation itself. Here’s the analysis on “general purpose.” Read more »

Center for Democracy and Technology Policy Counsel Harley Geiger (a friend and colleague) takes a look at a proposal at the Department of Health and Human Services that would affect the privacy of people who have been dead for 50 years. (Related: We’ve discussed controversies over the unknowing use of individuals’ DNA reasons beyond what was stated when the samples were taken. Arizona State University recently settled a lawsuit by the Havasupai Indians. DNA samples that were given to university researchers to study the tribe’s high rate of diabetes were also used — without their consent, tribe members say — “to study many other things, including mental illness and theories of the tribe’s geographical origins that contradict their traditional stories.” And in Texas, the Texas Tribune revealed that Texas officials “were turning over hundreds of dried blood samples to the federal government to help build a vast DNA database.”)

Geiger writes:

Currently, the law requires that the health information of the dead be protected in the same manner as that of the living. Generally speaking, health care organizations can use patient data for treatment, payment and operations purposes without the consent of the patient, but must get the consent of the patient for most other purposes, like marketing or research. When the patient is deceased, health care companies must seek consent from the dead person’s personal representative, like the executor of the estate. Read more »

The Wall Street Journal takes a look at the privacy risks that can arise from people voluntarily donating their DNA for research or other reasons. There have been several recent controversies over the unknowing use of individuals’ DNA reasons beyond what was stated when the samples were taken. Arizona State University recently settled a lawsuit by the Havasupai Indians. DNA samples that were given to university researchers to study the tribe’s high rate of diabetes were also used — without their consent, tribe members say — “to study many other things, including mental illness and theories of the tribe’s geographical origins that contradict their traditional stories,” reported the New York Times.

A few months ago, Texas announced that, as part of a lawsuit settlement agreement, it would destroy five million blood samples taken from babies and used for research without their parents’ consent. The blood was originally gathered to screen for birth defects. The Texas Tribune later revealed that Texas officials also “were turning over hundreds of dried blood samples to the federal government to help build a vast DNA database.”

The Journal reports:

At the Minnesota State Fair [...] you can stop by the University of Minnesota’s building and give samples of your and your children’s DNA for the university’s Gopher Kids Study.

As the Minneapolis Star Tribune reports, researchers are collecting information, including the genetic kind,  to see if the fair is an effective way to recruit and stay connected with study subjects. (Families are told to return for follow-up for the next two years.) Eventually researchers want to recruit thousands of kids in an attempt to study “what genes are involved in making a child grow and develop normally,” according to the study’s website. Read more »

In May, it was revealed that the University of California at Berkeley was asking incoming freshmen to voluntarily (and confidentially) submit DNA samples so that it can check “for three genes that help regulate the ability to metabolize alcohol, lactose and folates” because “students with certain genetic markers may be able to lead healthier lives by drinking less, avoiding dairy products or eating more leafy green vegetables.” At the time, I said that I was glad that the program was voluntary and confidential, but it was still troubling because there are easier and less-invasive ways to determine if someone is allergic or intolerant of alcohol, lactose or folates. Individual genetic data is not needed to teach students about responsible drinking or healthy diets. Genetic testing seems unnecessary, and it is too easy to see how quickly this could lead to mission creep. “Why don’t we test for something else, since we already have the data?” I noted several recent controversies over the unknowing use of individuals’ DNA reasons beyond what was stated when the samples were taken.

Now, the Los Angeles Times reports that Berkeley is changing its DNA collection program, though it still is requesting genetic data from incoming freshmen and transfer students.

In response to a state Public Health Department ruling on how DNA samples should be handled, UC Berkeley scientists reluctantly abandoned the idea to have freshmen and transfer students individually and confidentially learn about three of their own genetic traits. Instead, only collective results for all the 1,000 or so participants will be available and discussed at the orientation seminars next month. Read more »

The New York Times reports on the issue of genetic privacy as it relates to so-called “familial searching” of DNA databases. This type of search is controversial because the “near-match” person is not suspected — but that person’s relatives are. (Last year, George Washington law professor Jeffrey Rosen had an excellent article about increasing pressure for the expansion of familial searches of DNA databases.)

Although Britain has been using the technique for years, familial searching in the United States is the Botox of criminal investigation. Early-adopter states like California and Colorado have tried it, like it and plan, where appropriate, to use it again. The wait-and-see states are holding out while they consider the potential side effects and longer-term social ramifications. [...]

But the immediate concern is that kinship searches could produce a long list of convicted felons who are only partial matches to an unidentified suspect. The risk is that the police, while looking for a suspect’s family members, might intrude on people who have not committed a crime. Some lawyers call it guilt by genetic association. Read more »

The BBC reports on law enforcement developments in the United Kingdom and Europe:

Home Secretary Theresa May says the UK will opt in to an EU order allowing foreign police to be given evidence held in the UK. The European Investigation Order makes it easier for police to investigate suspects living in each other’s states. [...]

Critics predict forces will end up wasting resources working on unjustified investigations that breach civil liberties.

Under the current system, EU police forces who want to investigate a suspect in another member state ask their counterparts for help through special agreements called Mutual Legal Assistance. [...] Read more »