Each year, more than 3 million babies are born in the United States, and each one undergoes genetic testing. In 32 states, however, the residual dried-blood sample from every newborn is retained – in some states, they even become government property.
California, Indiana, Pennsylvania and Texas are just a few jurisdictions where genetic privacy has come to light -- but California is the only one where lawmakers are taking action. They are considering a measure that could potentially improve data security of genetic samples stored by the state.
Assembly Bill 170 requires the California Department of Public Health (DPH) to obtain a signed acknowledgment form from parents that has details on the storage, retention and use of newborn babies’ blood samples. The DPH must comply with any request from parents to not use their child’s blood sample for medical research, or to destroy it.
“Recent high-profile data breaches involving credit and medical records have heightened concerns about what personal information has fallen into the hands of criminals,” said Assemblyman Mike Gatto, D-Glendale, the bill’s sponsor, in a statement. “Now imagine a similar data breach resulting in your most personal data of all – your genetic make-up – falling into the wrong hands. AB 170 is a proactive step against such a breach."
In only four states – California, Maine, Utah and Washington – do newborn blood samples become state property, according to an academic article on the topic (PDF). And in only California and Maine can a parent object to this in writing.
In an interview with Government Technology, Gatto explained that the measure will ensure that parents are fully informed of their rights regarding their children’s dried blood spot samples. He added that the legislation doesn’t impact newborn medical screenings and the ability for doctors to test for major disorders.
Initially, AB 170 created an “opt-in” system for the storage, retention and medical research on dried blood spot samples of newborns. That resulted in significant opposition to the legislation from the Advanced Medical Technology Association, American Academy of Pediatrics – California, March of Dimes California Chapter and others.
Concern over the impact AB 170 would have on the available number of samples available to researchers, shifted the focus of the measure to better informing parents of their rights. After the changes, the majority of the opposition went neutral on the bill, except for the California Hospital Association (CHA)
The CHA stands against the measure primarily because of the additional clerical work hospitals would be responsible for, according to Lois Richardson, vice president of privacy and legal publications/education, for the CHA. She noted that mothers are already given two brochures with information on the blood spot samples and genetic research, and questioned the need to double the work.
“That administrative burden would fall on the hospital to get the mom’s signature, scan it, and put it in an electronic medical record,” Richardson said. “We think it is duplicative and completely unnecessary.”
Gatto, however, isn’t concerned with any further pushback from stakeholders on the measure.
“The state of California has been collecting these dried blood spots since 1982,” Gatto said. “California has 16 million samples stored in their BioBank in Richmond. There are 500,000 babies born every year in California and we by far have the largest BioBank in the country. I doubt researchers will run out of dried blood spot samples to conduct their research anytime soon.”
Looking ahead, AB 170 still needs to get through the Assembly Appropriations Committee, where it currently is on suspense. The decision to push the bill forward could come on Thursday, May 28, according to a spokesperson for Gatto. It would then head to the Assembly floor for a vote.