https://www.cbsnews.com/sanfrancisco/news/baby-dna-parental-consent-
genetic-records-california-law-newborns/?intcid=CNR-02-0623

Genealogy companies like Ancestry.com and 23andMe have to get your
permission before they store, use, or share your DNA, under the Genetic
Information Privacy Act. However, the California Department of Public
Health doesn't have to. In fact, the agency has been storing DNA samples
from every baby born in California since the 1980s.

Researchers can purchase those samples for state-approved studies and law
enforcement can access them with a court order, but state agency officials
recently refused to provide CBS News California with a list of recent law
enforcement and research requests for newborn bloodspots.

After more than a decade of CBS reporting on the biobank, this is the
first time California officials have refused to reveal to us who has
access to California's newborn bloodspots. Under previous administrations,
the agency regularly provided that information under the California Public
Records Act.

CONTINUING COVERAGE: Newborn Blood Spot Privacy Concerns

Keep in mind, if you're even related to someone born in California since
1983, thanks to genetic genealogy, portions of your DNA are in the biobank
too, and can likely be used to identify you.

While California's Newborn Genetic Biobank is undoubtedly saving lives,
the appearance of state secrecy is raising concerns. In response, some
California lawmakers are pushing for transparency, but they face an uphill
battle at the State Capitol. (To learn more about newborn blood storage,
and how to opt out, click here.)

For some, newborn DNA testing is a lifesaver
"He was a very cute, very adorable baby," Ronnie's dad said, as he
described seeing his son for the first time, "and perfectly healthy."

At the time, the new father (who for medical privacy reasons asked us not
to use full names in this report) didn't think much about what happened
next. Like every baby born in the state, Ronnie got a heel prick shortly
after birth. That blood filled six spots on a special card used to test
babies for dozens of disorders that, if treated early enough, could
prevent severe disabilities or death.

A couple of days after taking their seemingly healthy boy home from the
hospital, they got a call from the local pediatrician, who said the child
was diagnosed with "no immune system at all." They learned Ronnie's heel
prick revealed that he had a rare genetic disorder called SCID, also
referred to as "bubble boy disease" after David Vetter, who lived his life
in a bubble in the '70s before dying at age 12.

Ronnie's first infection could have killed him, but thanks to research,
the disease is no longer a death sentence. Ronnie was rushed to UCSF
Medical Center where he received lifesaving gene therapy. That's where he
met Dr. Jennifer Puck, who created the test that saved Ronnie's life.

"I could never have developed a newborn screening test for SCID if we
hadn't had stored dried blood spots," Puck said.

Doctors only need a few of the baby's blood spots for their own lifesaving
genetic test, but the rest becomes the property of the state and can be
purchased by outside researchers.

While newborn bloodspots had been used in research for years, the SCID
test was the first to be developed using extracted DNA from bloodspots
stored in California's massive newborn genetic biobank. The state doesn't
extract or sequence the DNA from bloodspots, they store the physical
bloodspot samples, which researchers can purchase for state-approved
studies and extract or sequence the DNA themselves.

"You have to go through a scientific review to say, is this a worthwhile
project," Puck explained.

Many parents don't know the state is collecting newborn DNA
California has amassed what's believed to be the largest stockpile of
newborn bloodspots in the country. It is one of the few states that is
still storing every baby's bloodspots indefinitely, without first getting
parents' consent.

Therein lies the concern. Back in 2018, CBS News California randomly
selected six new moms to ask what they knew about the newborn genetic
testing program. When asked whether they knew the state was storing their
children's DNA, all said they did not; when asked if they felt they should
have been made aware, they agreed they should have.

"I didn't know there was repository of every baby born in the state," one
concerned mother said. Another added, "There just should be accountability
and transparency."

Some states allow parents to opt-in to storage or give informed consent.
California automatically stores your baby's genetic material, then sends
you home from the hospital with a pamphlet that points you to a website
where you can request that they destroy the sample. But first, you'd have
to know they were storing it in the first place.

"I feel like that's something that should have been discussed with us in
person," one concerned mother said.

"Everyone who came into our room gave us another pamphlet," another added.

A CBS News-Survey USA news poll found three-quarters of new parents had no
idea the state was storing their baby's leftover bloodspots indefinitely
or that they had the right to have their child's sample destroyed.

"Blood is intrinsically personally identifiable," one mother pointed out.

Could privacy violations, lawsuits threaten California's biobank?
Public records CBS News California obtained from the California Department
of Public Health in 2010 revealed that, in addition to research, newborn
genetic bloodspots are also used by law enforcement.

Our reporting found at least five search warrants and four court orders
for identified blood spots, and that was before the Golden State killer
case made genetic geology a common law enforcement tool.

Since then, we know at least one cold case was recently solved with the
help of California's newborn blood spots.

A lawsuit alleges police subpoenaed a 9-year-old's newborn samples from
New Jersey's biobank to link his father to a cold case rape before the
child was born. And Texas reportedly provided race-specific blood spots to
the federal government to build a DNA database.

But when we recently asked California's health department for an updated
list of research and law enforcement requests, the agency denied us,
saying it "is no longer tracking" that information like it used to and
it's "not required to create a record" telling us who has access to
California's stored DNA:

"Unfortunately, GDSP is unable to provide you the information as
requested. Previously, GDSP provided you with an existing spreadsheet of
research studies... GDSP has since moved to a new computer program for
collecting this data and is no longer tracking research studies using the
spreadsheet and the table. Pursuant to Government Code section 6252,
subdivision (e), and established case law, a public agency is not required
to create a record that does not exist at the time of the PRA request.
(See Haynie v. Superior Court (2001) 26 Cal.4th 1061, 1075; Sander v.
Superior Court (2018) 26 Cal.App.5th 651, 665-666.)"

For years everyone from privacy advocates to lawmakers to genetic
detectives have warned California's secrecy could ultimately harm trust in
the biobank.

"People have the right to choose how their DNA is used and how their
children's DNA is used," said Cece Moore, a genetic detective.

Texas is one of several states that had to destroy their bloodspots after
being sued for storing them without consent. It was a devastating blow to
the research community and many worry that California's biobank could be
next.

"I think we need to find ways that parents can consent without harming
research," Puck said.

Medical community opposed allowing opt-ins in the past
The medical community has historically opposed allowing parents to opt
into storage, for a number of reasons.

"If you required consent, a lot of people would say yes, and some people
would say no," explained Puck. "And the people who say no, we don't know
if that's a biased sample. And so that would skew the biobank."

Puck adds there is also a possibility that the parent could say no and
then later really come to regret that decision.

However, the California Constitution guarantees the right to "pursue and
obtain privacy" and state law "prohibits health care providers from
sharing, selling, or using patient medical information without consent."

Legal experts involved in lawsuits in other states tell us that it's only
a matter of time before California's biobank is taken to court. If the
state proactively allowed consent, they say it could ultimately help save
the biobank.

Despite support, why has newborn DNA legislation stalled?
The Texas Law Review cited our ongoing reporting on this issue and so did
legislative analysts when our reporting led to a bill last year that would
have let parents opt out of storage or research before the samples were
stored. Even the powerful medical lobby removed their opposition to the
bill after the author made significant changes.