Newborn Screening Privacy Concerns

When babies are born in the US, a medical provider takes a few drops of blood from the baby’s heel, puts it on a special paper, and sends that paper to a lab for testing. This newborn screening is done on virtually every baby born in the US - four million per year. The goal of newborn screening is to diagnose babies with diseases earlier, and provide intervention or treatment. The specific diseases in the panel are determined by each state, but the federal government recommends a set of 35 diseases. These are chosen based on the evidence of benefit of treatment, among other principles.

As the procedure is for screening, it is done on all babies, particularly those who appear healthy. The program is highly lauded as having provided major benefits in terms of both health outcomes and economics. All states require newborn screening.

In this modern era of greater genetic knowledge and computerized storage systems, newborn screening poses a new opportunity as well as a new danger. Using these DNA samples to learn more about diseases could prove incredibly valuable. However, it is a key principle (and has been codified by US law) that research cannot be done without the express consent of the patient.

The storage and ongoing use of the blood samples has proven unconstitutional by a Michigan court and is being challenged in New Jersey. Yet, it was more than a decade ago that the Minnesota court ruled that holding onto, and using, newborn screening samples beyond what the parents consented to - the screening - violated Minnesota’s privacy laws. In Texas, the state turned over hundreds of samples to the military for a law enforcement database without informing or getting permission from families. These challenges have been addressed, ad-hoc, for years.

Still, there are no uniform laws or regulations about law enforcement’s access to genetic information, and access to these data increases daily – one estimate has 25 million people providing their DNA to Ancestry and 23andme, in order to trace genealogy or learn about health risks; add to this the millions of babies screened annually. There is no recent review of state laws; one study from 2011 found that the majority of states do not address these privacy concerns. Iowa has a law that prohibits the use of newborn screening without the consent of the patient, however it contains an exception for a state or federal actor performing “a legally authorized function of that agency or the department.” Texas law specifically prohibits the use of newborn screening for purposes unrelated to the health of the patient and public health reporting. These are the exceptions.

The choices could not be more stark. Continuing unfettered research and law enforcement access to genetic information will, and should, deter utilization of newborn screening. This will come at the very high cost of children’s health, if not their lives. Because we have an interest in privacy, consent and children’s health, we urge states and the federal government to set clear boundaries regarding law enforcement use of genetic information gathered for non-law enforcement purposes.