Richard H. Hughes, IV, Alaap B. Shah, and Spreeha Choudhury, attorneys in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, co-authored an article in HealthAffairs, titled “Newborn Screening Blood Spot Retention and Reuse: A Clash of Public Health and Privacy Interests.”

Following is an excerpt:

Before leaving the hospital, most babies in the United States are screened for multiple genetic, endocrine, and metabolic disorders and conditions. The first part of the screening process consists of a blood test performed by pricking the baby’s heel and collecting a small amount of blood on a filter paper card to create a dried blood spot (DBS). This DBS card is sent to a state public health laboratory to test the newborns for between 28 and 75 conditions, depending on the state.
States typically retain the DBS after confirming the results of initial newborn screenings. Retained DBS can be used for many reasons, including improvement of testing instruments and research to further the ability to test newborns for additional conditions. However, legal challenges have pushed back against various state retention policies and specific uses of the DBS, from secondary research to law enforcement investigations. These challenges have raised privacy considerations that should be factored into state privacy policies.
Public Health Benefits of Newborn Screening, Dried Blood Spot Retention
Newborn screening became possible in 1960s when a National Institutes of Health scientist, Robert Guthrie, MD, PhD, developed a mass screening test for the metabolic disorder phenylketonuria. Sickle cell anemia become detectable through newborn screening in the 1970s. Over the years, as advancements in technology made it possible to detect an increasing number of heritable conditions, states adopted requirements for screening.
Newborn screening is also a vital tool to advance broader public health objectives. Retained DBS play a necessary role in calibrating newborn screening equipment for all newborns. Research using retained DBS can uncover the epidemiology of infectious diseases, population-based exposures to environmental agents, and underlying reasons for birth defects or developmental disabilities. For example, researchers used retained DBS taken from babies born near the Rocky Mountains, where mining sites are common, to determine maternal exposure to lead and mercury. In the 1990s, retained DBS were tested to identify newborns exposed to HIV in utero.
Retained DBS are also used to develop new tests for newborn screening, allowing early detection of a growing number of conditions. If research shows that a new disease can be detected using retained DBS, it may be added to the state’s newborn screening panel so that all newborns in that state will be screened for it and have access to early, lifesaving interventions. For example, studies conducted in Minnesota using retained DBS demonstrate that newborn screening could be used to reliably detect congenital cytomegalovirus (cCMV) in newborns. And earlier intervention for those newborns could help to improve or mitigate hearing, speech, and other neurodevelopmental outcomes. Following research using the DBS, earlier this year, Minnesota became the first state in the country to routinely screen newborns for cCMV.

Jump to Page

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.