## Facts

- Minnesota’s Department of Health (MDH) operated a statewide newborn screening program requiring collection of heel-stick blood samples from virtually all newborns.
- The screening used most of the collected blood, leaving “residual” samples.
- By policy, absent a parental request for destruction, MDH retained residual blood samples indefinitely.
- MDH contracted with a laboratory to conduct screening; excess de-identified samples could be used for research unrelated to the screening program, and identified use required parental consent.
- MDH also permitted certain uses of stored samples for studies and for improving screening accuracy, sometimes after de-identification and/or consent.
- Several families sued, alleging MDH’s collection, storage, use, and dissemination of their newborns’ blood samples and test results without written informed consent violated Minnesota’s Genetic Privacy Act.

## Issues

1. Whether newborn blood samples and associated test results constitute “genetic information” under Minn. Stat. § 13.386.
2. Whether Minnesota’s newborn screening statutes (Minn. Stat. §§ 144.125–.128) create an express statutory exception displacing the Genetic Privacy Act’s written informed consent requirement.
3. Whether MDH may retain and use residual newborn blood samples for purposes beyond screening without written informed consent.

## Decision

- The Minnesota Supreme Court reversed in part the lower courts’ rulings for the State and remanded.
- The court held that newborn blood samples are “genetic information” covered by the Genetic Privacy Act.
- The court held the newborn screening statutes provide only a limited express exception to the Genetic Privacy Act—only as necessary to administer newborn screening.
- The court concluded the newborn screening statutes do not authorize indefinite retention or non-screening uses of residual samples without written informed consent.

## Legal Principles

- “Genetic information” under Minn. Stat. § 13.386 includes biological specimens themselves when they contain genetic markers (e.g., DNA), not only data derived from testing.
- Government entities may collect, use, store, or disseminate genetic information only with written informed consent, unless another law expressly provides otherwise.
- A claimed statutory exception to the Genetic Privacy Act must be express and is construed to the scope necessary to carry out the authorized governmental function.
- Minnesota’s newborn screening statutes expressly authorize screening-related activities (testing for specified disorders, recording and reporting results, maintaining a registry of positive cases for follow-up, and storing test results as required) but do not expressly authorize broader retention or research uses of residual samples without consent.

## Conclusion

The court held that residual newborn blood samples are regulated as “genetic information” and that, beyond the limited screening functions expressly authorized by the newborn screening statutes, MDH must obtain written informed consent to store, use, or disseminate the samples and related information.


Bearder v. State, 806 N.W.2d 766 (Minn. 2011)