Court Opinion

ID: 8245970
Source: CourtListenerOpinion
Date Created: 2022-10-16 09:33:29.655953+00
Date Added: 2024-06-11T16:42:42.637823
License: Public Domain

ANDERSON, PAUL H„ Justice
(concurring in part, dissenting in part).
I concur in part and dissent in part. I agree with the majority that test results generated by the Department of Health’s newborn screening program are “genetic information” subject to the requirements of Minn.Stat. § 13.386 (2010), the Genetic Privacy Act, except to the extent otherwise expressly authorized by law. I also agree with the majority’s conclusion that “the newborn screening statutes provide an express exception to the Genetic Privacy Act only to the extent that the Department is authorized to administer newborn screening by testing the samples for heritable and congenital disorders, recording and reporting those test results, maintaining a registry of positive eases for the purpose of follow-up services, and storing those test results as required by federal law.” To the extent that this conclusion applies to newborn screening test results, I concur.
But I disagree with the majority’s conclusion that the Genetic Privacy Act applies to blood samples obtained in the newborn screening program. The Genetic Privacy Act applies to “genetic information,” which, as defined by the statute, does not include specimens. Because newborn children’s blood samples are specimens, blood samples do not meet the definition of genetic information and the Genetic Privacy Act does not apply to them.
I.
The fundamental issue in this case is whether the Genetic Privacy Act applies to the test results and the blood samples collected pursuant to the newborn screening program. This dispute centers on the interaction of two sets of statutes: the newborn screening statutes, Minn.Stat. §§ 144.125-.128 (2010), and the Genetic Privacy Act, Minn.Stat. § 13.386. A review of the current version of these statutes and the history of each will be helpful to understanding the issue presented in this ease.

Newborn Screening Statutes

The newborn screening statutes are codified at Minn.Stat. §§ 144.125-128. These statutes provide for the testing of newborn children by the Minnesota Department of Health for more than 50 heritable and congenital disorders. Section 144.125 outlines the fundamental aspects and scope of the screening program.1 *778Subdivision 1 states who is responsible for arranging to have a newborn child’s blood sample sent to the Department of Health for testing. Minn.Stat. § 144.125, subd. 1. Subdivision 2 provides that the Commissioner of Health shall revise the list of tests the Department will use on the newborn children’s blood samples. Id., subd. 2. Subdivision 3 requires the individual responsible for arranging collection of the blood samples to inform the parents (1) that the Department may retain the blood sample and test results, (2) of the benefits of retention, and (3) that the parents have the right to refuse testing or to have the blood sample and test results destroyed. Id., subd. 3.
Section 144.1255 establishes an advisory committee and assigns to the committee various responsibilities. Some of these responsibilities include collecting information on the efficacy and reliability of tests for heritable and congenital disorders and the efficacy and availability of treatments for heritable and congenital disorders. Minn. Stat. § 144.1255, subd. 2(1), (2). Responsibilities also include assessing the costs and benefits of performing certain tests and assessing the “ethical considerations surrounding the testing, treatment, and handling of data and specimens generated by the testing requirements” of the statutes. Id., subd. 2(4), (5).
Section 144.128 outlines the duties of the Commissioner. In addition to adopting rules to carry out the newborn screening program, the Commissioner must “maintain a registry of the cases of heritable and congenital disorders detected by the screening program for the purpose of follow-up services,” comply with any requests to destroy test results and blood samples within 45 days, and notify the requesting individuals that the destruction has occurred.
The newborn screening program has undergone several changes since its inception over 46 years ago. The Legislature’s first statute establishing the newborn screening program was passed in 1965 as a program to test for “phenylketonuria and other inborn errors of metabolism causing mental retardation.” Act of April 15, 1965, ch. 205, § 1, 1965 Minn. Laws 312, 313 (codified as amended at Minn.Stat. § 144.125). Parents could object to the test on religious grounds. Id. The Legislature amended the statute in subsequent years in order to make certain minor changes. See, e.g., Act of May 27, 1977, ch. 305, § 45, 1977 Minn. Laws 575, 594 (codified as amended at Minn.Stat. § 144.125) (changing the use of “board of health” to the “commissioner”). The Commissioner’s duties were revised by statute in 1985, which included maintaining a registry of positive cases, and arranging treatment of diagnosed cases for uninsured poor families. Act of June 27, 1985, ch. 9, art. 2, § 10, 1985 Minn. Laws 1st Spec. Sess. 1694, 1726 (codified as amended at Minn. Stat. § 144.128).2
In 1988, the Legislature provided that another specific disorder be tested for and required the Commissioner to charge laboratory fees. Act of April 28, 1988, ch. 689, art. 2, § 31, 1988 Minn. Laws 1279, 1312 (codified as amended at Minn.Stat. § 144.125). In 1994, the Legislature elimi*779nated the language allowing parents to object to the testing on religious grounds. Act of May 10, 1994, ch. 636, art. 2, § 2, 1994 Minn. Laws 2170, 2188. In 1997, the Legislature modified the calculation of laboratory fees. The laboratory fees collected would be calculated using the costs of conducting the test and “implementing and maintaining a system to follow-up infants with inborn metabolic errors.” Act of June 2, 1997, ch. 203, art. 2, § 11, 1997 Minn. Laws 1587, 1638 (codified as amended at Minn.Stat. § 144.125). Also in 1997, the Legislature stopped listing specific disorders for the Department to test, leaving the tests to the discretion of the Commissioner. Act of May 22, 1997, ch. 205, § 19, 1997 Minn. Laws 1880, 1891 (codified as amended at Minn.Stat. § 144.125).
In 2003, the Legislature made dramatic changes to the statute and the newborn screening process and procedures took on their current form. The Legislature changed the name of the types of diseases to screen for, switching “inborn metabolic errors” to “heritable and congenital disorders.” The Legislature set the fee for performing the tests, and provided more guidance for the Commissioner in developing the list of tests to be performed. The Legislature added the requirement that responsible parties inform parents of their right to object to the tests or to have their infant’s blood samples and test results destroyed. Act of June 5, 2003, ch. 14, art. 7, § 26, 2003 Minn. Laws 1st Spec. Sess. 1751, 2073-75 (codified as amended at Minn.Stat. § 144.125). The 2003 Act also created the advisory committee discussed earlier. Act of June 5, 2003, ch. 14, art. 7, § 27, 2003 Minn. Laws 1st Spec. Sess. 1751, 2075-76 (codified at MinmStat. § 144.1255). Finally, the 2003 changes required the Commissioner to provide referrals for children who tested positive for a heritable or congenital disorder, rather than arrange for treatment for uninsured poor families. The Act also added a requirement that the Commissioner notify the newborn child’s physician of the tests performed by the Department. Act of June 5, 2003, ch. 14, art. 7, § 28, 2003 Minn. Laws 1st Spec. Sess. 1751, 2076 (codified as amended at MinmStat. § 144.128).
In 2006, the Legislature added to the Commissioner’s duties, primarily with respect to destruction requests for test results and blood samples. The Commissioner was required to develop forms for requesting destruction of test results and blood samples, to comply with a destruction request within 45 days, and to notify the requesting individual when destruction was complete. Act of June 1, 2006, ch. 253, § 9, 2006 Minn. Laws 424, 429 (codified at MinmStat. § 144.128).
In 2007 and 2009, the Legislature raised the fee and allocated a portion of the fee to a specific follow-up system. Act of May 25, 2007, ch. 147, art. 16, § 7, 2007 Minn. Laws 1804, 2164 (codified as amended at Minn.Stat. § 144.125); Act of May 14, 2009, ch. 79, art. 10, § 5, 2009 Minn. Laws 690, 945 (codified at Minn.Stat. § 144.125).

Genetic Privacy Act

The Genetic Privacy Act is codified at MinmStat. § 13.386 (2010). In 2006, the Legislature added the Genetic Privacy Act to the Minnesota Government Data Practices Act. Act of June 1, 2006, ch. 253, § 4, 2006 Minn. Laws 424, 426 (codified at Minn.Stat. § 13.386). The act that created the definition of “genetic information” at issue in this case is the same act that added duties to the Commissioner in the newborn screening statute-requiring the Commissioner to develop destruction request forms, to comply with destruction requests, and to notify individuals when destruction has been completed. Act of *780June 1, 2006, ch. 253, § 9, 2006 Minn. Laws 424, 429.
The Genetic Privacy Act currently requires written informed consent for the collection, use, storage, and dissemination of genetic information “[ujnless otherwise expressly provided by law.”3 Minn.Stat. § 13.386, subd. 3. The statute applies to “genetic information,” which has two narrow definitions:
(a) “Genetic information” means information about an identifiable individual derived from the presence, absence, alteration, or mutation of a gene, or the presence or absence of a specific DNA or RNA marker, which has been obtained from an analysis of:
(1) the individual’s biological information or specimen; or
(2) the biological information or specimen of a person to whom the individual is related.
(b) “Genetic information” also means medical or biological information collected from an individual about a particular genetic condition that is or might be used to provide medical care to that individual or the individual’s family members.
Minn.Stat. § 13.386, subd. 1.
II.
With the foregoing statutory framework in mind, I now address the central issue in this case — whether the Genetic Privacy Act applies to the test results and the blood samples obtained for use in the newborn screening program. If the Genetic Privacy Act applies, then written informed consent is required to collect, use, store, or disseminate the test results or blood sam-pies “[ujnless otherwise expressly provided by law.” Minn.Stat. § 13.386, subd. 3. Here, I concur with the conclusion of the majority that the test results obtained in the newborn screening program are subject to the Genetic Privacy Act. Before the Department may collect, use, store, or disseminate test results, there must be express written informed consent “[ujnless otherwise expressly provided by law.” See id. But I do not agree that blood samples are subject to the Genetic Privacy Act and, therefore, the Department does not need to obtain written informed consent for the collection, use, storage, or dissemination of the blood samples.

Blood Samples Are Not “Genetic Information” Under the Genetic Privacy Act

The plain reading of the two definitions indicates that blood samples, which are a type of specimen,4 are not included in the definition of “genetic information.” Subdivision 1(a) of the Genetic Privacy Act states the following:
“Genetic information” means information about an identifiable individual derived from the presence, absence, alteration, or mutation of a gene, or the presence or absence of a specific DNA or RNA marker, which has been obtained from an analysis of:
(1) the individual’s biological information or specimen; or
(2) the biological information or specimen of a person to whom the individual is related.
Minn.Stat. § 13.386, subd. 1(a). This definition essentially states that “genetic information” results from certain types of analyses of an individual’s (or related individual’s) biological information or speci*781men. Subdivision 1(a) does not say that the biological information or specimen itself is genetic information, only that results of certain analyses of either is genetic information. Therefore, I conclude, as does the majority, that the blood sample cannot meet the first definition of “genetic information.”
But subdivision 1(a) provides relevant information for our interpretation. Importantly, the definition in subdivision 1(a) uses the phrase “biological information or specimen.” MinnStat. § 13.386, subd. 1(a) (emphasis added). By using both the terms “biological information” and “specimen,” the statute draws a distinction between the two terms, and therefore, specimens cannot be “biological information.” See Minn.Stat. § 645.16 (2010) (“Every law shall be construed, if possible, to give effect to all its provisions.”); Cnty. of St. Louis v. Fed. Land Bank of St. Paul, 338 N.W.2d 741, 744 (Minn.1983) (stating that “every word and phrase of the statute should be given meaning if possible”). As a result, a blood sample, because it is a specimen, cannot be “biological information.” See Minn. R. 4615.0400 (defining “specimen” for the purposes of the newborn screening rules as “a specimen of dried blood from the newborn infant collected on a specimen card”). If biological information included specimens, the term “specimen” would be rendered superfluous in the statute.
The definition of “genetic information” provided in subdivision 1(b), reads as follows:
“Genetic information” also means medical or biological information collected from an individual about a particular genetic condition that is or might be used to provide medical care to that individual or the individual’s family members.
Minn.Stat. § 13.386, subd. 1(b). This definition includes certain types of medical or biological information but omits the term “specimen,” which term was included in the definition in subdivision 1(a). This omission leads to the inevitable conclusion that the definition in subdivision 1(b) does not include “specimens.” See Johnson v. Cook Cnty., 786 N.W.2d 291, 295 (Minn. 2010) (“We may not add words to a statute that the Legislature has not supplied.”). And, because blood samples are specimens and not biological or medical information, the definition in subdivision 1(b) does not apply to blood samples.
Because neither definition of “genetic information” applies to the blood samples, I conclude that the Genetic Privacy Act does not apply to the blood samples collected for the newborn screening program. Therefore, I would hold that the Department of Health is not limited by the Genetic Privacy Act’s opt-in framework for the collection, use, storage, and dissemination of blood samples.

The Majority’s Conclusion that the Blood Samples Are “Genetic Information” Is Erroneous

The majority concludes that the definition of “genetic information” includes the blood samples collected in the newborn screening program. There are numerous problems with the majority’s analysis and conclusion.
First, the only way for the majority to reach its conclusion that a blood sample meets the second definition of “genetic information” is to interpret the term “biological information” to have two different meanings when used in the same statute and subdivision. The two uses of “biological information,” however, are separated by fewer than 20 words. For instance, in definition (a), the majority should acknowledge that “biological information” does not include “specimen” because oth*782erwise “specimen” would be rendered superfluous. Minn.Stat. § 645.16 (“Every law shall be construed, if possible, to give effect to all its provisions.”). But in definition (b), the majority concludes that “biological information” does include “specimen.” This conclusion has no foundation and is contrary to settled rules of statutory interpretation.
Second, the majority’s conclusion conflicts with the Data Practices Act requirement that copies of the information be made available to the subject of the data. The Genetic Privacy Act classifies “genetic information” as “private data on individuals as defined by” MinmStat. § 13.02, subd. 12 (2010). Minn.Stat. § 13.386, subd. 2. Private data on individuals means that the information is “(a) not public; and (b) accessible to the individual subject of that data.” Minn.Stat. § 13.02, subd. 12. The individual who is the subject of the data has certain rights outlined in Minn. Stat. § 13.04 (2010). “The responsible authority or designee shall provide copies of the private or public data upon request by the individual subject of the data.” Minn. Stat. § 13.04, subd. 3. Therefore, under the majority’s interpretation of the definition of “genetic information,” the Department would be required to provide a copy of an individual’s blood sample upon request. Notably, because the majority concludes that the blood sample itself is “genetic information,” the Department would be required to provide a copy of the blood sample itself. In other words, the Department would somehow need to copy the physical blood sample, because a copy of a report based on the blood sample would not be a copy of the blood sample.
Third, and more fundamentally, the majority’s reliance on the common understanding of the term “genetic information” is flawed. First, when the statute provides an explicit definition of “genetic information,” the common understanding of the term “genetic information” is unhelpful. Moreover, the common understanding of the term “information” does not support the majority’s conclusion. “Genetic information” is partly defined with the terms “medical or biological information.” Information is not a physical object but is an intangible noun. The American Heritage Dictionary defines “information” as “[kjnowledge derived from study, experience, or instruction,” “[kjnowledge of a specific event or situation; intelligence,” “[a] collection of facts or data,” or “[tjhe act of informing or the condition of being informed.” The American Heritage Dictionary of the English Language 927 (3d ed.1992). A blood sample is a tangible object that conveys no information without analysis, and therefore, it cannot be “biological information.” The majority acknowledges that a blood sample is not information itself when it states “blood samples collected from the appellants in this case unquestionably contain biological information.” (Emphasis added.) I agree that a blood sample contains biological information, in the same way that a computer or a person can contain information. But the definition of “genetic information” is not “an object containing biological information.” Therefore, because the blood sample is not “biological information,” it cannot be “genetic information” under Minn.Stat. § 13.386, subd. 1.
Fourth, the majority’s conclusion that the Genetic Privacy Act applies to blood samples significantly, or even drastically, complicates the interpretation of the newborn screening program statute, Minn. Stat. § 144.125. The Genetic Privacy Act forbids the storage of genetic information without written informed consent, unless the authority is “otherwise expressly provided by law.” Minn.Stat. § 13.386, subd. 3. Further, subdivision 3 of Minn.Stat. § 144.125 requires responsible parties to *783tell parents of newborn children that blood samples and test results may be retained (and therefore stored) by the Department and that the parents have the option of opting out of the retention of blood samples and test results. Minn. Stat. § 144.125, subd. 3. But, if the blood samples are genetic information, then as the majority concludes, there is no express authority that allows the Department to retain the blood samples. Therefore, if the blood samples are “genetic information,” the newborn screening program statutes would require responsible parties to misinform parents of newborns as to the Department’s authority to retain blood samples and whether the parents are required to opt-out of the retention, or required to opt-in.5 However, if blood samples are not considered “genetic information,” as I conclude, this subdivision requires no misleading information be given to parents of newborn children.
Underlying the majority’s opinion appears to be a belief that it makes no sense for the Genetic Privacy Act to apply to the test results but not to the blood samples that are the source of the test results. The majority concludes that even if the definition of “genetic information” did not apply to blood samples, the Genetic Privacy Act would nonetheless apply because the blood samples “unquestionably contain genetic information.” But the majority overlooks the actual, narrow definition of “genetic information” in the statute to arrive at this conclusion. Blood samples do not, in every situation, contain genetic information, as defined by the Genetic Privacy Act.
Two examples illustrate this point. First, the second definition applies only to medical or biological information collected “about a particular genetic condition.” Minn.Stat. § 13.386, subd. 1(b). Even if we were to assume a blood sample can be genetic information, a blood sample collected with no intention of testing it for a particular genetic condition would not be “genetic information” under the plain terms of the statute. Secondly, the second definition applies only to medical or biological information that is capable of being used to treat the individual who provided the information or that individual’s family members. Id. Therefore, if an individual provided the government with medical or biological information only to be used to treat an unrelated friend’s genetic condition, it would not be “genetic information” because the medical or biological information would not be used to provide medical care to the individual who supplied the information, or that individual’s family members.
In conclusion, the majority repeatedly ignores the narrow definition of “genetic information” and relies instead on what it subjectively believes the term genetic information ought to mean. Just because an object may contain information does not necessarily make that object information itself. Looking at the Genetic Privacy Act, and only the statute, the only reasonable *784interpretation is that blood samples are not included in the definition of “genetic information.” Therefore, I would conclude that blood samples are not subject to the Genetic Privacy Act.
III.
At this point, a final comment is in order. The majority appears to be motivated by a policy concern that I share. The Department’s assertion that it can use, store, and disseminate the more than 800,-000 blood samples it has on file without violating the Genetic Privacy Act is troubling. While the policy implications of this case should not overshadow the plain language of the statute, it should be noted that these policy concerns, while very real, are not as severe as they initially appear.
The newborn screening statutes restrict what the Department may do with the blood samples it collects in the newborn screening program. First, the parties responsible for collecting the newborn blood samples are statutorily required to inform parents of their ability to refuse testing and to have their test results and blood samples destroyed. See Minn.Stat. § 144.125, subd. 3. In other words, parents may receive the testing that is beneficial to their newborns and still have the blood samples and test results destroyed upon request. The parents do not face the dilemma of choosing between testing accompanied by the Department’s retention of blood samples or no testing at all. Second, the Commissioner of the Department is statutorily required to destroy blood samples within 45 days of receiving a request. Minn.Stat. § 144.128(5). The parents may decide later that they want their child’s blood sample to be destroyed, and the Commissioner is obligated to do so. Third, the children are able to request that their own blood samples and test results be destroyed once they reach the age of majority. See Minn.Stat. § 144.128(4) (requiring the Commissioner to create a destruction request form for “adults who were tested as minors”).
In conclusion, I, unlike the majority, would hold that the Department is not violating Minn.Stat. § 13.386 by collecting, using, storing, or disseminating blood samples without written consent, because section 13.386 does not apply to specimens.

. Administrative rules provide more detail as to the mechanics of the program but are somewhat out-of-date. For example, the current program tests for more than 50 disorders, whereas the rules state that the purpose and scope of the program is to screen newborns for only five listed disorders. See Minn. R. 4615.0300 (2011). There are eight newborn screening program administrative rules. See Minn. R. 4615.0300-.0760 (2011). The first five rules provide the scope of the rules, define the terms used, and outline the duties of various parties with respect to newborn testing. The remaining three outline the scope, define various terms, and outline the *778responsibilities of the Department of Health with respect to follow-up services.

. The same act also required the Commissioner to provide "treatment control tests for which approved laboratory procedures are available for phenylketonuria and other metabolic” disorders. Act of June 27, 1985, ch. 9, art. 2, § 9, 1985 Minn. Laws 1st Spec. Sess. 1694, 1726 (codified at Minn.Stat. § 144.126). This provision has since been repealed. Act of June 5, 2003, ch. 14, art. 7, § 89, 2003 Minn. Laws 1st Spec. Sess. 1751, 2104.

. The statute also allows dissemination "if necessary in order to accomplish purposes” for which an individual has given informed consent. Minn.Stat. § 13.386, subd. 3(4).

. For the purposes of the newborn screening program rules, a "specimen” is the dried blood collected on a specimen card. Minn. R. 4615.0400, subp. 7.

. The majority attempts to avoid this conclusion by inventing express authority for the retention of blood samples in the newborn screening statutes. The majority concludes that the Commissioner's duty to "maintain a registry of the cases of heritable and congenital disorders detected by the screening program for the purpose of follow-up services” provides express authority to retain blood samples for that purpose. I agree that this provision requires that the Commissioner retain the name and some personal details about the individuals who have tested positively for a disorder in order to maintain a registry of positive cases. But I am unaware of how the majority can conclude that this language provides express authority to store the blood samples of those who have tested positively for a disorder.