Currently, 28 states require consent to either perform or require genetic testing or to obtain, retain or disclose genetic information through genetic-specific privacy laws. In addition, Washington includes genetic information in the definition of protected health information under the state's health privacy statute. Many of the states with genetic privacy laws exempt newborn screening from consent provisions, including Delaware, Illinois, Louisiana, Massachusetts, Michigan, Nevada, New Hampshire, New Jersey, New Mexico, New York, Oregon and Vermont. The chart below does not address consent requirements or exemptions for newborn screening that may be found in state administrative codes.

At least 23 states have laws that allow for an exemption to the newborn genetic screening requirements if parents object on religious grounds (Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, New Jersey, New York, North Dakota, Ohio, Rhode Island, South Carolina, Texas, Utah, Virginia, Washington and Wisconsin). Two states--Florida and Wyoming--allow for an exemption to the newborn genetic screening requirements if parents object on any grounds.

At least 12 states have confidentiality requirements related to newborn screening laws (Arizona, Colorado, Florida, Hawaii, Iowa, Louisiana, New Jersey, North Dakota, Ohio, South Carolina, Virginia and Wisconsin).

At least six states and the District of Columbia have laws related to obtaining consent from the parents of children before performing genetic tests (Hawaii, Ohio, Nebraska, Texas, Wisconsin and Wyoming). Kansas requires informed consent in order to monitor infants with genetic disorders.

Many states have laws regulating newborn hearing screening, but these laws do not necessarily apply to newborn genetic screening.

State

Newborn Genetic Screening Privacy Laws

Law Allows for a Religious Exemption

Genetic Privacy Law Allows for an Exemption for Newborn Screening

Alabama

Ala. Code § 22-20-3

Arizona

Ariz. Rev. Stat. Ann. § 12-2802 declares that genetic testing and information derived from genetic testing are confidential and considered privileged to the person tested and are to be released only to specified individuals and entities. The law requires such information to be provided to the authorized agent of a federal, state or county health department to conduct activities specifically authorized for the birth defects registry, children's rehabilitative services, newborn screening and sickle cell diagnosis and treatment programs and chronic, environmentally provoked and infectious disease programs.

Ariz. Rev. Stat. Ann. § 12-2803 prohibits a genetic test from being conducted on an unemancipated minor without the consent of the parent or legal guardian of the minor except for testing under the newborn screening program.

Arkansas

Ark. Stat. Ann. § 20-15-303

California

Cal. Health & Safety Code § 124975 clarifies that participation of people in hereditary disorders programs should be wholly voluntary, except for initial screening for phenylketonuria (PKU) and other genetic disorders treatable through the California newborn screening program. All information obtained from people involved in hereditary disorders programs in the state should be held strictly confidential.

Cal. Health & Safety Code § 124980 prohibits tests from being performed on any minor over the objection of the minor's parents or guardian. Tests may not be performed unless the parent or guardian is fully informed of the purposes of testing for hereditary disorders and is given reasonable opportunity to object to the testing. No testing, except initial screening for phenylketonuria (PKU) and other diseases that may be added to the newborn screening program, shall require mandatory participation. The law requires all testing results and personal information generated from hereditary disorders programs to be made available to individuals over 18 years of age, or to the individual's parent or guardian. All testing results and personal information from hereditary disorders programs shall be held confidential and be considered a confidential medical record except for information that the individual, parent, or guardian consents to be released.

Cal. Health & Safety Code § 125000

Colorado

Colo. Rev. Stat. § 25-4-1002 declares that participation in genetic counseling programs should be wholly voluntary and that all information obtained from individuals involved in such programs or in newborn screening programs in the state should be held strictly confidential.

Colo. Rev. Stat. § 25-4-1003 declares that information on the operation of all programs on newborn screening and genetic counseling and education within the state, except for confidential information obtained from participants in such programs, shall be open and freely available to the public.

Colo. Rev. Stat. § 25-4-1005

Connecticut

Conn. Gen. Stat. § 19a-55

Delaware

Del. Code Ann. tit. 16, § 203 relates to the Birth Defects Surveillance and Registry Program. The law allows for a parent, custodian or guardian of an infant having any birth defect to refuse disclosure to the surveillance system and registry of the infant's name and identifying information on the grounds that such birth defect identification is contrary to the religious tenets and practices of the infant's parent, custodian or guardian.

Del. Code Ann. tit. 16, § 203

Del. Code Ann. tit. 16, § 1220- 1227

District of Columbia

D.C. Code Ann. § 7-833 requires hospitals and maternity centers to inform parents of the availability of genetic tests and take appropriate blood samples for analysis by a laboratory--unless parental consent is withheld or an identical test has already been performed.

Florida

Fla. Stat. Ann. 29 § 383.14 includes an exemption to newborn screening requirements when parents or guardians of the child object. The law requires that a written statement of such objection be presented to the physician or other person whose duty it is to administer and report tests and screenings under this section. The law also requires that the department maintain a confidential registry of cases.

Georgia

Ga. Code Ann. § 31-12-7

Hawaii

Hawaii Rev. Stat. § 321-291 directs the department of health to adopt rules to inform parents about the purposes of newborn screening tests; and to maintain the confidentiality of affected families.

Idaho

Illinois

Ill. Rev. Stat. ch. 410, § 240/3

Ill. Rev. Stat. Ch §410-513

Indiana

Ind. Code § 16-41-17-2

Iowa

Iowa Code § 136A.6 allows the birth defects institute to maintain a central registry to collect and store report data to facilitate the compiling of statistical information on the causes, treatment, prevention, and cure of genetic disorders and birth defects. The law requires that identifying information remain confidential.

Kansas

Kan. Stat. Ann. § 65-180 directs the secretary of health and environment to provide a follow-up program by providing test results and other information to identified physicians and locating infants with abnormal newborn screening test results. The law also directs the secretary to, with parental consent, monitor infants to assure appropriate testing to either confirm or not confirm the disease suggested by the screening test results; and, with parental consent, monitor therapy and treatment for infants with confirmed diagnosis of certain genetic diseases being screened.

Kentucky

Ky. Rev. Stat. § 214.155

Louisiana

La. Rev. Stat. Ann. § 40: 1299.6 requires the results of any prenatal or postnatal genetic tests to be confidential medical information and be excluded from reporting requirements. The law also requires the results of such genetic tests to become part of the medical record of the person tested and be confidential unless express written consent to their release is granted by the person tested. The law provides an exception for genetic tests specifically mandated to be reported by law.

La. Rev. Stat. Ann. § 40:1299.1

La. Rev. stat. Ann. §22:213.7; §40:1299.6

Maine

Me. Rev. Stat. Ann. tit. 22, § 1533 establishes a voluntary statewide genetics program, which offers testing, counseling and education to parents and prospective parents.

Maryland

Massachusetts

Mass. Acts, Chap. 111 § 10A

Mass. Gen. Laws Ann. ch. 111, § 70G

Michigan

Mich. Comp. Laws § 333.5431 clarifies that the informed consent requirements do not apply to the tests required to newborn screening. The required tests must be administered and reported within a time and under conditions prescribed by the department. If the test results are positive, the results should be reported to the infant's parents, guardian, or person in loco parentis. The law provides requirements for the storage and disposal of blood specimens.

Mich. Comp. Laws § §333.17020;
§333.17520

Minnesota

Mississippi

Missouri

Montana

Nebraska

Neb. Rev. Stat. § 71-519 directs the department to, with the written consent of the parent or legal guardian of the infant, allow the blood specimens to be used for medical research in a manner that preserves the confidentiality of the test subjects. The law directs the department to prepare written materials that include the a description of the reasons that the infant's parent, guardian, or person in loco parentis should retain a blood specimen in a safe place. The written materials should also include the department's schedule for retaining and disposing of blood specimens.

The attending physician or person registering the birth may offer to draw an additional blood specimen from the infant. If the infant's parent, guardian, or person in loco parentis accepts the offer of an additional blood specimen, the blood specimen shall be preserved in a manner that does not require special storage conditions or techniques. The attending physician shall explain that the additional blood specimen can be used for future identification purposes and should be kept in a safe place. The physician may charge a fee. The parent or legal guardian of the infant must be informed of the tests and of the results of the tests and provided with a copy of the written materials.

Neb. Rev. Stat. § 71-522 directs the Department of Health and Human Services to establish and maintain a central data registry for the collection and storage of reported data concerning metabolic diseases. The law requires the department to use reported data to ensure that all infants born in the state are tested for certain specified diseases. The law directs the department to use reported data to evaluate the quality of the statewide system of newborn screening and develop procedures for quality assurance. Reported data in anonymous or statistical form may be made available by the department for purposes of research.

Neb. Rev. Stat. § 71-1, 104.1

Nevada

Nev. Rev. Stat. § 629.171

New Hampshire

N.H. Rev. Stat. Ann. § 141-H:2

New Jersey

N.J. Stat. Ann. § 26:2-111 allows information on newborn infants and their families compiled to be used by the department and certain agencies, but otherwise the information must be confidential.

N.J. Stat. Ann. § 26:2-111

N.J. Stat. Ann. § 10:5-45

N.J. Stat. Ann. § 10:5-47

New Mexico

N.M. Stat. Ann. § 24-21-1 to 7

New York

N.Y. Public Health Law § 2500-a

N.Y. Civil Rights Law § 79-L

North Carolina

North Dakota

N.D. Cent. Code § 23-01-03.1 allows the health council to authorize the use of newborn metabolic disease screening tests for research purposes. The law directs the council to adopt rules to ensure that the results are used for legitimate research purposes and to ensure that the confidentiality of the newborns and their families is protected.

N.D. Cent. Code § 25-17-04 directs the physician attending a newborn child to test for metabolic diseases, in the manner prescribed by the state department of health. The law requires the physician attending a patient with a metabolic disease to report the case to the state department of health.

N.D. Cent. Code § 25-17-04

Ohio

Ohio Rev. Code Ann. § 3705.32 requires records received and information assembled by the birth defects information system to be confidential medical records. The law allows the director of health to use the information to notify parents, guardians, and custodians of children with congenital anomalies or abnormal conditions of medical care and other services available for the child and family. The director may disclose information with the written consent of the parent or legal guardian of the child who is the subject of the information. The law provides additional direction regarding how the information may be used.

Ohio Rev. Code Ann. § 3701.501

Oklahoma

Oregon

Or. Rev. Stat. § 192.535

Or. Rev. Stat. § 192.537

Or. Rev. Stat. § 659.710

Pennsylvania

Rhode Island

R.I. Gen. Laws § 23-13-14

R.I. Gen. Laws § 27-18-52, 27-19-44, 27-20-39 and 27-41-53

South Carolina

S.C. Code Ann. § 44-37-30 clarifies that information obtained pursuant to newborn screening tests is confidential and may be released only to the parents of the child, the child's physician, and the child when 18 years of age or older.

S.C. Code Ann. § 44-37-30

S.C. Code Ann. §38-93-10 to §38-93-60

South Dakota

S.D. SB1 (2001)

Tennessee

Texas

Tex. Health & Safety Code Ann. § 33.013
exempts physicians, technicians, or other individuals administering the screening tests from liability or responsibility because of the failure or refusal of a parent, managing conservator, or guardian to consent to the tests for which this chapter provides.

Tex. Health & Safety Code Ann. § 33.033 prohibits the department from providing services without the consent of the individual or, if the individual is a minor, the minor's parent, managing conservator, or guardian.

Tex. Health & Safety Code Ann. § 33.012

Utah

Utah Code Ann. § 26-10-6

Vermont

Vt. Stat. Ann. tit. 18, § 9332

Virginia

Va. Code § 32.1-67.1 allows the results of the screening programs to be used for research and collective statistical purposes. However the law prohibits publication of information, biomedical research or medical data that identifies any infant having a genetic disease. All medical records maintained as part of the screening programs must be confidential.

Va. Code § 32.1-65

Washington

Wash. Rev. Code § 70.83.020

West Virginia

Wisconsin

Wis. Stat. Ann. § 253.13 prohibits any tests from being performed on an infant unless the parents or legal guardian are fully informed of the purposes of testing under this section and have been given reasonable opportunity to object.

The law requires the state laboratory of hygiene to provide the test results to the physician, who shall advise the parents or legal guardian of the results. No information obtained under this section from the parents or guardian or from specimens from the infant may be disclosed except for use in statistical data compiled by the department without reference to the identity of any individual. The state laboratory of hygiene board shall provide to the department the names and addresses of parents of infants who have positive test results.

Wis. Stat. Ann. § 253.13

Wyoming

Wyo. Stat. § 35-4-801 requires informed consent of parents to be obtained in order to screen for detection of metabolic diseases. If any parent or guardian of a child objects to a mandatory examination the child is exempt from the law.