CHAPTER 458

FORMERLY

SENATE BILL NO. 153

AS AMENDED BY SENATE AMENDMENT NO. 1 AND

HOUSE AMENDMENT NOS. 2,3 AND 5

AN ACT TO AMEND TITLE 16 OF THE DELAWARE CODE RELATING TO GENETIC INFORMATION.

WHEREAS, the DNA molecule contains information about an individual's probable medical future and this information is written in a code that is rapidly being broken; and

WHEREAS, genetic information is uniquely private and personal information that should not be collected, retained or disclosed without the individual's authorization; and

WHEREAS, the improper collection, retention or disclosure of genetic information can lead to significant harm to the individual, including stigmatization and discrimination in areas such as employment, education, health care and insurance; and

WHEREAS, an analysis of an individual's DNA provides information not only about an individual, but also about the individual's parents, siblings and children, thereby impacting family privacy, including reproductive decisions; and

WHEREAS, laws for the collection, storage and use of identifiable DNA samples and other samples and private genetic information obtained from those samples are needed both to protect individual privacy and to permit legitimate genetic research.

NOW THEREFORE:

BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF DELAWARE:

Section 1. Amend Chapter 12, Title 16, Delaware Code by re-titling the Chapter "Informed Consent and Confidentiality", creating a Subchapter Ito Chapter 12 entitled "HIV -Related Tests", placing existing §§1201-1205 of Chapter 12 in Subchapter I thereof, and by deleting "chapter" each time it appears in newly designated Subchapter I and by inserting in lieu thereof each time "Subchapter".

Section 2. Amend Chapter 12, Title 16, Delaware code by adding thereto a new Subchapter as follows:

"Subchapter 11 Genetic Information

§1220 Definitions

As used in this subchapter:

(1) 'Genetic characteristic' means any inherited gene or chromosome, or alternation thereof, that is scientifically or medically believed to predispose an individual to a disease, disorder or syndrome, or to be associated with a statistically significant increased risk of development of a disease, disorder or syndrome.

This includes, but is not limited to, information regarding carrier status, information regarding an increased likelihood of future disease or increased sensitivity to any substance, information derived from laboratory tests that identify mutations in specific genes or chromosomes, requests for genetic services or counseling, tests of gene products, and direct analysis of genes or chromosomes.

(0) 'Genetic information' means information about inherited genes or chromosomes, and of alterations thereof, whether obtained from an individual or family member, that is scientifically or medically believed to predispose an individual to disease, disorder or syndrome, or believed to be associated with a statistically significant increased risk of development of a disease, disorder or syndrome.

(3) `Genetic test' means a test for determining the presence or absence of an inherited genetic characteristic in an individual, including tests of nucleic acids such as DNA, RNA, and mitochondrial DNA, chromosomes or proteins in order to identify a predisposing genetic characteristic associated with disease, disorder or syndrome.

(4) 'Informed consent'

(A) for the purpose of obtaining genetic information, means the signing of a consent form which includes a description of the genetic test(s) to be performed, its purpose(s), potential uses, and limitations and the meaning of its results, and that the individual will receive the results unless the individual directs otherwise;

(B) for the purpose of retaining genetic information, means the signing of a consent form which includes an description of the genetic information to be retained, its potential uses and limitations;

(C) for the purpose of disclosing genetic information, means the signing of a consent form which includes a description of the genetic information to be disclosed and to whom.

(D) for the purpose of obtaining insurance, there may be a single signing which shall allow the obtaining, retaining and disclosure of genetic information, which, in addition to the requirements of paragraphs (A) and (B) of this subsection, shall:

(1) be written in plain language;

(2) be dated;

(0) name or identify by generic reference the persons authorized to disclose information about the individual;

(1) specify the nature of the information authorized to be disclosed;

(2) name or identify by generic reference the person to whom the individual is authorizing information to be disclosed, or subsequently redisclosed;

(3) describe the purpose for which the information is collected;

(4) specify the length of time such authorization shall remain valid; and,

(5) be signed by:

(a) the individual;

(b) such other person authorized to consent for such individual, if such individual lacks the capacity to consent; or;

(c) the claimant for the proceeds of an insurance policy.

§1221 Informed consent required to obtain genetic information.

(a) No person shall obtain genetic information about an individual without first obtaining informed consent from the individual.

(b) The requirements of this section shall not apply to genetic information obtained:

(1) By a State, county, municipal or federal law enforcement agency for the purposes of establishing the identity of a person in the course of a criminal investigation or prosecution;

(2) To determine paternity;

(3) Pursuant to the provisions of the DNA analysis and data bank requirements of §4713 of Title 29;

(4) To determine the identity of deceased individuals;

(5) For anonymous research where the identity of the subject will not be released;

(6) Pursuant to newborn screening requirements established by State or federal law; or

(7) As authorized by federal law for the identification of persons.

§1222 Authorization to retain genetic information and samples from which genetic information is derived.

(a) No person shall retain an individual's genetic information without first obtaining informed consent from the individual unless:

(1) Retention is necessary for the purposes of a criminal or death investigation or a criminal or juvenile proceeding;

(2) Retention is necessary to determine paternity;

(3) Retention is authorized by order of a court of competent jurisdiction;

(4) Retention is made pursuant to the provisions of the DNA analysis and data bank requirements of §4713 of Title 29; or

(5) Retention of information is for anonymous research where the identity of the subject will not be released.

(b) The sample of an individual from which genetic information has been obtained shall be destroyed promptly unless:

(1) Retention is necessary for the purposes of a criminal or death investigation or a criminal or juvenile proceeding;

(2) Retention is authorized by order of a court of competent jurisdiction; or Retention is authorized by the individual; or

(3) Retention is for anonymous research where the identity of the subject will not be released.

§ 1223 Genetic information access by the subject.

An individual promptly upon request, may inspect, request correction of and obtain genetic information from the records of that individual.

§ 1224 Conditions for disclosure to others of genetic information.

(a) Regardless of the manner of receipt or the source of genetic information, including information received from an individual, a person shall not disclose or be compelled, by subpoena or any other means, to disclose the identity of an individual upon whom a genetic test has been performed or to disclose genetic information about the individual in a manner that permits identification of the individual, unless:

(1) Disclosure is necessary for the purposes of a criminal or death investigation or a criminal or juvenile proceeding or to protect the interests of an issuer in the detection or prevention of fraud, material misrepresentation or material non-disclosure;Disclosure is necessary to determine paternity;

(2) Disclosure is authorized by order of a court of competent jurisdiction;

(3) Disclosure is made pursuant to the provisions of the DNA analysis and data bank requirements of §4713 of Title 29;

(0) Disclosure is authorized by obtaining informed consent of the tested individual describing the information to be disclosed and to whom;

(1) Disclosure is for the purpose of furnishing genetic information relating to a decedent for medical diagnosis of blood relatives of the decedent;

(2) Disclosure is for the purpose of identifying bodies;

(3) Disclosure is pursuant to newborn screening requirements established by State or federal law;

(4) Disclosure is authorized by federal law for the identification of persons; or

(5) Disclosure is by an insurer to an insurance regulatory authority;

(6) Disclosure is authorized in accordance with Section 1220(3)(D) of this subchapter; or

(12) Disclosure is otherwise permitted by law.

(b) The provisions of this section shall apply to any subsequent disclosure by any person after another person has disclosed genetic information or the identity of an individual upon whom a genetic test has been performed.

§ 1225 Subchapter applicability.

This Subchapter applies only to genetic information or samples that can be identified as belonging to an individual or family. This Subchapter does not apply to any law, contract or other arrangement that determines a person's rights to compensation relating to substances or information derived from a sample of an individual from which genetic information has been obtained.

§1226. Parental rights.

This Subchapter does not alter any right of parents or guardians to order medical and/or genetic tests of their children.

§1227 Violations, Penalties for unlawful disclosure of genetic information, Jurisdiction.

(a) Any person who willfully retains an individual's genetic information or retains an individual's sample in violation of this Subchapter shall be punished by a fine of not less than $1,000 nor more than $10,000.

(b) Any person who willfully obtains or discloses genetic information in violation of this Subchapter shall be punished by a fine not less than $5,000 nor more than $50,000.

(c) Any person who willfully discloses an individual's genetic information in violation of this Subchapter, shall be liable to the individual for all actual damages, including damages for economic, bodily, or emotional harm which is proximately caused by the disclosure.

(d) Superior Court shall have jurisdiction over all violations of this Subchapter." Section 3. Severability of provisions.

If any provision of this Act, or the application thereof to any person, thing or circumstances is held invalid, such invalidity shall not affect the provisions or application of this Act that can be given effect without the invalid provisions or application, and to this end the provisions of this Act are declared to be severable.

Approved July 17, 1998