2023 Delaware Code › Title 16 - Health and Safety › Chapter 12. INFORMED CONSENT AND CONFIDENTIALITY › Subchapter I. Genetic Information › § 1201. Definitions.

§ 1201. 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.
(2) “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 mitochrondrial 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 or tests to be performed, its purpose or purposes, 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 a 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 or a notice that the information will be available to individuals who have access to Electronic Medical Records (EMR) or to the Delaware Health Information Network (DHIN).
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 (4)a. and b. of this section, shall:
1. Be written in plain language;
2. Be dated;
3. Name or identify by generic reference the persons authorized to disclose information about the individual;
4. Specify the nature of the information authorized to be disclosed;
5. Name or identify by generic reference the person to whom the individual is authorizing information to be disclosed, or subsequently redisclosed;
6. Describe the purpose for which the information is collected;
7. Specify the length of time such authorization shall remain valid; and,
8. 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.
71 Del. Laws, c. 458, §  2;  78 Del. Laws, c. 277, §  3;  80 Del. Laws, c. 126, §  1;