Chapter 12

§ 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 ; § 1202 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 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. 71 Del. Laws, c. 458, §  2 ; 78 Del. Laws, c. 277, §  3 ; § 1203 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 DNA analysis and data bank requirements of § 4713 of Title 29; (5) Retention of information is for anonymous research where the identity of the subject will not be released; or (6) Retention is pursuant to newborn screening requirements established by state or federal law. (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 (3) Retention is authorized by the individual; or (4) Retention is for anonymous research where the identity of the subject will not be released. 71 Del. Laws, c. 458, §  2 ; 78 Del. Laws, c. 277, §  3 ; 80 Del. Laws, c. 96, §  2 ; § 1204 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. 71 Del. Laws, c. 458, §  2 ; 78 Del. Laws, c. 277, §  3 ; § 1205 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 nondisclosure; (2) Disclosure is necessary to determine paternity; (3) Disclosure is authorized by order of a court of competent jurisdiction; (4) Disclosure is made pursuant to the DNA analysis and data bank requirements of § 4713 of Title 29; (5) Disclosure is authorized by obtaining informed consent of the tested individual describing the information to be disclosed and to whom; (6) Disclosure is for the purpose of furnishing genetic information relating to a decedent for medical diagnosis of blood relatives of the decedent; (7) Disclosure is for the purpose of identifying bodies; (8) Disclosure is pursuant to newborn screening requirements established by state or federal law; (9) Disclosure is authorized by federal law for the identification of persons; or (10) Disclosure is by an insurer to an insurance regulatory authority; (11) Disclosure is authorized in accordance with § 1201(4)c. of this title; or (12) Disclosure is otherwise permitted by law. (b) 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. 71 Del. Laws, c. 458, §  2 ; 78 Del. Laws, c. 277, §  3 ; 80 Del. Laws, c. 126, §  1 ; § 1206 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. 71 Del. Laws, c. 458, §  2 ; 78 Del. Laws, c. 277, §  3 ; § 1207 Parental rights. This subchapter does not alter any right of parents or guardians to order medical and/or genetic tests of their children. 71 Del. Laws, c. 458, §  2 ; 78 Del. Laws, c. 277, §  3 ; § 1208 Violations, penalties for unlawful disclosure of genetic information, jurisdiction. (a) Any person who wilfully 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 wilfully 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 wilfully 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) The Superior Court shall have jurisdiction over all violations of this subchapter. 71 Del. Laws, c. 458, §  2 ; 78 Del. Laws, c. 277, §  3 ; Delaware General Assembly Judicial Executive Contact Twitter Help function submitSearch() { if (!window.location.origin) { window.location.origin = window.location.protocol + "//" + window.location.hostname + (window.location.port ? ':' + window.location.port : ''); } keyword = document.getElementById('srch-term').value; window.location.href = "/Search?query=" + keyword; } document.getElementById('srch-term').onkeyup = function (e) { if (e.keyCode == 13) { submitSearch(); } } § 1210 Definitions. As used in this subchapter: (1) “Expunge” or “expunged” means to permanently destroy, delete or make nonidentifiable. (2) “Informed consent” means a written authorization for the disclosure of protected health information on a form substantially similar to one promulgated by the Department of Health and Social Services which is signed in writing or electronically by the individual who is the subject of the information. This authorization shall be dated and shall specify to whom the disclosure is authorized, the general purpose for such disclosure, and the time period in which the authorization for the disclosure is effective. (3) “Legitimate public health purpose” means a population-based activity or individual effort primarily aimed at the prevention of injury, disease, or premature mortality or the promotion of health in the community, including all of the following: a. Assessing the health needs of the community through public health surveillance and epidemiological research. b. Developing public health policy. c. Responding to public health needs and emergencies. d. Review by the Maternal and Child Death Review Commission or the Child Protection Accountability Commission. e. Requests for hospital records by the Division of Health Care Quality pursuant to § 1212 of this title. f. Review by the Drug Overdose Fatality Review Commission. (4) “Protected health information” means any information, whether oral, written, electronic, visual, pictorial, physical or any other form, that relates to an individual’s past, present or future physical or mental health status, condition, treatment, service, products purchased, or provision of care and that reveals the identity of the individual whose healthcare is the subject of the information, or about which there is a reasonable basis to believe such information could be utilized (either alone or with other information that is or should reasonably be known to be available to predictable recipients of such information) to reveal the identity of that individual. (5) “Research” means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. 73 Del. Laws, c. 355, §  12 ; 75 Del. Laws, c. 361, §  4 ; 75 Del. Laws, c. 387, §  3 ; 77 Del. Laws, c. 307, §  1 ; 78 Del. Laws, c. 277, §  3 ; 80 Del. Laws, c. 187, §  10 ; 81 Del. Laws, c. 94, §  1 ; 81 Del. Laws, c. 209, § 6 ; 83 Del. Laws, c. 364, § 2 ; § 1211 Use of protected health information. (a) Protected health information collected by the Department of Health and Social Services or its agencies, the Maternal and Child Death Review Commission, the Child Protection Accountability Commission, and the Drug Overdose Fatality Review Commission shall be used solely for legitimate public health purposes. (b) Nonidentifiable health information shall be used by the Department of Health and Social Services and its agencies whenever possible consistent with the accomplishment of legitimate public health purposes. (c) Any use of protected health information permitted by this subchapter shall be limited to the minimum amount of information which the official using the information reasonably believes is necessary to accomplish the legitimate public health purpose. (d) Protected health information shall not be used by the State for commercial purposes. (e) Protected health information whose use no longer furthers the legitimate public health purpose for which it was acquired shall be expunged. 73 Del. Laws, c. 355, §  12 ; 75 Del. Laws, c. 361, §  5 ; 78 Del. Laws, c. 277, §  3 ; 80 Del. Laws, c. 187, §  11 ; 81 Del. Laws, c. 94, §  1 ; 83 Del. Laws, c. 364, § 2 ; § 1212 Disclosure of protected health information. (a) General privacy protection. — Protected health information is not public information as defined at § 10002 of Title 29 and may not be disclosed without the informed consent of the individual (or the individual’s lawful representative) who is the subject of the information except as expressly provided by statute. Whenever disclosure of protected health information is made pursuant to this subchapter, such disclosure shall be accompanied by a statement concerning the Department of Health and Social Services’ disclosure policy. (b) Scope of disclosure. — Protected health information shall be disclosed with the informed consent of the individual who is the subject of the information to any person and for any purpose for which the disclosure is authorized pursuant to informed consent. (c) Nonidentifiable information. — Any disclosure of protected health information permitted by this subchapter shall be disclosed in a nonidentifiable form whenever possible, consistent with the accomplishment of legitimate public health purposes, except when the disclosure is authorized through the informed consent of the person who is the subject of the information. Any disclosures of protected health information permitted by this subchapter shall also be limited to the minimum amount of information which the person making the disclosure reasonably believes is necessary to accomplish the purpose of the disclosure, except when the disclosure is authorized through the informed consent of the individual who is the subject of the information. (d) Disclosure without informed consent. — Protected health information may be disclosed without the informed consent of the individual who is the subject of the information where any of the following disclosures are made: (1) Directly to the individual. (2) To appropriate federal agencies or authorities as permitted by federal or state law and for law-enforcement purposes in accordance with 45 C.F.R. Parts 160, 162, and 164. (3) To health-care personnel to the extent necessary in an emergency to protect the health or life of the person who is the subject of the information from serious, imminent harm. (4) To the public safety authority during a public health emergency in accord with the uses described in § 1211 of this title. (5) In the course of any judicial or administrative proceeding in accordance with 45 C.F.R. Parts 160, 162, and 164, or pursuant to a court order to avert a clear danger to the individual or the public health. (6) To the Maternal and Child Death Review Commission or to the Child Protection Accountability Commission. (7) To the Division of Health Care Quality in cases where the Division is engaged in an investigation or survey involving the care or treatment of an individual at a facility licensed by the Division, and the individual has been admitted to a hospital from the facility or discharged from a hospital to the facility. The Division of Health Care Quality is an entity charged with helping to safeguard the health and safety of patients. It shall be recognized as a “public health authority” and as a “health oversight agency,” and it shall be recognized in the performance of its functions as a peer review organization or auditor or evaluator with respect to such aspects of health-care delivery systems or providers. (8) Pursuant to § 2005 of this title. (9) For research, regardless of the source of funding of the research, provided that the researcher provides documentation that an alteration to or waiver, in whole or in part, of the individual authorization required by subsection (a) of this section for use or disclosure of protected health information has been approved by the applicable privacy board in accordance with HIPAA regulations. Said approval shall not be granted until the Board has determined all of the following: a. The use or disclosure of protected health information involves no more than a minimal risk to the privacy of individuals, based on, at least, the presence of the following elements: 1. An adequate plan to protect the identifiers from improper use and disclosure; 2. An adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law; and 3. Adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research study, or for other research for which the use or disclosure of protected health information would be permitted by this subpart; b. The research could not practicably be conducted without the waiver or alteration; and c. The research could not practicably be conducted without access to and use of the protected health information. (10) For patient treatment and care coordination, defined as the provision, coordination, or management of health-care and related services by 1 or more health-care providers, including the coordination or management of health care by a health-care provider with a third party; consultation between health-care providers relating to a patient; or the referral of a patient for health care from 1 health-care provider to another. (11) To a health plan, health-care clearinghouse, business associate, or health-care provider, as each is defined by 45 C.F.R. Part 160, to use only in accordance with federal law for transactions that transmit information between 2 parties to carry out financial or administrative activities related to health care, health-care operations, and health insurance, as set forth in 45 C.F.R Parts 160, 162, and 164. (12) To the Drug Overdose Fatality Review Commission. (13) To the Prescription Monitoring Program. (14) To the Fatal Incident Review Team of the Domestic Violence Coordinating Council. The Fatal Incident Review Team of the Domestic Violence Coordinating Council is an entity charged with investigating and reviewing the facts and circumstances of all deaths and near deaths as a result of domestic violence. It shall be recognized as a “public health authority” and as a “health oversight agency,” and it shall be recognized in the performance of its functions as a peer review organization or auditor or evaluator with respect to any aspect of health-care delivery systems or providers. (15) As permitted by federal law, including regulations. (16) To the Division of Substance Abuse and Mental Health in cases where the Division is engaged in an audit, investigation, or survey involving the care or treatment of a client in a behavioral health treatment program licensed by the Division. Under § 7908 of Title 29, the Division protects the health and safety of clients. The Division is a “public health authority” and “health oversight agency,” related to the Division’s functions as a peer review organization, auditor, or evaluator for licensed behavioral health provider organizations and treatment programs. (e) Deceased individuals. — Nothing in this subchapter shall prohibit the disclosure of protected health information: (1) In a certificate of death, autopsy report or related documents prepared under applicable laws or regulations; (2) For the purposes of identifying a deceased individual; (3) For the purposes of determining a deceased individual’s manner of death by a medical examiner; or (4) To provide necessary information about a deceased individual who is a donor or prospective donor of an anatomical gift. (f) Informed consent by others. — When an individual who is the subject of protected health information is not competent or is otherwise legally unable to give informed consent for the disclosure of protected health information, informed consent may be given by the individual’s parents, legal guardians or other persons lawfully authorized to make health-care decisions for the individual. (g) Secondary disclosures. — No person to whom protected health information has been disclosed pursuant to this subchapter shall disclose the information to another person except as authorized by this subchapter. This section shall not apply to: (1) The individual who is the subject of the information; (2) The individual’s parents, legal guardians or other persons lawfully authorized to make healthcare decisions for the individual where the individual who is the subject of the information is unable to give legal consent pursuant to subsection (f) of this section; or (3) Any person who is specifically required by federal or state law to disclose the information. (h) Upon written request of an individual to a medical laboratory for a copy of the results of a laboratory examination of that individual, the medical laboratory shall provide a copy of those results that are sought to that individual. The medical laboratory may require a reasonable copying fee for copying and transmitting the records. (i) The Maternal and Child Death Review Commission and the Child Protection Accountability Commission are charged with helping to safeguard the health and safety of children. Each shall be recognized as a “health oversight agency,” and as a “public health authority,” and each shall be recognized in the performance of its functions as a peer review organization or auditor or evaluator with respect to any aspect of health-care delivery systems or providers. 73 Del. Laws, c. 355, §  12 ; 75 Del. Laws, c. 329, §  1 ; 75 Del. Laws, c. 361, §§  6, 7 ; 75 Del. Laws, c. 387, §  4 ; 76 Del. Laws, c. 292, §  3 ; 77 Del. Laws, c. 307, §§  2-4 ; 77 Del. Laws, c. 392, §§  1-4 ; 78 Del. Laws, c. 277, §  3 ; 80 Del. Laws, c. 187, §  12 ; 81 Del. Laws, c. 94, §  1 ; 81 Del. Laws, c. 209, § 7 ; 81 Del. Laws, c. 429, § 1 ; 82 Del. Laws, c. 243, § 36 ; 83 Del. Laws, c. 321, § 2 ; 83 Del. Laws, c. 364, § 2 ; 85 Del. Laws, c. 461, § 7 ; § 1213 Regulations. The Department of Health and Social Services shall enforce this subchapter and shall from time to time promulgate any additional forms and regulations that are necessary for this purpose. 76 Del. Laws, c. 292, §  4 ; 78 Del. Laws, c. 277, §  3 ; Delaware General Assembly Judicial Executive Contact Twitter Help function submitSearch() { if (!window.location.origin) { window.location.origin = window.location.protocol + "//" + window.location.hostname + (window.location.port ? ':' + window.location.port : ''); } keyword = document.getElementById('srch-term').value; window.location.href = "/Search?query=" + keyword; } document.getElementById('srch-term').onkeyup = function (e) { if (e.keyCode == 13) { submitSearch(); } } § 1220 Definitions. As used in this subchapter: (1) “Health-care practitioner” means as defined in § 701 of this title. (2) “Health-care professional” means as defined in § 701 of this title. (3) “Informed consent” means the signing of a consent form by the patient or a person authorized to make health-care decision on behalf of the patient that satisfies all of the following conditions: a. Is written in plain language. b. Is dated. c. Includes a description of the procedure to be performed. d. States if there will be a student or resident that will perform or be present at the patient’s examination. 82 Del. Laws, c. 211, § 1 ; § 1221 Pelvic, rectal, or prostate examinations. (a) A health-care practitioner or a health-care professional may not knowingly perform or supervise the performance of a pelvic, rectal, or prostate examination on a patient who is anesthetized or unconscious unless one of the following applies: (1) The patient or the person authorized to make health-care decisions for the patient has given informed consent to the examination. (2) The examination is necessary for diagnostic or treatment purposes. (3) An emergency exists and it and it is impracticable to obtain consent and the examination is necessary for diagnostic or treatment purposes. (4) A court of competent jurisdiction orders the performance of the examination for the collection of evidence and such order must be issued in compliance with all of the following provisions: a. The court must find that there is a compelling need for such examination, which cannot be accommodated by other means. In assessing compelling need, the court shall weigh the need for the examination and the disclosure of the results against the privacy interest of the individual to be examined. b. Pleadings pertaining to the ordering of the examination shall substitute a pseudonym for the true name of the subject of the examination. The true name shall be communicated confidentially to the court and kept under seal of the court. (b) A health-care practitioner or health-care professional shall notify the patient as soon as reasonably practical that an examination was performed pursuant to § 1221(a)(3) and (4) of this title. (c) Any health-care practitioner or health-care professional who violates § 1221(a) of this title is subject to discipline by the appropriate professional licensing board. 82 Del. Laws, c. 211, § 1 ; 82 Del. Laws, c. 211, § 1 ; Delaware General Assembly Judicial Executive Contact Twitter Help function submitSearch() { if (!window.location.origin) { window.location.origin = window.location.protocol + "//" + window.location.hostname + (window.location.port ? ':' + window.location.port : ''); } keyword = document.getElementById('srch-term').value; window.location.href = "/Search?query=" + keyword; } document.getElementById('srch-term').onkeyup = function (e) { if (e.keyCode == 13) { submitSearch(); } }