Mass. Gen. Laws ch. 111, sec. 70G — MA Code / Part I / Title XVI / Chapter 111 / Section 70G
Genetic information and reports protected as private information; prior written consent for genetic testing
Status: in_force

Section 70G. (a) For purposes of this section, the following words shall have the following meanings:— ''Confidential research information'', any results of a genetic test maintained pursuant to pharmacological or clinical research protocols which are subject to and conducted in accordance with the review and approval of an Institutional Review Board established pursuant to the provisions of 45 CFR 46 and 21 CFR 50 and 56 which protects the confidentiality of the individual who is the subject of the genetic test either by encryption, encoding or other means consistent with the requirements of said federal regulations, or where the identity of the individual is unknown or protected from disclosure by encrypting or encoding, or by other means consistent with the requirements of said federal regulations. ''Genetic information'', any written or recorded individually identifiable result of a genetic test as defined by this section or explanation of such a result. For purposes of this section, the term genetic information shall not include any information about an identifiable person that is taken: (1) as a biopsy, autopsy, or clinical specimen solely for the purpose of conducting an immediate clinical or diagnostic test that is not a test of DNA, RNA, mitochondrial DNA, chromosomes or proteins; (2) as a blood sample solely for blood banking; (3) as a newborn screening pursuant to section 110A; (4) as confidential research information for use in epidemiological and clinical research conducted for the purpose of generating scientific knowledge about genes or learning about genes or learning about the genetic basis of disease or for developing pharmaceutical and other treatments of disease; or (5) as information pertaining to the abuse of drugs or alcohol which is derived from tests given for the exclusive purpose of determining the abuse of drugs or alcohol. ''Genetic test'', a test of human DNA, RNA, mitochondrial DNA, chromosomes or proteins for the purpose of identifying genes, inherited or acquired genetic abnormalities, or the presence or absence of inherited or acquired characteristics in genetic material. For the purposes of this section, the term genetic test shall not include tests given for drugs, alcohol, cholesterol, or HIV; or any test for the purpose of diagnosing or detecting an existing disease, illness, impairment or disorder. ''Informed written consent'', a written consent form for the requested release of a person's genetic information, or the release of genetic information, or for the release of medical records containing such information. Such written consent form shall state the purpose for which the information is being requested and shall be distinguished from written consent for the release of any other medical information. ''Insurance Institution'', any corporation, association, partnership, reciprocal exchange, inter-insurer, insurance support organization as defined in chapter 175I, Lloyds insurer, so-called, fraternal benefit society or other person engaged in the business of insurance, including health maintenance organizations, medical service plans and hospital service plans, preferred provider arrangements and savings bank life insurance, as defined in chapters 175, 176, 176A, 176B, 176C, 176G, 176I, and 178A. ''Person'', any natural person, corporation, association, partnership or other legal entity. ''Prior written consent'', a written consent form signed by the person who is the subject of the test or, if that person lacks capacity to consent, signed by the person authorized to consent for such person which form shall not be a general waiver or consent for genetic testing and which shall include:— (1) a statement of the purpose of the test; (2) a statement that prior to signing the consent form, the consenting person discussed with the medical practitioner ordering the test the reliability of positive or negative test results and the level of certainty that a positive test result for that disease or condition serves as a predictor of such disease; (3) a statement that the consenting person was informed about the availability and importance of genetic counseling and provided with written information identifying a genetic counselor or medical geneticist from whom the consenting person might obtain such counseling; (4) a general description of each specific disease or condition tested for; and (5) the person or persons to whom the test results may be disclosed; (b) Hospital, dispensary, laboratory, hospital-affiliated registry, physician, insurance institution, insurance support organization, or insurance representative, and commercial genetic testing company, agency, or association reports and records pertaining to any genetic information shall not be public records, and the contents thereof shall not be divulged by any person having charge of or access to the same without informed written consent, except upon proper judicial order or to a person whose official duties, in the opinion of the commissioner, entitle receipt of the information contained therein, or except in connection with life, disability, and long term care insurance as authorized pursuant to chapter 175I or as confidential research information for use in epidemiological or clinical research conducted for the purpose of generating scientific knowledge about genes or learning about the genetic basis of disease or for developing pharmaceutical and other treatments of disease. A laboratory receiving a request to conduct a genetic test from a facility, as defined in section 70E, or a physician or health care provider may conduct the requested test only when the request is accompanied by a signed statement of the medical practitioner ordering the test warranting that the appropriate prior written consent has been obtained from the patient except where the test is conducted as confidential research information for use in epidemiological or clinical research conducted for the purpose of generating scientific knowledge about genes or learning about the genetic basis of disease or for developing pharmaceutical and other treatments of disease. The signed request authorizes the laboratory to perform the test and disclose the results to the medical practitioner. (c) No facility, as defined in section 70E, and no physician or health care provider shall: (1) test any person for genetic information without first obtaining the prior written consent; (2) disclose the results of a genetic test to any person other than the subject thereof without first obtaining the informed written consent except where the results disclosed will be used only as is confidential research information for use in epidemiological or clinical research conducted for the purpose of generating scientific knowledge about genes or learning about the genetic basis of disease or for developing pharmaceutical and other treatments of disease; or identify the person being tested to any other person without first obtaining informed written consent or upon proper judicial order. Organizations conducting pharmoco-economic studies in systematic research to determine the cost benefits of specific treatment for genetic based disease shall be exempted from the need to re-obtain informed written consent. (d) Whoever violates any provisions of this section shall be deemed to have violated section 2 of chapter 93A. Any person whose rights under this section have been violated, interfered with, or attempted to be interfered with may institute and prosecute in his own name and on his own behalf, or the attorney general, acting on behalf of the commonwealth, may institute a civil action for injunctive and other equitable relief. (e) This section shall not apply to a law enforcement official in the execution of his official duties; to a hospital, laboratory or physician carrying out tests upon proper judicial order; or to law enforcement or health care personnel, or any other person, in the execution of their official duties pursuant to chapter 22E.

Section 70G. (a) For purposes of this section, the following words shall have the following meanings:—

''Confidential research information'', any results of a genetic test maintained pursuant to pharmacological or clinical research protocols which are subject to and conducted in accordance with the review and approval of an Institutional Review Board established pursuant to the provisions of 45 CFR 46 and 21 CFR 50 and 56 which protects the confidentiality of the individual who is the subject of the genetic test either by encryption, encoding or other means consistent with the requirements of said federal regulations, or where the identity of the individual is unknown or protected from disclosure by encrypting or encoding, or by other means consistent with the requirements of said federal regulations.

''Genetic information'', any written or recorded individually identifiable result of a genetic test as defined by this section or explanation of such a result. For purposes of this section, the term genetic information shall not include any information about an identifiable person that is taken:

(1) as a biopsy, autopsy, or clinical specimen solely for the purpose of conducting an immediate clinical or diagnostic test that is not a test of DNA, RNA, mitochondrial DNA, chromosomes or proteins;

(2) as a blood sample solely for blood banking;

(3) as a newborn screening pursuant to section 110A;

(4) as confidential research information for use in epidemiological and clinical research conducted for the purpose of generating scientific knowledge about genes or learning about genes or learning about the genetic basis of disease or for developing pharmaceutical and other treatments of disease; or

(5) as information pertaining to the abuse of drugs or alcohol which is derived from tests given for the exclusive purpose of determining the abuse of drugs or alcohol.

''Genetic test'', a test of human DNA, RNA, mitochondrial DNA, chromosomes or proteins for the purpose of identifying genes, inherited or acquired genetic abnormalities, or the presence or absence of inherited or acquired characteristics in genetic material. For the purposes of this section, the term genetic test shall not include tests given for drugs, alcohol, cholesterol, or HIV; or any test for the purpose of diagnosing or detecting an existing disease, illness, impairment or disorder.

''Informed written consent'', a written consent form for the requested release of a person's genetic information, or the release of genetic information, or for the release of medical records containing such information. Such written consent form shall state the purpose for which the information is being requested and shall be distinguished from written consent for the release of any other medical information.

''Insurance Institution'', any corporation, association, partnership, reciprocal exchange, inter-insurer, insurance support organization as defined in chapter 175I, Lloyds insurer, so-called, fraternal benefit society or other person engaged in the business of insurance, including health maintenance organizations, medical service plans and hospital service plans, preferred provider arrangements and savings bank life insurance, as defined in chapters 175, 176, 176A, 176B, 176C, 176G, 176I, and 178A.

''Person'', any natural person, corporation, association, partnership or other legal entity.

''Prior written consent'', a written consent form signed by the person who is the subject of the test or, if that person lacks capacity to consent, signed by the person authorized to consent for such person which form shall not be a general waiver or consent for genetic testing and which shall include:—

(1) a statement of the purpose of the test;

(2) a statement that prior to signing the consent form, the consenting person discussed with the medical practitioner ordering the test the reliability of positive or negative test results and the level of certainty that a positive test result for that disease or condition serves as a predictor of such disease;

(3) a statement that the consenting person was informed about the availability and importance of genetic counseling and provided with written information identifying a genetic counselor or medical geneticist from whom the consenting person might obtain such counseling;

(4) a general description of each specific disease or condition tested for; and

(5) the person or persons to whom the test results may be disclosed;

(b) Hospital, dispensary, laboratory, hospital-affiliated registry, physician, insurance institution, insurance support organization, or insurance representative, and commercial genetic testing company, agency, or association reports and records pertaining to any genetic information shall not be public records, and the contents thereof shall not be divulged by any person having charge of or access to the same without informed written consent, except upon proper judicial order or to a person whose official duties, in the opinion of the commissioner, entitle receipt of the information contained therein, or except in connection with life, disability, and long term care insurance as authorized pursuant to chapter 175I or as confidential research information for use in epidemiological or clinical research conducted for the purpose of generating scientific knowledge about genes or learning about the genetic basis of disease or for developing pharmaceutical and other treatments of disease. A laboratory receiving a request to conduct a genetic test from a facility, as defined in section 70E, or a physician or health care provider may conduct the requested test only when the request is accompanied by a signed statement of the medical practitioner ordering the test warranting that the appropriate prior written consent has been obtained from the patient except where the test is conducted as confidential research information for use in epidemiological or clinical research conducted for the purpose of generating scientific knowledge about genes or learning about the genetic basis of disease or for developing pharmaceutical and other treatments of disease. The signed request authorizes the laboratory to perform the test and disclose the results to the medical practitioner.

(c) No facility, as defined in section 70E, and no physician or health care provider shall: (1) test any person for genetic information without first obtaining the prior written consent; (2) disclose the results of a genetic test to any person other than the subject thereof without first obtaining the informed written consent except where the results disclosed will be used only as is confidential research information for use in epidemiological or clinical research conducted for the purpose of generating scientific knowledge about genes or learning about the genetic basis of disease or for developing pharmaceutical and other treatments of disease; or identify the person being tested to any other person without first obtaining informed written consent or upon proper judicial order. Organizations conducting pharmoco-economic studies in systematic research to determine the cost benefits of specific treatment for genetic based disease shall be exempted from the need to re-obtain informed written consent.

(d) Whoever violates any provisions of this section shall be deemed to have violated section 2 of chapter 93A. Any person whose rights under this section have been violated, interfered with, or attempted to be interfered with may institute and prosecute in his own name and on his own behalf, or the attorney general, acting on behalf of the commonwealth, may institute a civil action for injunctive and other equitable relief.

(e) This section shall not apply to a law enforcement official in the execution of his official duties; to a hospital, laboratory or physician carrying out tests upon proper judicial order; or to law enforcement or health care personnel, or any other person, in the execution of their official duties pursuant to chapter 22E.