Genome Statute and Legislation Database

All testing results and personal information from hereditary disorders programs obtained from any individual, or from specimens from any individual, is confidential and is considered a confidential medical record except for information that the individual, parent, or guardian consents to be released, provided after being fully informed of the scope of the information requested to be released, of all of the risks, benefits, and purposes for the release, and of the identity of those to whom the information will be released or made available, except for data compiled without reference to the identity of any individual, and except for research purposes, provided that pursuant to the Common Rule The research must first be reviewed and approved by an IRB. The health department, any entities approved by the department, and researchers must maintain the confidentiality of patient information and blood samples in the same manner as other medical record information with patient identification and may use it only for approved research to (1) identify risk factors for children's and women's diseases;(2) research to develop and evaluate screening tests;(3) research to develop and evaluate prevention strategies; and (4) research to develop and evaluate treatments. The State Committee for the Protection of Human Subjects (CPHS) must determine if all of the if specified criteria are met for purposes of ensuring the security of a donor's personal information, before any blood samples are released pursuant for research purposes.

Provides for the protection of human subjects participating in medical experiments. Enacts the Experimental Subject's Bill of Rights, which details informed consent requirements.

Establishes the Center for Data Insights and Innovation within the California Health and Human Services Agency, and transfer the duties of the Office of Health Information Integrity and the Office of Patient Advocate to the center. Requires the center to: (1) assume responsibility for administering the State Committee for the Protection of Human Subjects; (2) keep all personal information obtained by the center confidential, as specified; and (3) meet various requirements with regard to the disclosure of information, including the development of a comprehensive program regarding the disclosure of information to qualified researchers according to specified data use agreements.

Authorizes an association of employers to offer a large group health care service plan contract or large group health insurance policy to small group employer members of the association consistent with federal Employee Retirement Income Security Act of 1974, if certain requirements are met. A policy or contract that covers a small employer, as defined in subsection (b) of Section 1304 of PPACA and in Section 1357.500 of the California Health and Safety Code, may not establish rules for eligibility, including continued eligibility, of an individual, or dependent of an individual, to enroll under the terms of the policy or contract based on any of the following health status-related factors, including genetic information.

An issuer of a Medicare supplement contract must adhere to the requirements imposed by the federal Genetic Information Nondiscrimination Act of 2008 (Public Law 110-233).

Health care service plans, self-insured employee welfare benefit plans, and multiple employer welfare arrangements may not refuse to enroll any person, refuse to accept or renew a subscriber, charge a higher rate, or offer different terms, conditions or benefits on the basis of genetic characteristics that may be associated with disability in that person or that persons offspring. A plan may not seek information about genetic characteristics for non-therapeutic purposes. Specific penalties are set forth for violations by self-insured employee welfare benefit plans and multiple employer welfare arrangements.

Health care service plans and carriers, agents or brokers offering health benefit plans to individuals or solicitors may not encourage or direct federally eligible defined individuals to refrain from an application for coverage because of genetic information. Plans, agents or brokers may not enter into any contract, agreement or arrangement with a solicitor that provides for or results in the compensation paid to a solicitor for the sale of a health care service plan contract or health benefit plan design to be varied because of genetic information.

The statutes require carriers and health care service plans offering plan contracts in the individual market, other than individual grandfathered plan coverage, to offer to the responsible party for a child coverage for the child that does not exclude or limit coverage due to any preexisting condition of the child. A health care service plan may not condition the issuance or offering of individual coverage on certain factors, including genetic information.

Disability insurers covering hospital, medical and surgical expenses may not fail or refuse to accept an application, fail or refuse to issue insurance, cancel or refuse to renew insurance, charge a higher rate or premium, offer or provide different terms, conditions or benefits, or place a limitation on coverage based on genetic characteristics that may be associated with disability in a person of that persons offspring. These insurers also may not seek information about a persons genetic characteristics for non-therapeutic purposes. Specific penalties are set forth for violations. Life and disability insurers may not discriminate based solely on the fact that the person to be insured carries a gene that may be associated with disability in that person or the persons offspring, but which causes no adverse effects in the carrier, including but not limited to Tay-Sachs trait, sickle cell trait, thalassemia trait, and X-linked hemophilia trait.

Tests for genetic characteristics may not be required to determine insurability for life and disability income insurance except for policies contingent on review or testing for other diseases and conditions and only with informed consent. Policies may only limit benefits otherwise payable if loss is caused or contributed to by the presence or absence of genetic characteristics if the insurer imposes limitations for other medical conditions that present an increased risk. A life or disability income insurer may not request a genetic test to determine eligibility for hospital, medical or surgical insurance coverage or coverage under a nonprofit hospital service or health care service plan. The statutes set forth civil and criminal penalties for violations.

Health-status related factor is defined to include genetic information in Title 10 Article 16, which pertains to health care coverage.

The law requires breast cancer screening with mammography annually for persons with a predisposition to breast cancer.

Genetic information the property of the individual, and written consent is required for its disclosure other than for diagnosis, treatment or therapy. Health care entities may not retain or use genetic information for non-therapeutic purposes or request or require a genetic test; however, test results may be used on a limited basis to make payment decisions. Exceptions under the law include the use of genetic information for scientific research if the identity of the individual to whom the genetic information pertains is not disclosed to a third party other than the individuals physician with written consent. The law provides remedies for individuals whose rights are violated.

Genetic information is the property of the individual to whom it pertains. Release of genetic information that identifies the person tested for purposes other than diagnosis, treatment and therapy requires specific written consent. Exemptions under the law include some uses by research facilities. researchers may use genetic testing information for scientific research as long as the identity of any individual to whom the information pertains is not disclosed to any third party except that the individuals identity may be disclosed to the individuals physician with written consent. Group disability or long-term care insurers that receive genetic information may not seek, use or keep the information for any non-therapeutic or underwriting purpose. Life insurers and individual disability insurers may not perform a genetic test without informed consent. Penalties are set forth for unfair trade practices with respect to group disability and long-term care insurance.

Prohibits direct primary health care providers from discriminating in the selection of patients on the basis of genetic information and other protected classes.

The Health Commissioner must review and approve research proposals to be conducted using personally identifiable information in the newborn screening system or requiring contact with affected individuals.

The statute provides coverage of specified services for women who meet the age requirements set forth in the statute. If a woman is believed to be at increased risk for breast cancer due to 1) family history or prior personal history of breast cancer or 2) positive genetic testing or other indications as determined by a woman's physician advanced practice registered nurse, individual and group health insurers must provide a mammogram, which may be provided by breast tomosynthesis at the option of the woman covered under the policy, and comprehensive ultrasound screening of an entire breast or breasts. Ultrasound screening is provided only if a mammogram demonstrates heterogeneous or dense breast tissue based on the Breast Imaging Reporting and Data System established by the American College of Radiology.

Prohibits insurers, health care centers and fraternal benefit societies from, in connection with the issuance, withholding, extension or renewal of an annuity or an insurance policy for life, credit life, disability, long-term care, accidental injury, specified disease, hospital indemnity or credit accident insurance: (1) requesting, requiring, purchasing or using information obtained from an entity providing direct-to-consumer genetic testing without the informed written consent of the individual who has been tested; (2) conditioning insurance rates, the provision or renewal of insurance coverage or benefit or other conditions of insurance for an individual on a requirement or agreement that the individual undergo genetic testing; and (3) conditioning insurance rates, the provision or renewal of insurance coverage or benefit or other conditions of insurance for an individual on the results of any genetic testing of a member of the individual's family unless the results are contained in the individual's medical record.

Any hospital and medical expense incurred policy, hospital or medical service plan contract and health care center subscriber contract providing individual or group health_insurance_coverage may not refuse to insure, continue to insure, limit coverage, or charge an individual a different rate because of genetic information. In this type of coverage and all health insurance plans pre-existing condition exclusions may not be based on genetic information in the absence of a diagnosis.

An insurance institution, agent or insurance support organization that collects, uses or discloses medical record information must have written policies, standards and procedures for the management, transfer and security of medical record information, including additional protection against unauthorized disclosure of sensitive health information such as information regarding genetic testing and the fact that an individual has undergone a genetic test.

It is a discriminatory practice for an employer, an employment agency, or for any labor organization to request or require genetic information from an employee, a person seeking employment or a member. These entities may not discharge, expel or otherwise discriminate against any person on the basis of genetic information.

Employers, employment agencies and labor organizations may not discriminate based on genetic information with some exceptions such as to investigate a workers' compensation claim. A health benefit plan or health insurer may not establish rules for the eligibility or adjust premium or contribution amounts for an individual on the basis of genetic information concerning the individual or his/her family member, including information about a request for or receipt of genetic services by an individual or the individual's family member. Health insurers also may not require or request a genetic test.

Informed consent is required to obtain or retain genetic information about an individual. Exemptions include anonymous research where the identity of the subject will not be released. A sample from which genetic information has been obtained must be promptly destroyed with certain exceptions, including retention for anonymous research. An individual may inspect, request correction of and obtain genetic information from the records of that individual. The law sets forth civil penalties for violations.

Discrimination is prohibited in the issuance, denial or renewal of or in the fixing of the rates, terms or conditions for health insurance, excluding disability or long-term care insurance. The law provides for a cause of action in the nature of defamation, invasion of privacy or negligence with some exceptions.

A health status-related factor is defined to include genetic information with respect to large group health plans, individual health plans and small employer health insurance. Group health insurers may not establish rules for eligibility of an individual to enroll based on a health status related factor. Individual health insurers may not establish rules for eligibility of an individual to enroll under the terms of the coverage based on a health status-related factor.

Employers, employment agencies, labor organization or joint labor-management committee controlling apprenticeships or other training may not discriminate based on genetic information. These entities may admit or employ any individual on the basis of genetic information in those certain instances where genetic information is a bona fide occupational qualification reasonably necessary to the normal operation of that particular business or enterprise. Enforcement provisions, processes for civil action by the Attorney General or charging party, judicial remedies and civil penalties are established.

Prohibits research utilizing stored blood specimens or the stored data without parental consent, except for population-based studies in which all identifying information is removed. Parents may elect not to participate in blood spot storage.

Creates the Parents' Bill of Rights. Parental rights include the right to consent in writing before any record of his or her minor child's blood or deoxyribonucleic acid (DNA) is created, stored, or shared, except as required by general law or authorized pursuant to a court order.

Prohibits life, long-term care, or disability income insurers from: (1) canceling, limiting or denying coverage, or establishing differentials in premium rates, based on genetic information in the absence of a diagnosis; (2) requiring or soliciting genetic information, using genetic test results, or considering a person's actions related to genetic testing for any insurance purpose.

Prohibits a person to from willfully, and without express consent: (1) collecting or retaining another person's DNA sample with the intent to perform DNA analysis; (2) submitting another person's DNA sample for analysis or conducting or procuring the conduct of another person's DNA analysis; (3) disclosing another person's DNA analysis result to a third party; and (4) selling or otherwise transferring another person's DNA sample or the results of another person's DNA analysis to third party, regardless of whether the DNA sample was originally collected, retained, or analyzed with express consent. The bill provides exemptions for certain activities such as research subject to, and conducted in compliance with, 45 C.F.R. part 46, 21 C.F.R. parts 50 and 56, or 45 C.F.R. parts 160 and 164.

No person, firm, corporation, unincorporated association, state agency, unit of local government, or any public or private entity shall deny or refuse employment to any person or discharge any person from employment solely because such person has the sickle-cell trait. These entities also may not require screening or testing for the sickle-cell trait as a condition for employment.

Insurers may not refuse to issue or deliver any policy of life insurance or disability insurance that affords certain services and benefits or impose a higher premium rate or charge for those policies solely because the person to be insured has the sickle-cell trait.

Insurers offering health insurance, a self-insured plan, a multiple employer welfare arrangement, a prepaid limited health service organization, a health maintenance organization, a prepaid health clinic, a fraternal benefit society or any health care arrangement where risk is assumed may not cancel, limit, or deny coverage or establish differentials in premium rates based on genetic information in the absence of a diagnosis. Health insurers may not require or solicit genetic information, use genetic test results, or consider a person's decisions or actions relating to genetic testing for any insurance purpose.

An insurer that offers a group health insurance policy may not establish rules for eligibility or continued eligibility based on certain health status-related factors, including genetic information or use genetic information in the absence of a diagnosis as the basis for a pre-existing condition exclusion.

Health care service programs may not treat genetic information as a preexisting condition in the absence of a diagnosis. A health maintenance organization that offers group health_insurance_coverage may not establish rules for eligibility or continued eligibility of an individual to enroll under the terms of the contract based on certain health status-related factors, including genetic information.

Informed consent is required to perform DNA analysis. The results of DNA analysis, whether held by a public or private entity, are the exclusive property of the person tested, are confidential, and may not be disclosed without express consent. A person who performs DNA analysis or receives records, results, or findings of DNA analysis must provide the person tested with notice that the analysis was performed or that the information was received.

Genetic information is the property of the individual tested. Prior written authorization is required for genetic testing and release of results to anyone other than the person tested. A fraternal benefit society, a nonprofit medical service corporation, a health care corporation, a health maintenance corporation, or a self-insured health plan not subject to the exclusive jurisdiction of ERISA may not seek information derived from genetic testing, and if it is received, the information may not be used for any nontherapeutic purpose or be released without explicit written consent. Exceptions include scientific research facilities, which may conduct genetic testing and use information derived from testing for scientific research if the identity of any individual tested is not disclosed to any third party, except to an individual's physician with consent.

Requires the state employees' health insurance and benefit plan to cover mammograms and breast imaging for individuals at high risk for breast cancer. Individuals at high risk include those with a known BRCA 1 or 2 mutation based on genetic testing or with a first degree relative with known mutation.

Employers may not discriminate against any individual because of being regarded as having an impairment, which includes employer consideration of (1) an individual's genetic information, (2) genetic information of any family member of an individual, or (3) the individual's refusal to submit to a genetic test as a condition of initial or continued employment. The statutes also contain provisions pertaining to employment agencies and labor organizations.

No insurer providing accident and health or sickness insurance coverage or extended health_insurance_coverage, mutual benefit society, fraternal benefit society, or health maintenance organization may use an individual's or a family member's genetic information or a request for genetic services to (1) deny or limit any coverage or (2) establish eligibility, continuation, enrollment, or premium payment. These entities may not request or require collection or disclosure of genetic information of an individual or family member or disclose genetic information without written consent.

An employer may not (1) access or otherwise take into account private genetic information, (2) request or require consent to a release of private genetic information, (3) request or require a genetic test, or (4) inquire about taking or refusal to take a genetic test in connection with a hiring, promotion, retention or other related decision. An exception is made under certain circumstances for an order compelling disclosure of private genetic information.

With respect to disability insurance or any health benefit plan, no person may discriminate on the basis of a genetic test or private genetic information in the issuance of coverage or the fixing of rates, terms or conditions.

General managed care plans and health benefit plans covering large and small employers may not treat genetic information in the absence of a diagnosis as a pre-existing condition.

If a firefighter is diagnosed with breast cancer after five years of employment, and the disease was not revealed during an initial employment medical screening examination, then the disease is presumed to be proximately caused by the firefighter's employment as a firefighter. The presumption applies to breast cancer diagnosed before the age of forty (40) years and when a breast cancer 1 or breast cancer 2 genetic predisposition is not present.

Individual and group health insurers, health maintenance organizations and the Illinois Department of Healthcare and Family Services (for eligible individuals) must provide coverage for a mammogram and a screening MRI at the age and intervals considered medically necessary by the woman's health care provider for women under 40 years of age and having a family history of breast cancer, prior personal history of breast cancer, positive genetic testing, or other risk factors. Coverage for a comprehensive ultrasound screening of an entire breast or breasts also is required if a mammogram demonstrates heterogeneous or dense breast tissue based on the Breast Imaging Reporting and Data System established by the American College of Radiology or if the woman is at increased risk for breast cancer due to family history or prior personal history of breast cancer, positive genetic testing, or other indications as determined by a woman's health care provider.

An insurer must comply with the provisions of the Genetic Information privacy Act in connection with the amendment, delivery, issuance, or renewal of, or claims for or denial of coverage under, an individual or group policy of accident and health insurance. Genetic information may not be treated as a pre-existing condition in the absence of a diagnosis of the condition under the Illinois Health Insurance Portability and Accountability Act.

Provides that an individual or group policy of accident and health insurance or managed care plan that is amended, delivered, issued, or renewed on or after the effective date of the amendatory Act must provide coverage for medically necessary comprehensive cancer testing and testing of blood or constitutional tissue for cancer predisposition testing as determined by a physician. Comprehensive cancer testing includes, but is not limited to, the following forms of testing: (1) targeted cancer gene panels; (2) whole-exome genome testing; (3) whole genome testing; (4) RNA sequencing; and (5) tumor mutation burden.

A group health plan and a health insurance issuer offering group health_insurance_coverage may not impose a pre-existing condition exclusion based on genetic information in the absence of a diagnosis or establish rules for eligibility or continued eligibility based on a health status-related factor, including genetic information.

Genetic information may only be released to the individual tested and to other authorized persons with a few exceptions. An insurer may not seek information derived from genetic testing for use in connection with a policy of accident and health insurance, and an insurer that receives this information may not use it for non-therapeutic purposes unless the favorable results of a genetic test are voluntarily submitted. An employer, employment agency, labor organization, and licensing agency must treat genetic testing and genetic information in a manner that is consistent with federal law, including but not limited to the Genetic Information Nondiscrimination Act of 2008. Prohibited actions by employers, employment agencies and labor organizations are specified. No person may disclose the identity of any person upon whom a genetic test is performed or the results of a genetic test in a manner that permits identification of the subject of the test with some exceptions. A company providing direct-to-consumer genetic testing must obtain consent from the individual tested to share genetic information with any health or life insurance company.

The state health department must develop a system for using, for epidemiological survey and research purposes, any waste blood specimen left over after newborn screening. Waste blood specimens used for the purpose of epidemiological survey may not include the name or other identifying characteristics that would identify the individual submitting the specimen.