Genome Statute and Legislation Database

The statutes related to research apply to genetic research studies approved by an institutional review board as defined in 21 CFR, � 50 or conducted subject to the requirements of the federal common rule at 21 CFR, � 50 and � 56, and 45 CFR, � 46. research records are confidential and may not be disclosed to employers or health insurers without informed consent. The provision does not apply to an insurer or to an individual dealing with an insurer in the course of underwriting, conducting or administering life, disability income or long-term care insurance. Stored tissues, including blood, that arise from surgery, other diagnostic or therapeutic steps, or autopsy may be disclosed for genetic or other research studies with informed consent. Results of genetic research studies may be published if no individual subject is identified.

The statutes prohibit discrimination based on genetic information of an individual or family member or the request or receipt of genetic services by a hospital, health, or medical expense insurance policy, hospital or medical service contract, employee welfare benefit plan, health and accident insurance policy, preferred provide organization or any other insurance contract of this type. Other restrictions also are placed on these entities with respect to genetic information and testing. An insurer offering individual or group health_insurance_coverage may request a genetic test if the request is made in compliance with the Common Rule and other specified criteria are met. Exceptions under the law include anonymous research where the identity of the subjects will not be released. An insured or enrollees genetic information is the property of the individual to whom it pertains and may not be retained without authorization with some exceptions. Civil penalties for violations are set forth.

The statutes contain provisions on the acquisition, collection, retention, transmission or use of genetic information. Consent requirements provide an exemption (1) if DNA, genetic information or results of genetic analysis are not identified with the person or person's family members or (2) for the purpose of medical or scientific research and education (including retention of gene products, genetic information or genetic analysis if the identity of the person or person's family members is not disclosed.) Discrimination by an insurer against a person or his/her family member based on genetic analysis, genetic information or genetic propensity is prohibited. Life, disability income or long-term care insurance are exempt if use is based on sound actuarial principles or related to actual or reasonably anticipated experience. Upon request a persons genetic information or samples must be promptly destroyed with some exceptions, including if retention is authorized under a research protocol approved by an institution review board pursuant to federal law. It is unlawful for a person to use genetic information in employment or recruiting. A person whose rights under the provisions of the Genetic Information privacy Act have been violated may bring a civil action for damages or other relief.

The statute requires the health department to develop a schedule for the retention and disposal of blood specimens. The schedule must allow for the blood specimens to be used for medical research during the established retention period, as long as the medical research is conducted in a manner that preserves the confidentiality of the test subjects and is consistent to protect human subjects from research risks under subpart A of part 46 of subchapter A of title 45 of the code of federal regulations.

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.

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.

The state board, the department of education, a unified school district or local education agency may not provide any personally identifiable information of any student or teacher, including a DNA sequence, to any federal agency, any Kansas state or local agency, state or local agency outside the state of Kansas, or any other organization or entity unless under specified circumstances. Died.

The public employee retirement commission, individual and group accident and sickness insurers, individual or group hospital service plans, individual or group medical service agreements, and individual or group health maintenance contracts must cover colorectal cancer screening as determined medically necessary by a physician. Coverage requirements include KRAS, BRAF, and PIK3CA arrays. 7/18/2018 Accompanied a study order, see H4778.

The provision pertaining to the use of genetic information in short term insurance plans was removed from the final version of this bill. 5/6/2019 Signed by the Governor.

The provision in the original version of the bill pertaining to the use of genetic information by carriers was amended. The enacted legislation establishes a workgroup on maintaining the protections established by the Affordable Care Act. May 13, 2019 Approved by the Governor - Chapter 418. Effective June 1, 2019.

The provision in the original version of the bill pertaining to the use of genetic information by carriers was amended. The enacted legislation establishes a workgroup on maintaining the protections established by the Affordable Care Act. May 13, 2019 Approved by the Governor - Chapter 417. Effective October 1, 2019.

The original version of this bill amended the newborn screening law pertaining to storage of blood samples. All language was subsequently deleted pertaining to the newborn screening program.

The Office of Management and Enterprise Services must contract with a vendor to conduct a pilot project to determine incentives to both health care providers and patients for each care encounter in which the provider and patient incorporate genetic testing for ability to metabolize prescription drugs, drug testing of persons prescribed narcotics and other proven medical interventions made available and recorded through the program in the rendering and utilization of health care. Died.

The law sets forth procedures for State employment appeals of grievances and disciplinary actions related to discrimination claims, including discrimination based on genetic information.

The law safeguards the rights and welfare of individual human subjects in the conduct of human research projects and provides protections against the possible conduct of medical or psychological research without voluntary informed consent.

The law requires the Minnesota Insurance Marketplace to provide any data subject asked to supply private data with a notice of rights related to the handling of genetic information. The Minnesota Insurance Marketplace is a state health benefit exchange as described in section 1311 of the federal Patient Protection and Affordable Care Act (Public Law 111-148), and further defined through amendments to the act and regulations issued under the act.

The law requires businesses to establish certain protections when using personal information. Personal information is defined to include an individual's genetic print.

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

The law requires a workgroup to develop a standard prior written authorization methodology for prescribers. If the workgroup develops a paper form, it must allow an insurer to request and require additional information beyond the form. Additional information may include patient clinical information regarding genetic tests.

The law prohibits the collection, retention and disclosure of genetic information without informed consent with some exceptions such as for law enforcement purposes, newborn screening and anonymous research. An individual may inspect, correct and obtain retained genetic information. A person conducting genetic analysis must destroy an individual's genetic information upon request. Genetic information about an individual obtained for purposes exempt from consent requirements may only be used for the purposes obtained and must be destroyed or returned to the individual upon completion of use or in accordance with law.

The law prohibits research using a human subject unless the person conducts the research in accordance with the federal regulations on the protection of human subjects.

The introduced version of the bill sought to protect confidential and sensitive information such as genetic testing information. The bill has been amended to establish a committee to study the use and regulation of biometric information. Signed by the Governor on 5/15/2018. Effective 5/15/ 2018.

The Insurance Information and privacy Protection Act defines health care information to include information about individual cells or their components or genetic information.

The informational content, including DNA/RNA and genetic sequences, contained in or on abandoned personal material is the property of the individual to whom it pertains regardless of its abandonment. No government or person may acquire, collect, retain or use of such informational content, with some exceptions such as for use by a law enforcement agency. Died on the table.

The health department must adopt and promulgate rules and regulations relating to the use_of_residual_newborn_screening_specimens and related information. Use may only be made for public health purposes and must comply with all applicable provisions of federal law. The department may charge a reasonable fee for evaluating proposals relating to the use of such specimens for public health research and for preparing and supplying specimens for research proposals approved by the department. The health department also must develop a pamphlet which explains that residual newborn blood specimens may be used for approved public health research.

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 health commissioner may collect, use, store, and disseminate biological specimens and health data to conduct research in a manner that is consistent with the federal common rule for the protection of human subjects in Code of Federal Regulations, title 45, part 46. Biological specimens is defined as tissue, fluids, excretions, or secretions that contain human DNA originating from an identifiable individual, either living or deceased.

The Division of Motor Vehicles or other state agency or department charged with motor vehicle registration or operation, the issuance or renewal of driver licenses or the issuance or renewal of any identification cards, must modify applications to include an exemption for a biometric and social security number religious exemption. Biometric data is defined to include DNA and RNA. Died.

The Department of Healthcare and Family Services must authorize the provision of, and payment for, a baseline mammograms for women 35-39 and mammograms at certain intervals for women over 40. Women under 40 with risk factors such as positive genetic testing should receive mammograms as medical necessary. Measure failed.

The department of education, a school administrative unit or a state agency may not collect, store, transmit or process the certain information, including DNA, from a student without the written consent of a parent or guardian of a student or an eligible student unless otherwise required or authorized by statute or rule. Died.

The Department of Education must prohibit the collection of confidential student information, including genetic information. The Department may not transfer student or redacted data that is confidential except under specified circumstances.

The controller of a legal entity that conducts business in the state may not process sensitive data concerning a consumer without obtaining the consumer's consent, or, in the case of the processing of personal data concerning a known child, without obtaining consent from the child's parent or lawful guardian, in accordance with the children's online privacy protection act requirements. Sensitive data is defined to include genetic or biometric data for the purpose of uniquely identifying a person. The law does not apply to various types of information and entities such as protected health information under HIPAA and identifiable private information according to federal policy for the protection of human subjects. Died.

The Commissioner of Social Services must provide Medicaid coverage to the extent permissible under federal law for pharmacogenomics tests determined to be medically necessary. The commissioner may not require prior authorization for medically necessary pharmacogenomics tests for persons being treated for (1) behavioral disorders, (2) psychiatry disorders, (3) cardiovascular disorders, and (4) chronic pain. Died.

The board of the Hawaii employer-union health benefits trust fund must require every health benefits plan established or contracted to include lower deductibles and co-payments for non-smokers of tobacco and other persons engaged in low risk health behaviors that are designed, in compliance with applicable federal and state laws, to encourage preventative health care, promote wellness, and discourage medically unnecessary use of health care services; provided that the board consults with medical professionals to determine what should be included as low risk health behaviors. Genetic factors and pre-existing medical conditions may not be considered as a behavior when determining what constitutes low risk behavior. Died.

The bills governs the use of personal information by state institutions. The definition of personal information includes a biometric or genetic print. Signed by the Governor on April 10, 2014.

The bill requires every policy of hospital, surgical or medical care or policies that provide reimbursement for laboratory tests or diagnostic X-rays must provide coverage for testing of familial dysautonomia, Canavan's disease and Tay-Sachs. Died.

The bill requires contractors and prospective contractors with the state or counties to comply with the Genetic Information Nondiscrimination Act of 2008. Died.

The bill requires contractors and prospective contractors with the state or counties to comply with the Genetic Information Nondiscrimination Act of 2008. Died.

The bill requires accident and health insurance policies to cover the cost of genetic testing for people with a family history of cancer when the attending physician determines the person has a significant risk of cancer. Died.

The bill provides options to parents regarding blood samples collected for the purpose of newborn screening, including the right to authorize in writing that the blood sample and test results may be used for public health studies or research. Died.

The bill establishes the right of parents to consent in writing before any record of the minor child's blood or deoxyribonucleic acid is created, stored or shared, with some exceptions such as for newborn screening. Signed by the Governor May 10, 2010.

The bill establishes the Florida Priority Care Project. The project aims to place a higher public priority on targeting the needs of adults who have a serious mental illness and who have a history that indicates a high probability that they could pose a threat to public safety. Requirements for the project include the use of genetic testing to help establish the correct medication regimes to be used to manage and treat a client's symptoms. Died.

The bill establishes requirements for the privacy of protected health information, including genetic information. Entities addressed in the bill include health care providers, health care data organizations, health plans, health oversight agencies, public health authorities, employers, insurers, health researchers, or edu�ational institutions. Died.

The bill establish fees, which the department may collect from researchers who have been approved by the department and who seek to umbilical cord blood, pregnancy blood collected by the Genetic Disease Screening Program, and stored by the Birth Defects Monitoring Program, and newborn blood collected by the Genetic Disease Screening Program. Fees may not to exceed the costs of administering the program and collection and storage of the samples. Signed by the Governor September 30, 2008.

The bill amends the state genetic nondiscrimination law by prohibiting discrimination on the basis of genetic information or a genetic test in the issuance of coverage, or the fixing of rates, terms or conditions, for any policy or contract of hospital or medical insurance or any health benefit plan. Measure failed.

The bill amends statute sections pertaining to the department of consumer affairs and business regulations relative to any person that owns or licenses personal information about a resident of the commonwealth. Changes add biometric information, including genetic information, to the types of personal information protected under the law. Died.

The bill amends statute sections pertaining to the department of consumer affairs and business regulations relative to any person that owns or licenses personal information about a resident of the commonwealth. Changes add biometric information, including genetic information, to the types of personal information protected under the law. Died.

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.

Substitute bill version: Requires the drug utilization review board to consider the safety, efficacy, and cost-effectiveness of drugs and gene therapies in its recommendations to the director of the authority regarding coverage for medical assistance programs. Died.

States that certain peace officer or custodial officer personnel records and records maintained by a state or local agency are not confidential and are should be made available for public inspection. Such records include those relating to an incident in which a sustained finding was made by any law enforcement agency or oversight agency that a peace officer or custodial officer engaged in conduct including, but not limited to, verbal statements, writings, online posts, recordings, and gestures, involving prejudice or discrimination against a person on the based on various characteristics, including genetic information. 10/5/21 Approved by the Governor. Effective 1/1/2022.