14 | | - | SECTION 1. IC 22-9-14 IS ADDED TO THE INDIANA CODE AS |
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15 | | - | A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE UPON |
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16 | | - | PASSAGE]: |
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| 68 | + | 1 SECTION 1. IC 22-9-14 IS ADDED TO THE INDIANA CODE AS |
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| 69 | + | 2 A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE UPON |
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| 70 | + | 3 PASSAGE]: |
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| 71 | + | 4 Chapter 14. Genetic Discrimination |
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| 72 | + | 5 Sec. 1. The definitions in IC 24-4-24 apply throughout this |
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| 73 | + | 6 chapter. |
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| 74 | + | 7 Sec. 2. A person may not discriminate against an individual on |
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| 75 | + | 8 the basis of the individual's solicitation and use of consumer |
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| 76 | + | 9 genetic testing services or on the basis of the results of genetic |
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| 77 | + | 10 testing performed by a consumer genetic testing provider, |
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| 78 | + | 11 including by discriminating against the individual in any of the |
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| 79 | + | 12 following ways: |
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| 80 | + | 13 (1) Denying the individual access to the person's goods or |
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| 81 | + | 14 services. |
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| 82 | + | 15 (2) Charging the individual a different rate for the person's |
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| 83 | + | 16 goods or services. |
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| 84 | + | 17 (3) Suggesting that the individual will be subject to any of the |
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| 85 | + | EH 1521—LS 7089/DI 119 2 |
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| 86 | + | 1 measures described in subdivisions (1) through (2). |
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| 87 | + | 2 SECTION 2. IC 24-4-24 IS ADDED TO THE INDIANA CODE AS |
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| 88 | + | 3 A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE UPON |
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| 89 | + | 4 PASSAGE]: |
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| 90 | + | 5 Chapter 24. Consumer Genetic Testing Providers |
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| 91 | + | 6 Sec. 1. (a) As used in this chapter, "consumer genetic testing" |
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| 92 | + | 7 means a service in which a person: |
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| 93 | + | 8 (1) provides an individual with a means of submitting a |
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| 94 | + | 9 sample of the individual's biological material directly to the |
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| 95 | + | 10 person; |
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| 96 | + | 11 (2) performs, or causes to be performed, genetic testing on the |
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| 97 | + | 12 submitted biological material; and |
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| 98 | + | 13 (3) returns the results of the genetic testing directly to the |
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| 99 | + | 14 individual. |
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| 100 | + | 15 (b) The term does not include genetic testing: |
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| 101 | + | 16 (1) of biological material of a patient of a health care provider |
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| 102 | + | 17 (as defined in IC 16-18-2-163(a)), the collection and testing of |
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| 103 | + | 18 which is: |
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| 104 | + | 19 (A) performed at the request or direction of the health care |
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| 105 | + | 20 provider for the purpose of the diagnosis, cure, mitigation, |
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| 106 | + | 21 treatment, or prevention of a physical or mental illness, |
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| 107 | + | 22 injury, disease, disorder, or disability; and |
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| 108 | + | 23 (B) subject to the Health Insurance Portability and |
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| 109 | + | 24 Accountability Act (HIPAA) (P.L. 104-191); |
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| 110 | + | 25 (2) performed as required by a court order; |
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| 111 | + | 26 (3) performed for purposes of a law enforcement investigation |
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| 112 | + | 27 at the request or direction of a law enforcement agency; |
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| 113 | + | 28 (4) performed at the request or direction of a coroner or |
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| 114 | + | 29 medical examiner for purposes of investigating the cause of an |
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| 115 | + | 30 individual's death; or |
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| 116 | + | 31 (5) performed for purposes of research (as defined in 45 CFR |
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| 117 | + | 32 164.501) that is subject to: |
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| 118 | + | 33 (A) 21 CFR 50 and 21 CFR 56; or |
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| 119 | + | 34 (B) 45 CFR 46. |
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| 120 | + | 35 Sec. 2. As used in this chapter, "consumer genetic testing |
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| 121 | + | 36 provider" or "provider" means a person that, in the ordinary |
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| 122 | + | 37 course of the person's business: |
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| 123 | + | 38 (1) offers consumer genetic testing; or |
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| 124 | + | 39 (2) collects, uses, or analyzes genetic data that: |
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| 125 | + | 40 (A) results from a consumer genetic testing product or |
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| 126 | + | 41 service; and |
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| 127 | + | 42 (B) is provided to the person by a consumer; |
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| 128 | + | EH 1521—LS 7089/DI 119 3 |
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| 129 | + | 1 in exchange for consideration. |
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| 130 | + | 2 Sec. 3. As used in this chapter, "deidentified data" means data |
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| 131 | + | 3 that cannot reasonably be used to infer information about, or |
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| 132 | + | 4 otherwise be linked to, an identifiable consumer and that: |
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| 133 | + | 5 (1) is subject to: |
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| 134 | + | 6 (A) administrative and technical measures to ensure that |
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| 135 | + | 7 the data cannot be associated with a particular consumer; |
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| 136 | + | 8 (B) public commitment by the holder of the data to: |
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| 137 | + | 9 (i) maintain and use the data in deidentified form; and |
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| 138 | + | 10 (ii) not attempt to reidentify the data; and |
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| 139 | + | 11 (C) legally enforceable contractual obligations that |
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| 140 | + | 12 prohibit any recipients of the data from attempting to |
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| 141 | + | 13 reidentify the data; or |
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| 142 | + | 14 (2) meets requirements for deidentification of the data set |
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| 143 | + | 15 forth in 45 CFR 164.514. |
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| 144 | + | 16 Sec. 4. As used in this chapter, "DNA" has the meaning set forth |
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| 145 | + | 17 in IC 10-13-6-2. |
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| 146 | + | 18 Sec. 5. As used in this chapter, "genetic data" means any data, |
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| 147 | + | 19 regardless of format, that: |
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| 148 | + | 20 (1) results from the analysis of an individual's biological |
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| 149 | + | 21 material, including analysis of: |
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| 150 | + | 22 (A) the complete DNA; |
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| 151 | + | 23 (B) regions of the DNA; |
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| 152 | + | 24 (C) chromosomes; |
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| 153 | + | 25 (D) genes; or |
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| 154 | + | 26 (E) gene products; and |
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| 155 | + | 27 (2) concerns an individual's genetic characteristics. |
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| 156 | + | 28 The term does not include deidentified data. |
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| 157 | + | 29 Sec. 6. As used in this chapter, "genetic testing" means analysis |
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| 158 | + | 30 of genetic data. |
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| 159 | + | 31 Sec. 7. As used in this chapter, "insurer" has the meaning set |
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| 160 | + | 32 forth in IC 27-1-2-3. |
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| 161 | + | 33 Sec. 8. (a) A consumer genetic testing provider may not |
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| 162 | + | 34 perform, or cause to be performed, genetic testing on an |
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| 163 | + | 35 individual's biological material unless the provider has provided |
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| 164 | + | 36 the individual with a written disclosure of the provider's privacy |
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| 165 | + | 37 policy, including the provider's policies and procedures regarding |
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| 166 | + | 38 the provider's collection, maintenance, security, retention, and use |
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| 167 | + | 39 of both biological material sent to the provider and data resulting |
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| 168 | + | 40 from genetic testing performed on the biological material. |
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| 169 | + | 41 (b) The disclosure under subsection (a) must include complete |
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| 170 | + | 42 information regarding the following: |
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| 171 | + | EH 1521—LS 7089/DI 119 4 |
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| 172 | + | 1 (1) The identity of any third party that may perform genetic |
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| 173 | + | 2 testing on biological material sent to the third party by the |
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| 174 | + | 3 provider. |
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| 175 | + | 4 (2) The manner in which: |
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| 176 | + | 5 (A) biological material sent to the provider; and |
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| 177 | + | 6 (B) data resulting from genetic testing performed on |
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| 178 | + | 7 biological material sent to the provider; |
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| 179 | + | 8 is stored, transferred, and secured. |
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| 180 | + | 9 (3) Any: |
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| 181 | + | 10 (A) testing or analysis that the provider performs or causes |
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| 182 | + | 11 to be performed on; or |
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| 183 | + | 12 (B) other purpose for which the provider uses; |
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| 184 | + | 13 biological material sent by an individual to the provider that |
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| 185 | + | 14 is in addition to the genetic testing requested by the |
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| 186 | + | 15 individual. |
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| 187 | + | 16 (4) The: |
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| 188 | + | 17 (A) identity of any third party to which the provider |
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| 189 | + | 18 provides access to: |
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| 190 | + | 19 (i) biological material sent to the provider; or |
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| 191 | + | 20 (ii) data resulting from genetic testing performed on |
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| 192 | + | 21 biological material sent to the provider; and |
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| 193 | + | 22 (B) purpose for which the third party uses the biological |
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| 194 | + | 23 material or data. |
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| 195 | + | 24 (c) A consumer genetic testing provider shall: |
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| 196 | + | 25 (1) publish the disclosure described in subsection (a) on the |
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| 197 | + | 26 provider's website; and |
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| 198 | + | 27 (2) include on the provider's website prominent directions and |
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| 199 | + | 28 hyperlinks to the location of the disclosure on the provider's |
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| 200 | + | 29 website. |
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| 201 | + | 30 Sec. 9. (a) A consumer genetic testing provider that performs, |
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| 202 | + | 31 or causes to be performed, genetic testing on an individual's |
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| 203 | + | 32 biological material may not take any of the following actions unless |
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| 204 | + | 33 the provider has solicited and received the individual's freely given, |
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| 205 | + | 34 specific, informed, and unambiguous consent to the action: |
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| 206 | + | 35 (1) Perform, or cause to be performed, any testing or analysis |
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| 207 | + | 36 of the individual's biological material that is not requested by |
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| 208 | + | 37 the individual except as required to comply with state and |
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| 209 | + | 38 federal law. |
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| 210 | + | 39 (2) Use the individual's biological material for any use other |
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| 211 | + | 40 than the genetic testing requested by the individual. |
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| 212 | + | 41 (3) Subject to section 10(b) of this chapter, provide access by |
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| 213 | + | 42 a third party to: |
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| 214 | + | EH 1521—LS 7089/DI 119 5 |
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| 215 | + | 1 (A) the individual's biological material; or |
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| 216 | + | 2 (B) data, other than deidentified data, resulting from |
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| 217 | + | 3 genetic testing performed on the individual's biological |
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| 218 | + | 4 material. |
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| 219 | + | 5 (4) Retain the individual's biological material for more than |
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| 220 | + | 6 thirty (30) days after the performance of the genetic testing |
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| 221 | + | 7 requested by the individual, except as required to comply with |
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| 222 | + | 8 state or federal law. |
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| 223 | + | 9 (5) Retain data, other than deidentified data, resulting from |
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| 224 | + | 10 genetic testing performed on the individual's biological |
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| 225 | + | 11 material for more than thirty (30) days after the completion |
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| 226 | + | 12 of the service except as required to comply with state and |
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| 227 | + | 13 federal law. |
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| 228 | + | 14 (6) Disseminate advertising or marketing communications to |
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| 229 | + | 15 the individual based on the individual's genetic testing results. |
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| 230 | + | 16 (7) Provide information regarding the individual's: |
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| 231 | + | 17 (A) solicitation and use of the provider's genetic testing |
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| 232 | + | 18 services; or |
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| 233 | + | 19 (B) use of the provider's: |
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| 234 | + | 20 (i) website; or |
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| 235 | + | 21 (ii) other remote or virtual services; |
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| 236 | + | 22 associated with the provider's genetic testing services; |
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| 237 | + | 23 to a third party to enable the third party to disseminate |
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| 238 | + | 24 advertising or marketing communications to the individual. |
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| 239 | + | 25 (b) A provider's solicitation of an individual's consent to an |
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| 240 | + | 26 action described in subsection (a) must: |
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| 241 | + | 27 (1) describe the action in terms that are sufficiently clear and |
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| 242 | + | 28 concise as to be reasonably understandable by a person of |
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| 243 | + | 29 ordinary intelligence; and |
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| 244 | + | 30 (2) solicit the individual's consent to the action separately |
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| 245 | + | 31 from a solicitation of the individual's consent to any other |
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| 246 | + | 32 action described in subsection (a). |
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| 247 | + | 33 (c) Consent to an action under subsection (a) is not freely given, |
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| 248 | + | 34 specific, informed, and unambiguous if the consent is provided by |
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| 249 | + | 35 any of the following means: |
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| 250 | + | 36 (1) The individual's inaction. |
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| 251 | + | 37 (2) The individual's acceptance of: |
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| 252 | + | 38 (A) general or broad terms of service; or |
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| 253 | + | 39 (B) any other document requiring agreement by an |
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| 254 | + | 40 individual using the provider's services; |
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| 255 | + | 41 containing information unrelated to the action under |
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| 256 | + | 42 subsection (a). |
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| 257 | + | EH 1521—LS 7089/DI 119 6 |
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| 258 | + | 1 (3) The individual closing, muting, pausing, or hovering a |
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| 259 | + | 2 computer cursor over a piece of content. |
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| 260 | + | 3 (4) The individual's communication of consent through an |
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| 261 | + | 4 Internet user interface that is designed or manipulated with |
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| 262 | + | 5 the substantial effect of subverting or impairing user |
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| 263 | + | 6 autonomy, decision making, or choice. |
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| 264 | + | 7 Sec. 10. (a) A consumer genetic testing provider that performs, |
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| 265 | + | 8 or causes to be performed, genetic testing on an individual's |
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| 266 | + | 9 biological material shall do the following: |
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| 267 | + | 10 (1) Implement commercially reasonable security measures to |
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| 268 | + | 11 protect: |
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| 269 | + | 12 (A) the individual's biological material; and |
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| 270 | + | 13 (B) data resulting from genetic testing performed on the |
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| 271 | + | 14 individual's biological material; |
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| 272 | + | 15 from unauthorized access, destruction, use, modification, or |
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| 273 | + | 16 disclosure. |
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| 274 | + | 17 (2) Allow the individual access to any data resulting from |
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| 275 | + | 18 genetic testing performed on the individual's biological |
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| 276 | + | 19 material. |
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| 277 | + | 20 (3) Provide the following: |
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| 278 | + | 21 (A) A procedure by which the individual can revoke any |
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| 279 | + | 22 consent provided by the individual under section 9 of this |
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| 280 | + | 23 chapter. The procedure must enable the individual to |
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| 281 | + | 24 communicate the revocation: |
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| 282 | + | 25 (i) directly to the provider; and |
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| 283 | + | 26 (ii) through one (1) or more means, at least one (1) of |
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| 284 | + | 27 which must be the primary means by which the provider |
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| 285 | + | 28 communicates with the individual. |
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| 286 | + | 29 (B) Both: |
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| 287 | + | 30 (i) notice of the existence of; and |
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| 288 | + | 31 (ii) instructions regarding the use of; |
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| 289 | + | 32 the procedure under clause (A) that are sufficiently clear |
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| 290 | + | 33 and concise as to be reasonably understandable by a |
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| 291 | + | 34 person of ordinary intelligence. |
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| 292 | + | 35 (4) Comply with a revocation of consent by the individual not |
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| 293 | + | 36 later than thirty (30) days after the individual communicates |
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| 294 | + | 37 the revocation to the provider, including by: |
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| 295 | + | 38 (A) destroying the individual's biological material not later |
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| 296 | + | 39 than thirty (30) days after the individual revokes the |
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| 297 | + | 40 individual's consent to the provider's retention of the |
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| 298 | + | 41 biological material under section 9(a)(4) of this chapter; |
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| 299 | + | 42 and |
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| 300 | + | EH 1521—LS 7089/DI 119 7 |
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| 301 | + | 1 (B) destroying any data resulting from genetic testing |
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| 302 | + | 2 performed on the individual's biological material not later |
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| 303 | + | 3 than thirty (30) days after the individual revokes the |
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| 304 | + | 4 individual's consent to the provider's retention of the data |
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| 305 | + | 5 under section 9(a)(5) of this chapter. |
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| 306 | + | 6 (5) Provide a third party with access to the individual's |
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| 307 | + | 7 biological material, or to data resulting from genetic testing |
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| 308 | + | 8 performed on the individual's biological material, only under |
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| 309 | + | 9 contractual terms that prohibit the third party from: |
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| 310 | + | 10 (A) using the biological material or data for any use to |
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| 311 | + | 11 which the individual has not consented under section 9 of |
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| 312 | + | 12 this chapter; |
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| 313 | + | 13 (B) providing another party with access to the biological |
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| 314 | + | 14 material or data; or |
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| 315 | + | 15 (C) retaining the biological material or data longer than |
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| 316 | + | 16 the provider is authorized to retain the biological material |
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| 317 | + | 17 or data under this chapter. |
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| 318 | + | 18 (6) Ensure that: |
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| 319 | + | 19 (A) any advertising or marketing communications sent to |
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| 320 | + | 20 the individual as a result of the individual's: |
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| 321 | + | 21 (i) solicitation and use of the provider's services; or |
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| 322 | + | 22 (ii) use of the provider's website or other remote or |
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| 323 | + | 23 virtual services; |
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| 324 | + | 24 are clearly and prominently denoted as advertising or |
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| 325 | + | 25 marketing materials; and |
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| 326 | + | 26 (B) advertising or marketing communications described in |
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| 327 | + | 27 clause (A) that are sent by a third party clearly and |
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| 328 | + | 28 prominently: |
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| 329 | + | 29 (i) identify the third party; and |
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| 330 | + | 30 (ii) notify the individual that any claims made in the |
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| 331 | + | 31 advertising or marketing communications have not been |
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| 332 | + | 32 evaluated by the provider. |
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| 333 | + | 33 (b) A consumer genetic testing provider may not provide data, |
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| 334 | + | 34 other than deidentified data, resulting from genetic testing |
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| 335 | + | 35 performed on an individual's biological material to: |
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| 336 | + | 36 (1) an insurer; |
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| 337 | + | 37 (2) a person that, in the ordinary course of the person's |
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| 338 | + | 38 business, provides information or data to insurers for the |
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| 339 | + | 39 purposes of underwriting or rating of risks; or |
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| 340 | + | 40 (3) a person that employs the individual; |
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| 341 | + | 41 regardless of whether the individual has consented to the provider |
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| 342 | + | 42 providing third parties with access to the data under section 9(a)(3) |
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| 343 | + | EH 1521—LS 7089/DI 119 8 |
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| 344 | + | 1 of this chapter. |
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| 345 | + | 2 (c) A consumer genetic testing provider may not charge a fee for |
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| 346 | + | 3 the provision of biological material or for the provision of data |
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| 347 | + | 4 resulting from genetic testing performed on biological material: |
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| 348 | + | 5 (1) to a law enforcement agency on the basis of a search |
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| 349 | + | 6 warrant; or |
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| 350 | + | 7 (2) as required by a court order; |
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| 351 | + | 8 that is more than the actual cost, not including labor costs or |
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| 352 | + | 9 overhead costs, to the consumer genetic testing provider of |
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| 353 | + | 10 providing the material or data. |
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| 354 | + | 11 Sec. 11. (a) The attorney general has exclusive authority to |
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| 355 | + | 12 enforce the provisions of this chapter. |
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| 356 | + | 13 (b) The attorney general may initiate an action in the name of |
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| 357 | + | 14 the state and may seek an injunction to restrain any violations of |
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| 358 | + | 15 this chapter and a civil penalty not to exceed seven thousand five |
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| 359 | + | 16 hundred dollars ($7,500) for each violation under this chapter. |
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| 360 | + | 17 (c) The attorney general may recover reasonable expenses |
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| 361 | + | 18 incurred in investigating and preparing the case, including |
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| 362 | + | 19 attorney's fees, in any action initiated under this section. |
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| 363 | + | 20 (d) Before initiating an action under this section, the attorney |
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| 364 | + | 21 general shall provide a provider thirty (30) days written notice |
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| 365 | + | 22 identifying the specific provisions of this chapter that the attorney |
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| 366 | + | 23 general alleges have been or are being violated. If, within the thirty |
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| 367 | + | 24 (30) day period set forth in this subsection, the provider: |
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| 368 | + | 25 (1) cures the alleged violation; and |
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| 369 | + | 26 (2) provides the attorney general an express written statement |
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| 370 | + | 27 that: |
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| 371 | + | 28 (A) the alleged violation has been cured; and |
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| 372 | + | 29 (B) actions have been taken to ensure no further such |
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| 373 | + | 30 violations will occur; |
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| 374 | + | 31 the attorney general shall not initiate an action against the |
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| 375 | + | 32 provider. |
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| 376 | + | 33 (e) If a provider: |
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| 377 | + | 34 (1) continues an alleged violation following the thirty (30) day |
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| 378 | + | 35 period set forth in subsection (d); or |
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| 379 | + | 36 (2) breaches an express written statement provided to the |
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| 380 | + | 37 attorney general under subsection (d)(2); |
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| 381 | + | 38 the attorney general may initiate an action against the provider |
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| 382 | + | 39 under subsection (b). |
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| 383 | + | 40 (f) Nothing in this section may be construed as providing the |
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| 384 | + | 41 basis for a private right of action for violations of this chapter or |
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| 385 | + | 42 any other law. |
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| 386 | + | EH 1521—LS 7089/DI 119 9 |
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| 387 | + | 1 SECTION 3. An emergency is declared for this act. |
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| 388 | + | EH 1521—LS 7089/DI 119 10 |
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| 389 | + | COMMITTEE REPORT |
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| 390 | + | Mr. Speaker: Your Committee on Commerce, Small Business and |
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| 391 | + | Economic Development, to which was referred House Bill 1521, has |
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| 392 | + | had the same under consideration and begs leave to report the same |
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| 393 | + | back to the House with the recommendation that said bill be amended |
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| 394 | + | as follows: |
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| 395 | + | Page 8, after line 24, begin a new paragraph and insert: |
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| 396 | + | "SECTION 2. IC 35-45-19-1.5, AS ADDED BY P.L.47-2019, |
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| 397 | + | SECTION 3, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE |
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| 398 | + | JULY 1, 2025]: Sec. 1.5. As used in this chapter, "human remains" |
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| 399 | + | means any part of the body of a deceased human being: |
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| 400 | + | (1) in any: |
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| 401 | + | (A) stage of decomposition; or |
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| 402 | + | (B) state of preservation; or |
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| 403 | + | (2) that indicate unique deoxyribonucleic acid (DNA). |
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| 404 | + | SECTION 3. IC 35-45-19-3, AS AMENDED BY P.L.47-2019, |
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| 405 | + | SECTION 4, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE |
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| 406 | + | JULY 1, 2025]: Sec. 3. A person who: |
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| 407 | + | (1) observes, discovers, or handles human remains when it |
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| 408 | + | appears the deceased person died: |
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| 409 | + | (A) by violence, suicide, or accident; |
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| 410 | + | (B) suddenly, while in apparent good health; |
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| 411 | + | (C) while unattended; |
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| 412 | + | (D) from poisoning or an overdose of drugs; |
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| 413 | + | (E) as the result of a disease that may constitute a threat to |
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| 414 | + | public health; |
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| 415 | + | (F) as the result of: |
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| 416 | + | (i) a disease; |
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| 417 | + | (ii) an injury; |
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| 418 | + | (iii) a toxic effect; or |
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| 419 | + | (iv) unusual exertion; |
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| 420 | + | incurred within the scope of the deceased person's |
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| 421 | + | employment; |
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| 422 | + | (G) due to sudden infant death syndrome; |
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| 423 | + | (H) as the result of a diagnostic or therapeutic procedure; or |
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| 424 | + | (I) under any other suspicious or unusual circumstances; and |
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| 425 | + | (2) knowingly or intentionally fails to report the observation, |
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| 426 | + | discovery, or handling of the human remains to a: |
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| 427 | + | (A) public safety officer; |
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| 428 | + | (B) coroner; |
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| 429 | + | (C) funeral director; |
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| 430 | + | EH 1521—LS 7089/DI 119 11 |
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| 431 | + | (D) physician; or |
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| 432 | + | (E) 911 telephone call center; |
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| 433 | + | within three (3) hours after finding the human remains; |
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| 434 | + | commits failure to report the observation, discovery, or handling of |
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| 435 | + | human remains, a Class A misdemeanor.". |
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| 436 | + | and when so amended that said bill do pass. |
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| 437 | + | (Reference is to HB 1521 as introduced.) |
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| 438 | + | MORRIS |
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| 439 | + | Committee Vote: yeas 9, nays 0. |
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| 440 | + | _____ |
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| 441 | + | COMMITTEE REPORT |
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| 442 | + | Mr. President: The Senate Committee on Commerce and |
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| 443 | + | Technology, to which was referred Engrossed House Bill No. 1521, has |
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| 444 | + | had the same under consideration and begs leave to report the same |
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| 445 | + | back to the Senate with the recommendation that said bill be |
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| 446 | + | AMENDED as follows: |
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| 447 | + | Page 1, between the enacting clause and line 1, begin a new |
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| 448 | + | paragraph and insert: |
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| 449 | + | "SECTION 1. IC 22-9-14 IS ADDED TO THE INDIANA CODE |
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| 450 | + | AS A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE |
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| 451 | + | UPON PASSAGE]: |
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31 | | - | measures described in subdivisions (1) through (2). |
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32 | | - | SECTION 2. IC 24-4-24 IS ADDED TO THE INDIANA CODE AS |
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33 | | - | A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE UPON |
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34 | | - | PASSAGE]: |
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35 | | - | Chapter 24. Consumer Genetic Testing Providers |
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36 | | - | HEA 1521 — Concur 2 |
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37 | | - | Sec. 1. (a) As used in this chapter, "consumer genetic testing" |
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38 | | - | means a service in which a person: |
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39 | | - | (1) provides an individual with a means of submitting a |
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40 | | - | sample of the individual's biological material directly to the |
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41 | | - | person; |
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42 | | - | (2) performs, or causes to be performed, genetic testing on the |
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43 | | - | submitted biological material; and |
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44 | | - | (3) returns the results of the genetic testing directly to the |
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45 | | - | individual. |
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46 | | - | (b) The term does not include genetic testing: |
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47 | | - | (1) of biological material of a patient of a health care provider |
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48 | | - | (as defined in IC 16-18-2-163(a)), the collection and testing of |
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49 | | - | which is: |
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50 | | - | (A) performed at the request or direction of the health care |
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51 | | - | provider for the purpose of the diagnosis, cure, mitigation, |
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52 | | - | treatment, or prevention of a physical or mental illness, |
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53 | | - | injury, disease, disorder, or disability; and |
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54 | | - | (B) subject to the Health Insurance Portability and |
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55 | | - | Accountability Act (HIPAA) (P.L. 104-191); |
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56 | | - | (2) performed as required by a court order; |
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57 | | - | (3) performed for purposes of a law enforcement investigation |
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58 | | - | at the request or direction of a law enforcement agency; |
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59 | | - | (4) performed at the request or direction of a coroner or |
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60 | | - | medical examiner for purposes of investigating the cause of an |
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61 | | - | individual's death; or |
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62 | | - | (5) performed for purposes of research (as defined in 45 CFR |
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63 | | - | 164.501) that is subject to: |
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64 | | - | (A) 21 CFR 50 and 21 CFR 56; or |
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65 | | - | (B) 45 CFR 46. |
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66 | | - | Sec. 2. As used in this chapter, "consumer genetic testing |
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67 | | - | provider" or "provider" means a person that, in the ordinary |
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68 | | - | course of the person's business: |
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69 | | - | (1) offers consumer genetic testing; or |
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70 | | - | (2) collects, uses, or analyzes genetic data that: |
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71 | | - | (A) results from a consumer genetic testing product or |
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72 | | - | service; and |
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73 | | - | (B) is provided to the person by a consumer; |
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74 | | - | in exchange for consideration. |
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75 | | - | Sec. 3. As used in this chapter, "deidentified data" means data |
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76 | | - | that cannot reasonably be used to infer information about, or |
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77 | | - | otherwise be linked to, an identifiable consumer and that: |
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78 | | - | (1) is subject to: |
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79 | | - | HEA 1521 — Concur 3 |
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80 | | - | (A) administrative and technical measures to ensure that |
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81 | | - | the data cannot be associated with a particular consumer; |
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82 | | - | (B) public commitment by the holder of the data to: |
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83 | | - | (i) maintain and use the data in deidentified form; and |
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84 | | - | (ii) not attempt to reidentify the data; and |
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85 | | - | (C) legally enforceable contractual obligations that |
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86 | | - | prohibit any recipients of the data from attempting to |
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87 | | - | reidentify the data; or |
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88 | | - | (2) meets requirements for deidentification of the data set |
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89 | | - | forth in 45 CFR 164.514. |
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90 | | - | Sec. 4. As used in this chapter, "DNA" has the meaning set forth |
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91 | | - | in IC 10-13-6-2. |
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92 | | - | Sec. 5. As used in this chapter, "genetic data" means any data, |
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93 | | - | regardless of format, that: |
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94 | | - | (1) results from the analysis of an individual's biological |
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95 | | - | material, including analysis of: |
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96 | | - | (A) the complete DNA; |
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97 | | - | (B) regions of the DNA; |
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98 | | - | (C) chromosomes; |
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99 | | - | (D) genes; or |
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100 | | - | (E) gene products; and |
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101 | | - | (2) concerns an individual's genetic characteristics. |
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102 | | - | The term does not include deidentified data. |
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103 | | - | Sec. 6. As used in this chapter, "genetic testing" means analysis |
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104 | | - | of genetic data. |
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105 | | - | Sec. 7. As used in this chapter, "insurer" has the meaning set |
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106 | | - | forth in IC 27-1-2-3. |
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107 | | - | Sec. 8. (a) A consumer genetic testing provider may not |
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108 | | - | perform, or cause to be performed, genetic testing on an |
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109 | | - | individual's biological material unless the provider has provided |
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110 | | - | the individual with a written disclosure of the provider's privacy |
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111 | | - | policy, including the provider's policies and procedures regarding |
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112 | | - | the provider's collection, maintenance, security, retention, and use |
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113 | | - | of both biological material sent to the provider and data resulting |
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114 | | - | from genetic testing performed on the biological material. |
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115 | | - | (b) The disclosure under subsection (a) must include complete |
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116 | | - | information regarding the following: |
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117 | | - | (1) The identity of any third party that may perform genetic |
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118 | | - | testing on biological material sent to the third party by the |
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119 | | - | provider. |
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120 | | - | (2) The manner in which: |
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121 | | - | (A) biological material sent to the provider; and |
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122 | | - | HEA 1521 — Concur 4 |
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123 | | - | (B) data resulting from genetic testing performed on |
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124 | | - | biological material sent to the provider; |
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125 | | - | is stored, transferred, and secured. |
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126 | | - | (3) Any: |
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127 | | - | (A) testing or analysis that the provider performs or causes |
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128 | | - | to be performed on; or |
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129 | | - | (B) other purpose for which the provider uses; |
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130 | | - | biological material sent by an individual to the provider that |
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131 | | - | is in addition to the genetic testing requested by the |
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132 | | - | individual. |
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133 | | - | (4) The: |
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134 | | - | (A) identity of any third party to which the provider |
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135 | | - | provides access to: |
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136 | | - | (i) biological material sent to the provider; or |
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137 | | - | (ii) data resulting from genetic testing performed on |
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138 | | - | biological material sent to the provider; and |
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139 | | - | (B) purpose for which the third party uses the biological |
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140 | | - | material or data. |
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141 | | - | (c) A consumer genetic testing provider shall: |
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142 | | - | (1) publish the disclosure described in subsection (a) on the |
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143 | | - | provider's website; and |
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144 | | - | (2) include on the provider's website prominent directions and |
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145 | | - | hyperlinks to the location of the disclosure on the provider's |
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146 | | - | website. |
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147 | | - | Sec. 9. (a) A consumer genetic testing provider that performs, |
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148 | | - | or causes to be performed, genetic testing on an individual's |
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149 | | - | biological material may not take any of the following actions unless |
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150 | | - | the provider has solicited and received the individual's freely given, |
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151 | | - | specific, informed, and unambiguous consent to the action: |
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152 | | - | (1) Perform, or cause to be performed, any testing or analysis |
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153 | | - | of the individual's biological material that is not requested by |
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154 | | - | the individual except as required to comply with state and |
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155 | | - | federal law. |
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156 | | - | (2) Use the individual's biological material for any use other |
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157 | | - | than the genetic testing requested by the individual. |
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158 | | - | (3) Subject to section 10(b) of this chapter, provide access by |
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159 | | - | a third party to: |
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160 | | - | (A) the individual's biological material; or |
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161 | | - | (B) data, other than deidentified data, resulting from |
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162 | | - | genetic testing performed on the individual's biological |
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163 | | - | material. |
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164 | | - | (4) Retain the individual's biological material for more than |
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165 | | - | HEA 1521 — Concur 5 |
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166 | | - | thirty (30) days after the performance of the genetic testing |
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167 | | - | requested by the individual, except as required to comply with |
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168 | | - | state or federal law. |
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169 | | - | (5) Retain data, other than deidentified data, resulting from |
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170 | | - | genetic testing performed on the individual's biological |
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171 | | - | material for more than thirty (30) days after the completion |
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172 | | - | of the service except as required to comply with state and |
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173 | | - | federal law. |
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174 | | - | (6) Disseminate advertising or marketing communications to |
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175 | | - | the individual based on the individual's genetic testing results. |
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176 | | - | (7) Provide information regarding the individual's: |
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177 | | - | (A) solicitation and use of the provider's genetic testing |
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178 | | - | services; or |
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179 | | - | (B) use of the provider's: |
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180 | | - | (i) website; or |
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181 | | - | (ii) other remote or virtual services; |
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182 | | - | associated with the provider's genetic testing services; |
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183 | | - | to a third party to enable the third party to disseminate |
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184 | | - | advertising or marketing communications to the individual. |
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185 | | - | (b) A provider's solicitation of an individual's consent to an |
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186 | | - | action described in subsection (a) must: |
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187 | | - | (1) describe the action in terms that are sufficiently clear and |
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188 | | - | concise as to be reasonably understandable by a person of |
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189 | | - | ordinary intelligence; and |
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190 | | - | (2) solicit the individual's consent to the action separately |
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191 | | - | from a solicitation of the individual's consent to any other |
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192 | | - | action described in subsection (a). |
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193 | | - | (c) Consent to an action under subsection (a) is not freely given, |
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194 | | - | specific, informed, and unambiguous if the consent is provided by |
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195 | | - | any of the following means: |
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196 | | - | (1) The individual's inaction. |
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197 | | - | (2) The individual's acceptance of: |
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198 | | - | (A) general or broad terms of service; or |
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199 | | - | (B) any other document requiring agreement by an |
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200 | | - | individual using the provider's services; |
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201 | | - | containing information unrelated to the action under |
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202 | | - | subsection (a). |
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203 | | - | (3) The individual closing, muting, pausing, or hovering a |
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204 | | - | computer cursor over a piece of content. |
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205 | | - | (4) The individual's communication of consent through an |
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206 | | - | Internet user interface that is designed or manipulated with |
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207 | | - | the substantial effect of subverting or impairing user |
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208 | | - | HEA 1521 — Concur 6 |
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209 | | - | autonomy, decision making, or choice. |
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210 | | - | Sec. 10. (a) A consumer genetic testing provider that performs, |
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211 | | - | or causes to be performed, genetic testing on an individual's |
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212 | | - | biological material shall do the following: |
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213 | | - | (1) Implement commercially reasonable security measures to |
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214 | | - | protect: |
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215 | | - | (A) the individual's biological material; and |
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216 | | - | (B) data resulting from genetic testing performed on the |
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217 | | - | individual's biological material; |
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218 | | - | from unauthorized access, destruction, use, modification, or |
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219 | | - | disclosure. |
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220 | | - | (2) Allow the individual access to any data resulting from |
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221 | | - | genetic testing performed on the individual's biological |
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222 | | - | material. |
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223 | | - | (3) Provide the following: |
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224 | | - | (A) A procedure by which the individual can revoke any |
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225 | | - | consent provided by the individual under section 9 of this |
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226 | | - | chapter. The procedure must enable the individual to |
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227 | | - | communicate the revocation: |
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228 | | - | (i) directly to the provider; and |
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229 | | - | (ii) through one (1) or more means, at least one (1) of |
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230 | | - | which must be the primary means by which the provider |
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231 | | - | communicates with the individual. |
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232 | | - | (B) Both: |
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233 | | - | (i) notice of the existence of; and |
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234 | | - | (ii) instructions regarding the use of; |
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235 | | - | the procedure under clause (A) that are sufficiently clear |
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236 | | - | and concise as to be reasonably understandable by a |
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237 | | - | person of ordinary intelligence. |
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238 | | - | (4) Comply with a revocation of consent by the individual not |
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239 | | - | later than thirty (30) days after the individual communicates |
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240 | | - | the revocation to the provider, including by: |
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241 | | - | (A) destroying the individual's biological material not later |
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242 | | - | than thirty (30) days after the individual revokes the |
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243 | | - | individual's consent to the provider's retention of the |
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244 | | - | biological material under section 9(a)(4) of this chapter; |
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245 | | - | and |
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246 | | - | (B) destroying any data resulting from genetic testing |
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247 | | - | performed on the individual's biological material not later |
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248 | | - | than thirty (30) days after the individual revokes the |
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249 | | - | individual's consent to the provider's retention of the data |
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250 | | - | under section 9(a)(5) of this chapter. |
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251 | | - | HEA 1521 — Concur 7 |
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252 | | - | (5) Provide a third party with access to the individual's |
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253 | | - | biological material, or to data resulting from genetic testing |
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254 | | - | performed on the individual's biological material, only under |
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255 | | - | contractual terms that prohibit the third party from: |
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256 | | - | (A) using the biological material or data for any use to |
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257 | | - | which the individual has not consented under section 9 of |
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258 | | - | this chapter; |
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259 | | - | (B) providing another party with access to the biological |
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260 | | - | material or data; or |
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261 | | - | (C) retaining the biological material or data longer than |
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262 | | - | the provider is authorized to retain the biological material |
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263 | | - | or data under this chapter. |
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264 | | - | (6) Ensure that: |
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265 | | - | (A) any advertising or marketing communications sent to |
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266 | | - | the individual as a result of the individual's: |
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267 | | - | (i) solicitation and use of the provider's services; or |
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268 | | - | (ii) use of the provider's website or other remote or |
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269 | | - | virtual services; |
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270 | | - | are clearly and prominently denoted as advertising or |
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271 | | - | marketing materials; and |
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272 | | - | (B) advertising or marketing communications described in |
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273 | | - | clause (A) that are sent by a third party clearly and |
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274 | | - | prominently: |
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275 | | - | (i) identify the third party; and |
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276 | | - | (ii) notify the individual that any claims made in the |
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277 | | - | advertising or marketing communications have not been |
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278 | | - | evaluated by the provider. |
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279 | | - | (b) A consumer genetic testing provider may not provide data, |
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280 | | - | other than deidentified data, resulting from genetic testing |
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281 | | - | performed on an individual's biological material to: |
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282 | | - | (1) an insurer; |
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283 | | - | (2) a person that, in the ordinary course of the person's |
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284 | | - | business, provides information or data to insurers for the |
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285 | | - | purposes of underwriting or rating of risks; or |
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286 | | - | (3) a person that employs the individual; |
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287 | | - | regardless of whether the individual has consented to the provider |
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288 | | - | providing third parties with access to the data under section 9(a)(3) |
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289 | | - | of this chapter. |
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290 | | - | (c) A consumer genetic testing provider may not charge a fee for |
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291 | | - | the provision of biological material or for the provision of data |
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292 | | - | resulting from genetic testing performed on biological material: |
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293 | | - | (1) to a law enforcement agency on the basis of a search |
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294 | | - | HEA 1521 — Concur 8 |
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295 | | - | warrant; or |
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296 | | - | (2) as required by a court order; |
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297 | | - | that is more than the actual cost, not including labor costs or |
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298 | | - | overhead costs, to the consumer genetic testing provider of |
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299 | | - | providing the material or data. |
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300 | | - | Sec. 11. (a) The attorney general has exclusive authority to |
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301 | | - | enforce the provisions of this chapter. |
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302 | | - | (b) The attorney general may initiate an action in the name of |
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303 | | - | the state and may seek an injunction to restrain any violations of |
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304 | | - | this chapter and a civil penalty not to exceed seven thousand five |
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305 | | - | hundred dollars ($7,500) for each violation under this chapter. |
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306 | | - | (c) The attorney general may recover reasonable expenses |
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307 | | - | incurred in investigating and preparing the case, including |
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308 | | - | attorney's fees, in any action initiated under this section. |
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309 | | - | (d) Before initiating an action under this section, the attorney |
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310 | | - | general shall provide a provider thirty (30) days written notice |
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311 | | - | identifying the specific provisions of this chapter that the attorney |
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312 | | - | general alleges have been or are being violated. If, within the thirty |
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313 | | - | (30) day period set forth in this subsection, the provider: |
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314 | | - | (1) cures the alleged violation; and |
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315 | | - | (2) provides the attorney general an express written statement |
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316 | | - | that: |
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317 | | - | (A) the alleged violation has been cured; and |
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318 | | - | (B) actions have been taken to ensure no further such |
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319 | | - | violations will occur; |
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320 | | - | the attorney general shall not initiate an action against the |
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321 | | - | provider. |
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322 | | - | (e) If a provider: |
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323 | | - | (1) continues an alleged violation following the thirty (30) day |
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324 | | - | period set forth in subsection (d); or |
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325 | | - | (2) breaches an express written statement provided to the |
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326 | | - | attorney general under subsection (d)(2); |
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327 | | - | the attorney general may initiate an action against the provider |
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328 | | - | under subsection (b). |
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329 | | - | (f) Nothing in this section may be construed as providing the |
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330 | | - | basis for a private right of action for violations of this chapter or |
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331 | | - | any other law. |
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332 | | - | SECTION 3. An emergency is declared for this act. |
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333 | | - | HEA 1521 — Concur Speaker of the House of Representatives |
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334 | | - | President of the Senate |
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335 | | - | President Pro Tempore |
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336 | | - | Governor of the State of Indiana |
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337 | | - | Date: Time: |
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338 | | - | HEA 1521 — Concur |
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| 466 | + | measures described in subdivisions (1) through (2).". |
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| 467 | + | Page 1, line 2, delete "JULY" and insert "UPON PASSAGE]:". |
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| 468 | + | EH 1521—LS 7089/DI 119 12 |
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| 469 | + | Page 1, delete line 3. |
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| 470 | + | Page 8, delete lines 25 through 42, begin a new paragraph and |
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| 471 | + | insert: |
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| 472 | + | "SECTION 3. An emergency is declared for this act.". |
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| 473 | + | Delete page 9. |
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| 474 | + | Renumber all SECTIONS consecutively. |
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| 475 | + | and when so amended that said bill do pass. |
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| 476 | + | (Reference is to HB 1521 as printed February 6, 2025.) |
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| 477 | + | BUCHANAN, Chairperson |
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| 478 | + | Committee Vote: Yeas 10, Nays 1. |
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| 479 | + | EH 1521—LS 7089/DI 119 |
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