1 | 1 | | |
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2 | 2 | | |
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3 | 3 | | EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW. |
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4 | 4 | | [Brackets] indicate matter deleted from existing law. |
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5 | 5 | | *sb0987* |
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6 | 6 | | |
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7 | 7 | | SENATE BILL 987 |
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8 | 8 | | J1, J5, S1 5lr2205 |
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9 | 9 | | |
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10 | 10 | | By: Senator Lam |
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11 | 11 | | Introduced and read first time: January 28, 2025 |
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12 | 12 | | Assigned to: Finance |
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13 | 13 | | |
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14 | 14 | | A BILL ENTITLED |
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15 | 15 | | |
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16 | 16 | | AN ACT concerning 1 |
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17 | 17 | | |
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18 | 18 | | Artificial Intelligence – Health Software and Health Insurance Decision Making 2 |
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19 | 19 | | |
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20 | 20 | | FOR the purpose of requiring the Maryland Health Care Commission to maintain a registry 3 |
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21 | 21 | | of artificial intelligence health software that may be distributed or operated in the 4 |
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22 | 22 | | State; prohibiting a person from distributing or operating artificial intelligence 5 |
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23 | 23 | | health software unless the software is registered with the Commission; prohibiting 6 |
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24 | 24 | | a health insurance carrier from using artificial intelligence to decide or directly 7 |
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25 | 25 | | influence a health care decision or a decision directly related to health care; and 8 |
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26 | 26 | | generally relating to artificial intelligence in health care. 9 |
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27 | 27 | | |
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28 | 28 | | BY repealing and reenacting, without amendments, 10 |
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29 | 29 | | Article – Health – General 11 |
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30 | 30 | | Section 19–101 12 |
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31 | 31 | | Annotated Code of Maryland 13 |
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32 | 32 | | (2023 Replacement Volume and 2024 Supplement) 14 |
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33 | 33 | | |
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34 | 34 | | BY adding to 15 |
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35 | 35 | | Article – Health – General 16 |
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36 | 36 | | Section 19–150 to be under the new part “Part VI. Artificial Intelligence Health 17 |
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37 | 37 | | Software” 18 |
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38 | 38 | | Annotated Code of Maryland 19 |
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39 | 39 | | (2023 Replacement Volume and 2024 Supplement) 20 |
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40 | 40 | | |
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41 | 41 | | BY adding to 21 |
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42 | 42 | | Article – Insurance 22 |
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43 | 43 | | Section 15–147 23 |
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44 | 44 | | Annotated Code of Maryland 24 |
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45 | 45 | | (2017 Replacement Volume and 2024 Supplement) 25 |
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46 | 46 | | |
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47 | 47 | | BY repealing and reenacting, without amendments, 26 |
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48 | 48 | | Article – State Finance and Procurement 27 2 SENATE BILL 987 |
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49 | 49 | | |
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50 | 50 | | |
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51 | 51 | | Section 3.5–801(a) and (c) 1 |
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52 | 52 | | Annotated Code of Maryland 2 |
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53 | 53 | | (2021 Replacement Volume and 2024 Supplement) 3 |
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54 | 54 | | |
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55 | 55 | | SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 4 |
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56 | 56 | | That the Laws of Maryland read as follows: 5 |
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57 | 57 | | |
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58 | 58 | | Article – Health – General 6 |
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59 | 59 | | |
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60 | 60 | | 19–101. 7 |
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61 | 61 | | |
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62 | 62 | | In this subtitle, “Commission” means the Maryland Health Care Commission. 8 |
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63 | 63 | | |
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64 | 64 | | PART VI. ARTIFICIAL INTELLIGENCE HEALTH SOFTWARE. 9 |
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65 | 65 | | |
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66 | 66 | | 19–150. 10 |
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67 | 67 | | |
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68 | 68 | | (A) THE COMMISSION SHALL MAINTAIN A REGISTRY OF ARTIFICIAL 11 |
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69 | 69 | | INTELLIGENCE HEALTH SOFTWARE THAT MAY BE DISTRIBUTED OR OPERA TED IN 12 |
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70 | 70 | | THE STATE. 13 |
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71 | 71 | | |
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72 | 72 | | (B) A PERSON MAY NOT DISTR IBUTE OR OPERATE ART IFICIAL 14 |
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73 | 73 | | INTELLIGENCE HEALTH SOFTWARE IN THE STATE UNLESS THE SOFTWARE IS 15 |
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74 | 74 | | REGISTERED WITH THE COMMISSION. 16 |
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75 | 75 | | |
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76 | 76 | | (C) THE COMMISSION SHALL ADOP T REGULATIONS THAT: 17 |
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77 | 77 | | |
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78 | 78 | | (1) DEFINE ARTIFICIAL INT ELLIGENCE HEALTH SOF TWARE; 18 |
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79 | 79 | | |
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80 | 80 | | (2) DETERMINE THE INFORMATION ABOUT AR TIFICIAL 19 |
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81 | 81 | | INTELLIGENCE HEALTH SOFTWARE TO BE COLLECTED FOR THE REGISTRY; AND 20 |
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82 | 82 | | |
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83 | 83 | | (3) SET A REGISTRATION DEADLINE FOR WHEN TH E COMMISSION 21 |
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84 | 84 | | WILL BEGIN TO ISSUE FINES TO A PERSON THAT DISTRIBUTES OR OPERATE S 22 |
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85 | 85 | | UNREGISTERED ARTIFIC IAL INTELLIGENCE HEA LTH SOFTWARE IN THE STATE. 23 |
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86 | 86 | | |
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87 | 87 | | (D) (1) IF A PERSON DISTRIBUT ES OR OPERATES UNREGISTERED 24 |
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88 | 88 | | ARTIFICIAL INTELLIGE NCE HEALTH SOFTWARE IN THE STATE, THE COMMISSION 25 |
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89 | 89 | | MAY FINE THE PERSON UP TO $10,000 FOR EACH DAY THE VIOLATION OCCURRED. 26 |
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90 | 90 | | |
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91 | 91 | | (2) THE AMOUNT OF THE FINE IMPOSED BY THE COMMISSION UNDER 27 |
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92 | 92 | | PARAGRAPH (1) OF THIS SUBSECTION SHALL BE BASED ON : 28 |
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93 | 93 | | SENATE BILL 987 3 |
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94 | 94 | | |
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95 | 95 | | |
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96 | 96 | | (I) THE EXTENT OF ACTUAL OR POTENTIAL HARM RELATED TO 1 |
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97 | 97 | | THE VIOLATION; 2 |
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98 | 98 | | |
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99 | 99 | | (II) THE COST OF INVESTIGA TING THE VIOLATION ; AND 3 |
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100 | 100 | | |
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101 | 101 | | (III) WHETHER THE PERSON CO MMITTED PREVIOUS 4 |
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102 | 102 | | VIOLATIONS OF THIS SECTION. 5 |
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103 | 103 | | |
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104 | 104 | | Article – Insurance 6 |
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105 | 105 | | |
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106 | 106 | | 15–147. 7 |
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107 | 107 | | |
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108 | 108 | | (A) (1) IN THIS SECTION THE FOLLOWING WORDS HAVE THE MEANINGS 8 |
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109 | 109 | | INDICATED. 9 |
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110 | 110 | | |
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111 | 111 | | (2) “ARTIFICIAL INTELLIGEN CE” HAS THE MEANING STAT ED IN § 10 |
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112 | 112 | | 3.5–801 OF THE STATE FINANCE AND PROCUREMENT ARTICLE. 11 |
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113 | 113 | | |
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114 | 114 | | (3) “CARRIER” MEANS: 12 |
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115 | 115 | | |
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116 | 116 | | (I) AN INSURER; 13 |
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117 | 117 | | |
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118 | 118 | | (II) A NONPROFIT HEALTH S ERVICE PLAN; 14 |
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119 | 119 | | |
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120 | 120 | | (III) A HEALTH MAINTENANCE ORGANIZATION ; 15 |
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121 | 121 | | |
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122 | 122 | | (IV) A DENTAL PLAN ORGANI ZATION; OR 16 |
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123 | 123 | | |
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124 | 124 | | (V) ANY OTHER PERSON THA T PROVIDES HEALTH BENEFIT 17 |
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125 | 125 | | PLANS SUBJECT TO REG ULATION BY THE STATE. 18 |
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126 | 126 | | |
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127 | 127 | | (B) A CARRIER MAY NOT USE ARTIF ICIAL INTELLIGENCE TO DECIDE OR 19 |
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128 | 128 | | DIRECTLY INFLUENCE A HEALTH CARE DECISION OR A DECISION DIRECTLY 20 |
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129 | 129 | | RELATED TO HEALTH CARE . 21 |
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130 | 130 | | |
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131 | 131 | | (C) THIS SECTION MAY NOT BE CONSTRUED TO PROH IBIT A CARRIER FROM 22 |
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132 | 132 | | USING ARTIFICIAL INT ELLIGENCE TO PERFORM TASKS OR MAKE DECISI ONS THAT 23 |
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133 | 133 | | ARE NOT RELATED TO HEALTH CARE . 24 |
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134 | 134 | | |
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135 | 135 | | Article – State Finance and Procurement 25 |
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136 | 136 | | |
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137 | 137 | | 3.5–801. 26 |
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138 | 138 | | |
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139 | 139 | | (a) In this subtitle the following words have the meanings indicated. 27 4 SENATE BILL 987 |
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140 | 140 | | |
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141 | 141 | | |
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142 | 142 | | |
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143 | 143 | | (c) “Artificial intelligence” means a machine–based system that: 1 |
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144 | 144 | | |
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145 | 145 | | (1) can, for a given set of human–defined objectives, make predictions, 2 |
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146 | 146 | | recommendations, or decisions influencing real or virtual environments; 3 |
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147 | 147 | | |
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148 | 148 | | (2) uses machine and human–based inputs to perceive real and virtual 4 |
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149 | 149 | | environments and abstracts those perceptions into models through analysis in an 5 |
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150 | 150 | | automated manner; and 6 |
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151 | 151 | | |
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152 | 152 | | (3) uses model inference to formulate options for information or action. 7 |
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153 | 153 | | |
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154 | 154 | | SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 8 |
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155 | 155 | | October 1, 2025. 9 |
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