1 | 1 | | II |
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2 | 2 | | 118THCONGRESS |
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3 | 3 | | 1 |
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4 | 4 | | STSESSION S. 323 |
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5 | 5 | | To ensure the privacy of pregnancy termination or loss information under |
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6 | 6 | | the HIPAA privacy regulations and the HITECH Act. |
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7 | 7 | | IN THE SENATE OF THE UNITED STATES |
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8 | 8 | | FEBRUARY9, 2023 |
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9 | 9 | | Ms. H |
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10 | 10 | | IRONO(for herself, Mr. BENNET, Mrs. GILLIBRAND, Ms. WARREN, Mr. |
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11 | 11 | | W |
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12 | 12 | | YDEN, Mr. BROWN, Mrs. FEINSTEIN, Ms. CORTEZMASTO, Ms. |
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13 | 13 | | D |
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14 | 14 | | UCKWORTH, Mrs. MURRAY, and Mr. BOOKER) introduced the following |
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15 | 15 | | bill; which was read twice and referred to the Committee on Health, Edu- |
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16 | 16 | | cation, Labor, and Pensions |
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17 | 17 | | A BILL |
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18 | 18 | | To ensure the privacy of pregnancy termination or loss infor- |
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19 | 19 | | mation under the HIPAA privacy regulations and the |
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20 | 20 | | HITECH Act. |
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21 | 21 | | Be it enacted by the Senate and House of Representa-1 |
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22 | 22 | | tives of the United States of America in Congress assembled, 2 |
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23 | 23 | | SECTION 1. SHORT TITLE. 3 |
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24 | 24 | | This Act may be cited as the ‘‘Secure Access for Es-4 |
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25 | 25 | | sential Reproductive Health Act of 2023’’ or the ‘‘SAFER 5 |
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26 | 26 | | Health Act of 2023’’. 6 |
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29 | 29 | | •S 323 IS |
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30 | 30 | | SEC. 2. ENSURING THE PRIVACY OF PREGNANCY TERMI-1 |
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31 | 31 | | NATION OR LOSS INFORMATION UNDER THE 2 |
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32 | 32 | | HIPAA PRIVACY REGULATIONS AND THE 3 |
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33 | 33 | | HITECH ACT. 4 |
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34 | 34 | | (a) I |
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35 | 35 | | NGENERAL.— 5 |
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36 | 36 | | (1) P |
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37 | 37 | | ROHIBITION ON DISCLOSURE .—Subject to 6 |
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38 | 38 | | paragraph (2) and notwithstanding any regulations 7 |
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39 | 39 | | promulgated pursuant to section 264(c) of the 8 |
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40 | 40 | | Health Insurance Portability and Accountability Act 9 |
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41 | 41 | | of 1996 (42 U.S.C. 1320d–2 note; Public Law 104– 10 |
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42 | 42 | | 191), a covered entity or a business associate of a 11 |
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43 | 43 | | covered entity may not disclose pregnancy termi-12 |
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44 | 44 | | nation or loss information of an individual in Fed-13 |
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45 | 45 | | eral, State, local, or Tribal proceedings, including 14 |
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46 | 46 | | civil, criminal, administrative, legislative, or other 15 |
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47 | 47 | | proceedings, without the valid authorization of the 16 |
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48 | 48 | | individual made in accordance with section 164.508 17 |
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49 | 49 | | of title 45, Code of Federal Regulations (or a suc-18 |
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50 | 50 | | cessor regulation). 19 |
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51 | 51 | | (2) E |
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52 | 52 | | XCEPTIONS.—Paragraph (1) shall not 20 |
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53 | 53 | | apply in the case of a disclosure of pregnancy termi-21 |
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54 | 54 | | nation or loss information of an individual by a cov-22 |
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55 | 55 | | ered entity or a business associate of a covered enti-23 |
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56 | 56 | | ty if— 24 |
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57 | 57 | | (A) the pregnancy termination or loss in-25 |
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58 | 58 | | formation is necessary for use in defense of a 26 |
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61 | 61 | | •S 323 IS |
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62 | 62 | | professional liability action or proceeding 1 |
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63 | 63 | | against the covered entity or business associate 2 |
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64 | 64 | | and the pregnancy termination or loss informa-3 |
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65 | 65 | | tion is disclosed by— 4 |
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66 | 66 | | (i) the covered entity or business asso-5 |
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67 | 67 | | ciate to the covered entity’s or business as-6 |
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68 | 68 | | sociate’s attorney or professional liability 7 |
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69 | 69 | | insurer or insurer’s agent; or 8 |
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70 | 70 | | (ii) the authorized attorney of the cov-9 |
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71 | 71 | | ered entity or business associate to a court 10 |
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72 | 72 | | or body hearing the action or proceeding; 11 |
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73 | 73 | | or 12 |
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74 | 74 | | (B)(i) the pregnancy termination or loss 13 |
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75 | 75 | | information is necessary to investigate physical 14 |
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76 | 76 | | harm to the individual by another person di-15 |
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77 | 77 | | rectly relating to the loss or termination of the 16 |
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78 | 78 | | pregnancy; and 17 |
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79 | 79 | | (ii) the individual is unable to provide con-18 |
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80 | 80 | | sent due to death or incapacity. 19 |
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81 | 81 | | (b) HITECH.— 20 |
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82 | 82 | | (1) P |
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83 | 83 | | RIVACY EXCEPTION.—The Secretary shall 21 |
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84 | 84 | | revise section 171.202 of title 45, Code of Federal 22 |
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85 | 85 | | Regulations, to clarify that an entity’s practice of 23 |
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86 | 86 | | not fulfilling a request to access, exchange, or use 24 |
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87 | 87 | | electronic health information in order to comply with 25 |
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90 | 90 | | •S 323 IS |
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91 | 91 | | subsection (a) shall not be considered information 1 |
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92 | 92 | | blocking (as defined in section 171.103 of title 45, 2 |
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93 | 93 | | Code of Federal Regulations (or a successor regula-3 |
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94 | 94 | | tion)) if the information is pregnancy termination or 4 |
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95 | 95 | | loss information. 5 |
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96 | 96 | | (2) G |
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97 | 97 | | REATER SECURITY.—The Secretary shall 6 |
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98 | 98 | | revise section 170.401 of title 45, Code of Federal 7 |
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99 | 99 | | Regulations, to require that as a condition of certifi-8 |
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100 | 100 | | cation (as described in that section), a health IT de-9 |
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101 | 101 | | veloper (as so described) shall implement practices 10 |
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102 | 102 | | that allow for the segregation of data relating to 11 |
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103 | 103 | | pregnancy termination or loss information to ensure 12 |
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104 | 104 | | compliance with subsection (a). 13 |
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105 | 105 | | (c) P |
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106 | 106 | | REEMPTION; MODIFICATION OF STATEPRE-14 |
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107 | 107 | | EMPTIONEXCEPTIONS.— 15 |
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108 | 108 | | (1) P |
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109 | 109 | | REEMPTION.— 16 |
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110 | 110 | | (A) I |
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111 | 111 | | N GENERAL.—This section shall pre-17 |
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112 | 112 | | empt any State law to the extent that the State 18 |
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113 | 113 | | law conflicts with or prevents application of this 19 |
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114 | 114 | | section. 20 |
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115 | 115 | | (B) E |
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116 | 116 | | FFECT.—Nothing in subparagraph 21 |
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117 | 117 | | (A) shall be construed to preempt a State law 22 |
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118 | 118 | | to the extent that the State law provides great-23 |
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119 | 119 | | er privacy protections for pregnancy termi-24 |
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122 | 122 | | •S 323 IS |
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123 | 123 | | nation or loss information than provided under 1 |
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124 | 124 | | this section. 2 |
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125 | 125 | | (2) M |
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126 | 126 | | ODIFICATION.—The Secretary shall revise 3 |
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127 | 127 | | section 160.203 of title 45, Code of Federal Regula-4 |
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128 | 128 | | tions, to ensure that no exception to the general pre-5 |
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129 | 129 | | emption rule stated in that section applies with re-6 |
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130 | 130 | | spect to pregnancy termination or loss information 7 |
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131 | 131 | | other than the exception described in paragraph 8 |
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132 | 132 | | (1)(B). 9 |
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133 | 133 | | (d) O |
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134 | 134 | | UTREACH.—The Secretary shall conduct an out-10 |
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135 | 135 | | reach campaign to ensure that covered entities, business 11 |
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136 | 136 | | associates of covered entities, the public, and affected indi-12 |
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137 | 137 | | viduals are aware of the requirements of this section and 13 |
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138 | 138 | | any revisions to regulations made pursuant to this section. 14 |
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139 | 139 | | (e) P |
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140 | 140 | | ROCEDURE.— 15 |
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141 | 141 | | (1) I |
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142 | 142 | | NTERIM FINAL RULE .—Not later than 90 16 |
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143 | 143 | | days after the date of enactment of this Act, the 17 |
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144 | 144 | | Secretary shall revise each regulation as required by 18 |
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145 | 145 | | this section through publication of an interim final 19 |
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146 | 146 | | rule in the Federal Register. 20 |
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147 | 147 | | (2) F |
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148 | 148 | | INAL RULE.—Not later than 270 days 21 |
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149 | 149 | | after the date on which an interim final rule is pub-22 |
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150 | 150 | | lished under paragraph (1), the Secretary, after pro-23 |
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151 | 151 | | viding opportunity for public comment, shall publish 24 |
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154 | 154 | | •S 323 IS |
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155 | 155 | | in the Federal Register a final rule with such modi-1 |
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156 | 156 | | fications as the Secretary determines appropriate. 2 |
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157 | 157 | | (f) D |
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158 | 158 | | EFINITIONS.—In this section: 3 |
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159 | 159 | | (1) HIPAA |
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160 | 160 | | TERMS.—The terms ‘‘business asso-4 |
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161 | 161 | | ciate’’, ‘‘covered entity’’, and ‘‘protected health infor-5 |
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162 | 162 | | mation’’ have the meanings given those terms in sec-6 |
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163 | 163 | | tion 160.103 of title 45, Code of Federal Regula-7 |
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164 | 164 | | tions (or a successor regulation). 8 |
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165 | 165 | | (2) P |
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166 | 166 | | REGNANCY TERMINATION OR LOSS INFOR -9 |
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167 | 167 | | MATION.—The term ‘‘pregnancy termination or loss 10 |
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168 | 168 | | information’’ means protected health information of 11 |
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169 | 169 | | an individual that relates to information that could 12 |
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170 | 170 | | reveal having or seeking an abortion or care for 13 |
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171 | 171 | | pregnancy loss, including, without limitation, any re-14 |
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172 | 172 | | quest for, or receipt of, items, services, education, 15 |
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173 | 173 | | counseling, or referrals relating to the termination 16 |
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174 | 174 | | or loss of a pregnancy of the individual, including 17 |
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175 | 175 | | abortion, miscarriage, stillbirth, and ectopic preg-18 |
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176 | 176 | | nancy. 19 |
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177 | 177 | | (3) S |
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178 | 178 | | ECRETARY.—The term ‘‘Secretary’’ means 20 |
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179 | 179 | | the Secretary of Health and Human Services. 21 |
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180 | 180 | | Æ |
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