1 | 1 | | 83R20242 YDB-F |
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2 | 2 | | By: Howard, Zerwas, Callegari H.B. No. 772 |
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3 | 3 | | Substitute the following for H.B. No. 772: |
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4 | 4 | | By: Collier C.S.H.B. No. 772 |
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5 | 5 | | |
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6 | 6 | | |
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7 | 7 | | A BILL TO BE ENTITLED |
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8 | 8 | | AN ACT |
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9 | 9 | | relating to the immunization data included in and excluded from the |
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10 | 10 | | immunization registry. |
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11 | 11 | | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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12 | 12 | | SECTION 1. Section 161.007, Health and Safety Code, is |
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13 | 13 | | amended by amending Subsections (a), (a-2), (b), (b-1), (c), (d), |
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14 | 14 | | and (e) and adding Subsections (e-1), (l), and (m) to read as |
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15 | 15 | | follows: |
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16 | 16 | | (a) The department, for the primary purpose of establishing |
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17 | 17 | | and maintaining a single repository of accurate, complete, and |
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18 | 18 | | current immunization records to be used in aiding, coordinating, |
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19 | 19 | | and promoting efficient and cost-effective communicable disease |
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20 | 20 | | prevention and control efforts, shall establish and maintain an |
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21 | 21 | | immunization registry. The executive commissioner of the Health |
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22 | 22 | | and Human Services Commission by rule shall develop guidelines to: |
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23 | 23 | | (1) protect the confidentiality of patients in |
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24 | 24 | | accordance with Section 159.002, Occupations Code; |
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25 | 25 | | (2) inform the individual or the individual's legally |
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26 | 26 | | authorized representative about the registry and that registry |
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27 | 27 | | information may be released under Section 161.00735; |
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28 | 28 | | (3) [require the written or electronic consent of the |
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29 | 29 | | individual or the individual's legally authorized representative |
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30 | 30 | | before any information relating to the individual is included in |
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31 | 31 | | the registry; |
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32 | 32 | | [(4)] permit the individual or the individual's |
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33 | 33 | | legally authorized representative to request that the individual's |
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34 | 34 | | information be removed from [withdraw consent for the individual to |
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35 | 35 | | be included in] the registry; |
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36 | 36 | | (4) provide opportunities for the individual or the |
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37 | 37 | | individual's legally authorized representative to request removal: |
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38 | 38 | | (A) at the time of the individual's birth if |
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39 | 39 | | attended by a health care provider who administers immunizations; |
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40 | 40 | | (B) at the time the individual receives any |
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41 | 41 | | immunization administered by a health care provider in this state; |
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42 | 42 | | (C) through electronic submission of a request |
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43 | 43 | | for removal using a request for removal procedure available on the |
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44 | 44 | | department's Internet website; |
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45 | 45 | | (D) through submission to the department of a |
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46 | 46 | | written request for removal; and |
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47 | 47 | | (E) following a natural or man-made disaster; and |
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48 | 48 | | (5) include on each immunization record generated by |
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49 | 49 | | the registry the procedures for requesting removal from the |
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50 | 50 | | registry [determine the process by which consent is verified, |
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51 | 51 | | including affirmation by a health care provider, birth registrar, |
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52 | 52 | | regional health information exchange, or local immunization |
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53 | 53 | | registry that consent has been obtained]. |
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54 | 54 | | (a-2) An individual's legally authorized representative or |
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55 | 55 | | the individual, after the individual has attained 18 years of age, |
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56 | 56 | | may submit a request [consent] in writing or electronically for the |
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57 | 57 | | individual's information to be removed from [remain in] the |
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58 | 58 | | registry [after the individual's 18th birthday and for the |
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59 | 59 | | individual's subsequent immunizations to be included in the |
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60 | 60 | | registry. The written or electronic consent of the minor's legally |
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61 | 61 | | authorized representative as described by Section 161.0001(1-c)(A) |
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62 | 62 | | must be submitted to the department before the individual's 18th |
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63 | 63 | | birthday. The written or electronic consent of the individual or |
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64 | 64 | | the individual's legally authorized representative as described by |
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65 | 65 | | Section 161.0001(1-c)(B) or (C) must be submitted to the department |
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66 | 66 | | not later than the individual's 19th birthday. The consent of the |
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67 | 67 | | representative or individual is valid until the individual or the |
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68 | 68 | | individual's legally authorized representative withdraws consent |
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69 | 69 | | in writing or electronically. The department may not include in the |
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70 | 70 | | registry the immunization information of an individual who is 18 |
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71 | 71 | | years of age or older until written or electronic consent has been |
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72 | 72 | | obtained as provided by this subsection]. The department shall |
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73 | 73 | | coordinate with the Texas Education Agency to distribute materials |
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74 | 74 | | described in Section 161.0095(a)(2) to students and parents through |
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75 | 75 | | local school districts. |
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76 | 76 | | (b) Except as provided by Section 161.0071, the |
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77 | 77 | | immunization registry must contain information on the immunization |
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78 | 78 | | history that is obtained by the department under: |
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79 | 79 | | (1) this section of each individual for whom |
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80 | 80 | | immunization information [consent] has been obtained, unless the |
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81 | 81 | | individual or the individual's legally authorized representative |
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82 | 82 | | has requested that the individual's information be removed from the |
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83 | 83 | | registry in accordance with guidelines adopted under Subsection (a) |
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84 | 84 | | [or (a-3), as applicable]; |
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85 | 85 | | (2) Section 161.00705 of persons immunized to prepare |
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86 | 86 | | for or in response to a declared disaster, public health emergency, |
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87 | 87 | | terrorist attack, hostile military or paramilitary action, or |
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88 | 88 | | extraordinary law enforcement emergency; |
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89 | 89 | | (3) Section 161.00706 of first responders or their |
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90 | 90 | | immediate family members; and |
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91 | 91 | | (4) Section 161.00735 of persons evacuated or |
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92 | 92 | | relocated to this state because of a disaster. |
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93 | 93 | | (b-1) The department shall remove from the registry |
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94 | 94 | | information for any individual for whom [consent has been |
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95 | 95 | | withdrawn. The department may not retain individually identifiable |
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96 | 96 | | information about any individual: |
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97 | 97 | | [(1) for whom consent has been withdrawn; |
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98 | 98 | | [(2) for whom a consent for continued inclusion in the |
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99 | 99 | | registry following the end of the declared disaster, public health |
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100 | 100 | | emergency, terrorist attack, hostile military or paramilitary |
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101 | 101 | | action, or extraordinary law enforcement emergency has not been |
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102 | 102 | | received under Section 161.00705(f); |
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103 | 103 | | [(3) for whom a request to be removed from the registry |
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104 | 104 | | has been received under Section 161.00706(e); |
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105 | 105 | | [(4) for whom consent for continued inclusion in the |
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106 | 106 | | registry following the end of a disaster has not been received under |
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107 | 107 | | Section 161.00735(f); or |
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108 | 108 | | [(5) for whom] a request to remove information from |
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109 | 109 | | the registry has been received under this subchapter [Section |
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110 | 110 | | 161.00735(g)]. |
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111 | 111 | | (c) A payor that receives data elements from a health care |
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112 | 112 | | provider who administers an immunization to an individual younger |
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113 | 113 | | than 18 years of age shall provide the data elements to the |
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114 | 114 | | department. A payor is required to provide the department with only |
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115 | 115 | | the data elements the payor receives from a health care provider. A |
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116 | 116 | | payor that receives data elements from a health care provider who |
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117 | 117 | | administers an immunization to an individual 18 years of age or |
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118 | 118 | | older may provide the data elements to the department. The data |
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119 | 119 | | elements shall be submitted in a format prescribed by the |
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120 | 120 | | department. [The department shall verify consent before including |
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121 | 121 | | the reported information in the immunization registry. The |
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122 | 122 | | department may not retain individually identifiable information |
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123 | 123 | | about an individual for whom consent cannot be verified.] |
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124 | 124 | | (d) A health care provider who administers an immunization |
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125 | 125 | | to an individual younger than 18 years of age shall provide data |
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126 | 126 | | elements regarding an immunization to the department. A health |
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127 | 127 | | care provider who administers an immunization to an individual 18 |
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128 | 128 | | years of age or older may submit data elements regarding an |
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129 | 129 | | immunization to the department. The data elements shall be |
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130 | 130 | | submitted in a format prescribed by the department. A health care |
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131 | 131 | | provider who administers an immunization to any individual and |
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132 | 132 | | provides data elements to the department shall notify the |
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133 | 133 | | individual or the individual's legally authorized representative: |
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134 | 134 | | (1) that the individual's immunization information |
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135 | 135 | | will be included in the registry unless removal from the registry is |
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136 | 136 | | requested in accordance with the guidelines adopted under |
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137 | 137 | | Subsection (a); and |
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138 | 138 | | (2) of the procedures for requesting removal from the |
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139 | 139 | | registry. [The department shall verify consent before including the |
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140 | 140 | | information in the immunization registry. The department may not |
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141 | 141 | | retain individually identifiable information about an individual |
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142 | 142 | | for whom consent cannot be verified.] |
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143 | 143 | | (e) The department shall: |
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144 | 144 | | (1) make available on the department's Internet |
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145 | 145 | | website a printable form that states an individual's immunization |
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146 | 146 | | information will be included in the registry unless removal from |
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147 | 147 | | the registry is requested and that details the procedures for |
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148 | 148 | | submitting an electronic or written request for removal from the |
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149 | 149 | | registry [provide notice to a health care provider that submits an |
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150 | 150 | | immunization history for an individual for whom consent cannot be |
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151 | 151 | | verified. The notice shall contain instructions for obtaining |
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152 | 152 | | consent] in accordance with guidelines adopted under Subsection |
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153 | 153 | | [Subsections] (a); and |
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154 | 154 | | (2) make the form described by Subdivision (1) |
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155 | 155 | | available for distribution to health care providers [and (a-3) and |
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156 | 156 | | resubmitting the immunization history to the department]. |
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157 | 157 | | (e-1) A health care provider may use the printable form |
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158 | 158 | | described by Subsection (e) to provide the notification required |
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159 | 159 | | under Subsection (d). |
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160 | 160 | | (l) Registry information may not be used to exclude any |
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161 | 161 | | individual from the receipt of any service during a natural or |
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162 | 162 | | man-made disaster unless the service is withheld because of a |
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163 | 163 | | medical contraindication. |
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164 | 164 | | (m) The department may not sell registry information to any |
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165 | 165 | | public or private entity. |
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166 | 166 | | SECTION 2. Section 161.00705(f), Health and Safety Code, is |
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167 | 167 | | amended to read as follows: |
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168 | 168 | | (f) Unless an individual or the individual's legally |
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169 | 169 | | authorized representative [consents] in writing or electronically |
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170 | 170 | | requests that [to continued inclusion of] the individual's |
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171 | 171 | | information be removed from [in] the registry, the department shall |
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172 | 172 | | include [remove] the immunization records collected under this |
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173 | 173 | | section in [from] the registry [on expiration of the period |
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174 | 174 | | prescribed under Subsection (e)]. |
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175 | 175 | | SECTION 3. Sections 161.0071(a) and (b), Health and Safety |
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176 | 176 | | Code, are amended to read as follows: |
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177 | 177 | | (a) The first time the department receives registry data for |
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178 | 178 | | an individual [for whom the department has received consent] to be |
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179 | 179 | | included in the registry, the department shall send notice to the |
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180 | 180 | | individual or the individual's legally authorized representative |
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181 | 181 | | disclosing: |
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182 | 182 | | (1) that providers and payors may be sending the |
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183 | 183 | | individual's immunization information to the department; |
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184 | 184 | | (2) the information that is included in the registry; |
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185 | 185 | | (3) the persons to whom the information may be |
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186 | 186 | | released under Sections 161.00735(b) and 161.008(d); |
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187 | 187 | | (4) the purpose and use of the registry; |
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188 | 188 | | (5) the procedure to exclude an individual from the |
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189 | 189 | | registry; and |
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190 | 190 | | (6) the procedure to report a violation if an |
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191 | 191 | | individual's information is included in the registry after |
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192 | 192 | | exclusion has been requested [or consent has been withdrawn]. |
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193 | 193 | | (b) The [On discovering that consent to be included in the |
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194 | 194 | | registry has not been granted or has been withdrawn, the] |
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195 | 195 | | department shall exclude [the individual's immunization records] |
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196 | 196 | | from the registry and any other registry-related department record |
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197 | 197 | | that individually identifies the individual the immunization |
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198 | 198 | | record of any individual from whom a request for exclusion has been |
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199 | 199 | | received by the department. |
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200 | 200 | | SECTION 4. Section 161.0073, Health and Safety Code, is |
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201 | 201 | | amended by amending Subsection (a) and adding Subsections (e), (f), |
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202 | 202 | | and (g) to read as follows: |
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203 | 203 | | (a) Except as provided by this section and Sections 161.007, |
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204 | 204 | | 161.00705, 161.00706, [and] 161.00735, and 161.008, information |
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205 | 205 | | that individually identifies an individual that is received by the |
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206 | 206 | | department for the immunization registry is confidential and may be |
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207 | 207 | | used by the department for registry purposes only. |
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208 | 208 | | (e) The department may use registry information for |
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209 | 209 | | internal public health research on approval of the department's |
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210 | 210 | | institutional review board. |
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211 | 211 | | (f) The department may release registry information for |
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212 | 212 | | external public health research if: |
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213 | 213 | | (1) the individual or the individual's legally |
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214 | 214 | | authorized representative submits a written authorization to the |
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215 | 215 | | department for release of the individual's registry data; |
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216 | 216 | | (2) the department does not disclose individually |
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217 | 217 | | identifiable information; or |
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218 | 218 | | (3) the department's institutional review board |
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219 | 219 | | approves the release of individually identifiable information |
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220 | 220 | | subject to Subsection (g). |
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221 | 221 | | (g) The department's institutional review board may not |
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222 | 222 | | approve the release of individually identifiable information for a |
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223 | 223 | | research proposal unless the proposal includes a provision |
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224 | 224 | | requiring the proposal's researchers to obtain informed consent |
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225 | 225 | | from each individual or the individual's legally authorized |
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226 | 226 | | representative before the department releases the individual's |
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227 | 227 | | registry data to the researchers. |
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228 | 228 | | SECTION 5. Sections 161.00735(c) and (h), Health and Safety |
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229 | 229 | | Code, are amended to read as follows: |
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230 | 230 | | (c) The department may receive immunization information |
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231 | 231 | | from a health authority of another state or from a local health |
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232 | 232 | | authority in another state if the department determines that |
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233 | 233 | | residents of that state have evacuated or relocated to this state in |
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234 | 234 | | response to a disaster. The department shall include information |
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235 | 235 | | received under this subsection in the registry. [Notwithstanding |
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236 | 236 | | Section 161.007, the department is not required to obtain written |
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237 | 237 | | consent for the inclusion in the registry of information received |
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238 | 238 | | under this subsection.] |
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239 | 239 | | (h) The executive commissioner of the Health and Human |
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240 | 240 | | Services Commission shall make every effort to enter into a |
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241 | 241 | | memorandum of agreement with each state to which residents of this |
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242 | 242 | | state are likely to evacuate in a disaster on: |
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243 | 243 | | (1) the release to and use by [of registry information |
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244 | 244 | | under this section to] the appropriate health authority or local |
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245 | 245 | | health authority of that state of registry information under this |
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246 | 246 | | section[, including the length of time the information may be |
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247 | 247 | | retained by that state]; and |
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248 | 248 | | (2) the receipt and use of information submitted by |
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249 | 249 | | the health authority or local health authority of that state for |
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250 | 250 | | inclusion in the registry under this section. |
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251 | 251 | | SECTION 6. Sections 161.008(c) and (e), Health and Safety |
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252 | 252 | | Code, are amended to read as follows: |
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253 | 253 | | (c) The department may obtain the data constituting an |
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254 | 254 | | immunization record for an individual from a public health |
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255 | 255 | | district, a local health department, the individual or the |
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256 | 256 | | individual's legally authorized representative, a physician to the |
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257 | 257 | | individual, a payor, or any health care provider licensed or |
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258 | 258 | | otherwise authorized to administer vaccines. [The department shall |
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259 | 259 | | verify consent before including the reported information in the |
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260 | 260 | | immunization registry. The department may not retain individually |
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261 | 261 | | identifiable information about an individual for whom consent |
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262 | 262 | | cannot be verified.] |
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263 | 263 | | (e) An individual or the individual's legally authorized |
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264 | 264 | | representative may obtain and on request to the department shall be |
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265 | 265 | | provided with all individually identifiable immunization registry |
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266 | 266 | | information concerning the individual and information on the |
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267 | 267 | | procedure for requesting removal from the registry. |
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268 | 268 | | SECTION 7. Section 161.0095(a), Health and Safety Code, is |
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269 | 269 | | amended to read as follows: |
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270 | 270 | | (a) The department shall develop: |
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271 | 271 | | (1) continuing education programs for health care |
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272 | 272 | | providers relating to immunizations and the vaccines for children |
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273 | 273 | | program operated by the department under authority of 42 U.S.C. |
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274 | 274 | | Section 1396s; and |
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275 | 275 | | (2) educational information, for health care |
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276 | 276 | | providers, health care clinics, hospitals, and any other health |
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277 | 277 | | care facility that provides health care to children 14 to 18 years |
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278 | 278 | | of age, relating to the immunization registry and the option for an |
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279 | 279 | | individual or the individual's legally authorized representative |
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280 | 280 | | to request removal [who is 18 years of age or older to consent to |
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281 | 281 | | submission and retention] of the individual's information from [in] |
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282 | 282 | | the immunization registry. |
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283 | 283 | | SECTION 8. Section 161.0107(c), Health and Safety Code, is |
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284 | 284 | | amended to read as follows: |
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285 | 285 | | (c) The executive commissioner of the Health and Human |
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286 | 286 | | Services Commission by rule shall specify: |
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287 | 287 | | (1) the fields necessary to populate the immunization |
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288 | 288 | | registry[, including a field that indicates the patient's consent |
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289 | 289 | | to be listed in the immunization registry has been obtained]; and |
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290 | 290 | | (2) the data standards that must be used for |
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291 | 291 | | electronic submission of immunization information. |
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292 | 292 | | SECTION 9. The following provisions of the Health and |
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293 | 293 | | Safety Code are repealed: |
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294 | 294 | | (1) Sections 161.007(a-1) and (a-3); |
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295 | 295 | | (2) Sections 161.00705(e) and (h); and |
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296 | 296 | | (3) Sections 161.00735(e) and (f). |
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297 | 297 | | SECTION 10. The changes in law made by this Act to |
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298 | 298 | | Subchapter A, Chapter 161, Health and Safety Code, apply to |
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299 | 299 | | immunization information received by the Department of State Health |
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300 | 300 | | Services before, on, or after January 1, 2015. An individual whose |
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301 | 301 | | immunization information was included immediately before January |
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302 | 302 | | 1, 2015, in the immunization registry established under Subchapter |
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303 | 303 | | A, Chapter 161, Health and Safety Code, is subject to the changes in |
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304 | 304 | | law made by this Act to that subchapter, including the procedures |
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305 | 305 | | established by that subchapter as amended by this Act. |
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306 | 306 | | SECTION 11. As soon as practicable after the effective date |
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307 | 307 | | of this Act, the Department of State Health Services shall conduct a |
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308 | 308 | | public awareness campaign to educate health care providers, |
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309 | 309 | | parents, payors, schools, and the public about the changes in law |
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310 | 310 | | made by this Act. |
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311 | 311 | | SECTION 12. (a) Except as provided by Subsection (b) of this |
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312 | 312 | | section, this Act takes effect January 1, 2015. |
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313 | 313 | | (b) Section 11 of this Act takes effect September 1, 2013. |
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