| 1 | 1 | | 84R1792 LED-F |
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| 2 | 2 | | By: Howard H.B. No. 465 |
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| 3 | 3 | | |
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| 4 | 4 | | |
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| 5 | 5 | | A BILL TO BE ENTITLED |
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| 6 | 6 | | AN ACT |
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| 7 | 7 | | relating to the immunization data included in and excluded from the |
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| 8 | 8 | | immunization registry. |
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| 9 | 9 | | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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| 10 | 10 | | SECTION 1. Section 161.007, Health and Safety Code, is |
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| 11 | 11 | | amended by amending Subsections (a), (a-2), (b), (b-1), (c), (d), |
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| 12 | 12 | | and (e) and adding Subsections (e-1), (l), and (m) to read as |
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| 13 | 13 | | follows: |
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| 14 | 14 | | (a) The department, for the primary purpose of establishing |
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| 15 | 15 | | and maintaining a single repository of accurate, complete, and |
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| 16 | 16 | | current immunization records to be used in aiding, coordinating, |
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| 17 | 17 | | and promoting efficient and cost-effective communicable disease |
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| 18 | 18 | | prevention and control efforts, shall establish and maintain an |
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| 19 | 19 | | immunization registry. The executive commissioner of the Health |
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| 20 | 20 | | and Human Services Commission by rule shall develop guidelines to: |
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| 21 | 21 | | (1) protect the confidentiality of patients in |
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| 22 | 22 | | accordance with Section 159.002, Occupations Code; |
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| 23 | 23 | | (2) inform the individual or the individual's legally |
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| 24 | 24 | | authorized representative about the registry and that registry |
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| 25 | 25 | | information may be released under Section 161.00735; |
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| 26 | 26 | | (3) [require the written or electronic consent of the |
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| 27 | 27 | | individual or the individual's legally authorized representative |
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| 28 | 28 | | before any information relating to the individual is included in |
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| 29 | 29 | | the registry; |
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| 30 | 30 | | [(4)] permit the individual or the individual's |
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| 31 | 31 | | legally authorized representative to request that the individual's |
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| 32 | 32 | | information be removed from [withdraw consent for the individual to |
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| 33 | 33 | | be included in] the registry; |
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| 34 | 34 | | (4) provide opportunities for the individual or the |
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| 35 | 35 | | individual's legally authorized representative to request removal |
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| 36 | 36 | | at any time, including: |
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| 37 | 37 | | (A) at the time of the individual's birth if |
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| 38 | 38 | | attended by a health care provider who administers immunizations; |
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| 39 | 39 | | (B) each time the individual receives any |
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| 40 | 40 | | immunization administered by a health care provider in this state; |
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| 41 | 41 | | (C) through electronic submission of a request |
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| 42 | 42 | | for removal using a request for removal procedure available on the |
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| 43 | 43 | | department's Internet website; |
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| 44 | 44 | | (D) through submission to the department of a |
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| 45 | 45 | | written request for removal; and |
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| 46 | 46 | | (E) following a natural or man-made disaster; |
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| 47 | 47 | | [and] |
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| 48 | 48 | | (5) ensure that an individual or the individual's |
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| 49 | 49 | | legally authorized representative is not required to request |
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| 50 | 50 | | removal from the registry more than one time and that, after a |
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| 51 | 51 | | request for removal is made, the individual's immunization |
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| 52 | 52 | | information will not be included in the registry unless the |
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| 53 | 53 | | individual or the individual's legally authorized representative |
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| 54 | 54 | | submits to the department a written request for inclusion of the |
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| 55 | 55 | | individual's information in the registry; and |
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| 56 | 56 | | (6) include on each immunization record generated by |
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| 57 | 57 | | the registry the procedures for requesting removal from the |
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| 58 | 58 | | registry [determine the process by which consent is verified, |
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| 59 | 59 | | including affirmation by a health care provider, birth registrar, |
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| 60 | 60 | | regional health information exchange, or local immunization |
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| 61 | 61 | | registry that consent has been obtained]. |
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| 62 | 62 | | (a-2) An individual's legally authorized representative or |
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| 63 | 63 | | the individual, after the individual has attained 18 years of age, |
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| 64 | 64 | | may submit a request [consent] in writing or electronically for the |
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| 65 | 65 | | individual's information to be removed from [remain in] the |
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| 66 | 66 | | registry [after the individual's 18th birthday and for the |
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| 67 | 67 | | individual's subsequent immunizations to be included in the |
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| 68 | 68 | | registry. The written or electronic consent of the minor's legally |
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| 69 | 69 | | authorized representative as described by Section 161.0001(1-c)(A) |
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| 70 | 70 | | must be submitted to the department before the individual's 18th |
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| 71 | 71 | | birthday. The written or electronic consent of the individual or |
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| 72 | 72 | | the individual's legally authorized representative as described by |
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| 73 | 73 | | Section 161.0001(1-c)(B) or (C) must be submitted to the department |
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| 74 | 74 | | not later than the individual's 19th birthday. The consent of the |
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| 75 | 75 | | representative or individual is valid until the individual or the |
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| 76 | 76 | | individual's legally authorized representative withdraws consent |
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| 77 | 77 | | in writing or electronically. The department may not include in the |
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| 78 | 78 | | registry the immunization information of an individual who is 18 |
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| 79 | 79 | | years of age or older until written or electronic consent has been |
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| 80 | 80 | | obtained as provided by this subsection]. The department shall |
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| 81 | 81 | | coordinate with the Texas Education Agency to distribute materials |
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| 82 | 82 | | described in Section 161.0095(a)(2) to students and parents through |
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| 83 | 83 | | local school districts. |
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| 84 | 84 | | (b) Except as provided by Section 161.0071, the |
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| 85 | 85 | | immunization registry must contain information on the immunization |
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| 86 | 86 | | history that is obtained by the department under: |
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| 87 | 87 | | (1) this section of each individual for whom |
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| 88 | 88 | | immunization information [consent] has been obtained, unless the |
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| 89 | 89 | | individual or the individual's legally authorized representative |
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| 90 | 90 | | has requested that the individual's information be removed from the |
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| 91 | 91 | | registry in accordance with guidelines adopted under Subsection (a) |
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| 92 | 92 | | [or (a-3), as applicable]; |
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| 93 | 93 | | (2) Section 161.00705 of persons immunized to prepare |
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| 94 | 94 | | for or in response to a declared disaster, public health emergency, |
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| 95 | 95 | | terrorist attack, hostile military or paramilitary action, or |
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| 96 | 96 | | extraordinary law enforcement emergency; |
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| 97 | 97 | | (3) Section 161.00706 of first responders or their |
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| 98 | 98 | | immediate family members; and |
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| 99 | 99 | | (4) Section 161.00735 of persons evacuated or |
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| 100 | 100 | | relocated to this state because of a disaster. |
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| 101 | 101 | | (b-1) The department shall remove from the registry |
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| 102 | 102 | | information for any individual for whom [consent has been |
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| 103 | 103 | | withdrawn. The department may not retain individually identifiable |
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| 104 | 104 | | information about any individual: |
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| 105 | 105 | | [(1) for whom consent has been withdrawn; |
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| 106 | 106 | | [(2) for whom a consent for continued inclusion in the |
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| 107 | 107 | | registry following the end of the declared disaster, public health |
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| 108 | 108 | | emergency, terrorist attack, hostile military or paramilitary |
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| 109 | 109 | | action, or extraordinary law enforcement emergency has not been |
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| 110 | 110 | | received under Section 161.00705(f); |
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| 111 | 111 | | [(3) for whom a request to be removed from the registry |
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| 112 | 112 | | has been received under Section 161.00706(e); |
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| 113 | 113 | | [(4) for whom consent for continued inclusion in the |
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| 114 | 114 | | registry following the end of a disaster has not been received under |
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| 115 | 115 | | Section 161.00735(f); or |
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| 116 | 116 | | [(5) for whom] a request to remove information from |
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| 117 | 117 | | the registry has been received under this subchapter [Section |
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| 118 | 118 | | 161.00735(g)]. |
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| 119 | 119 | | (c) A payor that receives data elements from a health care |
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| 120 | 120 | | provider who administers an immunization to an individual younger |
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| 121 | 121 | | than 18 years of age shall provide the data elements to the |
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| 122 | 122 | | department. A payor is required to provide the department with only |
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| 123 | 123 | | the data elements the payor receives from a health care provider. A |
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| 124 | 124 | | payor that receives data elements from a health care provider who |
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| 125 | 125 | | administers an immunization to an individual 18 years of age or |
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| 126 | 126 | | older may provide the data elements to the department. The data |
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| 127 | 127 | | elements shall be submitted in a format prescribed by the |
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| 128 | 128 | | department. [The department shall verify consent before including |
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| 129 | 129 | | the reported information in the immunization registry. The |
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| 130 | 130 | | department may not retain individually identifiable information |
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| 131 | 131 | | about an individual for whom consent cannot be verified.] |
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| 132 | 132 | | (d) A health care provider who administers an immunization |
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| 133 | 133 | | to an individual younger than 18 years of age shall provide data |
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| 134 | 134 | | elements regarding an immunization to the department. A health |
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| 135 | 135 | | care provider who administers an immunization to an individual 18 |
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| 136 | 136 | | years of age or older may submit data elements regarding an |
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| 137 | 137 | | immunization to the department. The data elements shall be |
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| 138 | 138 | | submitted in a format prescribed by the department. A health care |
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| 139 | 139 | | provider who administers an immunization to any individual and |
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| 140 | 140 | | provides data elements to the department shall notify the |
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| 141 | 141 | | individual or the individual's legally authorized representative: |
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| 142 | 142 | | (1) that the individual's immunization information |
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| 143 | 143 | | will be included in the registry unless removal from the registry is |
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| 144 | 144 | | requested in accordance with the guidelines adopted under |
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| 145 | 145 | | Subsection (a); and |
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| 146 | 146 | | (2) of the procedures for requesting removal from the |
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| 147 | 147 | | registry. [The department shall verify consent before including the |
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| 148 | 148 | | information in the immunization registry. The department may not |
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| 149 | 149 | | retain individually identifiable information about an individual |
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| 150 | 150 | | for whom consent cannot be verified.] |
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| 151 | 151 | | (e) The department shall: |
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| 152 | 152 | | (1) make available on the department's Internet |
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| 153 | 153 | | website a printable form that states an individual's immunization |
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| 154 | 154 | | information will be included in the registry unless removal from |
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| 155 | 155 | | the registry is requested and that details the procedures for |
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| 156 | 156 | | submitting an electronic or written request for removal from the |
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| 157 | 157 | | registry [provide notice to a health care provider that submits an |
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| 158 | 158 | | immunization history for an individual for whom consent cannot be |
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| 159 | 159 | | verified. The notice shall contain instructions for obtaining |
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| 160 | 160 | | consent] in accordance with guidelines adopted under Subsection |
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| 161 | 161 | | [Subsections] (a); and |
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| 162 | 162 | | (2) make the form described by Subdivision (1) |
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| 163 | 163 | | available for distribution to health care providers [and (a-3) and |
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| 164 | 164 | | resubmitting the immunization history to the department]. |
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| 165 | 165 | | (e-1) A health care provider may use the printable form |
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| 166 | 166 | | described by Subsection (e) to provide the notification required |
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| 167 | 167 | | under Subsection (d). |
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| 168 | 168 | | (l) Registry information may not be used to exclude any |
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| 169 | 169 | | individual from the receipt of any service during a natural or |
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| 170 | 170 | | man-made disaster unless the service is withheld because of a |
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| 171 | 171 | | medical contraindication. |
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| 172 | 172 | | (m) The department may not sell registry information to any |
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| 173 | 173 | | public or private entity. |
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| 174 | 174 | | SECTION 2. Section 161.00705(f), Health and Safety Code, is |
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| 175 | 175 | | amended to read as follows: |
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| 176 | 176 | | (f) Unless an individual or the individual's legally |
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| 177 | 177 | | authorized representative [consents] in writing or electronically |
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| 178 | 178 | | requests that [to continued inclusion of] the individual's |
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| 179 | 179 | | information be removed from [in] the registry, the department shall |
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| 180 | 180 | | include [remove] the immunization records collected under this |
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| 181 | 181 | | section in [from] the registry [on expiration of the period |
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| 182 | 182 | | prescribed under Subsection (e)]. |
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| 183 | 183 | | SECTION 3. Sections 161.0071(a) and (b), Health and Safety |
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| 184 | 184 | | Code, are amended to read as follows: |
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| 185 | 185 | | (a) The first time the department receives registry data for |
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| 186 | 186 | | an individual [for whom the department has received consent] to be |
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| 187 | 187 | | included in the registry, the department shall send notice to the |
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| 188 | 188 | | individual or the individual's legally authorized representative |
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| 189 | 189 | | disclosing: |
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| 190 | 190 | | (1) that providers and payors may be sending the |
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| 191 | 191 | | individual's immunization information to the department; |
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| 192 | 192 | | (2) the information that is included in the registry; |
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| 193 | 193 | | (3) the persons to whom the information may be |
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| 194 | 194 | | released under Sections 161.00735(b) and 161.008(d); |
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| 195 | 195 | | (4) the purpose and use of the registry; |
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| 196 | 196 | | (5) the procedure to exclude an individual from the |
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| 197 | 197 | | registry; and |
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| 198 | 198 | | (6) the procedure to report a violation if an |
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| 199 | 199 | | individual's information is included in the registry after |
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| 200 | 200 | | exclusion has been requested [or consent has been withdrawn]. |
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| 201 | 201 | | (b) The [On discovering that consent to be included in the |
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| 202 | 202 | | registry has not been granted or has been withdrawn, the] |
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| 203 | 203 | | department shall exclude [the individual's immunization records] |
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| 204 | 204 | | from the registry and any other registry-related department record |
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| 205 | 205 | | that individually identifies the individual the immunization |
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| 206 | 206 | | record of any individual from whom a request for exclusion has been |
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| 207 | 207 | | received by the department. |
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| 208 | 208 | | SECTION 4. Section 161.0073, Health and Safety Code, is |
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| 209 | 209 | | amended by amending Subsection (a) and adding Subsections (e), (f), |
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| 210 | 210 | | and (g) to read as follows: |
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| 211 | 211 | | (a) Except as provided by this section and Sections 161.007, |
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| 212 | 212 | | 161.00705, 161.00706, [and] 161.00735, and 161.008, information |
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| 213 | 213 | | that individually identifies an individual that is received by the |
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| 214 | 214 | | department for the immunization registry is confidential and may be |
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| 215 | 215 | | used by the department for registry purposes only. |
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| 216 | 216 | | (e) The department may use registry information for |
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| 217 | 217 | | internal public health research on approval of the department's |
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| 218 | 218 | | institutional review board. |
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| 219 | 219 | | (f) The department may release registry information for |
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| 220 | 220 | | external public health research if: |
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| 221 | 221 | | (1) the individual or the individual's legally |
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| 222 | 222 | | authorized representative submits a written authorization to the |
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| 223 | 223 | | department for release of the individual's registry data; |
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| 224 | 224 | | (2) the department does not disclose individually |
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| 225 | 225 | | identifiable information; or |
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| 226 | 226 | | (3) the department's institutional review board |
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| 227 | 227 | | approves the release of individually identifiable information |
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| 228 | 228 | | subject to Subsection (g). |
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| 229 | 229 | | (g) The department's institutional review board may not |
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| 230 | 230 | | approve the release of individually identifiable information for a |
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| 231 | 231 | | research proposal unless the proposal includes a provision |
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| 232 | 232 | | requiring the proposal's researchers to obtain informed consent |
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| 233 | 233 | | from each individual or the individual's legally authorized |
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| 234 | 234 | | representative before the department releases the individual's |
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| 235 | 235 | | registry data to the researchers. |
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| 236 | 236 | | SECTION 5. Sections 161.00735(c) and (h), Health and Safety |
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| 237 | 237 | | Code, are amended to read as follows: |
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| 238 | 238 | | (c) The department may receive immunization information |
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| 239 | 239 | | from a health authority of another state or from a local health |
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| 240 | 240 | | authority in another state if the department determines that |
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| 241 | 241 | | residents of that state have evacuated or relocated to this state in |
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| 242 | 242 | | response to a disaster. The department shall include information |
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| 243 | 243 | | received under this subsection in the registry. [Notwithstanding |
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| 244 | 244 | | Section 161.007, the department is not required to obtain written |
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| 245 | 245 | | consent for the inclusion in the registry of information received |
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| 246 | 246 | | under this subsection.] |
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| 247 | 247 | | (h) The executive commissioner of the Health and Human |
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| 248 | 248 | | Services Commission shall make every effort to enter into a |
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| 249 | 249 | | memorandum of agreement with each state to which residents of this |
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| 250 | 250 | | state are likely to evacuate in a disaster on: |
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| 251 | 251 | | (1) the release to and use by [of registry information |
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| 252 | 252 | | under this section to] the appropriate health authority or local |
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| 253 | 253 | | health authority of that state of registry information under this |
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| 254 | 254 | | section[, including the length of time the information may be |
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| 255 | 255 | | retained by that state]; and |
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| 256 | 256 | | (2) the receipt and use of information submitted by |
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| 257 | 257 | | the health authority or local health authority of that state for |
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| 258 | 258 | | inclusion in the registry under this section. |
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| 259 | 259 | | SECTION 6. Sections 161.008(c) and (e), Health and Safety |
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| 260 | 260 | | Code, are amended to read as follows: |
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| 261 | 261 | | (c) The department may obtain the data constituting an |
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| 262 | 262 | | immunization record for an individual from a public health |
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| 263 | 263 | | district, a local health department, the individual or the |
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| 264 | 264 | | individual's legally authorized representative, a physician to the |
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| 265 | 265 | | individual, a payor, or any health care provider licensed or |
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| 266 | 266 | | otherwise authorized to administer vaccines. [The department shall |
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| 267 | 267 | | verify consent before including the reported information in the |
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| 268 | 268 | | immunization registry. The department may not retain individually |
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| 269 | 269 | | identifiable information about an individual for whom consent |
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| 270 | 270 | | cannot be verified.] |
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| 271 | 271 | | (e) An individual or the individual's legally authorized |
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| 272 | 272 | | representative may obtain and on request to the department shall be |
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| 273 | 273 | | provided with all individually identifiable immunization registry |
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| 274 | 274 | | information concerning the individual and information on the |
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| 275 | 275 | | procedure for requesting removal from the registry. |
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| 276 | 276 | | SECTION 7. Section 161.0095(a), Health and Safety Code, is |
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| 277 | 277 | | amended to read as follows: |
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| 278 | 278 | | (a) The department shall develop: |
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| 279 | 279 | | (1) continuing education programs for health care |
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| 280 | 280 | | providers relating to immunizations and the vaccines for children |
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| 281 | 281 | | program operated by the department under authority of 42 U.S.C. |
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| 282 | 282 | | Section 1396s; and |
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| 283 | 283 | | (2) educational information, for health care |
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| 284 | 284 | | providers, health care clinics, hospitals, and any other health |
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| 285 | 285 | | care facility that provides health care to children 14 to 18 years |
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| 286 | 286 | | of age, relating to the immunization registry and the option for an |
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| 287 | 287 | | individual or the individual's legally authorized representative |
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| 288 | 288 | | to request removal [who is 18 years of age or older to consent to |
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| 289 | 289 | | submission and retention] of the individual's information from [in] |
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| 290 | 290 | | the immunization registry. |
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| 291 | 291 | | SECTION 8. Section 161.0107(c), Health and Safety Code, is |
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| 292 | 292 | | amended to read as follows: |
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| 293 | 293 | | (c) The executive commissioner of the Health and Human |
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| 294 | 294 | | Services Commission by rule shall specify: |
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| 295 | 295 | | (1) the fields necessary to populate the immunization |
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| 296 | 296 | | registry[, including a field that indicates the patient's consent |
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| 297 | 297 | | to be listed in the immunization registry has been obtained]; and |
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| 298 | 298 | | (2) the data standards that must be used for |
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| 299 | 299 | | electronic submission of immunization information. |
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| 300 | 300 | | SECTION 9. The following provisions of the Health and |
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| 301 | 301 | | Safety Code are repealed: |
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| 302 | 302 | | (1) Sections 161.007(a-1) and (a-3); |
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| 303 | 303 | | (2) Sections 161.00705(e) and (h); and |
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| 304 | 304 | | (3) Sections 161.00735(e) and (f). |
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| 305 | 305 | | SECTION 10. (a) The changes in law made by this Act to |
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| 306 | 306 | | Subchapter A, Chapter 161, Health and Safety Code, apply to |
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| 307 | 307 | | immunization information received by the Department of State Health |
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| 308 | 308 | | Services before, on, or after January 1, 2017. An individual whose |
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| 309 | 309 | | immunization information was included immediately before January |
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| 310 | 310 | | 1, 2017, in the immunization registry established under Subchapter |
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| 311 | 311 | | A, Chapter 161, Health and Safety Code, is subject to the changes in |
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| 312 | 312 | | law made by this Act to that subchapter, including the procedures |
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| 313 | 313 | | established by that subchapter as amended by this Act. |
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| 314 | 314 | | (b) The changes in law made by this Act do not authorize the |
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| 315 | 315 | | Department of State Health Services to include in the immunization |
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| 316 | 316 | | registry established under Subchapter A, Chapter 161, Health and |
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| 317 | 317 | | Safety Code, immunization information of an individual who is 18 |
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| 318 | 318 | | years of age or older and whose immunization information was not |
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| 319 | 319 | | included in the registry on or before January 1, 2017, unless the |
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| 320 | 320 | | department receives immunization data from a health care provider |
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| 321 | 321 | | who: |
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| 322 | 322 | | (1) administers an immunization to the individual |
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| 323 | 323 | | after that date and elects to provide the individual's immunization |
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| 324 | 324 | | information to the department; and |
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| 325 | 325 | | (2) notifies the individual before submission of the |
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| 326 | 326 | | information to the department: |
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| 327 | 327 | | (A) that the health care provider is providing |
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| 328 | 328 | | the information to the department for inclusion in the registry; |
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| 329 | 329 | | (B) that the information will remain in the |
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| 330 | 330 | | registry until removal is requested by the individual or the |
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| 331 | 331 | | individual's legally authorized representative; and |
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| 332 | 332 | | (C) of the procedures for requesting removal from |
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| 333 | 333 | | the registry under Subchapter A, Chapter 161, Health and Safety |
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| 334 | 334 | | Code, as amended by this Act. |
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| 335 | 335 | | SECTION 11. As soon as practicable after the effective date |
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| 336 | 336 | | of this section, the Department of State Health Services shall |
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| 337 | 337 | | conduct a public awareness campaign to educate health care |
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| 338 | 338 | | providers, parents, payors, schools, and the public about the |
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| 339 | 339 | | changes in law made by this Act. |
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| 340 | 340 | | SECTION 12. (a) Except as provided by Subsection (b) of this |
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| 341 | 341 | | section, this Act takes effect January 1, 2017. |
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| 342 | 342 | | (b) Section 11 of this Act takes effect September 1, 2015. |
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