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A BILL TO BE ENTITLED
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AN ACT
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relating to the immunization data included in and excluded from the |
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immunization registry. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Section 161.007, Health and Safety Code, is |
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amended by amending Subsections (a), (a-2), (b), (b-1), (c), (d), |
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and (e) and adding Subsections (e-1), (l), and (m) to read as |
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follows: |
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(a) The department, for the primary purpose of establishing |
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and maintaining a single repository of accurate, complete, and |
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current immunization records to be used in aiding, coordinating, |
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and promoting efficient and cost-effective communicable disease |
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prevention and control efforts, shall establish and maintain an |
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immunization registry. The executive commissioner by rule shall |
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develop guidelines to: |
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(1) protect the confidentiality of patients in |
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accordance with Section 159.002, Occupations Code; |
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(2) inform the individual or the individual's legally |
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authorized representative about the registry and that registry |
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information may be released under Section 161.00735; |
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(3) [require the written or electronic consent of the
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individual or the individual's legally authorized representative
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before any information relating to the individual is included in
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the registry;
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[(4)] permit the individual or the individual's |
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legally authorized representative to request that the individual's |
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information be removed from [withdraw consent for the individual to
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be included in] the registry; |
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(4) provide opportunities for the individual or the |
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individual's legally authorized representative to request removal |
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at any time, including: |
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(A) at the time of the individual's birth if |
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attended by a health care provider who administers immunizations; |
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(B) each time the individual receives any |
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immunization administered by a health care provider in this state; |
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(C) through electronic submission of a request |
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for removal using a request for removal procedure available on the |
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department's Internet website; |
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(D) through submission to the department of a |
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written request for removal; and |
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(E) following a natural or man-made disaster; |
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[and] |
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(5) ensure that an individual or the individual's |
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legally authorized representative is not required to request |
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removal from the registry more than one time and that, after a |
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request for removal is made, the individual's immunization |
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information will not be included in the registry unless the |
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individual or the individual's legally authorized representative |
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submits to the department a written request for inclusion of the |
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individual's information in the registry; and |
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(6) include on each immunization record generated by |
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the registry the procedures for requesting removal from the |
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registry [determine the process by which consent is verified,
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including affirmation by a health care provider, birth registrar,
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regional health information exchange, or local immunization
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registry that consent has been obtained]. |
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(a-2) [The written or electronic consent required by
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Subsection (a)(3) for an individual who is 18 years of age or older
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is required to be obtained only one time and must be received from
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the individual before the information may be released.] An |
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individual's legally authorized representative or the individual, |
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after the individual has attained 18 years of age, may submit a |
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request [consent] in writing or electronically for the individual's |
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information to be removed from [remain in] the registry. [The
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consent of the representative or individual is valid until the
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individual or the individual's legally authorized representative
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withdraws consent in writing or electronically.
The department
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may not include in the registry the immunization information of an
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individual who is 26 years of age or older until written or
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electronic consent has been obtained as provided by this
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subsection.] The department shall coordinate with the Texas |
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Education Agency to distribute materials described in Section |
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161.0095(a)(2) to students and parents through local school |
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districts. |
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(b) Except as provided by Section 161.0071, the |
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immunization registry must contain information on the immunization |
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history that is obtained by the department under: |
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(1) this section of each individual for whom |
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immunization information [consent] has been obtained, unless the |
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individual or the individual's legally authorized representative |
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has requested that the individual's information be removed from the |
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registry in accordance with guidelines adopted under Subsection |
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(a); |
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(2) Section 161.00705 of persons immunized to prepare |
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for or in response to a declared disaster, public health emergency, |
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terrorist attack, hostile military or paramilitary action, or |
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extraordinary law enforcement emergency; |
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(3) Section 161.00706 of first responders or their |
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immediate family members; and |
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(4) Section 161.00735 of persons evacuated or |
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relocated to this state because of a disaster. |
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(b-1) The department shall remove from the registry |
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information for any individual for whom [consent has been
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withdrawn.
The department may not retain individually identifiable
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information about any individual:
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[(1) for whom consent has been withdrawn;
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[(2)
for whom a consent for continued inclusion in the
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registry following the end of the declared disaster, public health
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emergency, terrorist attack, hostile military or paramilitary
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action, or extraordinary law enforcement emergency has not been
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received under Section 161.00705(f);
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[(3)
for whom a request to be removed from the registry
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has been received under Section 161.00706(e);
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[(4)
for whom consent for continued inclusion in the
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registry following the end of a disaster has not been received under
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Section 161.00735(f); or
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[(5) for whom] a request to remove information from |
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the registry has been received under this subchapter [Section
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161.00735(g)]. |
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(c) A payor that receives data elements from a health care |
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provider who administers an immunization to an individual younger |
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than 18 years of age shall provide the data elements to the |
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department. A payor is required to provide the department with only |
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the data elements the payor receives from a health care provider. A |
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payor that receives data elements from a health care provider who |
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administers an immunization to an individual 18 years of age or |
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older may provide the data elements to the department. The data |
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elements shall be submitted in a format prescribed by the |
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department. [The department shall verify consent before including
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the reported information in the immunization registry.
The
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department may not retain individually identifiable information
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about an individual for whom consent cannot be verified.] |
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(d) A health care provider who administers an immunization |
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to an individual younger than 18 years of age shall provide data |
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elements regarding an immunization to the department. A health |
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care provider who administers an immunization to an individual 18 |
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years of age or older may submit data elements regarding an |
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immunization to the department. At the request and with the |
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authorization of the health care provider, the data elements may be |
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submitted through a health information exchange as defined by |
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Section 182.151. The data elements shall be submitted in a format |
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prescribed by the department. A health care provider who |
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administers an immunization to any individual and provides data |
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elements to the department shall notify the individual or the |
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individual's legally authorized representative: |
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(1) that the individual's immunization information |
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will be included in the registry unless removal from the registry is |
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requested in accordance with the guidelines adopted under |
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Subsection (a); and |
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(2) of the procedures for requesting removal from the |
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registry. [The department shall verify consent before including
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the information in the immunization registry.
The department may
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not retain individually identifiable information about an
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individual for whom consent cannot be verified.] |
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(e) The department shall: |
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(1) make available on the department's Internet |
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website a printable form that states an individual's immunization |
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information will be included in the registry unless removal from |
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the registry is requested and that details the procedures for |
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submitting an electronic or written request for removal from the |
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registry [provide notice to a health care provider that submits an
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immunization history for an individual for whom consent cannot be
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verified.
The notice shall contain instructions for obtaining
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consent] in accordance with guidelines adopted under Subsection |
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(a); and |
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(2) make the form described by Subdivision (1) |
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available for distribution to health care providers [and
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resubmitting the immunization history to the department]. |
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(e-1) A health care provider may use the printable form |
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described by Subsection (e) to provide the notification required |
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under Subsection (d). |
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(l) Registry information may not be used to exclude any |
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individual from the receipt of any service during a natural or |
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man-made disaster unless the service is withheld because of a |
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medical contraindication. |
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(m) The department may not sell registry information to any |
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public or private entity. |
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SECTION 2. Section 161.00705(f), Health and Safety Code, is |
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amended to read as follows: |
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(f) Unless an individual or the individual's legally |
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authorized representative [consents] in writing or electronically |
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requests that [to continued inclusion of] the individual's |
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information be removed from [in] the registry, the department shall |
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include [remove] the immunization records collected under this |
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section in [from] the registry [on expiration of the period
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prescribed under Subsection (e)]. |
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SECTION 3. Sections 161.0071(a) and (b), Health and Safety |
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Code, are amended to read as follows: |
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(a) The first time the department receives registry data for |
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an individual [for whom the department has received consent] to be |
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included in the registry, the department shall send notice to the |
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individual or the individual's legally authorized representative |
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disclosing: |
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(1) that providers and payors may be sending the |
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individual's immunization information to the department; |
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(2) the information that is included in the registry; |
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(3) the persons to whom the information may be |
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released under Sections 161.00735(b) and 161.008(d); |
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(4) the purpose and use of the registry; |
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(5) the procedure to exclude an individual from the |
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registry; and |
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(6) the procedure to report a violation if an |
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individual's information is included in the registry after |
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exclusion has been requested [or consent has been withdrawn]. |
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(b) The [On discovering that consent to be included in the
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registry has not been granted or has been withdrawn, the] |
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department shall exclude [the individual's immunization records] |
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from the registry and any other registry-related department record |
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that individually identifies the individual the immunization |
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record of any individual from whom a request for exclusion has been |
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received by the department. |
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SECTION 4. Section 161.0073, Health and Safety Code, is |
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amended by amending Subsection (a) and adding Subsections (e), (f), |
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(g), and (h) to read as follows: |
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(a) Except as provided by this section and Sections 161.007, |
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161.00705, 161.00706, [and] 161.00735, and 161.008, information |
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that individually identifies an individual that is received by the |
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department for the immunization registry is confidential and may be |
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used by the department for registry purposes only. |
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(e) The department may use registry information for |
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internal public health research on approval of the department's |
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institutional review board. |
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(f) The department may release registry information for |
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external public health research if: |
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(1) the individual or the individual's legally |
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authorized representative submits a written authorization to the |
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department for release of the individual's registry data; |
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(2) the department does not disclose individually |
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identifiable information; or |
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(3) the department's institutional review board |
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approves the release of individually identifiable information |
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subject to Subsection (g). |
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(g) The department's institutional review board may not |
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approve the release of individually identifiable information for a |
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research proposal unless the proposal includes a provision |
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requiring the proposal's researchers to obtain informed consent |
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from each individual or the individual's legally authorized |
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representative before the department releases the individual's |
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registry data to the researchers. |
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(h) The executive commissioner shall adopt rules to ensure |
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that the use or release of registry information under this |
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subchapter complies with all state and federal laws relating to the |
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privacy, protection, confidentiality, and transmission of health |
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information, including the Health Insurance Portability and |
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Accountability Act of 1996 (Pub. L. No. 104-191) and rules adopted |
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under that Act. |
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SECTION 5. Sections 161.00735(c) and (h), Health and Safety |
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Code, are amended to read as follows: |
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(c) The department may receive immunization information |
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from a health authority of another state or from a local health |
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authority in another state if the department determines that |
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residents of that state have evacuated or relocated to this state in |
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response to a disaster. The department shall include information |
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received under this subsection in the registry. [Notwithstanding
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Section 161.007, the department is not required to obtain written
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consent for the inclusion in the registry of information received
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under this subsection.] |
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(h) The executive commissioner shall make every effort to |
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enter into a memorandum of agreement with each state to which |
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residents of this state are likely to evacuate in a disaster on: |
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(1) the release to and use by [of registry information
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under this section to] the appropriate health authority or local |
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health authority of that state of registry information under this |
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section[, including the length of time the information may be
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retained by that state]; and |
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(2) the receipt and use of information submitted by |
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the health authority or local health authority of that state for |
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inclusion in the registry under this section. |
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SECTION 6. Sections 161.008(c) and (e), Health and Safety |
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Code, are amended to read as follows: |
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(c) The department may obtain the data constituting an |
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immunization record for an individual from a public health |
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district, a local health department, the individual or the |
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individual's legally authorized representative, a physician to the |
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individual, a payor, or any health care provider licensed or |
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otherwise authorized to administer vaccines. [The department shall
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verify consent before including the reported information in the
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immunization registry.
The department may not retain individually
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identifiable information about an individual for whom consent
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cannot be verified.] |
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(e) An individual or the individual's legally authorized |
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representative may obtain and on request to the department shall be |
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provided with all individually identifiable immunization registry |
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information concerning the individual and information on the |
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procedure for requesting removal from the registry. |
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SECTION 7. Section 161.0095(a), Health and Safety Code, is |
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amended to read as follows: |
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(a) The department shall develop: |
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(1) continuing education programs for health care |
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providers relating to immunizations and the vaccines for children |
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program operated by the department under authority of 42 U.S.C. |
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Section 1396s; and |
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(2) educational information, for health care |
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providers, health care clinics, hospitals, and any other health |
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care facility that provides health care to children 14 to 18 years |
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of age, relating to the immunization registry and the option for an |
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individual or the individual's legally authorized representative |
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to request removal [who is 18 years of age or older to consent to
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submission and retention] of the individual's information from [in] |
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the immunization registry. |
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SECTION 8. Section 161.0107(c), Health and Safety Code, is |
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amended to read as follows: |
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(c) The executive commissioner by rule shall specify: |
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(1) the fields necessary to populate the immunization |
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registry[, including a field that indicates the patient's consent
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to be listed in the immunization registry has been obtained]; and |
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(2) the data standards that must be used for |
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electronic submission of immunization information. |
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SECTION 9. The following provisions of the Health and |
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Safety Code are repealed: |
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(1) Sections 161.007(a-1), (a-3), (a-4), (a-5), and |
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(a-6); |
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(2) Sections 161.00705(e) and (h); and |
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(3) Sections 161.00735(e) and (f). |
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SECTION 10. (a) The changes in law made by this Act to |
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Subchapter A, Chapter 161, Health and Safety Code, apply to |
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immunization information received by the Department of State Health |
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Services before, on, or after January 1, 2019. An individual whose |
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immunization information was included immediately before January |
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1, 2019, in the immunization registry established under Subchapter |
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A, Chapter 161, Health and Safety Code, is subject to the changes in |
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law made by this Act to that subchapter, including the procedures |
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established by that subchapter as amended by this Act. |
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(b) The changes in law made by this Act do not authorize the |
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Department of State Health Services to include in the immunization |
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registry established under Subchapter A, Chapter 161, Health and |
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Safety Code, immunization information of an individual who is 18 |
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years of age or older and whose immunization information was not |
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included in the registry on or before January 1, 2019, unless the |
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department receives immunization data from a health care provider |
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who: |
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(1) administers an immunization to the individual |
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after that date and elects to provide the individual's immunization |
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information to the department; and |
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(2) notifies the individual before submission of the |
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information to the department: |
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(A) that the health care provider is providing |
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the information to the department for inclusion in the registry; |
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(B) that the information will remain in the |
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registry until removal is requested by the individual or the |
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individual's legally authorized representative; and |
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(C) of the procedures for requesting removal from |
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the registry under Subchapter A, Chapter 161, Health and Safety |
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Code, as amended by this Act. |
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SECTION 11. (a) As soon as practicable after the effective |
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date of this section, the Department of State Health Services shall |
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conduct a public awareness campaign to educate health care |
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providers, parents, payors, schools, and the public about the |
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changes in law made by this Act. |
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(b) As soon as practicable after the effective date of this |
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section, the executive commissioner of the Health and Human |
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Services Commission shall adopt the rules required by Section |
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161.0073(h), Health and Safety Code, as added by this Act. |
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SECTION 12. (a) Except as provided by Subsection (b) of this |
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section, this Act takes effect January 1, 2019. |
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(b) Section 11 of this Act takes effect September 1, 2017. |