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A BILL TO BE ENTITLED
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AN ACT
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relating to the confidentiality of newborn screening information. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Section 33.017, Health and Safety Code, as added |
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by Chapter 179 (H.B. 1672), Acts of the 81st Legislature, Regular |
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Session, 2009, is amended by amending Subsections (b) and (c) and |
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adding Subsections (e), (f), and (g) to read as follows: |
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(b) Notwithstanding other law, reports, records, and |
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information obtained or developed by the department under this |
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chapter may be disclosed: |
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(1) for purposes of diagnosis or follow-up authorized |
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under Section 33.014; |
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(2) with the consent of each identified individual or |
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an individual authorized to consent on behalf of an identified |
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child; |
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(3) as authorized by court order; |
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(4) to a medical examiner authorized to conduct an |
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autopsy on a child or an inquest on the death of a child; or |
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(5) to public health programs of the department for |
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public health research purposes, provided that the disclosure is |
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approved by: |
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(A) the commissioner or the commissioner's |
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designee; and |
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(B) an institutional review board or privacy |
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board of the department as authorized by the federal privacy |
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requirements adopted under the Health Insurance Portability and |
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Accountability Act of 1996 (Pub. L. No. 104-191) contained in 45 |
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C.F.R. Part 160 and 45 C.F.R. Part 164, Subparts A and E. |
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(c) Notwithstanding other law, reports, records, and |
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information that do not identify a child or the family of a child |
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may be released without consent if the disclosure is for: |
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(1) statistical purposes; |
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(2) purposes related to obtaining or maintaining |
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federal certification, including related [, approval, or] quality |
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assurance, for: |
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(A) the department's laboratory; or |
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(B) a public or private laboratory to perform |
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newborn screening tests that are not part of inter-laboratory |
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exchanges required for federal certification of the department's |
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laboratory, provided that the disclosure is approved by the |
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commissioner or the commissioner's designee; |
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(3) purposes relating to: |
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(A) review or [,] quality assurance[, or
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improvement] of the department's newborn screening under this |
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chapter or the department's newborn screening program services |
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under Subchapter C; or |
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(B) improvement of the department's newborn |
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screening under this chapter or the department's newborn screening |
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program services under Subchapter C, provided that the disclosure |
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is approved by the commissioner or the commissioner's designee; |
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(4) public health research purposes, provided that the |
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disclosure is approved by: |
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(A) an institutional review board or privacy |
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board of the department; and |
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(B) the commissioner; or |
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(5) other quality assurance purposes related to public |
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health testing equipment and supplies, provided that the disclosure |
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is approved by: |
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(A) the commissioner [assessment is performed by
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a person who is not a laboratory]; and |
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(B) [only newborn screening specimens are
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disclosed; and
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[(C) the disclosure is approved by] an |
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institutional review board or privacy board of the department. |
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(e) If disclosure is approved by the commissioner under |
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Subsection (c)(4) or (5), the department shall post notice on the |
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newborn screening web page on the department's Internet website |
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that disclosure has been approved. The commissioner shall |
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determine the form and content of the notice. |
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(f) In accordance with this section, the commissioner or the |
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commissioner's designee: |
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(1) may approve disclosure of reports, records, or |
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information obtained or developed under this chapter only for a |
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public health purpose; and |
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(2) may not approve disclosure of reports, records, or |
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information obtained or developed under this chapter for purposes |
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related to forensic science or health insurance underwriting. |
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(g) In this section, "commissioner" means the commissioner |
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of state health services. |
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SECTION 2. This Act takes effect immediately if it receives |
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a vote of two-thirds of all the members elected to each house, as |
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provided by Section 39, Article III, Texas Constitution. If this |
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Act does not receive the vote necessary for immediate effect, this |
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Act takes effect September 1, 2011. |