2023 Texas Statutes › Health and Safety Code › Title 2 - Health › Subtitle B - Health Programs › Chapter 33 - Phenylketonuria, Other Heritable Diseases, Hypothyroidism, and Certain Other Disorders › Subchapter B. Newborn Screening › Section 33.018. Confidentiality

Sec. 33.018.  CONFIDENTIALITY.  (a)  In this section:
(1)  "Affiliated with a health agency" means a person who is an employee or former employee of a health agency.
(2)  Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(16), eff. April 2, 2015.
(3)  Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(16), eff. April 2, 2015.
Text of subdivision effective until April 01, 2025
(4)  "Health agency" means the commission and the health and human services agencies listed in Section 531.001, Government Code.
Text of subdivision effective on April 01, 2025
(4)  "Health agency" means the commission and the health and human services agencies listed in Section 521.0001, Government Code.
(5)  "Public health purpose" means a purpose that relates to cancer, a birth defect, an infectious disease, a chronic disease, environmental exposure, or newborn screening.
(a-1)  Reports, records, and information obtained or developed by the department under this chapter are confidential and are not subject to disclosure under Chapter 552, Government Code, are not subject to subpoena, and may not otherwise be released or made public except as provided by this section.
(b)  Notwithstanding other law, reports, records, and information obtained or developed by the department under this chapter may be disclosed:
(1)  for purposes of diagnosis or follow-up authorized under Section 33.014;
(2)  with the consent of each identified individual or an individual authorized to consent on behalf of an identified child;
(3)  as authorized by court order;
(4)  to a medical examiner authorized to conduct an autopsy on a child or an inquest on the death of a child;
(5)  to public health programs of the department for public health research purposes, provided that the disclosure is approved by:
(A)  the commissioner or the commissioner's designee; and
(B)  an institutional review board or privacy board of the department as authorized by the federal privacy requirements adopted under the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191) contained in 45 C.F.R. Part 160 and 45 C.F.R. Part 164, Subparts A and E;
(6)  for purposes relating to review or quality assurance of the department's newborn screening under this chapter or the department's newborn screening program services under Subchapter C, provided that no disclosure occurs outside of the department's newborn screening program;
(7)  for purposes related to obtaining or maintaining federal certification, including related quality assurance, for the department's laboratory, provided that no disclosure occurs outside of the department's newborn screening program; or
(8)  for purposes relating to improvement of the department's newborn screening under this chapter or the department's newborn screening program services under Subchapter C, provided that the disclosure is approved by the commissioner or the commissioner's designee.
(c)  Notwithstanding other law, reports, records, and information that do not identify a child or the family of a child may be released without consent if the disclosure is for:
(1)  statistical purposes;
(2)  purposes related to obtaining or maintaining federal certification, including related review and quality assurance:
(A)  for the department's laboratory that require disclosure outside of the department's newborn screening program; or
(B)  for a public or private laboratory to perform newborn screening tests that are not part of inter-laboratory exchanges required for federal certification of the department's laboratory, provided that the disclosure is approved by the commissioner or the commissioner's designee; or
(3)  other  quality assurance purposes related to public health testing equipment and supplies, provided that the disclosure is approved by:
(A)  the commissioner or the commissioner's designee; and
(B)  an institutional review board or privacy board of the department.
(c-1)  Notwithstanding other law, reports, records, and information that do not identify a child or the family of a child may be released for public health research purposes not described by Subsection (b)(5) if:
(1)  a parent, managing conservator, or guardian of the child consents to the disclosure; and
(2)  the disclosure is approved by:
(A)  an institutional review board or privacy board of the department; and
(B)  the commissioner or the commissioner's designee.
(d)  A state officer or employee, a department contractor, or a department contractor's employee, officer, director, or subcontractor may not be examined in a civil, criminal, special, or other judicial or administrative proceeding as to the existence or contents of records, reports, or information made confidential by this section unless disclosure is authorized by this section.
(e)  If disclosure is approved by the commissioner or the commissioner's designee under Subsection (c)(3) or (c-1), the department shall post notice on the newborn screening web page on the department's Internet website that disclosure has been approved.  The commissioner shall determine the form and content of the notice.
(f)  In accordance with this section, the commissioner or the commissioner's designee:
(1)  may approve disclosure of reports, records, or information obtained or developed under this chapter only for a public health purpose; and
(2)  may not approve disclosure of reports, records, or information obtained or developed under this chapter for purposes related to forensic science or health insurance underwriting.
(g)  An institutional review board or privacy board of the department that reviews a potential disclosure under this section must include at least three persons who are not affiliated with a health agency, one of whom must be a member of the public.
(h)  Nothing in this section affects the requirement that screening tests be performed under Section 33.011.
(i)  If a parent, managing conservator, or guardian of a child consents to disclosure under this section:
(1)  the parent, managing conservator, or guardian who consented to the disclosure may revoke the consent, in writing, at any time by using a form designated by the department; and
(2)  the child may revoke the consent, in writing, at any time on or after the date the child attains the age of majority by using a form designated by the department.
(j)  If a person revokes consent under Subsection (i), the department shall destroy any genetic material obtained from the child as provided by Section 33.0112.
Added by Acts 2009, 81st Leg., R.S., Ch. 179 (H.B. 1672), Sec. 3, eff. May 27, 2009.
Redesignated from Health and Safety Code, Section 33.017 by Acts 2011, 82nd Leg., R.S., Ch. 91 (S.B. 1303), Sec. 27.001(24), eff. September 1, 2011.
Amended by:
Acts 2011, 82nd Leg., R.S., Ch. 1273 (H.B. 411), Sec. 4, eff. June 1, 2012.
Acts 2011, 82nd Leg., R.S., Ch. 1273 (H.B. 411), Sec. 4, eff. June 17, 2011.
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1639(16), eff. April 2, 2015.
Acts 2023, 88th Leg., R.S., Ch. 769 (H.B. 4611), Sec. 2.27, eff. April 1, 2025.