By: Laubenberg, Crownover H.B. No. 411
A BILL TO BE ENTITLED
AN ACT
relating to the confidentiality of newborn screening information.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Section 33.017, Health and Safety Code, as added
by Chapter 179 (H.B. 1672), Acts of the 81st Legislature, Regular
Session, 2009, is amended by amending Subsections (a), (b), and (c)
and adding Subsections (a-1), (c-1), (e), (f), (g), and (h) to read
as follows:
(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) "Commission" means the Health and Human Services
Commission.
(3) "Commissioner" means the commissioner of state
health services.
(4) "Health agency" means the commission and the
health and human services agencies listed in Section 531.001,
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; or
(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.
(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 [, approval, or] quality
assurance, for:
(A) the department's laboratory; or
(B) 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;
(3) purposes relating to:
(A) review or [,] quality assurance[, or
improvement] of the department's newborn screening under this
chapter or the department's newborn screening program services
under Subchapter C; or
(B) 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; or
(4) other [research purposes, provided that the
disclosure is approved by an institutional review board or privacy
board of the department; or
[(5)] 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 [assessment is performed by a person who is not a
laboratory]; and
(B) [only newborn screening specimens are
disclosed; and
[(C) the disclosure is approved by] 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 if:
(1) a parent 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.
(e) If disclosure is approved by the commissioner or the
commissioner's designee under Subsection (c)(4) 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 approves 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) The requirement that consent be obtained before certain
disclosures of reports, records, or information may be made under
this section does not affect the requirement that screening tests
be performed under Section 33.011.
SECTION 2. This Act takes effect immediately if it receives
a vote of two-thirds of all the members elected to each house, as
provided by Section 39, Article III, Texas Constitution. If this
Act does not receive the vote necessary for immediate effect, this
Act takes effect September 1, 2011.