CHAPTER 4. BIRTH PROBLEMS REGISTRY
IC 16-38-4
Chapter 4. Birth Problems Registry
IC 16-38-4-1
"Birth problems" defined
Sec. 1. As used in this chapter, "birth problems" means one (1) or
more of the following conditions:
(1) A structural deformation.
(2) A developmental malformation.
(3) A genetic, inherited, or biochemical disease.
(4) A condition of a chronic nature, including central nervous
system hemorrhage or infection of the central nervous system,
that may result in a need for long term health care.
(5) A pervasive developmental disorder that is recognized in a
child before the child becomes five (5) years of age.
(6) A fetal alcohol spectrum disorder that is recognized before
a child becomes five (5) years of age.
(7) Any other severe disability that is:
(A) designated in a rule adopted by the state department; and
(B) recognized in a child after birth and before the child
becomes three (3) years of age.
As added by P.L.180-1993, SEC.2. Amended by P.L.93-2001, SEC.3;
P.L.17-2004, SEC.5.
IC 16-38-4-2
"Other severe disability" defined
Sec. 2. As used in this chapter, "other severe disability" means a
severe physical disability or developmental delay that results from
injury, infection, or disease, is chronic in nature, and requires long
term health care.
As added by P.L.180-1993, SEC.2. Amended by P.L.23-1993,
SEC.76.
IC 16-38-4-3
"Patient" defined
Sec. 3. As used in this chapter, "patient" means:
(1) a child born with a birth problem; or
(2) a parent or a guardian of a child born with a birth problem.
As added by P.L.180-1993, SEC.2.
IC 16-38-4-4
"Person" defined
Sec. 4. As used in this chapter, "person" means an individual,
association, partnership, corporation, or governmental entity.
As added by P.L.180-1993, SEC.2.
IC 16-38-4-5
"Registry" defined
Sec. 5. As used in this chapter, "registry" refers to the birth
problems registry established under this chapter.
As added by P.L.180-1993, SEC.2.
IC 16-38-4-6
"State department" defined
Sec. 6. As used in this chapter, "state department" refers to the
state department of health.
As added by P.L.180-1993, SEC.2.
IC 16-38-4-7
Rules to define birth problems; reporting requirements
Sec. 7. (a) The state department shall adopt rules under IC 4-22-2
to:
(1) define a birth problem; and
(2) establish reporting requirements regarding birth problems
for:
(A) hospitals;
(B) physicians;
(C) local health departments; and
(D) other health care providers designated by the state
department.
(b) In adopting rules regarding the reporting of birth problems, the
state department shall give consideration to the following factors:
(1) The extent to which a condition can be measured or
identified.
(2) The extent to which there is a known intervention for a
condition.
(3) The significance of the burden imposed on the life of the
individual by a condition.
(4) Other factors that the state department determines
appropriate.
As added by P.L.180-1993, SEC.2. Amended by P.L.93-2001, SEC.4.
IC 16-38-4-8
Department to establish birth problems registry; rationale; sources
of data; report
Sec. 8. (a) The state department shall establish a birth problems
registry for the purpose of recording all cases of birth problems that
occur in Indiana residents and compiling necessary and appropriate
information concerning those cases, as determined by the state
department, in order to:
(1) conduct epidemiologic and environmental studies and to
apply appropriate preventive and control measures;
(2) inform the parents of children with birth problems:
(A) at the time of discharge from the hospital; or
(B) if a birth problem is diagnosed during a physician or
hospital visit that occurs before the child is:
(i) except as provided in item (ii), three (3) years of age at
the time of diagnosis; or
(ii) five (5) years of age at the time of diagnosis if the
disorder is a pervasive developmental disorder or a fetal
alcohol spectrum disorder;
about physicians, care facilities, and appropriate community
resources, including local step ahead agencies and the infants
and toddlers with disabilities program (IC 12-12.7-2); or
(3) inform citizens regarding programs designed to prevent or
reduce birth problems.
(b) The state department shall record in the birth problems
registry:
(1) all data concerning birth problems of children that are
provided from the certificate of live birth; and
(2) any additional information that may be provided by an
individual or entity described in section 7(a)(2) of this chapter
concerning a birth problem that is:
(A) designated in a rule adopted by the state department; and
(B) recognized:
(i) after the child is discharged from the hospital as a
newborn;
(ii) before the child is five (5) years of age if the child is
diagnosed with a pervasive developmental disorder or a
fetal alcohol spectrum disorder; and
(iii) before the child is three (3) years of age for any
diagnosis not specified in item (ii).
(c) The state department shall:
(1) provide a physician and a local health department with
necessary forms for reporting under this chapter; and
(2) report in an electronic format under IC 5-14-6 to the
legislative council any birth problem trends that are identified
through the data collected under this chapter.
As added by P.L.180-1993, SEC.2. Amended by P.L.93-2001, SEC.5;
P.L.11-2002, SEC.1; P.L.28-2004, SEC.138; P.L.17-2004, SEC.6;
P.L.2-2005, SEC.57; P.L.93-2006, SEC.14.
IC 16-38-4-9
Reports of birth problems to registry
Sec. 9. (a) Nurse midwives and individuals and entities described
in section 7(a)(2) of this chapter shall report each confirmed case of
a birth problem that is recognized at the time of birth to the registry
not later than sixty (60) days after the birth. An individual or entity
described in section 7(a)(2) of this chapter who recognizes a birth
problem in a child after birth but before the child is five (5) years of
age shall report the birth problem to the registry not later than sixty
(60) days after recognizing the birth problem. Information may be
provided to amend or clarify an earlier reported case.
(b) A person required to report information to the registry under
this section may use, when completing reports required by this
chapter, information submitted to any other public or private registry
or required to be filed with federal, state, or local agencies. However,
the state department may require additional, definitive information.
(c) Exchange of information between state department registries
is authorized. The state department may use information from
another registry administered by the state department. Information
used from other registries remains subject to the confidentiality
restrictions on the other registries.
As added by P.L.180-1993, SEC.2. Amended by P.L.93-2001, SEC.6;
P.L.17-2004, SEC.7.
IC 16-38-4-10
Confidentiality of information
Sec. 10. Except as provided in sections 11, 12, and 13 of this
chapter, information that:
(1) is obtained under this chapter by the state department
concerning individual patients; and
(2) is not otherwise a matter of public record;
is for the confidential use of the state department only.
As added by P.L.180-1993, SEC.2.
IC 16-38-4-11
Access to confidential information for research
Sec. 11. The state department shall grant any person involved in
a legitimate research activity access to confidential information
concerning individual patients obtained by the state department
under this chapter if:
(1) the person conducting the research provides written
information about the purpose of the research project, the nature
of the data to be collected and how the researcher intends to
analyze it, the records the researcher wishes to review, and the
safeguards the researcher will take to protect the identity of the
patients whose records the researcher will be reviewing;
(2) the proposed safeguards are adequate to protect the identity
of each patient whose records will be reviewed; and
(3) an agreement is executed between the state department and
the researcher that specifies the terms of the researcher's use of
the records and that prohibits the publication or release of the
names of individual patients or any facts tending to lead to the
identification of individual patients.
As added by P.L.180-1993, SEC.2.
IC 16-38-4-12
Requests for additional information
Sec. 12. Researchers may, with the approval of the state
department, use the names of individual patients when requesting
additional information for research purposes. However, if a
researcher requests additional information, the researcher must then
obtain the individual patient's written consent by having the patient
complete a release of confidential medical information form.
As added by P.L.180-1993, SEC.2.
IC 16-38-4-13
Release of confidential information
Sec. 13. The state department may release confidential
information concerning individual patients to:
(1) the birth problems registry of another state; and
(2) physicians and local health officers for diagnostic and
treatment purposes;
if the patient gives written consent by completing a release of
confidential medical information form.
As added by P.L.180-1993, SEC.2.
IC 16-38-4-14
Persons reporting to registry; immunity from liability for released
information
Sec. 14. A person who reports information to the registry under
this chapter is immune from any civil or criminal liability that might
otherwise be imposed because of the release of what is otherwise
confidential information.
As added by P.L.180-1993, SEC.2.
IC 16-38-4-15
Epidemiological and environmental information; release permitted
Sec. 15. This chapter does not prevent the release to any
interested person of epidemiological and environmental information
that does not identify individual patients.
As added by P.L.180-1993, SEC.2.
IC 16-38-4-16
Educational programs
Sec. 16. (a) The state department shall conduct intensive
educational programs for health professionals and members of the
public concerning the nature and purpose of the birth problems
registry, the reporting and informational requirements, and the causes
and detection of birth problems.
(b) The state department shall develop educational program
materials appropriate for use in education concerning the
transmission of HIV prenatally and neonatally. The state department
shall promote the use of the educational program materials by health
care providers that furnish prenatal health care services.
As added by P.L.180-1993, SEC.2. Amended by P.L.126-1995,
SEC.3.
IC 16-38-4-16.5
Review of medical records
Sec. 16.5. To assure accurate, complete, and timely reporting of
birth problems to the registry, the state department may review the
medical records of an individual or entity required to report birth
problems under this chapter.
As added by P.L.93-2001, SEC.7.
IC 16-38-4-17
Birth problems registry fund
Sec. 17. (a) The birth problems registry fund is established for the
purpose of carrying out this chapter. The fund shall be administered
by the state department.
(b) The expenses of administering the fund shall be paid from
money in the fund.
(c) Money in the fund at the end of a particular fiscal year does
not revert to the state general fund.
(d) The state department is not required to implement the
provisions of this chapter regarding birth problems described in
section 1(7) of this chapter until the state department receives the
funding necessary for implementation.
As added by P.L.180-1993, SEC.2. Amended by P.L.93-2001, SEC.8.
IC 16-38-4-18
Reports by department
Sec. 18. The state department shall report to the legislative
council and the governor each year before November 1, the
following:
(1) The numbers and types of birth problems occurring in
Indiana by county.
(2) The amount of use of the birth problems registry by
researchers.
(3) Proposals for the prevention of birth problems occurring in
Indiana.
A report under this section to the legislative council must be in an
electronic format under IC 5-14-6.
As added by P.L.180-1993, SEC.2. Amended by P.L.28-2004,
SEC.139.
IC 16-38-4-19
Abolition of registry
Sec. 19. The registry is abolished July 1, 2017.
As added by P.L.180-1993, SEC.2. Amended by P.L.28-2004,
SEC.140; P.L.193-2007, SEC.2.