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) ormore 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 nervoussystem 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 achild before the child becomes five (5) years of age.
(6) A fetal alcohol spectrum disorder that is recognized beforea 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 childbecomes 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 asevere physical disability or developmental delay that results frominjury, infection, or disease, is chronic in nature, and requires longterm 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 birthproblems 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 thestate 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 4-22-2to:
(1) define a birth problem; and
(2) establish reporting requirements regarding birth problemsfor:
(A) hospitals;
(B) physicians;
(C) local health departments; and
(D) other health care providers designated by the statedepartment.
(b) In adopting rules regarding the reporting of birth problems, thestate department shall give consideration to the following factors:
(1) The extent to which a condition can be measured oridentified.
(2) The extent to which there is a known intervention for acondition.
(3) The significance of the burden imposed on the life of theindividual by a condition.
(4) Other factors that the state department determinesappropriate.
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; sourcesof data; report
Sec. 8. (a) The state department shall establish a birth problemsregistry for the purpose of recording all cases of birth problems thatoccur in Indiana residents and compiling necessary and appropriateinformation concerning those cases, as determined by the statedepartment, in order to:
(1) conduct epidemiologic and environmental studies and toapply 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 orhospital visit that occurs before the child is:
(i) except as provided in item (ii), three (3) years of age atthe time of diagnosis; or
(ii) five (5) years of age at the time of diagnosis if thedisorder is a pervasive developmental disorder or a fetal
alcohol spectrum disorder;
about physicians, care facilities, and appropriate communityresources, including local step ahead agencies and the infantsand toddlers with disabilities program (IC 12-12.7-2); or
(3) inform citizens regarding programs designed to prevent orreduce birth problems.
(b) The state department shall record in the birth problemsregistry:
(1) all data concerning birth problems of children that areprovided from the certificate of live birth; and
(2) any additional information that may be provided by anindividual or entity described in section 7(a)(2) of this chapterconcerning 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 anewborn;
(ii) before the child is five (5) years of age if the child isdiagnosed with a pervasive developmental disorder or afetal alcohol spectrum disorder; and
(iii) before the child is three (3) years of age for anydiagnosis not specified in item (ii).
(c) The state department shall:
(1) provide a physician and a local health department withnecessary forms for reporting under this chapter; and
(2) report in an electronic format under IC 5-14-6 to thelegislative council any birth problem trends that are identifiedthrough 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 describedin section 7(a)(2) of this chapter shall report each confirmed case ofa birth problem that is recognized at the time of birth to the registrynot later than sixty (60) days after the birth. An individual or entitydescribed in section 7(a)(2) of this chapter who recognizes a birthproblem in a child after birth but before the child is five (5) years ofage shall report the birth problem to the registry not later than sixty(60) days after recognizing the birth problem. Information may beprovided to amend or clarify an earlier reported case.
(b) A person required to report information to the registry underthis section may use, when completing reports required by thischapter, information submitted to any other public or private registryor 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 registriesis authorized. The state department may use information from
another registry administered by the state department. Informationused from other registries remains subject to the confidentialityrestrictions 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 thischapter, information that:
(1) is obtained under this chapter by the state departmentconcerning 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 ina legitimate research activity access to confidential informationconcerning individual patients obtained by the state departmentunder this chapter if:
(1) the person conducting the research provides writteninformation about the purpose of the research project, the natureof the data to be collected and how the researcher intends toanalyze it, the records the researcher wishes to review, and thesafeguards the researcher will take to protect the identity of thepatients whose records the researcher will be reviewing;
(2) the proposed safeguards are adequate to protect the identityof each patient whose records will be reviewed; and
(3) an agreement is executed between the state department andthe researcher that specifies the terms of the researcher's use ofthe records and that prohibits the publication or release of thenames of individual patients or any facts tending to lead to theidentification 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 statedepartment, use the names of individual patients when requestingadditional information for research purposes. However, if aresearcher requests additional information, the researcher must thenobtain the individual patient's written consent by having the patientcomplete 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 andtreatment purposes;
if the patient gives written consent by completing a release ofconfidential 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 releasedinformation
Sec. 14. A person who reports information to the registry underthis chapter is immune from any civil or criminal liability that mightotherwise be imposed because of the release of what is otherwiseconfidential 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 anyinterested person of epidemiological and environmental informationthat 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 intensiveeducational programs for health professionals and members of thepublic concerning the nature and purpose of the birth problemsregistry, the reporting and informational requirements, and the causesand detection of birth problems.
(b) The state department shall develop educational programmaterials appropriate for use in education concerning thetransmission of HIV prenatally and neonatally. The state departmentshall promote the use of the educational program materials by healthcare 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 ofbirth problems to the registry, the state department may review themedical records of an individual or entity required to report birthproblems 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 administeredby the state department.
(b) The expenses of administering the fund shall be paid frommoney in the fund.
(c) Money in the fund at the end of a particular fiscal year doesnot revert to the state general fund.
(d) The state department is not required to implement theprovisions of this chapter regarding birth problems described insection 1(7) of this chapter until the state department receives thefunding 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 legislativecouncil and the governor each year before November 1, thefollowing:
(1) The numbers and types of birth problems occurring inIndiana by county.
(2) The amount of use of the birth problems registry byresearchers.
(3) Proposals for the prevention of birth problems occurring inIndiana.
A report under this section to the legislative council must be in anelectronic 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.