DEPARTMENT OF HEALTH AND HUMAN SERVICES  
DIVISION FOR VITAL RECORDS AND HEALTH STATISTICS  
BIRTH DEFECTS REPORTING  
(By authority conferred on the department of health and human services by section  
5721 of 1978 PA 368, MCL 333.5721 and Executive Reorganization Order No. 1996-1,  
MCL 330.3101.)  
R 325.9071 Definitions.  
Rule 1. (1) As used in these rules:  
(a) "Birth defect" means an abnormality of the body's structure or inherent function  
present at birth, whether the abnormality is detected in utero at the time of delivery or  
becomes apparent at a later date.  
(b) "Birth defects registry" means the data base that contains individual case level  
demographic and diagnostic information maintained by the department.  
(c) "Department" means the department of health and human services.  
(d) "Institutional Review Board for the Protection of Human Research Subjects  
(IRB)" means the board within the department of health and human services that is  
established under 45 CFR 46.  
(e) "Registrant" means a child who is diagnosed with a reportable birth defect.  
(f) "Reporting entity" means a hospital, clinical laboratory, physician, genetic  
counselor, health clinic, and other health professional or health facility required to report  
birth defects under R 325.9072.  
(2) The terms "clinical laboratory" and "hospital," as defined in sections 20104 and  
20106, 1978 PA 368, MCL 333.20104 and 333.20106 have the same meanings when  
used in these rules.  
History: 1991 AACS; 2011 AACS; 2017 AACS.  
R 325.9072 Reportable birth defects.  
Rule 2. (1) Reportable birth defects are those birth defects identified in the  
following list of medical conditions:  
(a) Congenital anomalies of the central nervous system.  
(b) Congenital anomalies of the eye.  
(c) Congenital anomalies of the ear, face, and neck.  
(d) Congenital anomalies of the heart and circulatory system.  
(e) Congenital anomalies of the respiratory system.  
(f) Cleft palate and cleft lip.  
(g) Congenital anomalies of the upper alimentary canal/ digestive system.  
(h) Congenital anomalies of the genital and urinary systems.  
(i) Congenital anomalies of the musculoskeletal system.  
(j) Congenital anomalies of the integument.  
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(k) Chromosomal anomalies.  
(2) Other congenital anomalies, including the following:  
(a) Infectious conditions occurring in the perinatal period, including the following:  
(i) Syphilis.  
(ii) Congenital rubella.  
(iii) Cytomegalovirus.  
(iv) Listeriosis.  
(v) Herpes simplex.  
(vi) Malaria.  
(vii) Toxoplasmosis.  
(viii) Tuberculosis.  
(ix) Zika.  
(b) Familial/congenital neoplasms.  
(c) Endocrine/metabolic disorders.  
(d) Diseases of the blood and blood forming organs including the following:  
(i) Hereditary hemolytic anemias.  
(ii) Familial hypoplastic anemia.  
(iii) Coagulation defects.  
(iv) Primary thrombocytopenia.  
(e) Diseases of the central and peripheral nervous system, including the following:  
(i) Cerebral lipidoses.  
(ii) Cerebral degeneration.  
(iii) Hereditary spastic paraplegia.  
(iv) Cerebral palsy.  
(v) Werdnig-hoffman disease.  
(vi) Disorders of the autonomic nervous system.  
(vii) Cerebral palsy and spasms.  
(viii) Cerebral cysts.  
(ix) Polyneuritis cranialis.  
(x) Hereditary and idiopathic peripheral neuropathy.  
(xi) Myoneural disorders.  
(xii) Muscular dystrophies and other myopathies.  
(f) Diseases of the eye, including the following:  
(i) Retinal disorders.  
(ii) Chorioretinitis.  
(iii) Blindness and low vision.  
(iv) Hereditary optic atrophy and nystagmus.  
(v) Any other irregular movement of the eye.  
(g) Hearing deficiency, including structural and functional deficiencies.  
(h) Diseases of the heart and circulatory system including the following:  
(i) Cardiomyopathy.  
(ii) Conductive cardiac disorders.  
(iii) Dysrhythmias.  
(iv) Occlusions of coronary arteries.  
(v) Budd-chiari syndrome.  
(i) Diseases of the gastrointestinal system, including the following:  
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(i) Anomalies of teeth, jaw, or hernia.  
(ii) Stricture.  
(iii) Volvulus.  
(iv) Fistula of organs.  
(j) Diseases of the genital and urinary systems involving fistula and obstruction.  
(k) Fetal/placental anomalies.  
(l) Musculoskeletal system diseases involving abnormal bone growth.  
(m) Maternal causes of fetal morbidity, including the following:  
(i) Infections, including those infections specified in subrule (2)(a) of this rule.  
(ii) Alcohol use including fetal alcohol spectrum disorders.  
(iii) Cocaine use, opioid use, and other toxic or medicinal agents affecting the fetus.  
(n) Autism spectrum disorders, including Asperger syndrome and Rett  
syndrome.  
(3) Diagnoses of birth defects that occur in children from birth to 2 years of age  
shall be reported to the department by those entities listed in subrules (3), (4), and (5) of  
this rule in a manner that is consistent with these rules. This subrule applies whether or  
not a child dies 2 years of age. The director of the department may designate the  
reporting of birth defects, diagnosed up to and including 12 years of age, for medical  
conditions that require surveillance and are commonly diagnosed after 2 years of age,  
including, but not limited to, any of the following:  
(a) Fetal alcohol spectrum disorders.  
(b) Cystic fibrosis.  
(c) Muscular dystrophy.  
(d) Autism.  
(e) Cerebral palsy.  
(4) Hospitals shall report diagnoses of birth defects. The administrative officer of  
each reporting facility shall establish the reporting procedures at that facility. These  
procedures shall ensure that every child from birth to 2 years of age, or up to 12 years of  
age for defects designated under subrule (2) of this rule, who is diagnosed either in the  
facility operated inpatient or outpatient setting as having a birth defect is reported to the  
birth defects registry. If a child is transported to another facility, the health care facility at  
which a reportable diagnosis is first made is responsible for reporting.  
(5) Clinical laboratories shall report diagnoses of birth defects. The director of a  
laboratory that conducts postmortem examinations or cytogenetic tests shall report to the  
department any potential registrant who has a reportable birth defect.  
(6) The director may designate diagnoses of birth defects to be reported by  
physicians, genetic counselors, health clinics, and other health professionals or health  
facilities involved in the diagnosis or treatment of children with birth defects as necessary  
to assure efficient and comprehensive surveillance of birth defects.  
(7) Diagnoses of birth defects may be reported by local public health officials, other  
programs within the department, and by programs in other departments that provide  
treatment, services, medical, or other benefits to children with birth defects and their  
families.  
(8) Reports shall be submitted within 30 days of a diagnosis in a form prescribed  
and approved by the department.  
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(9) Reports that are submitted on forms provided by the department or by electronic  
media shall meet data quality, format, and timeliness standards prescribed by the  
department, as described in the manual for completing the birth defects registry report  
form.  
History: 1991 AACS; 2011 AACS; 2017 AACS.  
Editor's Note: An obvious error in R 325.9072 was corrected at the request of the promulgating  
agency, pursuant to Section 56 of 1969 PA 306, as amended by 2000 PA 262, MCL 24.256. The rule  
containing the error was published in Michigan Register, 2017 MR 24. The memorandum requesting the  
correction was published in Michigan Register, 2018 MR 1.  
R 325.9073 Quality assurance.  
Rule 3. (1) For the purposes of assuring the quality of submitted data, each  
reporting entity shall allow the department or an authorized agent of the department,  
with not less than 5 working days' notice and during reasonable working hours, to  
inspect the parts of a patient's medical records as necessary to verify the accuracy of the  
submitted data.  
(2) A reporting entity shall, upon the request of the department, supply missing  
information, if known, or clarify information submitted to the department.  
(3) Upon mutual agreement between a reporting entity and the department, the  
reporting entity may elect to submit copies of medical records instead of on-site  
inspection of the records by the department. Each copy of a medical record or part  
thereof that is submitted to the department under this rule shall be used only for  
verification of corresponding reported data, shall not be recopied by the department, and  
shall be kept in a locked file cabinet when not being used. The copies shall be  
promptly destroyed following verification of the corresponding reported data or, if the  
reported data appears to be inaccurate, following clarification or correction of the  
reported data.  
(4) Both of the following provisions shall be complied with to preserve the  
confidentiality of each patient's medical records:  
(a) Each reporting entity, when requested, shall provide the department with, for  
inspection only, all of the following records and reports:  
(i) Reports of diagnoses of birth defects and notations of the reasons for such  
diagnoses, including the primary clinician's reports and consultation reports.  
(ii) Those parts of medical records that contain the specific information required to  
be reported.  
(b) A reporting entity shall not be required by this rule to allow the inspection of  
any part of any patient's record other than those parts specified in subrule (1) of this  
rule. A reporting entity may allow the inspection of medical records from which  
parts, other than those specified, have been deleted, masked, crossed out, or otherwise  
rendered illegible.  
History: 1991 AACS; 2011 AACS.  
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R 325.9074 Confidentiality of reports.  
Rule 4. (1) The department shall maintain the confidentiality of all reports of  
birth defects submitted to the department and shall not release such reports or any  
information which, because of name, identifying number, mark, or description, can be  
readily associated with a particular individual, except in accordance subrules (2), (3), (4),  
(5), and (6) of this rule. The department shall not release any information that would  
indicate if the name of a particular person is listed in the registry, except in accordance  
with subrules (2), (3), (4), (5), and (6) of this rule.  
(2) A report of birth defects that is submitted to the department concerning a  
particular individual, and any other information maintained in the birth defects registry  
reporting system which, because of name, identifying number, mark, or description,  
can be readily associated with a particular individual, shall be released only as follows:  
(a) To the particular individual upon compliance with both of the following  
provisions:  
(i) Receipt of a written request which is signed by the particular individual and  
which is witnessed or notarized as required by subrule (3) of this rule.  
(ii) Presentation by the particular individual of suitable identification as required by  
subrule (4) of this rule.  
(b) If the particular individual is a minor, to a parent of the particular individual  
upon compliance with all of the following provisions:  
(i) Receipt of a written request which is signed by the parent and which is witnessed  
or notarized as required by subrule (3) of this rule.  
(ii) Receipt of a certified copy of the birth certificate of the particular individual.  
(iii) Presentation by the parent of suitable identification as required by subrule (4)  
of this rule.  
(c) If the particular individual has a court-appointed guardian or if the particular  
individual is deceased, then to the court-appointed guardian or to the executor or  
administrator of the particular individual's estate upon compliance with all of the  
following provisions:  
(i) Receipt of a written request which is signed by the court-appointed guardian,  
executor, or administrator and which is witnessed or notarized as required subrule (3) of  
this rule.  
(ii) Receipt of a certified copy of the order or decree which appoints the guardian,  
executor, or administrator.  
(iii) Presentation by the guardian, executor, or administrator of suitable  
identification as required by subrule (4) of this rule.  
(d) To an attorney or other person who is designated by the particular individual  
upon compliance with both of the following provisions:  
(i) Receipt of a written request which is signed by the particular individual,  
which is witnessed or notarized as required by subrule (3) of this rule, and which  
requests release of the information to the attorney or other person.  
(ii) Presentation by the attorney or other person of suitable identification as  
required by subrule (4) of this rule.  
(e) To an attorney or other person who is designated by the court-  
appointed guardian of the particular individual or who is designated by the executor or  
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administrator of the estate of the particular individual upon compliance with all of the  
following provisions:  
(i) Receipt of a written request which is signed by the court-appointed guardian,  
executor, or administrator, which is witnessed or notarized as required by subrule (3)  
of this rule, and which requests release of the information to the attorney or other  
person.  
(ii) Receipt of a certified copy of the order or decree which appoints the guardian,  
executor, or administrator.  
(iii) Presentation by the attorney or other person of suitable identification as  
required by subrule (4) of this rule.  
(f) If the particular individual is a minor, to an attorney or other person who is  
designated by the parent of the particular individual upon compliance with all of the  
following provisions:  
(i) Receipt of a written request which is signed by the parent, which is witnessed  
or notarized as required by subrule (3) of this rule, and which requests release of the  
information to the attorney or other person.  
(ii) Receipt of a certified copy of the birth certificate of the particular individual.  
(iii) Presentation by the attorney or other person of suitable identification as  
required by subrule (4) of this rule.  
(3) Every written request for the release of information that is submitted under  
subrule (2) of this rule shall be signed by the person who makes the written request.  
The signature shall comply with either of the following provisions:  
(a) Be witnessed by an employee of the department who has been designated to  
witness such requests and to whom the person making the request presents suitable  
identification as required by subrule (4) of this rule.  
(b) Be notarized by a notary public or magistrate.  
(4) Any person who is required by subrule (2) or (3) of this rule to present  
suitable identification shall present an identification document, such as a driver's  
license, or other document which contains both a picture of the person and the signature  
or mark of the person.  
(5) The director may, under R 325.9074 and R 325.9075, release information from  
the birth defects registry to an authorized representative of a study or research project that  
shall be reviewed by a scientific advisory panel, reviewed and approved by the  
department's IRB, and approved by the director. The process for release of information  
that identifies the registrant shall be as set forth in this subrule for any research  
proposals that require contact with the family of the child including direct contact with  
the child. After the proposal for the research has been reviewed and approved under R  
325.9075, and before any information is released to the researcher, information  
shall be sent to the parent or parents or legal guardian of the registrant or to the  
registrant, if an adult, that describes the goals and process of the research project. The  
parent, parents, or legal guardian or registrant, as appropriate, shall be asked to indicate  
if he or she wishes to participate in the project. The name of the registrant shall only be  
released  
to the director of the research project when the parent, parents, or legal guardian  
grants approval for such release. The department shall not release any part of a patient's  
medical record obtained under R 325.9073.  
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(6) The director may authorize information from the birth defects registry to be used  
within the department or by an authorized agent of the department, including a local  
health department, to offer medical and other support services to the registrant. The  
department may contact the parent, parents, or legal guardian or registrant, if an adult,  
who is identified in the birth defects registry to offer referral to medical and other  
support services as appropriate. The department shall not release any part of a patient's  
medical record obtained under R 325.9073.  
History: 1991 AACS; 2011 AACS.  
R 325.9075 Scientific advisory panel; release of information for research.  
Rule 5. (1) The director of the department shall appoint a scientific advisory panel  
of not less than 3 scientists to review research proposals for which a release of  
information which is maintained by the department and which identifies an individual  
reported to have a diagnosis of a birth defect is required.  
(2) The scientific advisory panel shall review a research proposal that requires the  
release of information that identifies an individual who has a reported diagnosis of a birth  
defect.  
(3) The panel shall, in writing, advise the director on the merits of the study.  
(4) The study or research project shall not publish the name of any individual who  
is or was the subject of a report of a birth defect that was submitted to the department.  
The study or research project shall not release any identifying number, mark, or  
description that can be readily associated with an individual who is or was the subject of  
a report of a birth defect that was submitted to the department. A formal memorandum of  
agreement that is signed by an authorized representative of the department and the  
director of the research project shall include all of the following provisions:  
(a) That electronic files, optical files, or hard copy of the data provided by the  
department shall not be copied for retention, resold, or otherwise provided to another  
person or agency and will be returned to the department upon completion of processing  
of the study.  
(b) That any reports or published papers relying in whole or in part on the data  
furnished by the department to the study or research project shall acknowledge the  
Michigan birth defects registry of the Michigan department of health and human services  
as the source of the data.  
(c) That a prepublication copy of all resulting papers shall be sent to the department  
at least 15 days before to the expected date of publication.  
History: 1991 AACS; 2017 AACS.  
R 325.9076 Rescinded.  
History: 1991 AACS; 2011 AACS.  
R 325.9077 Exchange of records.  
Rule 7. The department, by agreement, may transmit transcripts or copies of reports  
of birth defects diagnoses to state or national birth defects registries when the reports  
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relate to residents of other states or countries. The agreement shall require that the  
transcripts or records be used only for statistical or research purposes, or to offer referrals  
to medical and other support services.  
History: 2017 AACS.  
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;