Report Title:

Birth Defects Program and Registry

 

Description:

Establishes the Hawaii birth defects program and registry. (SD1)

THE SENATE

S.B. NO.

2763

TWENTY-FIRST LEGISLATURE, 2002

S.D. 1

STATE OF HAWAII

  

 

A BILL FOR AN ACT

 

RELATING TO BIRTH DEFECTS.

 

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:

SECTION 1. Chapter 321, Hawaii Revised Statutes, is amended by adding a new part to be appropriately designated and to read as follows:

"PART . HAWAII BIRTH DEFECTS PROGRAM

§321- Definitions. As used in this part, unless the context requires otherwise:

"Adverse reproductive outcome" means a birth defect, stillbirth, infant death up to one year of age, or spontaneous or medical termination of pregnancy for a birth defect.

"Birth defect" means an abnormality of structure, function, or body metabolism present at birth that adversely affects a child’s health and development, results in a physical or mental disability, or is fatal.

"Institutional review board" means an institutional review board established in accordance with 7 Code of Federal Regulations 1c.107, 10 Code of Federal Regulations 745.107, 14 Code of Federal Regulations 1230.107, 15 Code of Federal Regulations 27.107, 16 Code of Federal Regulations 1028.107, 21 Code of Federal Regulations 56.107, 22 Code of Federal Regulations 225.107, 24 Code of Federal Regulations 60.107, 28 Code of Federal Regulations 46.107, 32 Code of Federal Regulations 219.107, 34 Code of Federal Regulations 97.107, 38 Code of Federal Regulations 16.107, 40 Code of Federal Regulations 26.107, 45 Code of Federal Regulations 46.107, 45 Code of Federal Regulations 690.107, or 49 Code of Federal Regulations 11.107.

§321-   Birth defects program. The department of health shall establish the statewide Hawaii birth defects program that shall:

(1) Collect surveillance information on birth defects and other adverse reproductive outcomes;

(2) Report the incidence, trends, and causes of birth defects and other adverse reproductive outcomes;

(3) Report information for the development of prevention strategies to reduce the incidence of birth defects and other adverse reproductive outcomes; and

(4) Develop strategies to improve the access of children with birth defects to health and early intervention services.

§321-   Confidentiality of data. (a) The identity, or any information which alone or in combination with other reasonably available information may be used to identify any person whose information is collected under this part shall be confidential.

(b) Statistical data and information that do not allow the identification of any person may be released.

§321-   Rules. The department may adopt rules pursuant to chapter 91, as necessary for this part.

§321-   Requests for information. The department shall provide information about appropriate health and early intervention services to persons who request the information.

§321-   Penalty. Any person violating this part shall be guilty of a misdemeanor and fined not more than $500."

SECTION 2. Chapter 324, Hawaii Revised Statutes, is amended by adding a new part to be appropriately designated and to read as follows:

"Part . BIRTH DEFECTS STUDIES

§324-   Information collection. (a) Health care facilities and health care providers shall make available to the Hawaii birth defects program information contained in health care records that pertains to birth defects or other adverse reproductive outcomes.

(b) Any person, or public or private health care facility may provide information, or other data or relevant material relating to individuals with birth defects or adverse reproductive outcomes to the Hawaii birth defects program, for inclusion in the birth defects registry.

(c) Birth defects information shall not be collected from medical records in which individuals note in writing that they do not wish to have their medical records reviewed by the Hawaii birth defects program.

(d) No liability of any kind or character for damages or other relief shall arise or be enforced against any person or organization by reason of having provided the information or material to the Hawaii birth defects program.

§324-   Use of collected information. (a) The information collected under this part shall be used by the department of health or researchers only for the purpose of advancing medical and public health research, medical education, or education of the public in the interest of reducing morbidity or mortality, and only as approved by an institutional review board as defined in section 321-   .

(b) The identity, or any information which alone or in combination with other reasonably available information could be used to identify any person whose condition or treatment has been studied under this part shall be confidential.

(c) If the Hawaii birth defects program or researchers intend to collect additional information directly from a patient or patient’s relative for research studies approved by an institutional review board, the researcher shall first obtain approval for the request from the patient's attending physician. The use of such additional information obtained by researchers shall be governed by subsection (a)."

SECTION 3. There is appropriated out of the general revenues of the State of Hawaii the sum of $500,000, or so much thereof as may be necessary for fiscal year 2002-2003.

The sum appropriated shall be expended by the department of health for the purposes of this Act.

SECTION 4. This Act shall take effect on July 1, 2002.