§ 130A-131.17. Confidentiality of information; research.
§130A‑131.17. Confidentiality of information; research.
(a) All informationcollected and analyzed by the Program pursuant to this Part shall beconfidential insofar as the identity of the individual patient is concerned. This information shall not be considered public record open to inspection. Access to the information shall be limited to Program staff authorized by theDirector of the State Center for Health and Environmental Statistics. TheDirector of the State Center for Health and Environmental Statistics may alsoauthorize access to this information to persons engaged in demographic,epidemiological, or other similar scientific studies related to health. TheCommission shall adopt rules that establish strict criteria for the use ofmonitoring Program information for scientific research. All persons givenauthorized access to Program information shall agree, in writing, to maintainconfidentiality.
(b) All scientificresearch proposed to be conducted by persons other than authorized Program staffusing the information from the Program, shall first be reviewed and approved bythe Director of the State Center for Health and Environmental Statistics and anappropriate committee for the protection of human subjects which is approved bythe United States Department of Health and Human Services pursuant to Part 46of Title 45 of the Code of Federal Regulations. Satisfaction of the terms ofthe Commission's rules for data access shall entitle the researcher to obtaininformation from the Program and, if part of the research protocol, to contactcase subjects.
(c) Whenever authorizedProgram staff propose a research protocol that includes contacting casesubjects, the Director of the State Center for Health and EnvironmentalStatistics shall submit a protocol describing the research to the State HealthDirector and to an appropriate committee for the protection of human subjectswhich is approved by the United States Department of Health and Human Servicespursuant to Part 46 of Title 45 of the Code of Federal Regulations. If andwhen the protocol is approved by the committee and by the State Health Directorpursuant to the rules of the Commission, then Program staff shall be entitledto complete the approved project and to contact case subjects.
(d) The Program shallmaintain a record of all persons who are given access to the information in thesystem. The record shall include the following:
(1) The name of theperson authorizing access;
(2) The name, title, andorganizational affiliation of persons given access;
(3) The dates of access;and
(4) The specificpurposes for which information is to be used.
The record required under thissubsection shall be open to public inspection during normal operating hours.
(e) Nothing in thissection prohibits the Program from publishing statistical compilations relatingto birth defects that do not in any way identify individual patients. (1995,c. 268, s. 1.)