Public Health Law: Article 21, Title 6, Section 2168 - Statewide Immunization Registry

Effective April 7, 2009

§ 2168. Statewide immunization information system. 1. The department is hereby directed to establish a statewide automated and electronic immunization information system that will serve, and shall be administered consistent with, the following public health purposes:

(a) collect reports of immunizations and thus reduce the incidence of illness, disability and death due to vaccine preventable diseases and collect results of blood lead analyses performed by physician office laboratories to provide to the statewide registry of lead levels of children established pursuant to section thirteen hundred seventy-a of this chapter;

(b) establish the public health infrastructure necessary to obtain, collect, preserve, and disclose information relating to vaccine preventable disease as it may promote the health and well-being of all children in this state;

(c) make available to an individual, or parents, guardians, or other person in a custodial relation to a child or, to local health districts, local social services districts responsible for the care and custody of children, health care providers and their designees, schools, WIC programs, and third party payers the immunization status of children; and

(d) appropriately protecting the confidentiality of individual identifying information and the privacy of persons included in the statewide immunization information system and their families.

2. For the purposes of this section:

(a) The term "authorized user" shall mean any person or entity authorized to provide information to or to receive information from the statewide immunization information system and shall include health care providers and their designees, as defined in paragraph (d) of this subdivision, schools as defined in paragraph (a) of subdivision one of section twenty-one hundred sixty-four of this title, third party payer as defined in paragraph (f) of this subdivision, local health districts as defined by paragraph (c) of subdivision one of section two of this chapter, local social services districts and the office of children and family services with regard to children in their legal custody, and WIC programs as defined in paragraph (g) of this subdivision. An authorized user may be located outside New York State. An entity other than a local health district shall be an authorized user only with respect to a person seeking or receiving a health care service from the health care provider, a person enrolled or seeking to be enrolled in the school, a person insured by the third party payer, a person in the custody of the local social services district or the office of children and family services, or a person seeking or receiving services through WIC programs, as the case may be.

(b) The term "statewide immunization information system" or "system" shall mean a statewide-computerized database maintained by the department capable of collecting, storing, and disclosing the electronic and paper records of vaccinations received by persons less than nineteen years of age.

(c) The term "citywide immunization registry" shall mean the computerized database maintained by the city of New York department of health and mental hygiene capable of collecting, storing, and disclosing the electronic and paper records of vaccinations received by persons less than nineteen years of age. The term "citywide immunization registry" shall not include the childhood blood lead registry established pursuant to the health code of the city of New York. For the purposes of this section the term New York city department of health and mental hygiene, shall mean such agency or any successor agency responsible for the citywide immunization registry.

(d) The term "health care provider" shall mean any person authorized by law to order an immunization or analysis of a blood sample for lead or any health care facility licensed under article twenty-eight of this chapter or any certified home health agency established under section thirty-six hundred six of this chapter; with respect to a person seeking or receiving a health care service from the health care provider.

(e) For purposes of this section a school is a public health authority, as defined in section 164.501 of part 45 of the federal code of rules, responsible for screening the immunization status of each child pursuant to section twenty-one hundred sixty-four of this article.

(f) The term "third party payer" shall mean health maintenance organizations certified under article forty-four of this chapter, health service corporations licensed pursuant to article forty-three of the insurance law, self-insured plans that pay for health care services, health insurance companies subject to article thirty-two of the insurance law which offer preferred provider products, corporations subject to article forty-three of the insurance law which offer preferred provider products, municipal cooperative health benefit plans certified pursuant to article forty-seven of the insurance law which offer preferred provider products, and preferred provider organizations as defined in section three hundred fifty-two of the workers' compensation law.

(g) For purposes of this section the term "WIC program" shall mean a state or local agency, as described pursuant to section 1786 of title 42 of the United States Code.

(h) The term "physician office laboratory" shall mean a laboratory operated by a health care provider pursuant to subdivision one of section five hundred seventy-nine of this chapter that is certified by the Centers for Medicare and Medicaid Services under regulations implementing the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA).

3. (a) Any health care provider who administers any vaccine to a person less than nineteen years of age or, on or after September first, two thousand nine, conducts a blood lead analysis of a sample obtained from a person under eighteen years of age in accordance with paragraph (h) of subdivision two of this section; and immunizations received by a person less than nineteen years of age in the past if not already reported, shall report all such immunizations and the results of any blood lead analysis to the department in a format prescribed by the commissioner within fourteen days of administration of such immunizations or of obtaining the results of any such blood lead analysis. Health care providers administering immunizations to persons less than nineteen years of age in the city of New York shall report, in a format prescribed by the city of New York commissioner of health and mental hygiene, all such immunizations to the citywide immunization registry. The commissioner, and for the city of New York the commissioner of health and mental hygiene, shall have the discretion to accept for inclusion in the system information regarding immunizations administered to individuals nineteen years of age or older with the express written consent of the vaccine. Health care providers who conduct a blood lead analysis on a person under eighteen years of age and who report the results of such analysis to the city of New York commissioner of health and mental hygiene pursuant to New York city reporting requirements shall be exempt from this requirement for reporting blood lead analysis results to the state commissioner of health; provided, however, blood lead analysis data collected from physician office laboratories by the commissioner of health and mental hygiene of the city of New York pursuant to the health code of the city of New York shall be provided to the department in a format prescribed by the commissioner.

(b) The statewide immunization information system shall provide a method for health care providers to determine when the registrant is due or late for a recommended immunization and shall serve as a means for authorized users to receive prompt and accurate information, as reported to the system, about the vaccines that the registrant has received.

4. (a) All information maintained by the department, or in the case of the citywide immunization registry, the city of New York under the provisions of this section shall be confidential except as necessary to carry out the provisions of this section and shall not be released for any other purpose.

(b) The department and for the city of New York the department of health and mental hygiene may also disclose or provide such information to an authorized user when (i) such person or agency provides sufficient identifying information satisfactory to the department to identify such registrant and (ii) such disclosure or provision of information is in the best interests of the registrant or his or her family, or will contribute to the protection of the public health.

(c) Any data collected by the department may be included in the statewide immunization information system and the statewide registry of lead levels of children if collection, storage and access of such data is otherwise authorized. Such data may be disclosed to the statewide immunization information system only if provided for in statute and regulation, and shall be subject to any provisions in such statute or regulation limiting the use or redisclosure of the data. Nothing contained in this paragraph shall permit inclusion of data in the statewide immunization information system if that data could not otherwise be accessed or disclosed in the absence of the system. For the city of New York the commissioner of health and mental hygiene may include data collected in the citywide immunization registry as provided in this paragraph.

(d) A person, institution or agency to whom such immunization information is furnished or to whom, access to records or information has been given, shall not divulge any part thereof so as to disclose the identity of such person to whom such information or record relates, except insofar as such disclosure is necessary for the best interests of the person or other persons, consistent with the purposes of this section.

5. (a) All health care providers and their designees, except for providers reporting to the citywide immunization registry, shall submit to the commissioner information about any vaccinee less than nineteen years of age and about each vaccination given after January first, two thousand eight. The information provided to the system or the citywide immunization registry shall include the national immunization program data elements and other elements required by the commissioner. For the city of New York the commissioner of health and mental hygiene may require additional elements with prior notice to the commissioner of any changes.

(b) In addition to the immunization administration information required by this section, the operation of any immunization registry established under chapter five hundred twenty-one of the laws of nineteen hundred ninety-four, section 11.07 of title twenty-four of volume eight of the compilation of the rules of the city of New York and administered by a local health district collecting information from health care providers about vaccinations previously administered to a vaccinee prior to the effective date of this section shall provide the commissioner access to such information.

(c) All health care providers shall provide the department or, as appropriate, the city of New York with additional or clarifying information upon request reasonably related to the purposes of this section.

(d) Notwithstanding the above, submission of incomplete information shall not prohibit entry of incomplete but viable data into the statewide immunization information system.

(e) The commissioner of the department of health and mental hygiene for the city of New York shall implement the requirements of this subdivision.

(f) The immunization status of children exempt from immunizations pursuant to subdivision eight of this section and a parent claiming exemption pursuant to subdivision nine of section twenty-one hundred sixty-four of this title shall be reported by the health care provider.

6. In the city of New York, the commissioner of the department of health and mental hygiene of the city of New York may maintain its existing registry consistent with the requirements of this section and shall provide information to the commissioner and to authorized users.

7. Each parent or legal guardian of a newborn infant or a child newly enrolled in the statewide immunization information system shall receive information, developed by the department, describing the enrollment process and how to review and correct information and obtain a copy of the child's immunization record. The city of New York will be responsible for providing information about the processes for enrollment and access to the citywide immunization registry by a parent or legal guardian of a newborn infant or newly enrolled child residing in the city of New York.

8. Access and use of identifiable registrant information shall be limited to authorized users consistent with this subdivision and the purposes of this section.

(a) The commissioner shall provide a method by which authorized users apply for access to the system. For the city of New York, the commissioner of health and mental hygiene shall provide a method by which authorized users apply for access to the citywide immunization registry.

(b) (i) The commissioner may use the statewide immunization information system and the blood lead information in such system for purposes of outreach, quality improvement and accountability, research, epidemiological studies and disease control, and to obtain blood lead test results from physician office laboratories for the statewide registry of lead levels of children established pursuant to subdivision two of section thirteen hundred seventy-a of this chapter; (ii) the commissioner of health and mental hygiene for the city of New York may use the immunization registry and the blood lead information in such system for purposes of outreach, quality improvement and accountability, research, epidemiological studies and disease control; (iii) local health departments shall have access to the immunization information system and the blood lead information in such system for purposes of outreach, quality improvement and accountability, epidemiological studies and disease control within their county; and

(c) health care providers and their designees shall have access to the statewide immunization information system and the blood lead information in such system only for purposes of submission of information about vaccinations received by a specific registrant, determination of the immunization status of a specific registrant, determination of the blood lead testing status of a specific registrant, submission of the results from a blood lead analysis of a sample obtained from a specific registrant in accordance with paragraph (h) of subdivision two of this section, review of practice coverage, generation of reminder notices, quality improvement and accountability and printing a copy of the immunization or lead testing record for the registrant's medical record, for the registrant's parent or guardian, or other person in parental or custodial relation to a child, or for a registrant upon reaching eighteen years of age.

(d) The following authorized users shall have access to the statewide immunization information system and the blood lead information in such system and the citywide immunization registry for the purposes stated in this paragraph: (i) schools for verifying immunization status for eligibility for admission; (ii) third party payer for performing quality assurance, accountability and outreach, relating to enrollees covered by the third party payer; (iii) commissioners of local social services districts with regard to a child in his/her legal custody; (iv) the commissioner of the office of children and family services with regard to children in their legal custody, and for quality assurance and accountability of commissioners of local social services districts, care and treatment of children in the custody of commissioners of local social services districts; and (v) WIC programs for the purposes of verifying immunization and lead testing status for those seeking or receiving services.

9. The commissioner may judge the legitimacy of any request for immunization system information and may refuse access to the statewide immunization information system based on the authenticity of the request, credibility of the authorized user or other reasons as provided for in regulation. For the city of New York the commissioner of health and mental hygiene may judge the legitimacy of requests for access to the citywide immunization registry and refuse access to the immunization registry based on the authenticity of the request, credibility of the authorized user or other reasons as provided for in regulation.

10. The person to whom any immunization record relates, or his or her parent, or guardian, or other person in parental or custodial relation to such person may request a copy of an immunization or lead testing record from the registrant's healthcare provider, the statewide immunization information system or the citywide immunization registry according to procedures established by the commissioner or, in the case of the citywide immunization registry, by the city of New York commissioner of the department of health and mental hygiene.

11. The commissioner, or in the city of New York, the commissioner of the department of health and mental hygiene, may provide registrant specific immunization records to other state registries pursuant to a written agreement requiring that the out-of-state registry conform to national standards for maintaining the integrity of the data and will not be used for purposes inconsistent with the provisions of this section.

12. Information that would be provided upon the enrollment in the statewide immunization information system of a child being vaccinated, from birth records of all infants born in New York state on or after January first, two thousand four shall be entered into the statewide immunization information system, except in the city of New York, where birth record information shall be entered into the citywide immunization registry.

13. The commissioner shall promulgate regulations as necessary to effectuate the provisions of this section. Such regulations shall include provision for orderly implementation and operation of the statewide immunization information system, including the method by which each category of authorized user may access the system. Access standards shall include at a minimum a method for assigning and authenticating each user identification and password assigned.

14. No authorized user shall be subjected to civil or criminal liability, or be deemed to have engaged in unprofessional conduct for reporting to, receiving from, or disclosing information relating to the statewide immunization information system when made reasonably and in good faith and in accordance with the provisions of this section or any regulation adopted thereto.