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SECTION 2168
Statewide immunization information system
Public Health (PBH) CHAPTER 45, ARTICLE 21, TITLE 6
§ 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, colleges as defined
in section two of the education law, professional and technical schools
as referred to in the definition of higher education in section two of
the education law, children's overnight camps and summer day camps as
defined in section thirteen hundred ninety-two of this chapter, 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, WIC programs as defined in paragraph (g) of this
subdivision, registered professional nurses, and pharmacists authorized
to administer immunizations pursuant to subdivision two of section
sixty-eight hundred one of the education law. 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 under 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) (i) 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. 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.

(ii) A pharmacist who administers a vaccine pursuant to subdivision
two of section sixty-eight hundred one of the education law, to a person
less than nineteen years of age, shall report all such immunizations to
the department in a format prescribed by the commissioner within
fourteen days of administration of such immunizations. Pharmacists
administering immunizations pursuant to subdivision two of section
sixty-eight hundred one of the education law 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.

(b) (i) Any health care provider who administers any vaccine to a
person nineteen years of age or older, may report, with the consent of
the vaccinee, all such immunizations to the department in a format
prescribed by the commissioner within fourteen days of administration of
such immunizations. Health care providers administering immunizations to
persons nineteen years of age or older in the city of New York may
report, with the consent of the vaccinee, in a format prescribed by the
city of New York commissioner of health and mental hygiene, all such
immunizations to the citywide immunization registry.

(ii) A registered professional nurse, or a pharmacist who administers
a vaccine pursuant to subdivision two of section sixty-eight hundred one
of the education law, to a person nineteen years of age or older, shall
report, with the consent of the vaccinee, all such immunizations to the
department in a format prescribed by the commissioner within fourteen
days of administration of such immunizations. Registered professional
nurses or pharmacists administering immunizations pursuant to
subdivision two of section sixty-eight hundred one of the education law,
to persons nineteen years of age or older in the city of New York shall
report, with the consent of the vaccinee, in a format prescribed by the
city of New York commissioner of health and mental hygiene, all such
immunizations to the citywide immunization registry.

(c) 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 or
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.

(c-1) The department may require the collection of, maintenance and
access to newborn infant hearing screening data and results through the
statewide immunization information system in accordance with section
twenty-five hundred-g of this chapter.

(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 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, registered professional
nurses, and pharmacists authorized to administer immunizations pursuant
to subdivision two of section sixty-eight hundred one of the education
law 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 the purpose of verifying immunization
status for eligibility for admission, for the purpose of confirming a
student has been screened for lead when enrolling in child care,
pre-school or kindergarten, and for the provision of appropriate
educational materials developed by the department pursuant to section
thirteen hundred seventy-a of this chapter on the dangers of lead
exposure, and the health risks associated with elevated blood lead
levels to the parents or legal guardians of the student with an elevated
blood lead level, as such term is defined in subdivision six of section
thirteen hundred seventy of this chapter, as well as information on
programs that may be available to the student and the parents or legal
guardians of the student. For each school that has the technical ability
to batch download sets of immunization records, the department shall
make available such sets of immunization records of only those children
submitted by the school for which the school has obtained a certificate
of immunization or for which the school has responsibility to verify the
immunization status for school attendance purposes under section
twenty-one hundred sixty-four of this article. Schools shall properly
safeguard such information for use only as authorized by this section;
(ii) colleges for verifying immunization status for eligibility for
admission; (iii) professional and technical schools for verifying
immunization status for eligibility for admission; (iv) children's
overnight camps and summer day camps for verifying immunization status
of children attending camp; (v) third party payer for performing quality
assurance, accountability and outreach, relating to enrollees covered by
the third party payer; (vi) commissioners of local social services
districts with regard to a child in his/her legal custody; (vii) 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 (viii) WIC programs for the purposes of
verifying immunization and lead testing status for those seeking or
receiving services.

(e) Institutes of higher education, medical research centers or other
institutions engaged in epidemiological research or other public health
research shall have access to de-identified registrant information in
the statewide immunization information system or the citywide
immunization registry for research purposes if approved by the
commissioner or the commissioner of the department of health and mental
hygiene of the city of New York, as appropriate.

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 and lead test records to other state or city
registries and registries maintained by the Indian Health Service and
tribal nations recognized by the state or the United States pursuant to
a written agreement requiring that the other 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.