N.Y. Public Health Law § 2168: Statewide immunization information system

§ 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, including

professional responsibility proceedings of the office of professional

medical conduct and the state education department, 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,

including professional responsibility proceedings of the office of

professional medical conduct and the state education department, 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, pre-kindergarten 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 the federal centers for

disease control and prevention or its successor agency, 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 that the data will only be used for purposes consistent with the

provisions of this section and provided that disclosure of identifiable

registrant information shall be limited to the minimum amount necessary

to accomplish the purposes consistent with the provisions of this

section as determined by the commissioner, or in the city of New York,

the commissioner of the department of health and mental hygiene.

11-a. The commissioner, or in the city of New York, the commissioner

of the department of health and mental hygiene, may only share registry

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 with the federal Centers for Disease Control and Prevention, or

successor agency, for public health purposes in summary, statistical,

aggregate, or other form such that no individual person can be

identified, except that either such commissioner may disclose

identifiable registrant information to the federal Centers for Disease

Control and Prevention, or its successor agency, when the commissioner

has determined that the disclosure is in the best interests of the

registrant or will contribute to the protection of public health and

that the objective of the disclosure cannot be served by disclosure

limited to de-identified information, or the federal health officials

have committed in writing not to redisclose to or share registrant

information with any other federal agency, including but not limited to

the department of homeland security, immigration and customs

enforcement, customs and border protection, or any successor agency, or

any law enforcement agency; provided that either such commissioner may

forgo the written commitment if requiring written commitment would

result in the actual withholding of federal funds.

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.