NY Pub Health L § 2168 (2021)
2021 New York Laws PBH - Public Health Article 21 - Control of Acute Communicable Diseases Title 6 - Poliomyelitis and Other Diseases 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, 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;  (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.