1.1                          A bill for an act 
  1.2             relating to health; authorizing the creation of 
  1.3             community and statewide immunization registries; 
  1.4             providing criminal penalties; proposing coding for new 
  1.5             law in Minnesota Statutes, chapter 144. 
  1.6   BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA: 
  1.7      Section 1.  [144.2601] [DEFINITIONS.] 
  1.8      Subdivision 1.  [APPLICATION.] The definitions in this 
  1.9   section apply to sections 144.2601 to 144.2609. 
  1.10     Subd. 2.  [ACCESS.] "Access" means allowing people with a 
  1.11  legitimate need for immunization-related information on a 
  1.12  specific individual to enter or review immunization record data. 
  1.13     Subd. 3.  [BOARD OF HEALTH.] "Board of health" means an 
  1.14  administrative authority established under sections 145A.03 and 
  1.15  145A.04. 
  1.16     Subd. 4.  [COMMISSIONER.] "Commissioner" means the 
  1.17  commissioner of health. 
  1.18     Subd. 5.  [COMMUNITY-BASED REGISTRY.] "Community-based 
  1.19  registry" means a population-based immunization registry 
  1.20  established by a board of health or its agent in conjunction 
  1.21  with providers and group purchasers in a particular geographic 
  1.22  area for the purposes of exchanging shared immunization records, 
  1.23  ensuring a complete individual immunization record exists to 
  1.24  avoid under- and over-immunization of individuals, conducting 
  1.25  immunization reminder and recall, and conducting immunization 
  2.1   assessments. 
  2.2      Subd. 6.  [CONFIDENTIALITY.] "Confidentiality" refers to 
  2.3   the duty of health care providers, boards of health, and the 
  2.4   department to not disclose information about individuals to 
  2.5   others except as authorized. 
  2.6      Subd. 7.  [DEPARTMENT.] "Department" means the department 
  2.7   of health. 
  2.8      Subd. 8.  [ENROLLEE.] "Enrollee" means a person enrolled in 
  2.9   an immunization registry. 
  2.10     Subd. 9.  [ENROLLMENT.] "Enrollment" means the 
  2.11  establishment of a new and unique immunization record for an 
  2.12  individual in a population-based immunization registry. 
  2.13     Subd. 10.  [GROUP PURCHASER.] "Group purchaser" has the 
  2.14  meaning given in section 62J.03, subdivision 6, and includes a 
  2.15  health plan. 
  2.16     Subd. 11.  [IMMUNIZATION ASSESSMENT.] "Immunization 
  2.17  assessment" means the periodic analysis of immunization records 
  2.18  to measure the proportion of a defined age cohort that has 
  2.19  received age-appropriate immunizations as defined by the 
  2.20  department in its schedule of recommended childhood and adult 
  2.21  immunizations. 
  2.22     Subd. 12.  [IMMUNIZATION RECORD.] "Immunization record" 
  2.23  includes information to correctly identify a person, ensure 
  2.24  age-appropriate immunizations are delivered, and describe each 
  2.25  immunization provided. 
  2.26     Subd. 13.  [IMMUNIZATION REGISTRY.] "Immunization registry" 
  2.27  means the central collection of data related to vaccines 
  2.28  administered to a person and any information needed to correctly 
  2.29  identify that person.  An immunization registry may be: 
  2.30     (1) provider-based, maintaining immunization records of a 
  2.31  specific provider or clinic; or 
  2.32     (2) population-based, maintaining immunization records for 
  2.33  all persons in a geographic area, starting with birth records. 
  2.34     Subd. 14.  [IMMUNIZATION REMINDER AND 
  2.35  RECALL.] "Immunization reminder and recall" means a system 
  2.36  associated with an immunization registry designed to notify 
  3.1   enrollees of upcoming or past due immunizations in order to 
  3.2   support enrollees or providers in achieving age-appropriate 
  3.3   immunizations. 
  3.4      Subd. 15.  [PATIENT.] "Patient" has the meaning given in 
  3.5   section 144.335, subdivision 1. 
  3.6      Subd. 16.  [PRIVACY.] "Privacy" refers to the interest of 
  3.7   an individual to control the dissemination and use of 
  3.8   information that relates to the individual. 
  3.9      Subd. 17.  [PROVIDER.] "Provider" has the meaning given in 
  3.10  section 144.335, subdivision 1. 
  3.11     Subd. 18.  [SCHOOL.] "School" has the meaning given in 
  3.12  sections 123.70, subdivision 9, and 135A.14, subdivision 1. 
  3.13     Subd. 19.  [SECURITY.] "Security" refers to the procedures 
  3.14  to protect data from accidental or intentional disclosure to an 
  3.15  unauthorized person and to protect data from loss or 
  3.16  unauthorized alterations. 
  3.17     Subd. 20.  [SHARED IMMUNIZATION RECORD.] "Shared 
  3.18  immunization record" refers to the standardized immunization 
  3.19  data that is shared between those authorized to do so pursuant 
  3.20  to sections 144.2607 and 144.3351 and that contains the 
  3.21  following information, unless otherwise specified by rule 
  3.22  adopted under section 144.2602: 
  3.23     (1) registry identification (local registry number); 
  3.24     (2) Minnesota immunization number; 
  3.25     (3) first name; 
  3.26     (4) middle name; 
  3.27     (5) last name; 
  3.28     (6) birth date; 
  3.29     (7) gender; 
  3.30     (8) apartment or box number; 
  3.31     (9) street address; 
  3.32     (10) city; 
  3.33     (11) state; 
  3.34     (12) zip code; 
  3.35     (13) contraindication indicator; 
  3.36     (14) mother's first name; 
  4.1      (15) mother's middle name; 
  4.2      (16) mother's last name; 
  4.3      (17) immunization date; 
  4.4      (18) vaccine type; 
  4.5      (19) vaccine manufacturer; 
  4.6      (20) vaccine lot number; 
  4.7      (21) immunization event record location; and 
  4.8      (22) immunization adverse reaction indicator. 
  4.9      Subd. 21.  [STATEWIDE REGISTRY.] "Statewide registry" means 
  4.10  a population-based immunization registry operated by the 
  4.11  department to support provider- and community-based registries 
  4.12  and to conduct immunization assessments and public health 
  4.13  research. 
  4.14     Subd. 22.  [VACCINE.] "Vaccine" means those biologics that 
  4.15  are used to provide immunity against diseases, including 
  4.16  diphtheria, tetanus, pertussis, polio, measles, mumps, rubella, 
  4.17  haemophilus influenza type b, hepatitis B, hepatitis A, 
  4.18  varicella, influenza, and pneumococcal pneumonia. 
  4.19     Sec. 2.  [144.2602] [DUTIES OF THE COMMISSIONER.] 
  4.20     Subdivision 1.  [RULEMAKING.] The commissioner shall adopt 
  4.21  rules related to the operation of a statewide registry system.  
  4.22  The rules shall include, but not be limited to, the following: 
  4.23     (1) standards for submitting shared immunization records to 
  4.24  a population-based registry; 
  4.25     (2) criteria for allowing authorized access to shared 
  4.26  immunization records consistent with section 144.2607 for: 
  4.27     (i) providers for the purpose of providing appropriate 
  4.28  immunizations; 
  4.29     (ii) schools and others for the purpose of verifying 
  4.30  compliance with school and child care immunization requirements; 
  4.31     (iii) public health research and other studies; and 
  4.32     (iv) individuals or parents or guardians of minors, for the 
  4.33  purpose of obtaining a complete immunization history; 
  4.34     (3) criteria by which the commissioner certifies 
  4.35  community-based registries, including but not limited to: 
  4.36     (i) a minimum voluntary participation level of providers in 
  5.1   the geographic area served by the community-based registry; 
  5.2      (ii) a minimum proportion of births within the geographic 
  5.3   area served by a community-based registry being voluntarily 
  5.4   enrolled in the registry; and 
  5.5      (iii) operational procedures consistent with section 
  5.6   144.2603; 
  5.7      (4) procedures by which an individual may be disenrolled in 
  5.8   a registry; 
  5.9      (5) a process by which a community-based registry applies 
  5.10  to become certified by the commissioner; and 
  5.11     (6) the procedures and schedule for mandatory immunization 
  5.12  event reporting to community-based registries once a registry is 
  5.13  certified by the commissioner. 
  5.14     Subd. 2.  [IMMUNIZATION REGISTRY ADVISORY TASK FORCE.] The 
  5.15  commissioner shall establish an immunization registry advisory 
  5.16  task force to advise on rulemaking under subdivision 1 and the 
  5.17  planning, establishment, implementation, and operation of 
  5.18  population-based immunization registries, including issues 
  5.19  relating to confidentiality, access to records, privacy, data 
  5.20  security, and public health research.  The advisory task force 
  5.21  shall be appointed by the commissioner and be composed of, but 
  5.22  is not limited to, representatives from boards of health, 
  5.23  providers, group purchasers, schools, and consumers.  The 
  5.24  advisory task force is governed by section 15.014, and expires 
  5.25  June 30, 2002. 
  5.26     Sec. 3.  [144.2603] [POPULATION-BASED REGISTRIES.] 
  5.27     Subdivision 1.  [COMMUNITY-BASED REGISTRIES.] Subject to 
  5.28  the availability of funds, boards of health, singly or jointly, 
  5.29  or an assigned agent of a board of health, may develop and 
  5.30  maintain community-based registries to support the ongoing 
  5.31  efforts of providers and health plans to ensure age-appropriate 
  5.32  immunizations.  Registries established in accordance with this 
  5.33  provision shall operate according to rules adopted under section 
  5.34  144.2602.  These registries shall, at a minimum, establish the 
  5.35  following: 
  5.36     (1) operational procedures that include, but are not 
  6.1   limited to: 
  6.2      (i) creating and updating immunization records for all 
  6.3   persons of a defined age cohort who were born or live within the 
  6.4   geographic area served by the community-based registry, 
  6.5   consistent with standards developed by the department and 
  6.6   reviewed by the immunization registry advisory task force, 
  6.7   including procedures for notification of enrollment as described 
  6.8   in section 144.2606; 
  6.9      (ii) quality assurance procedures for maintaining timely, 
  6.10  accurate, and complete data; 
  6.11     (iii) procedures for exchanging shared immunization records 
  6.12  between provider-based, community-based, and statewide 
  6.13  registries; 
  6.14     (iv) a method of notifying in writing a provider or group 
  6.15  purchaser when the registry indicates that an enrollee is due to 
  6.16  receive a scheduled immunization or when the enrollee has missed 
  6.17  a scheduled immunization, if the notification is requested by 
  6.18  the enrollee's provider or group purchaser; 
  6.19     (v) a method of notifying an enrollee, or the parent or 
  6.20  guardian of a minor enrollee, when the registry indicates that 
  6.21  an enrollee is due to receive a scheduled immunization or when 
  6.22  the enrollee has missed a scheduled immunization, if the 
  6.23  enrollee has no provider or group purchaser of record or if the 
  6.24  notification is requested by the enrollee's provider or group 
  6.25  purchaser; 
  6.26     (vi) procedures for ensuring that parents, schools, and 
  6.27  providers receive timely and accurate responses to authorized 
  6.28  requests for immunization records; and 
  6.29     (vii) procedures for conducting assessments of immunization 
  6.30  rates for providers, group purchasers, or for a birth cohort 
  6.31  within a geographic area, if requested to do so by a provider, 
  6.32  group purchaser, or the department; 
  6.33     (2) agreements with participating providers that allow a 
  6.34  provider or a group purchaser to submit shared immunization 
  6.35  records to and obtain shared immunization records from the 
  6.36  immunization registry; 
  7.1      (3) written policies related to data security, access, and 
  7.2   confidentiality, consistent with section 144.2607; 
  7.3      (4) procedures for using the registry data to conduct 
  7.4   immunization assessments of the community; and 
  7.5      (5) an advisory group to advise on the establishment and 
  7.6   operation of the community-based registry. 
  7.7      Subd. 2.  [STATEWIDE REGISTRY.] Subject to the availability 
  7.8   of funds, the department shall establish a statewide registry 
  7.9   that connects community-based registries across the state.  A 
  7.10  registry established in accordance with this subdivision shall 
  7.11  operate according to rules adopted under section 144.2602.  The 
  7.12  registry shall, at a minimum, establish the following: 
  7.13     (1) operational procedures that include, but are not 
  7.14  limited to: 
  7.15     (i) creating and updating immunization records of all 
  7.16  persons born or living within the state for a particular age 
  7.17  cohort, including procedures for enrollment notification as 
  7.18  described in section 144.2606; 
  7.19     (ii) quality assurance procedures as defined by rule; and 
  7.20     (iii) procedures for sharing or transferring shared 
  7.21  immunization records with other immunization registries within 
  7.22  the state; 
  7.23     (2) written policies related to data security, access, and 
  7.24  confidentiality consistent with section 144.2607; 
  7.25     (3) procedures for using the registry data to conduct 
  7.26  statewide or community immunization assessments, consistent with 
  7.27  rules adopted under section 144.2602; and 
  7.28     (4) procedures for using the registry data to conduct 
  7.29  public health research and other studies consistent with section 
  7.30  144.2607 and rules adopted under section 144.2602. 
  7.31     Sec. 4.  [144.2604] [REPORTING TO COMMUNITY-BASED 
  7.32  REGISTRIES.] 
  7.33     When a community-based registry is certified according to 
  7.34  rules adopted under section 144.2602, a provider that operates 
  7.35  in the geographic area served by the registry shall report all 
  7.36  immunization events in a format and according to procedures 
  8.1   established by rule. 
  8.2      Sec. 5.  [144.2606] [ENROLLMENT.] 
  8.3      Subdivision 1.  [BIRTH REGISTRATION; ENROLLMENT.] Birth 
  8.4   registration under section 144.215 shall be used to enroll all 
  8.5   newborn Minnesota residents in immunization registries.  
  8.6   Individuals moving into a geographic area served by an 
  8.7   immunization registry may be enrolled in the registry at any 
  8.8   time by a provider, board of health, school, or group purchaser. 
  8.9      Subd. 2.  [NOTIFICATION.] Within 30 calendar days of an 
  8.10  individual being enrolled in an immunization registry, the 
  8.11  enrollee, or the parents or guardians of a minor enrollee, shall 
  8.12  be notified of the enrollment by the community-based registry, a 
  8.13  provider, board of health, birthing facility, or group 
  8.14  purchaser, or the department.  Notification of enrollment shall 
  8.15  include the purposes of immunization registries, how the 
  8.16  information collected will be used, the benefits to the enrollee 
  8.17  and to providers of the immunization registries, precautions 
  8.18  that are taken to prevent unauthorized uses of the immunization 
  8.19  data, under what conditions third parties may or may not obtain 
  8.20  access to personally identifiable information, and the 
  8.21  procedures by which a person may disenroll from a 
  8.22  community-based registry. 
  8.23     Subd. 3.  [CONSENT.] Nothing in this section requires the 
  8.24  consent of a person, or the parent or guardian of a minor 
  8.25  person, prior to enrolling the person in a registry. 
  8.26     Sec. 6.  [144.2607] [DATA PROTECTION.] 
  8.27     Subdivision 1.  [DATA CLASSIFICATION; IMMUNIZATION 
  8.28  RECORDS.] Immunization records shall be private data on 
  8.29  individuals as defined under section 13.02, subdivision 12, 
  8.30  except as specified in section 144.3351 and as determined by 
  8.31  rule. 
  8.32     Subd. 2.  [DATA CLASSIFICATION; ASSESSMENT 
  8.33  DATA.] Notwithstanding section 13.03 or any other law to the 
  8.34  contrary, the immunization assessment data generated by a 
  8.35  registry shall be private and may be published only in aggregate 
  8.36  form and in a manner that does not identify individuals, 
  9.1   individual providers or clinics, or group purchasers. 
  9.2      Subd. 3.  [PROTECTION POLICY.] A population-based registry 
  9.3   shall establish a written policy consistent with criteria 
  9.4   established by rule addressing the issues of privacy, 
  9.5   confidentiality, and security.  The policy shall address how the 
  9.6   registry will ensure: 
  9.7      (1) the integrity of immunization record data so that the 
  9.8   information is accurate, complete, and trustworthy; 
  9.9      (2) the availability of shared immunization records so that 
  9.10  an authorized person who needs the information for legitimate 
  9.11  health purposes has ready access to the data; and 
  9.12     (3) the privacy of enrollees so they can be assured that 
  9.13  personal information is appropriately protected. 
  9.14     Subd. 4.  [ACCESS POLICY.] (a) A population-based registry 
  9.15  shall establish a written policy consistent with criteria 
  9.16  established by rule to define who will have access and to what 
  9.17  data they will have access.  Access to the registry may be 
  9.18  granted to: 
  9.19     (1) a provider, group purchaser, board of health, or other 
  9.20  entity authorized to administer immunizations and to share 
  9.21  immunization data as authorized in section 144.3351; 
  9.22     (2) a parent or legal guardian who may request correction 
  9.23  or amendment of a child's immunization records, if the records 
  9.24  contain errors; 
  9.25     (3) a board of health; 
  9.26     (4) the department; 
  9.27     (5) a school and others with appropriate need for 
  9.28  immunization records with limited personal identifiers; and 
  9.29     (6) a researcher and others with appropriate need for 
  9.30  immunization information without personal identifiers. 
  9.31     (b) A population-based registry shall establish a policy 
  9.32  for reviewing, on a case-by-case basis, requests for access from 
  9.33  a person not listed in paragraph (a). 
  9.34     (c) An individual authorized to receive data from the 
  9.35  registry shall adhere to the principles of confidentiality, 
  9.36  privacy, and security as described in this section and section 
 10.1   144.335. 
 10.2      Subd. 5.  [USE OF DATA.] (a) Data collected for shared 
 10.3   immunization records may only be used: 
 10.4      (1) to assess a person's immunization status; 
 10.5      (2) for reminder and recall; 
 10.6      (3) to notify a person of a vaccine-preventable disease 
 10.7   outbreak to which that person may be susceptible; 
 10.8      (4) for individual immunization reports for school 
 10.9   admission, child care enrollment, or other enrollment purposes 
 10.10  that require an immunization history; or 
 10.11     (5) in the aggregate as provided under paragraph (b). 
 10.12     (b) Data collected for shared immunization records may be 
 10.13  used in the aggregate to assess immunization levels in an entire 
 10.14  birth cohort, provided that no person's first or last name, 
 10.15  address, social security number, or other personally 
 10.16  identifiable information is used.  The birth date, which is 
 10.17  necessary to establish a person's birth cohort, and the county 
 10.18  or zip code of residence, which is necessary to determine the 
 10.19  immunization levels of geographic areas, may be used in the 
 10.20  aggregate to assess immunization levels in an entire birth 
 10.21  cohort.  Use of the shared immunization record data for 
 10.22  proprietary or commercial use is prohibited. 
 10.23     (c) Registries shall establish policies and procedures to 
 10.24  authenticate users of the registry. 
 10.25     Subd. 6.  [PENALTY.] A person who through willful 
 10.26  misconduct or gross negligence accesses or discloses private 
 10.27  data in violation of this section is guilty of a misdemeanor. 
 10.28     Sec. 7.  [144.2608] [LIABILITY.] 
 10.29     Subdivision 1.  [GOOD FAITH IMMUNITY.] A provider, board of 
 10.30  health, school, group purchaser, or individual submitting 
 10.31  immunization data to a population-based immunization registry 
 10.32  shall be immune from civil or criminal liability that otherwise 
 10.33  might result from their actions, if they are acting in good 
 10.34  faith that the immunization data they are submitting is truthful 
 10.35  and accurate. 
 10.36     Subd. 2.  [PENALTY.] A person who knowingly and maliciously 
 11.1   falsifies or fabricates immunization data in a population-based 
 11.2   immunization registry is guilty of a misdemeanor. 
 11.3      Sec. 8.  [144.2609] [PARENTAL RESPONSIBILITY; EXEMPTIONS.] 
 11.4      Subdivision 1.  [PARENTAL RESPONSIBILITY.] Nothing in 
 11.5   sections 144.2601 to 144.2609 is intended to mitigate the 
 11.6   responsibility of a parent or guardian to have a child immunized 
 11.7   as specified in section 123.70. 
 11.8      Subd. 2.  [EXEMPTIONS.] Nothing in sections 144.2601 to 
 11.9   144.2609 is intended to require immunization of a person who is 
 11.10  exempt from immunization requirements based on medical, 
 11.11  religious, or other reasons as specified in section 123.70. 
 11.12     Sec. 9.  [EFFECTIVE DATE.] 
 11.13     Sections 1 to 8 are effective the day following final 
 11.14  enactment.