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; amending Minnesota 
  1.5             Statutes 1996, section 144.3351; proposing coding for 
  1.6             new law in Minnesota Statutes, chapter 144. 
  1.7   BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA: 
  1.8      Section 1.  Minnesota Statutes 1996, section 144.3351, is 
  1.9   amended to read: 
  1.10     144.3351 [IMMUNIZATION DATA.] 
  1.11     Providers as defined in section 144.335, subdivision 1, 
  1.12  population-based immunization registries as defined in section 
  1.13  144.3402, subdivision 13, group purchasers as defined in section 
  1.14  62J.03, subdivision 6, elementary or secondary schools or child 
  1.15  care facilities as defined in section 123.70, subdivision 9, 
  1.16  public or private post-secondary educational institutions as 
  1.17  defined in section 135A.14, subdivision 1, paragraph (b), a 
  1.18  board of health as defined in section 145A.02, subdivision 2, 
  1.19  community action agencies as defined in section 268.53, 
  1.20  subdivision 1, and the commissioner of health may exchange 
  1.21  immunization data with one another, without the patient's 
  1.22  consent, if the person requesting access provides services on 
  1.23  behalf of the patient.  For purposes of this section 
  1.24  immunization data includes:  
  1.25     (1) patient's name, address, date of birth, gender, parent 
  1.26  or guardian's name; and 
  2.1      (2) date vaccine was received, vaccine type, lot number, 
  2.2   and manufacturer of all immunizations received by the patient, 
  2.3   and whether there is a contraindication or an adverse reaction 
  2.4   indication. 
  2.5      This section applies to all immunization data, regardless 
  2.6   of when the immunization occurred. 
  2.7      Sec. 2.  [144.3401] [CONSTRUCTION.] 
  2.8      Sections 144.3401 to 144.3409 shall be liberally construed 
  2.9   to: 
  2.10     (1) enable the development of population-based immunization 
  2.11  registries, which shall include: 
  2.12     (i) community-based registries operated by boards of health 
  2.13  to exchange shared immunization data to support age-appropriate 
  2.14  immunizations; and 
  2.15     (ii) a statewide registry operated by the commissioner to 
  2.16  maintain immunization data of enrollees, link community-based 
  2.17  registries, conduct public health research, and perform 
  2.18  statewide assessment to prevent and control vaccine-preventable 
  2.19  diseases; 
  2.20     (2) authorize the commissioner to certify community-based 
  2.21  registries which meet specific criteria; 
  2.22     (3) require health care provider reporting of shared 
  2.23  immunization data to certified community-based registries; and 
  2.24     (4) establish data privacy requirements for the collection, 
  2.25  maintenance, access to, and sharing of immunization data 
  2.26  maintained by population-based registries. 
  2.27     Sec. 3.  [144.3402] [DEFINITIONS.] 
  2.28     Subdivision 1.  [APPLICATION.] The definitions in this 
  2.29  section apply to sections 144.3401 to 144.3409. 
  2.30     Subd. 2.  [ACCESS.] "Access" means allowing people with an 
  2.31  authorized need for immunization-related information on a 
  2.32  specific individual to enter or review immunization data. 
  2.33     Subd. 3.  [BOARD OF HEALTH.] "Board of health" means an 
  2.34  administrative authority established under sections 145A.03 and 
  2.35  145A.04. 
  2.36     Subd. 4.  [CERTIFICATION.] "Certification" means approval 
  3.1   by the commissioner after determining that a community-based 
  3.2   registry has fulfilled the requirements of sections 144.3404, 
  3.3   144.3406, and 144.3407. 
  3.4      Subd. 5.  [COMMISSIONER.] "Commissioner" means the 
  3.5   commissioner of health. 
  3.6      Subd. 6.  [COMMUNITY-BASED REGISTRY.] "Community-based 
  3.7   registry" means a population-based immunization registry 
  3.8   established by a board of health or its agent in conjunction 
  3.9   with providers and group purchasers in a particular geographic 
  3.10  area to exchange shared immunization data to support 
  3.11  age-appropriate immunizations. 
  3.12     Subd. 7.  [CONFIDENTIALITY.] "Confidentiality" refers to 
  3.13  the duty of health care providers, boards of health, and the 
  3.14  department to not disclose information about individuals to 
  3.15  others except as authorized. 
  3.16     Subd. 8.  [DEPARTMENT.] "Department" means the department 
  3.17  of health. 
  3.18     Subd. 9.  [ENROLLEE.] "Enrollee" means a person, or the 
  3.19  parent or legal guardian of a minor person, enrolled in a 
  3.20  population-based immunization registry. 
  3.21     Subd. 10.  [ENROLLMENT.] "Enrollment" means the recording 
  3.22  of shared immunization data for a new person in a 
  3.23  population-based immunization registry. 
  3.24     Subd. 11.  [GROUP PURCHASER.] "Group purchaser" has the 
  3.25  meaning given in section 62J.03, subdivision 6, and includes a 
  3.26  health plan. 
  3.27     Subd. 12.  [IMMUNIZATION ASSESSMENT.] "Immunization 
  3.28  assessment" means the periodic analysis of immunization data to 
  3.29  measure the proportion of a population that has received 
  3.30  age-appropriate immunizations as defined by the commissioner in 
  3.31  the schedule of recommended childhood and adult immunizations. 
  3.32     Subd. 13.  [POPULATION-BASED IMMUNIZATION 
  3.33  REGISTRY.] "Population-based immunization registry" means the 
  3.34  central collection of shared immunization data for all persons 
  3.35  of a defined age, starting with birth registration.  
  3.36  Population-based immunization registries include both 
  4.1   community-based and statewide registries. 
  4.2      Subd. 14.  [IMMUNIZATION REMINDER AND 
  4.3   RECALL.] "Immunization reminder and recall" means a system 
  4.4   associated with a population-based immunization registry 
  4.5   designed to notify enrollees or providers of upcoming or past 
  4.6   due immunizations in order to support enrollees or providers in 
  4.7   achieving age-appropriate immunizations. 
  4.8      Subd. 15.  [PRIVACY.] "Privacy" refers to the interest of 
  4.9   an individual to control the dissemination and use of 
  4.10  information that relates to the individual. 
  4.11     Subd. 16.  [PROVIDER.] "Provider" has the meaning given in 
  4.12  section 144.335, subdivision 1. 
  4.13     Subd. 17.  [SCHOOL.] "School" has the meaning given in 
  4.14  sections 123.70, subdivision 9, and 135A.14, subdivision 1. 
  4.15     Subd. 18.  [SECURITY.] "Security" refers to the procedures 
  4.16  to protect data from accidental or intentional disclosure to an 
  4.17  unauthorized person and to protect data from loss or 
  4.18  unauthorized alterations. 
  4.19     Subd. 19.  [SHARED IMMUNIZATION DATA.] "Shared immunization 
  4.20  data" refers to the standardized immunization data that is 
  4.21  shared between those authorized to do so according to sections 
  4.22  144.3351 and 144.3407 and that contains the following 
  4.23  information: 
  4.24     (1) local registry number or other registry identification; 
  4.25     (2) Minnesota immunization number; 
  4.26     (3) first name; 
  4.27     (4) middle name; 
  4.28     (5) last name; 
  4.29     (6) birth date; 
  4.30     (7) gender; 
  4.31     (8) apartment or box number; 
  4.32     (9) street address; 
  4.33     (10) city; 
  4.34     (11) state; 
  4.35     (12) zip code; 
  4.36     (13) contraindication indicator; 
  5.1      (14) legal mother's first name; 
  5.2      (15) legal mother's middle name; 
  5.3      (16) legal mother's last name; 
  5.4      (17) immunization date; 
  5.5      (18) vaccine type; 
  5.6      (19) vaccine manufacturer; 
  5.7      (20) lot number; 
  5.8      (21) name of medical clinic providing immunization; and 
  5.9      (22) immunization adverse reaction indicator. 
  5.10     Subd. 20.  [STATEWIDE REGISTRY.] "Statewide registry" means 
  5.11  a population-based immunization registry operated by the 
  5.12  commissioner to maintain immunization data of enrollees, link 
  5.13  community-based registries, conduct public health research, and 
  5.14  perform statewide assessment to prevent and control 
  5.15  vaccine-preventable diseases. 
  5.16     Subd. 21.  [VACCINE.] "Vaccine" means those biologics that 
  5.17  are used to provide immunity against diseases included in the 
  5.18  schedule of recommended immunizations issued by the 
  5.19  commissioner, which include, but are not limited to, diphtheria, 
  5.20  tetanus, pertussis, polio, measles, mumps, rubella, hemophilus 
  5.21  influenza type b, hepatitis B, hepatitis A, varicella, 
  5.22  influenza, and pneumococcal pneumonia. 
  5.23     Sec. 4.  [144.3403] [DUTIES OF THE COMMISSIONER.] 
  5.24     Subdivision 1.  [RECOMMENDATIONS TO THE LEGISLATURE.] The 
  5.25  commissioner shall prepare recommendations for the 1998 
  5.26  legislature that include, but are not limited to, the following: 
  5.27     (1) criteria for allowing authorized access, including 
  5.28  telecommunications access, to shared immunization data 
  5.29  consistent with section 144.3407; 
  5.30     (2) procedures by which an individual may claim an 
  5.31  exemption to the exchange of their shared immunization data 
  5.32  between authorized users for reminder and recall purposes, or 
  5.33  for other purposes; and 
  5.34     (3) criteria, including data security and quality assurance 
  5.35  procedures, by which the commissioner certifies community-based 
  5.36  registries pursuant to subdivision 3. 
  6.1      Subd. 2.  [IMMUNIZATION REGISTRY ADVISORY TASK FORCE.] The 
  6.2   commissioner shall establish an immunization registry advisory 
  6.3   task force to advise on the development of recommendations as 
  6.4   specified in subdivision 1.  The advisory task force shall be 
  6.5   appointed by the commissioner and be composed of, but not 
  6.6   limited to, representatives from boards of health, providers, 
  6.7   group purchasers, schools, and consumers.  The task force shall 
  6.8   include persons with expertise in immunizations.  The advisory 
  6.9   task force is governed by section 15.014, and expires no later 
  6.10  than June 30, 2002. 
  6.11     Subd. 3.  [CERTIFICATION.] The commissioner may certify a 
  6.12  community-based registry when the board of health operating the 
  6.13  registry submits an application and the commissioner has 
  6.14  evaluated and approved the operation of the registry for 
  6.15  compliance with sections 144.3404, 144.3406, and 144.3407. 
  6.16     Subd. 4.  [STATEWIDE REGISTRY.] Subject to the availability 
  6.17  of funds, the commissioner may establish a statewide registry 
  6.18  that links community-based registries across the state.  The 
  6.19  statewide registry shall, at a minimum, establish procedures for 
  6.20  collecting and exchanging shared immunization data, assuring its 
  6.21  reliability, and providing for data protection according to 
  6.22  chapter 13 and section 144.3407. 
  6.23     Sec. 5.  [144.3404] [COMMUNITY-BASED REGISTRIES.] 
  6.24     Subdivision 1.  [REQUIREMENTS.] Subject to the availability 
  6.25  of funds, boards of health, singly or jointly, or an assigned 
  6.26  agent of a board of health, may develop and maintain 
  6.27  community-based registries.  Registries shall operate according 
  6.28  to this section, and sections 144.3406 and 144.3407.  Registries 
  6.29  shall, at a minimum, establish the following: 
  6.30     (1) policies and operational procedures for collecting and 
  6.31  exchanging shared immunization data, assuring its reliability, 
  6.32  and providing for data privacy, security, and confidentiality 
  6.33  according to chapter 13 and section 144.3407; 
  6.34     (2) agreements with participating providers that allow a 
  6.35  provider or a group purchaser to submit shared immunization data 
  6.36  to and obtain shared immunization data from the community-based 
  7.1   registry; and 
  7.2      (3) a local advisory group to advise on the establishment 
  7.3   and operation of the community-based registry, and to review and 
  7.4   approve the procedures, policies, and agreements developed for 
  7.5   the registry.  
  7.6      Subd. 2.  [CERTIFICATION NOT REQUIRED.] A community-based 
  7.7   registry may operate without certification, provided that the 
  7.8   board of health notifies the commissioner in writing of its 
  7.9   intent to establish a community-based registry. 
  7.10     Subd. 3.  [REPORTING TO STATEWIDE REGISTRY.] Upon the 
  7.11  establishment of a statewide registry under section 144.3403, 
  7.12  subdivision 4, a community-based registry shall report shared 
  7.13  immunization data maintained by the community-based registry to 
  7.14  the statewide registry. 
  7.15     Sec. 6.  [144.3405] [REPORTING TO COMMUNITY-BASED 
  7.16  REGISTRIES.] 
  7.17     After the commissioner has certified a community-based 
  7.18  registry as specified in section 144.3403, subdivision 3, all 
  7.19  providers who administer immunizations in the geographic area 
  7.20  served by the community-based registry shall report shared 
  7.21  immunization data to the community-based registry. 
  7.22     Sec. 7.  [144.3406] [ENROLLMENT.] 
  7.23     Subdivision 1.  [BIRTH REGISTRATION; ENROLLMENT.] Birth 
  7.24  registration data collected under section 144.215 shall be used 
  7.25  to enroll all newborn Minnesota residents in immunization 
  7.26  registries, but shall be limited to the shared immunization data 
  7.27  as defined in section 144.3402, subdivision 19, to the extent 
  7.28  that birth registration data is known.  Individuals moving into 
  7.29  a geographic area served by a population-based registry shall be 
  7.30  enrolled in the registry by a provider, board of health, school, 
  7.31  or group purchaser. 
  7.32     Subd. 2.  [NOTIFICATION.] Within 30 calendar days of an 
  7.33  enrollee being enrolled in a population-based registry, the 
  7.34  community-based registry shall ensure that the enrollee is 
  7.35  notified of the enrollment.  Notification of enrollment shall 
  7.36  include the purposes of immunization registries, how the 
  8.1   information collected will be used, the benefits to the enrollee 
  8.2   and to providers of the immunization registries, precautions 
  8.3   that are taken to prevent unauthorized uses of the immunization 
  8.4   data, under what conditions third parties may obtain access to 
  8.5   personally identifiable information, and the procedures by which 
  8.6   a person may elect to request that specific information not be 
  8.7   shared from a population-based registry. 
  8.8      Subd. 3.  [CONSENT.] Nothing in this section requires the 
  8.9   consent of an enrollee prior to enrollment in a population-based 
  8.10  registry. 
  8.11     Sec. 8.  [144.3407] [ACCESS TO SHARED IMMUNIZATION DATA.] 
  8.12     Subdivision 1.  [DATA CLASSIFICATION; SHARED IMMUNIZATION 
  8.13  DATA.] (a) Shared immunization data created, collected, or 
  8.14  maintained by population-based registries are classified as 
  8.15  health data pursuant to section 13.38.  Shared immunization data 
  8.16  from which an enrollee or provider can be identified are private 
  8.17  data.  Immunization data not on enrollees are nonpublic data.  
  8.18  Shared immunization data may be released pursuant to this 
  8.19  section and sections 13.38 and 144.3351.  Shared immunization 
  8.20  data created, collected, or maintained by population-based 
  8.21  registries shall retain the classification designated and shall 
  8.22  not be disclosed pursuant to section 13.03, subdivisions 6 to 8; 
  8.23  13.10, subdivisions 1 to 4; or 138.17.  
  8.24     (b) An individual authorized to receive data from the 
  8.25  population-based registry shall maintain the privacy of the data 
  8.26  as specified in chapter 13 and as otherwise specified in law. 
  8.27     Subd. 2.  [DATA CLASSIFICATION; ASSESSMENT 
  8.28  DATA.] Notwithstanding section 13.03 or any other law to the 
  8.29  contrary, the immunization assessment data created, collected, 
  8.30  and maintained by population-based registries from which 
  8.31  individual enrollees or providers can be identified are private 
  8.32  data on individuals.  Immunization assessment data not on 
  8.33  individuals are nonpublic data.  Immunization assessment data 
  8.34  generated by population-based registries is nonpublic data and 
  8.35  may be published only in summary form and in a manner that does 
  8.36  not identify individuals, individual providers or clinics, or 
  9.1   group purchasers. 
  9.2      Subd. 3.  [USE OF DATA.] (a) Data created, collected, and 
  9.3   maintained by a population-based registry may only be used: 
  9.4      (1) to assess a person's immunization status for the 
  9.5   purpose of determining needed vaccines; 
  9.6      (2) for reminder and recall; 
  9.7      (3) to notify a person of a vaccine-preventable disease 
  9.8   outbreak to which that person may be susceptible; 
  9.9      (4) for individual immunization reports for school 
  9.10  admission, child care enrollment, or other enrollment purposes 
  9.11  that require an immunization history; or 
  9.12     (5) in summary form as provided under paragraph (b). 
  9.13     (b) Data collected for shared immunization data may be used 
  9.14  in the aggregate to assess immunization levels, provided that no 
  9.15  identifiable information is used.  The birth date, which is 
  9.16  necessary to establish a person's age, and the county or zip 
  9.17  code of residence, which is necessary to determine the 
  9.18  immunization levels of geographic areas, may be used in the 
  9.19  aggregate to assess immunization levels in an entire 
  9.20  population.  Data created, collected, and maintained by a 
  9.21  population-based registry shall not be used for proprietary or 
  9.22  commercial use. 
  9.23     Subd. 4.  [ACCESS TO DATA.] Access to the shared 
  9.24  immunization data created, collected, and maintained by a 
  9.25  population-based registry shall be the same as defined under 
  9.26  section 144.3351. 
  9.27     Sec. 9.  [144.3408] [LIABILITY.] 
  9.28     Subdivision 1.  [GOOD FAITH IMMUNITY.] A provider, board of 
  9.29  health, school, group purchaser, or individual submitting 
  9.30  immunization data to a population-based immunization registry 
  9.31  shall be immune from civil or criminal liability that otherwise 
  9.32  might result from their actions, if they are acting in good 
  9.33  faith that the immunization data they are submitting is reliable 
  9.34  and accurate. 
  9.35     Subd. 2.  [VIOLATIONS.] A person or entity who violates any 
  9.36  data privacy provisions of sections 144.3401 to 144.3409 shall 
 10.1   be subject to sections 13.08 and 13.09. 
 10.2      Sec. 10.  [144.3409] [PARENTAL RESPONSIBILITY; EXEMPTIONS.] 
 10.3      Subdivision 1.  [PARENTAL RESPONSIBILITY.] Nothing in 
 10.4   sections 144.3401 to 144.3409 is intended to mitigate the 
 10.5   responsibility of a parent or guardian to have a child immunized 
 10.6   as specified in section 123.70. 
 10.7      Subd. 2.  [EXEMPTIONS.] Nothing in sections 144.3401 to 
 10.8   144.3409 is intended to require immunization of a person who is 
 10.9   exempt from immunization requirements based on medical, 
 10.10  religious, or other reasons as specified in section 123.70. 
 10.11     Sec. 11.  [EFFECTIVE DATE.] 
 10.12     Sections 1 to 10 are effective the day following final 
 10.13  enactment.