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 144.3410 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 registry immunization data to support 
  2.14  age-appropriate 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 registry 
  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 144.3410. 
  2.30     Subd. 2.  [BOARD OF HEALTH.] "Board of health" means an 
  2.31  administrative authority established under sections 145A.03 and 
  2.32  145A.04. 
  2.33     Subd. 3.  [CERTIFICATION.] "Certification" means approval 
  2.34  by the commissioner after determining that a community-based 
  2.35  registry has fulfilled the requirements of sections 144.3404, 
  2.36  144.3406, and 144.3408. 
  3.1      Subd. 4.  [COMMISSIONER.] "Commissioner" means the 
  3.2   commissioner of health. 
  3.3      Subd. 5.  [COMMUNITY-BASED REGISTRY.] "Community-based 
  3.4   registry" means a population-based immunization registry 
  3.5   established by a board of health or its agent in conjunction 
  3.6   with providers and group purchasers in a particular geographic 
  3.7   area to exchange registry immunization data to support 
  3.8   age-appropriate immunizations. 
  3.9      Subd. 6.  [DEPARTMENT.] "Department" means the department 
  3.10  of health. 
  3.11     Subd. 7.  [ENROLLEE.] "Enrollee" means a person, or the 
  3.12  parent or legal guardian of a minor person, enrolled in a 
  3.13  population-based immunization registry. 
  3.14     Subd. 8.  [ENROLLMENT.] "Enrollment" means the recording of 
  3.15  registry immunization data for a new person in a 
  3.16  population-based immunization registry. 
  3.17     Subd. 9.  [GROUP PURCHASER.] "Group purchaser" has the 
  3.18  meaning given in section 62J.03, subdivision 6, and includes a 
  3.19  health plan. 
  3.20     Subd. 10.  [IMMUNIZATION ASSESSMENT.] "Immunization 
  3.21  assessment" means summary data measuring the proportion of a 
  3.22  population that has received age-appropriate immunizations as 
  3.23  identified by the commissioner. 
  3.24     Subd. 11.  [POPULATION-BASED IMMUNIZATION REGISTRY.] 
  3.25  "Population-based immunization registry" means the central 
  3.26  collection of registry immunization data for all persons of an 
  3.27  age specified by the registry within a geographic area, 
  3.28  beginning with the filing of their birth registrations.  
  3.29  Population-based immunization registries include both 
  3.30  community-based and statewide registries but do not include 
  3.31  provider registries. 
  3.32     Subd. 12.  [IMMUNIZATION REMINDER AND RECALL.] 
  3.33  "Immunization reminder and recall" means a system associated 
  3.34  with a population-based immunization registry designed to notify 
  3.35  enrollees or providers of upcoming or past due immunizations in 
  3.36  order to support enrollees or providers in achieving 
  4.1   age-appropriate immunizations. 
  4.2      Subd. 13.  [PERSON.] "Person" means a natural person, 
  4.3   parent of a minor, or guardian. 
  4.4      Subd. 14.  [PROVIDER.] "Provider" has the meaning given in 
  4.5   section 144.335, subdivision 1. 
  4.6      Subd. 15.  [SCHOOL.] "School" has the meaning given in 
  4.7   sections 123.70, subdivision 9, and 135A.14, subdivision 1. 
  4.8      Subd. 16.  [SECURITY.] "Security" refers to the procedures 
  4.9   to protect data from accidental or intentional disclosure to an 
  4.10  unauthorized person and to protect data from loss or 
  4.11  unauthorized alterations. 
  4.12     Subd. 17.  [REGISTRY IMMUNIZATION DATA.] "Registry 
  4.13  immunization data" includes only the following information: 
  4.14     (1) local registry number or other registry identification; 
  4.15     (2) Minnesota immunization number; 
  4.16     (3) first name; 
  4.17     (4) middle name; 
  4.18     (5) last name; 
  4.19     (6) birth date; 
  4.20     (7) gender; 
  4.21     (8) apartment or box number; 
  4.22     (9) street address; 
  4.23     (10) city; 
  4.24     (11) state; 
  4.25     (12) zip code; 
  4.26     (13) contraindication indicator; 
  4.27     (14) legal mother's first name; 
  4.28     (15) legal mother's middle name; 
  4.29     (16) legal mother's last name; 
  4.30     (17) immunization date; 
  4.31     (18) vaccine type; 
  4.32     (19) vaccine manufacturer; 
  4.33     (20) lot number; 
  4.34     (21) name of medical clinic providing immunization; and 
  4.35     (22) immunization adverse reaction indicator. 
  4.36     Subd. 18.  [STATEWIDE REGISTRY.] "Statewide registry" means 
  5.1   a population-based immunization registry operated by the 
  5.2   commissioner to maintain immunization data of enrollees, link 
  5.3   community-based registries, conduct public health research, and 
  5.4   perform statewide assessment to prevent and control 
  5.5   vaccine-preventable diseases. 
  5.6      Subd. 19.  [VACCINE.] "Vaccine" means those biologics that 
  5.7   are used to provide immunity against diseases included in the 
  5.8   schedule of recommended immunizations issued by the 
  5.9   commissioner, which include, but are not limited to, diphtheria, 
  5.10  tetanus, pertussis, polio, measles, mumps, rubella, hemophilus 
  5.11  influenza type b, hepatitis B, hepatitis A, varicella, 
  5.12  influenza, and pneumococcal pneumonia. 
  5.13     Sec. 4.  [144.3403] [DUTIES OF THE COMMISSIONER.] 
  5.14     Subdivision 1.  [RECOMMENDATIONS TO THE LEGISLATURE.] The 
  5.15  commissioner shall prepare recommendations for the 1998 
  5.16  legislature that include, but are not limited to, the following: 
  5.17     (1) criteria for allowing authorized access, including 
  5.18  telecommunications access, to registry immunization data 
  5.19  consistent with section 144.3408; 
  5.20     (2) criteria, including data security and quality assurance 
  5.21  procedures, by which the commissioner certifies community-based 
  5.22  registries pursuant to subdivision 3; and 
  5.23     (3) provider reporting procedures to community-based 
  5.24  registries. 
  5.25     Subd. 2.  [IMMUNIZATION REGISTRY ADVISORY TASK FORCE.] The 
  5.26  commissioner shall establish an immunization registry advisory 
  5.27  task force to advise on the development of recommendations 
  5.28  pursuant to subdivision 1.  The advisory task force shall be 
  5.29  appointed by the commissioner and be composed of, but not 
  5.30  limited to, representatives from boards of health, providers, 
  5.31  group purchasers, schools, and consumers.  The task force shall 
  5.32  include persons with expertise in immunizations.  The advisory 
  5.33  task force is governed by section 15.014, and expires no later 
  5.34  than June 30, 2002. 
  5.35     Subd. 3.  [CERTIFICATION.] When the board of health 
  5.36  operating the community-based registry submits an application 
  6.1   and the commissioner has evaluated and approved the operation of 
  6.2   the registry pursuant to standards adopted by the legislature 
  6.3   following implementation of this section and for compliance with 
  6.4   sections 144.3404, 144.3406, and 144.3408, the commissioner 
  6.5   shall certify a community-based registry. 
  6.6      Subd. 4.  [STATEWIDE REGISTRY.] Subject to the availability 
  6.7   of funds, the commissioner may establish a statewide registry 
  6.8   that links community-based registries across the state.  In 
  6.9   establishing a statewide registry, the commissioner shall, at a 
  6.10  minimum, establish procedures for collecting and exchanging 
  6.11  registry immunization data, ensuring their reliability, and 
  6.12  providing for data protection according to chapter 13 and 
  6.13  section 144.3408. 
  6.14     Sec. 5.  [144.3404] [COMMUNITY-BASED REGISTRIES.] 
  6.15     Subdivision 1.  [REQUIREMENTS.] Subject to the availability 
  6.16  of funds, boards of health, singly or jointly, or an agent 
  6.17  designated by a board of health, may develop and maintain 
  6.18  community-based registries.  Boards of health or their 
  6.19  designated agent shall operate according to this section, and 
  6.20  sections 144.3406 and 144.3408.  Community-based registries 
  6.21  shall: 
  6.22     (1) establish policies and operational procedures for 
  6.23  collecting and exchanging registry immunization data, ensuring 
  6.24  their reliability, and providing for data privacy and security 
  6.25  according to chapter 13 and section 144.3408; 
  6.26     (2) enter into agreements with participating providers that 
  6.27  allow a provider or a group purchaser to submit registry 
  6.28  immunization data to and obtain registry immunization data from 
  6.29  the community-based registry; 
  6.30     (3) establish policies and operating procedures to comply 
  6.31  with an enrollee's request to not receive immunization reminder 
  6.32  and recall notices from population-based registries; and 
  6.33     (4) convene a local advisory group to advise on the 
  6.34  establishment and operation of the community-based registry, and 
  6.35  to review and approve the procedures, policies, and agreements 
  6.36  developed for the registry.  
  7.1      Subd. 2.  [CERTIFICATION NOT REQUIRED.] A community-based 
  7.2   registry may operate prior to certification, provided that the 
  7.3   board of health notifies the commissioner in writing of its 
  7.4   intent to establish a community-based registry. 
  7.5      Subd. 3.  [REPORTING TO STATEWIDE REGISTRY.] Upon the 
  7.6   establishment of a statewide registry under section 144.3403, 
  7.7   subdivision 4, a community-based registry shall report registry 
  7.8   immunization data maintained by the community-based registry to 
  7.9   the statewide registry. 
  7.10     Sec. 6.  [144.3405] [REPORTING TO COMMUNITY-BASED 
  7.11  REGISTRIES.] 
  7.12     After the commissioner has certified a community-based 
  7.13  registry as specified in section 144.3403, subdivision 3, all 
  7.14  providers who administer immunizations in the geographic area 
  7.15  served by the community-based registry shall report registry 
  7.16  immunization data to the community-based registry. 
  7.17     Sec. 7.  [144.3406] [ENROLLMENT.] 
  7.18     Subdivision 1.  [BIRTH REGISTRATION; ENROLLMENT.] Except as 
  7.19  provided in subdivision 4, birth registration data collected 
  7.20  under section 144.215 shall be used to enroll all newborn 
  7.21  Minnesota residents in population-based immunization registries, 
  7.22  but shall be limited to the registry immunization data as 
  7.23  defined in section 144.3402, subdivision 17, to the extent that 
  7.24  birth registration data is known.  Birth registration data that 
  7.25  are otherwise prohibited from disclosure under section 144.225 
  7.26  shall be included in population-based immunization registries, 
  7.27  except for data relating to the original birth certificate of an 
  7.28  adopted child, and only to the extent that such data are 
  7.29  registry immunization data as defined in section 144.3402, 
  7.30  subdivision 17.  Except as provided in subdivision 4, 
  7.31  individuals moving into a geographic area served by a 
  7.32  population-based registry shall be enrolled in the registry by a 
  7.33  provider, board of health, school, or group purchaser. 
  7.34     Subd. 2.  [NOTIFICATION.] Within 30 calendar days of an 
  7.35  enrollee being enrolled in a population-based registry, the 
  7.36  community-based registry shall make a good faith effort to 
  8.1   notify the enrollee.  Notification of enrollment shall include 
  8.2   the purposes of immunization registries, how the information 
  8.3   collected will be used, the benefits to the enrollee and to 
  8.4   providers of the immunization registries, precautions that are 
  8.5   taken to prevent unauthorized uses of the immunization data, 
  8.6   identification of those persons who have lawful access to the 
  8.7   registry immunization data, and instructions on how a person may 
  8.8   request to not receive immunization reminder and recall notices 
  8.9   or claim an exemption from enrollment. 
  8.10     Subd. 3.  [CONSENT.] Nothing in this section requires the 
  8.11  consent of an enrollee prior to enrollment in a population-based 
  8.12  registry. 
  8.13     Subd. 4.  [EXEMPTION FROM ENROLLMENT.] (a) A person may 
  8.14  object in writing to enrollment in a population-based 
  8.15  immunization registry, including enrollment pursuant to this 
  8.16  section, based upon conscientiously held beliefs of the person.  
  8.17  A person filing a written objection with a population-based 
  8.18  registry or a provider shall specify one of the following 
  8.19  options: 
  8.20     (1) retaining the child's first name, middle name, last 
  8.21  name, and date of birth, the legal mother's last name, and an 
  8.22  indication that the data is not available at the request of the 
  8.23  person.  Providers who provide services to the person and who 
  8.24  have authorized access to the population-based registry shall 
  8.25  not subsequently attempt to enroll the person in the registry; 
  8.26  or 
  8.27     (2) removing all data concerning the enrollee from the 
  8.28  population-based immunization registry or not enrolling the 
  8.29  person pursuant to subdivision 1. 
  8.30     (b) A provider who receives a written objection shall 
  8.31  forward it to the population-based registry.  The 
  8.32  population-based immunization registry shall comply with the 
  8.33  choice made by the person filing the objection.  The exemption 
  8.34  remains in effect until withdrawn in writing by the person. 
  8.35     Sec. 8.  [144.3407] [DATA RESTRICTION.] 
  8.36     No statewide registry, community-based registry, or 
  9.1   population-based immunization registry shall collect or maintain:
  9.2      (1) social security numbers; or 
  9.3      (2) any other data on individuals not listed in section 
  9.4   144.3402, subdivision 17. 
  9.5      Sec. 9.  [144.3408] [ACCESS TO REGISTRY IMMUNIZATION DATA.] 
  9.6      Subdivision 1.  [DATA CLASSIFICATION; REGISTRY IMMUNIZATION 
  9.7   DATA.] Registry immunization data on individuals created, 
  9.8   collected, or maintained by population-based registries are 
  9.9   private data as defined in section 13.02, subdivision 12.  Data 
  9.10  not on individuals are nonpublic data as defined in section 
  9.11  13.02, subdivision 9.  All data created, collected, or 
  9.12  maintained by population-based registries shall not be disclosed 
  9.13  except as provided in sections 144.3401 to 144.3410 and 
  9.14  144.3351, and are not subject to release under section 13.03, 
  9.15  subdivisions 6 to 8; 13.05, subdivision 9; or 138.17, 
  9.16  subdivision 1a. 
  9.17     Subd. 2.  [USE OF DATA.] Data created, collected, and 
  9.18  maintained by a population-based registry shall only be used: 
  9.19     (1) on individuals: 
  9.20     (i) to assess a person's immunization status for the 
  9.21  purpose of determining needed vaccines; 
  9.22     (ii) for reminder and recall; 
  9.23     (iii) to notify a person of a vaccine-preventable disease 
  9.24  outbreak to which that person may be susceptible; 
  9.25     (iv) for individual immunization reports for school 
  9.26  admission, child care enrollment, or other enrollment purposes 
  9.27  that require an immunization history; or 
  9.28     (2) in summary form to conduct immunization assessment. 
  9.29     The birth date, which is necessary to establish a person's 
  9.30  age, and the county or zip code of residence, which is necessary 
  9.31  to determine the immunization levels of geographic areas, may be 
  9.32  used in the aggregate to assess immunization levels in an entire 
  9.33  population. 
  9.34     Subd. 3.  [ACCESS TO DATA.] Access to the registry 
  9.35  immunization data created, collected, and maintained by a 
  9.36  population-based registry shall be given only to enrollees and 
 10.1   those authorized to exchange immunization data under section 
 10.2   144.3351, and only for the purposes specified in subdivision 2. 
 10.3      Subd. 4.  [SHARING AMONG REGISTRIES.] All population-based 
 10.4   immunization registries shall share registry immunization data 
 10.5   with each other to conduct immunization assessment or to assist 
 10.6   community-based registries to provide services on behalf of an 
 10.7   enrollee. 
 10.8      Sec. 10.  [144.3409] [LIABILITY.] 
 10.9      Subdivision 1.  [GOOD FAITH IMMUNITY.] A provider, board of 
 10.10  health, school, group purchaser, or individual submitting 
 10.11  immunization data to a population-based immunization registry 
 10.12  shall be immune from civil or criminal liability that otherwise 
 10.13  might result from their actions, if they are acting in good 
 10.14  faith that the immunization data they are submitting is reliable 
 10.15  and accurate. 
 10.16     Subd. 2.  [VIOLATIONS.] A person or entity who violates any 
 10.17  data privacy provisions of sections 144.3401 to 144.3410 shall 
 10.18  be subject to sections 13.08 and 13.09. 
 10.19     Sec. 11.  [144.3410] [PARENTAL RESPONSIBILITY; EXEMPTIONS.] 
 10.20     Subdivision 1.  [PARENTAL RESPONSIBILITY.] Nothing in 
 10.21  sections 144.3401 to 144.3410 is intended to mitigate the 
 10.22  responsibility of a parent or guardian to have a child immunized 
 10.23  as specified in section 123.70. 
 10.24     Subd. 2.  [EXEMPTIONS.] Nothing in sections 144.3401 to 
 10.25  144.3410 is intended to require immunization of a person who is 
 10.26  exempt from immunization requirements referenced in section 
 10.27  123.70. 
 10.28     Sec. 12.  [EFFECTIVE DATE.] 
 10.29     Sections 1 to 11 are effective the day following final 
 10.30  enactment.