1.1                          A bill for an act
  1.2             relating to health; establishing a birth defects 
  1.3             information system; appropriating money; amending 
  1.4             Minnesota Statutes 1996, sections 13.99, by adding a 
  1.5             subdivision; and 144.2215; proposing coding for new 
  1.6             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 13.99, is 
  1.9   amended by adding a subdivision to read: 
  1.10     Subd. 32a.  [BIRTH DEFECTS INFORMATION SYSTEM DATA.] Data 
  1.11  in the birth defects information system maintained by the 
  1.12  commissioner of health are classified in section 144.2217. 
  1.13     Sec. 2.  Minnesota Statutes 1996, section 144.2215, is 
  1.14  amended to read: 
  1.15     144.2215 [BIRTH DEFECTS REGISTRY INFORMATION SYSTEM.] 
  1.16     Subdivision 1.  [ESTABLISHMENT.] The commissioner of health 
  1.17  shall develop a statewide birth defects registry system to 
  1.18  provide for the collection, analysis, and dissemination of birth 
  1.19  defects information.  The commissioner shall consult with 
  1.20  representatives and experts in epidemiology, medicine, 
  1.21  insurance, health maintenance organizations, genetics, 
  1.22  consumers, and voluntary organizations in developing the system 
  1.23  and may phase in the implementation of the system establish a 
  1.24  statewide population-based birth defects information system to 
  1.25  collect, analyze, and disseminate information regarding the risk 
  1.26  for and incidence of birth defects. 
  2.1      Subd. 2.  [DUTIES OF COMMISSIONER.] The commissioner of 
  2.2   health shall design the birth defects information system to 
  2.3   allow the commissioner to: 
  2.4      (1) monitor incidence trends of birth defects to detect 
  2.5   potential public health problems, predict risks, and assist in 
  2.6   responding to birth defects clusters; 
  2.7      (2) more accurately target intervention resources for 
  2.8   communities and individuals and their families after birth; 
  2.9      (3) inform health professionals and the public of the 
  2.10  prevalence of and risks for birth defects; and 
  2.11     (4) promote high quality research to provide better 
  2.12  information for the prevention of birth defects. 
  2.13     Subd. 3.  [RULEMAKING.] Upon consultation with the advisory 
  2.14  committee identified in subdivision 6, the commissioner of 
  2.15  health shall adopt rules necessary to implement and administer 
  2.16  the birth defects information system.  The rules must address, 
  2.17  but are not limited to, the following: 
  2.18     (1) defining "case" for purposes of birth defects data 
  2.19  collection; 
  2.20     (2) establishing the type and scope of data to be collected 
  2.21  for each case; 
  2.22     (3) establishing criteria for the timeliness of data 
  2.23  collection.  Data will not be collected sooner than the expected 
  2.24  birth date of the child and shall only be collected on 
  2.25  individuals born on or after July 1, 1995, in the case of the 
  2.26  pilot projects under subdivision 5, and otherwise on individuals 
  2.27  born on or after July 1, 1997; 
  2.28     (4) establishing a mechanism and assigning responsibility 
  2.29  for identification of cases; 
  2.30     (5) establishing standards for the reporting of birth 
  2.31  defects cases; 
  2.32     (6) establishing criteria for contracts made with outside 
  2.33  entities to conduct studies using data collected by the birth 
  2.34  defects information system.  The criteria may include 
  2.35  requirements for a written protocol outlining the purpose and 
  2.36  public benefit of the study, peer review by other scientists, 
  3.1   methods and facilities to protect the privacy of the data, and 
  3.2   qualifications of the researcher proposing to undertake the 
  3.3   study; and 
  3.4      (7) specifying fees to be charged under section 13.05, 
  3.5   subdivision 7, for the cost of preparing summary data, as 
  3.6   defined in section 13.02, subdivision 19, or specific analyses 
  3.7   of data requested by public and private agencies, organizations, 
  3.8   and individuals not otherwise included in the commissioner's 
  3.9   annual summary reports.  Fees collected are appropriated to the 
  3.10  commissioner to offset the cost of providing the data. 
  3.11     Subd. 4.  [NOTICE.] Within 30 days after making a 
  3.12  determination to enter a case into the birth defects information 
  3.13  system, the commissioner of health shall make a reasonable 
  3.14  effort to notify the individual, or the individual's parent or 
  3.15  guardian if the individual is a minor, that data on the 
  3.16  individual has been entered into the system. 
  3.17     Subd. 5.  [PILOT PROJECTS.] The commissioner of health 
  3.18  shall evaluate and modify, as necessary, the birth defects 
  3.19  information system using pilot projects.  The commissioner shall 
  3.20  use the results of the pilot projects to implement a refined 
  3.21  birth defects information system statewide. 
  3.22     Subd. 6.  [ADVISORY COMMITTEE.] The commissioner of health 
  3.23  shall appoint an advisory committee of 16 members to advise the 
  3.24  commissioner on the planning, implementation, evaluation, and 
  3.25  review of the birth defects information system.  The terms, 
  3.26  compensation, and removal of members are governed by section 
  3.27  15.059, except that the members do not receive per diem 
  3.28  compensation.  Members of the advisory committee shall represent 
  3.29  the geographical diversity of the state.  Each of the following 
  3.30  experts and representatives must be represented in the advisory 
  3.31  committee:  epidemiologist, public health specialist, physician, 
  3.32  medical ethicist, geneticist, health care provider, health 
  3.33  information management specialist, health insurance provider, 
  3.34  parent of a child with a birth defect, and representative of an 
  3.35  organization that advocates for disabled individuals.  The 
  3.36  advisory committee shall expire on June 30, 2001. 
  4.1      Subd. 7.  [REPORT.] The commissioner of health shall 
  4.2   prepare and transmit to the governor and the legislature a 
  4.3   report on the status and activities of the birth defects 
  4.4   information system no later than January 15 of every 
  4.5   odd-numbered year beginning in 1999. 
  4.6      Sec. 3.  [144.2216] [BIRTH DEFECTS RECORDS AND REPORTS 
  4.7   REQUIRED.] 
  4.8      Subdivision 1.  [PERSON PRACTICING HEALING ARTS.] A person 
  4.9   licensed to practice the healing arts in any form, upon request 
  4.10  of the commissioner of health, shall provide the commissioner 
  4.11  with access to information or copies of reports on each birth 
  4.12  defect case, subject to the limitations in subdivision 6 in the 
  4.13  manner and at the times that the commissioner designates, until 
  4.14  rules are promulgated by the commissioner. 
  4.15     Subd. 2.  [HOSPITALS AND SIMILAR INSTITUTIONS.] A hospital, 
  4.16  medical clinic, medical laboratory, or other institution for the 
  4.17  hospitalization, clinical or laboratory diagnosis, or care of 
  4.18  human beings shall provide the commissioner of health with 
  4.19  access to information or copies of reports on each birth defect 
  4.20  case, subject to the limitations in subdivision 6 in the manner 
  4.21  and at the times that the commissioner designates.  This 
  4.22  subdivision does not apply to institutions described in section 
  4.23  144A.09, subdivision 1. 
  4.24     Subd. 3.  [OTHER DATA REPOSITORIES.] Other repositories of 
  4.25  data on the diagnosis or care of human beings may provide the 
  4.26  commissioner of health with access to information or copies of 
  4.27  reports on each case of birth defects, subject to the 
  4.28  limitations in subdivision 6 in the manner and at the times that 
  4.29  the commissioner designates. 
  4.30     Subd. 4.  [PATIENT CONSENT.] (a) For any release of health 
  4.31  records to the commissioner under subdivision 1, 2, or 3, 
  4.32  patient consent is not required pursuant to section 144.335, 
  4.33  subdivision 3a, paragraph (a). 
  4.34     (b) For any release of health records when the commissioner 
  4.35  contracts with an outside entity to conduct a study using data 
  4.36  collected by the birth defects information system, the 
  5.1   commissioner must comply with the requirements imposed on a 
  5.2   provider under section 144.335, subdivision 3a, paragraph (d). 
  5.3      Subd. 5.  [REPORTING WITHOUT LIABILITY.] Any person, 
  5.4   hospital, medical clinic, medical laboratory, data repository, 
  5.5   or other institution furnishing information under this section, 
  5.6   in good faith, is immune from liability in any civil, criminal, 
  5.7   administrative, or disciplinary action. 
  5.8      Subd. 6.  [RELIGIOUS ACCOMMODATION.] A parent or guardian 
  5.9   of an infant with birth defects may refuse disclosure to the 
  5.10  information system of the infant's name and identifying 
  5.11  information on the grounds that such birth defect identification 
  5.12  is contrary to the religious tenets and practices of the 
  5.13  infant's parent or guardian. 
  5.14     Sec. 4.  [144.2217] [CLASSIFICATION OF BIRTH DEFECTS 
  5.15  INFORMATION SYSTEM DATA.] 
  5.16     All data on individuals, including the names and personal 
  5.17  identifiers of persons who report under section 144.2216, 
  5.18  created, collected, received, or maintained by the commissioner 
  5.19  of health for the birth defects information system are health 
  5.20  data as defined in section 13.38. 
  5.21     Sec. 5.  [144.2218] [TRANSFERS OF BIRTH DEFECTS INFORMATION 
  5.22  SYSTEM DATA TO OTHER GOVERNMENT AGENCIES.] 
  5.23     Subdivision 1.  [INTERSTATE TRANSFERS OF DATA.] If the 
  5.24  commissioner of health obtains the prior consent of the 
  5.25  individual, or the individual's parent or guardian if the 
  5.26  individual is a minor, data collected by the birth defects 
  5.27  information system may be disseminated to a state government 
  5.28  agency in another state upon determination by the commissioner 
  5.29  that: 
  5.30     (1) the subject of the data is a resident of the other 
  5.31  state; 
  5.32     (2) the agency in the other state is authorized under its 
  5.33  state law to use the data solely for purposes consistent with 
  5.34  sections 144.2215 to 144.2218; and 
  5.35     (3) the agency in the other state is required under its 
  5.36  state law to maintain the privacy of the data. 
  6.1      Subd. 2.  [INTRASTATE TRANSFERS OF DATA.] Data collected by 
  6.2   the birth defects information system may be disseminated to 
  6.3   another state government agency in this state upon determination 
  6.4   by the commissioner of health that another state government 
  6.5   agency could assist an individual registered in the system in 
  6.6   gaining access to social, educational, or medical services for 
  6.7   which the individual is eligible if the commissioner of health 
  6.8   obtains the prior consent of the individual. 
  6.9      Sec. 6.  [APPROPRIATION.] 
  6.10     $....... is appropriated from the general fund to the 
  6.11  commissioner of health to administer the birth defects 
  6.12  information system under sections 1 to 5, to be available until 
  6.13  June 30, 1999.