1.1                          A bill for an act
  1.2             relating to health; establishing a birth defects 
  1.3             information system; providing criminal penalties; 
  1.4             appropriating money; amending Minnesota Statutes 1996, 
  1.5             sections 13.99, by adding a subdivision; and 144.2215; 
  1.6             proposing coding for new law in Minnesota Statutes, 
  1.7             chapter 144. 
  1.8   BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA: 
  1.9      Section 1.  Minnesota Statutes 1996, section 13.99, is 
  1.10  amended by adding a subdivision to read: 
  1.11     Subd. 32a.  [BIRTH DEFECTS INFORMATION SYSTEM.] Data on 
  1.12  individuals in the birth defects information system maintained 
  1.13  by the commissioner of health are classified in section 144.2217.
  1.14     Sec. 2.  Minnesota Statutes 1996, section 144.2215, is 
  1.15  amended to read: 
  1.16     144.2215 [BIRTH DEFECTS REGISTRY INFORMATION SYSTEM.] 
  1.17     Subdivision 1.  [ESTABLISHMENT.] The commissioner of health 
  1.18  shall develop a statewide birth defects registry system to 
  1.19  provide for the collection, analysis, and dissemination of birth 
  1.20  defects information.  The commissioner shall consult with 
  1.21  representatives and experts in epidemiology, medicine, 
  1.22  insurance, health maintenance organizations, genetics, 
  1.23  consumers, and voluntary organizations in developing the system 
  1.24  and may phase in the implementation of the system establish a 
  1.25  statewide population-based birth defects information system to 
  1.26  collect, analyze, and disseminate information regarding the risk 
  2.1   for and incidence of birth defects. 
  2.2      Subd. 2.  [DUTIES OF COMMISSIONER.] The commissioner of 
  2.3   </u>
  2.4   health shall design the birth defects information system to 
  2.5   allow the commissioner to: 
  2.6      (1) monitor incidence trends of birth defects to detect 
  2.7   potential public health problems, predict risks, and assist in 
  2.8   responding to birth defects clusters; 
  2.9      (2) more accurately target intervention resources for 
  2.10  communities and individuals and their families; 
  2.11     (3) inform health professionals and the public of the 
  2.12  prevalence of and risks for birth defects; and 
  2.13     (4) promote high quality research to provide better 
  2.14  information for the prevention of birth defects. 
  2.15     Subd. 3.  [RULEMAKING.] The commissioner of health shall 
  2.16  adopt rules necessary to implement and administer the birth 
  2.17  defects information system.  The rules must address, but are not 
  2.18  limited to, the following: 
  2.19     (1) defining "case" for purposes of birth defects data 
  2.20  collection; 
  2.21     (2) establishing the type and scope of data to be collected 
  2.22  for each case; 
  2.23     (3) establishing a mechanism and assigning responsibility 
  2.24  for case ascertainment; and 
  2.25     (4) establishing criteria for contracts made with outside 
  2.26  entities to conduct studies using data collected by the birth 
  2.27  defects information system.  The criteria may include 
  2.28  requirements for a written protocol outlining the purpose and 
  2.29  public benefit of the study, peer review by other scientists, 
  2.30  methods and facilities to protect the privacy of the data, and 
  2.31  qualifications of the researcher proposing to undertake the 
  2.32  study.  
  2.33     Subd. 4.  [NOTICE.] (a) Within 30 days after making a 
  2.34  determination to enter a case into the birth defects information 
  2.35  system, the commissioner of health shall make a good faith 
  2.36  reasonable effort to notify the individual, or the parent or 
  2.37  guardian if the individual is a minor, of what data on the 
  3.1   individual has been entered into the system.  
  3.2      (b) Notice under this subdivision is not required if a 
  3.3   birth defect case was identified solely by prenatal diagnosis or 
  3.4   through fetal death or death certificate data. 
  3.5      Subd. 5.  [DEMONSTRATION PROJECTS.] The commissioner of 
  3.6   health shall evaluate and modify, as necessary, the birth 
  3.7   defects information system using demonstration projects.  The 
  3.8   commissioner shall use the results of the demonstration projects 
  3.9   to implement a refined birth defects information system 
  3.10  statewide. 
  3.11     Subd. 6.  [ADVISORY COMMITTEE.] The commissioner of health 
  3.12  shall appoint an advisory committee of 16 members to advise the 
  3.13  commissioner on the planning, implementation, evaluation, and 
  3.14  review of the birth defects information system.  The terms, 
  3.15  compensation, and removal of members are governed by section 
  3.16  15.059, except that the members do not receive per diem 
  3.17  compensation.  Members of the advisory committee shall represent 
  3.18  various geographical regions of the state.  Each of the 
  3.19  following professions must be represented in the advisory 
  3.20  committee:  epidemiologist, public health specialist, physician, 
  3.21  geneticist, health care provider, and health insurance 
  3.22  provider.  The advisory committee shall expire on June 30, 2001. 
  3.23     Subd. 7.  [REPORT.] The commissioner of health shall 
  3.24  prepare and transmit to the governor and the legislature a 
  3.25  report on the status and activities of the birth defects 
  3.26  information system no later than January 15 of every 
  3.27  odd-numbered year beginning in 1999. 
  3.28     Sec. 3.  [144.2216] [BIRTH DEFECTS RECORDS AND REPORTS 
  3.29  REQUIRED.] 
  3.30     Subdivision 1.  [PERSON PRACTICING HEALING 
  3.31  ARTS.] Notwithstanding section 144.335, a person licensed to 
  3.32  practice the healing arts in any form, upon request of the 
  3.33  commissioner of health, shall provide the commissioner with 
  3.34  access to information on each birth defect case in the manner 
  3.35  and at the times that the commissioner designates. 
  3.36     Subd. 2.  [HOSPITALS AND SIMILAR 
  4.1   INSTITUTIONS.] Notwithstanding section 144.335, a hospital, 
  4.2   medical clinic, medical laboratory, or other institution for the 
  4.3   hospitalization, clinical or laboratory diagnosis, or care of 
  4.4   human beings shall provide the commissioner of health with 
  4.5   access to information on each birth defect case in the manner 
  4.6   and at the times that the commissioner designates.  This 
  4.7   subdivision does not apply to institutions described in section 
  4.8   144A.09, subdivision 1. 
  4.9      Subd. 3.  [OTHER DATA REPOSITORIES.] Notwithstanding 
  4.10  section 144.335, other repositories of data on the diagnosis or 
  4.11  care of human beings may provide the commissioner of health with 
  4.12  access to information on each case of birth defects in the 
  4.13  manner and at the times that the commissioner designates. 
  4.14     Subd. 4.  [REPORTING WITHOUT LIABILITY.] Furnishing 
  4.15  information under this section in good faith shall not subject a 
  4.16  person, hospital, medical clinic, medical laboratory, data 
  4.17  repository, or other institution to an action for damages or 
  4.18  other relief. 
  4.19     Sec. 4.  [144.2217] [CLASSIFICATION OF BIRTH DEFECTS 
  4.20  INFORMATION SYSTEM DATA.] 
  4.21     Data on individuals in the birth defects information system 
  4.22  are private data on individuals as defined in section 13.02, 
  4.23  subdivision 12.  Notwithstanding section 13.05, subdivision 9, 
  4.24  or any other law to the contrary, data on individuals in the 
  4.25  birth defects registry system may not be disclosed except as 
  4.26  provided in sections 144.2215 to 144.2218. 
  4.27     Sec. 5.  [144.2218] [TRANSFERS OF BIRTH DEFECTS INFORMATION 
  4.28  SYSTEM DATA TO OTHER GOVERNMENT AGENCIES.] 
  4.29     Subdivision 1.  [INTERSTATE TRANSFERS OF DATA.] Data 
  4.30  collected by the birth defects information system may be 
  4.31  disseminated to a state government agency in another state 
  4.32  solely for purposes consistent with sections 144.2215 to 
  4.33  144.2218, provided that the state government agency agrees to 
  4.34  maintain the data as provided by section 144.2217. 
  4.35     Subd. 2.  [INTRASTATE TRANSFERS OF DATA.] Data collected by 
  4.36  the birth defects information system may be disseminated to 
  5.1   another state government agency in this state upon determination 
  5.2   by the commissioner of health that another state government 
  5.3   agency could help an individual registered in the system gain 
  5.4   access to social, educational, or medical services for which the 
  5.5   individual is eligible, if the commissioner of health obtains 
  5.6   the prior consent of the individual. 
  5.7      Sec. 6.  [APPROPRIATION.] 
  5.8      $....... is appropriated from the general fund to the 
  5.9   commissioner of health to administer the birth defects 
  5.10  information system under sections 1 to 5, to be available until 
  5.11  June 30, 1999.