Florida Senate - 2025                      CS for CS for SB 1356
       
       
        
       By the Committees on Fiscal Policy; and Education Postsecondary;
       and Senators Burton and Berman
       
       
       
       
       594-03194-25                                          20251356c2
    1                        A bill to be entitled                      
    2         An act relating to the Florida Institute for Pediatric
    3         Rare Diseases; creating s. 1004.4211, F.S.;
    4         establishing the Florida Institute for Pediatric Rare
    5         Diseases within the Florida State University College
    6         of Medicine; providing the purpose of the institute;
    7         providing the goals of the institute; requiring the
    8         institute to establish and administer the Sunshine
    9         Genetics Pilot Program for a specified period;
   10         providing the purpose of the pilot program; providing
   11         institute responsibilities and duties relating to the
   12         pilot program; providing requirements for
   13         participation in the pilot program and data collection
   14         and release in the pilot program; defining the term
   15         “health care practitioner”; providing reporting
   16         requirements for the pilot program; establishing the
   17         Sunshine Genetics Consortium for specified purposes;
   18         requiring the consortium to be administered at the
   19         institute by an oversight board; providing for the
   20         membership and terms of the board; providing reporting
   21         requirements for the consortium; specifying that
   22         implementation of the act is subject to appropriation;
   23         providing an effective date.
   24          
   25  Be It Enacted by the Legislature of the State of Florida:
   26  
   27         Section 1. Section 1004.4211, Florida Statutes, is created
   28  to read:
   29         1004.4211The Florida Institute for Pediatric Rare
   30  Diseases; the Sunshine Genetics Pilot Program; the Sunshine
   31  Genetics Consortium.—
   32         (1)The Florida Institute for Pediatric Rare Diseases is
   33  established within the Florida State University College of
   34  Medicine as a statewide resource for pediatric rare disease
   35  research and clinical care. The purpose of the institute is to
   36  improve the quality of life and health outcomes for children and
   37  families affected by rare diseases by advancing knowledge,
   38  diagnosis, and treatment of pediatric rare diseases through
   39  research, clinical care, education, and advocacy.
   40         (2)The goals of the institute are to:
   41         (a)Conduct research to better understand the causes,
   42  mechanisms, and potential treatments for pediatric rare
   43  diseases, including leveraging emerging research methods.
   44         (b)Develop advanced diagnostic and genetic screening tools
   45  and techniques to enable health care providers to identify rare
   46  diseases in newborns and children more rapidly, accurately, and
   47  economically.
   48         (c)Provide comprehensive multidisciplinary clinical
   49  services and care for children with rare diseases. Such care may
   50  include, but is not limited to, patient, family, and caregiver
   51  support and resources to help navigate the challenges associated
   52  with these conditions, support groups, and patient advocacy.
   53         (d)Educate and train health care professionals, including,
   54  but not limited to, genetic counselors, pediatricians,
   55  scientists, and other specialists in the field of pediatric rare
   56  diseases.
   57         (e)Establish collaborations with other research
   58  institutions, medical centers, patient and family advocacy
   59  organizations, and government agencies whenever deemed
   60  appropriate by the institute director to share expertise, raise
   61  awareness, and promote a collective effort to tackle pediatric
   62  rare diseases.
   63         (3)(a)The institute shall establish and administer the
   64  Sunshine Genetics Pilot Program to be administered for a period
   65  of 5 years. The pilot program shall provide newborn genetic
   66  screening, including, but not limited to, whole genome
   67  sequencing. Genetic screening shall be performed by the
   68  institute and institutional members of the oversight board upon
   69  approval of the oversight board.
   70         (b)The institute may establish partnerships with Florida
   71  universities and colleges and health care service providers to
   72  promote and assist in the implementation of the pilot program.
   73         (c)The pilot program shall be an opt-in program and a
   74  parent of a newborn must provide consent to participate in the
   75  pilot program.
   76         (d)The institute and institutional members of the
   77  oversight board shall release clinical findings of a newborn’s
   78  screening to the newborn’s health care practitioner and the
   79  newborn’s parent. As used in this paragraph, the term “health
   80  care practitioner” means a physician or physician assistant
   81  licensed under chapter 458; an osteopathic physician or
   82  physician assistant licensed under chapter 459; an advanced
   83  practice registered nurse, registered nurse, or licensed
   84  practical nurse licensed under part I of chapter 464; a midwife
   85  licensed under chapter 467; a speech-language pathologist or
   86  audiologist licensed under part I of chapter 468; a dietitian or
   87  nutritionist licensed under part X of chapter 468; or a genetic
   88  counselor licensed under part III of chapter 483.
   89         (e)The institute shall:
   90         1.Maintain a secure database to collect and store all
   91  pilot program data, including, but not limited to, newborn
   92  genomics sequence data and deidentified newborn data.
   93         2.Provide deidentified newborn data to members of the
   94  consortium pursuant to a data sharing agreement to support
   95  ongoing and future research.
   96         (f)By December 1, 2030, the institute shall provide a
   97  report on the Sunshine Genetics Pilot Program to the Governor,
   98  the President of the Senate, and the Speaker of the House of
   99  Representatives. The report must include, at a minimum:
  100         1.Study population and enrollment metrics.
  101         2.Whole genome sequencing metrics.
  102         3.Clinical and public health impact.
  103         4.Cost effectiveness and economic benefits.
  104         (4)(a)The Sunshine Genetics Consortium is established to
  105  create a network of clinical and academic research
  106  professionals, geneticists, and physicians from state
  107  universities and this state’s children’s hospitals to
  108  collaborate with leaders in the genetics industry and build and
  109  support a culture of collaborative research and the development
  110  of cutting-edge genetic and precision medicine in the state. The
  111  consortium shall:
  112         1.Integrate state-of-the-art genomic sequencing
  113  technologies.
  114         2.Advance research and the development of cutting-edge
  115  genetic and precision medicine.
  116         3.Leverage advancements in artificial intelligence
  117  utilization in genomics.
  118         4.Develop educational opportunities for clinicians on
  119  genomic tools.
  120         5.Support the growth and education of geneticists to meet
  121  demand.
  122         6.Solicit and leverage funds from nonprofits, private
  123  industry, and others for the purpose of expanding the Sunshine
  124  Genetics Pilot Program and to support genetic screenings by
  125  institutional members of the oversight board.
  126         7.Promote patient care that supports families with
  127  children diagnosed with genetic disorders.
  128         8.Report on the use of deidentified newborn data by
  129  members of the consortium.
  130         (b)1.The consortium shall be administered at the institute
  131  by an oversight board. The board shall convene at least once
  132  every 6 months.
  133         2.The oversight board for the consortium shall consist of
  134  the director of the institute, who shall serve as chair, and the
  135  following voting members, who shall serve 2-year terms:
  136         a.One member nominated by the dean of the University of
  137  Florida’s College of Medicine and approved by the university’s
  138  president.
  139         b.One member nominated by the dean of the University of
  140  South Florida’s College of Medicine and approved by the
  141  university’s president.
  142         c.One member nominated by the dean of the University of
  143  Miami’s School of Medicine and approved by the university’s
  144  president.
  145         d.One member nominated by the dean of Florida
  146  International University’s School of Medicine and approved by
  147  the university’s president.
  148         e.One member nominated by Nicklaus Children’s Hospital and
  149  approved by the hospital’s president and chief executive
  150  officer.
  151         f.One member appointed by the Governor.
  152         g.One member appointed by the President of the Senate.
  153         h.One member appointed by the Speaker of the House of
  154  Representatives.
  155         3.The board shall be responsible for the promotion and
  156  oversight of the consortium, including, but not limited to, the
  157  nomination and appointment of members of the consortium.
  158         (c)Beginning October 15, 2026, and annually thereafter,
  159  the consortium shall provide a report to the Governor, the
  160  President of the Senate, and the Speaker of the House of
  161  Representatives on research projects, research findings,
  162  community outreach initiatives, and future plans for the
  163  consortium.
  164         (5)The provisions of this section shall be implemented to
  165  the extent of available appropriations contained in the annual
  166  General Appropriations Act for such purpose.
  167         Section 2. This act shall take effect July 1, 2025.