Florida Senate - 2025                                    SB 1356
       
       
        
       By Senator Burton
       
       
       
       
       
       12-01277B-25                                          20251356__
    1                        A bill to be entitled                      
    2         An act relating to the Florida Institute for Pediatric
    3         Rare Diseases; creating s. 1004.4210, F.S.;
    4         establishing the Florida Institute for Pediatric Rare
    5         Diseases within the Florida State University College
    6         of Medicine; providing the goals of the institute;
    7         requiring the institute to establish and administer
    8         the Sunshine Genetics Pilot Program for a specified
    9         period; providing the purpose of the pilot program;
   10         providing institute responsibilities and duties
   11         relating to the pilot program; providing requirements
   12         for participation in the pilot program and data
   13         collection in the pilot program; providing reporting
   14         requirements for the pilot program; establishing the
   15         Sunshine Genetics Consortium for specified purposes;
   16         requiring the consortium to be administered at the
   17         institute by a board; providing for the membership and
   18         terms of the board; providing reporting requirements
   19         for the consortium; providing appropriations;
   20         providing an effective date.
   21          
   22  Be It Enacted by the Legislature of the State of Florida:
   23  
   24         Section 1. Section 1004.4210, Florida Statutes, is created
   25  to read:
   26         1004.4210The Florida Institute for Pediatric Rare
   27  Diseases; the Sunshine Genetics Pilot Program; the Sunshine
   28  Genetics Consortium.—
   29         (1)The Florida Institute for Pediatric Rare Diseases is
   30  established within the Florida State University College of
   31  Medicine as a statewide resource for pediatric rare disease
   32  research and clinical care. The purpose of the institute is to
   33  improve the quality of life and health outcomes for children and
   34  families affected by rare diseases by advancing knowledge,
   35  diagnosis, and treatment of pediatric rare diseases through
   36  research, clinical care, education, and advocacy.
   37         (2)The goals of the institute are to:
   38         (a)Conduct research to better understand the causes,
   39  mechanisms, and potential treatments for pediatric rare
   40  diseases, including leveraging emerging research methods.
   41         (b)Develop advanced diagnostic and genetic screening tools
   42  and techniques to enable health care providers to identify rare
   43  diseases in newborns and children more rapidly, accurately, and
   44  economically.
   45         (c)Provide comprehensive multidisciplinary clinical
   46  services and care for children with rare diseases. Such care may
   47  include patient, family, and caregiver support and resources to
   48  help navigate the challenges associated with these conditions,
   49  support groups, and patient advocacy.
   50         (d)Educate and train health care professionals, including
   51  genetic counselors, pediatricians, scientists, and other
   52  specialists in the field of pediatric rare diseases.
   53         (e)Establish collaborations with other research
   54  institutions, medical centers, and government agencies whenever
   55  deemed appropriate by the institute director and to share
   56  expertise, raise awareness, and promote a collective effort to
   57  tackle pediatric rare diseases.
   58         (3)(a)The institute shall establish and administer the
   59  Sunshine Genetics Pilot Program to be administered for a period
   60  of 3 years. The pilot program shall offer genetic testing to
   61  newborns in addition to the state’s newborn screening program.
   62         (b)The institute shall partner with qualified state
   63  universities, colleges, and health care service providers to
   64  implement the pilot program and deliver and analyze genetic
   65  testing results for the pilot program.
   66         (c)The pilot program shall be an opt-in program and a
   67  parent of a newborn must provide parental consent to join the
   68  pilot program.
   69         (d)Upon the completion of the genetic testing through the
   70  pilot program, all testing data and reports shall be delivered
   71  to the parent’s health care provider.
   72         (e)The institute shall:
   73         1.Conduct the pilot program in accordance with the
   74  requirements of s. 760.40.
   75         2.Maintain a secure database to store all pilot program
   76  data, including newborn testing data.
   77         3.Deidentify all patient data.
   78         4.Upon the approval of the board of the Sunshine Genetics
   79  Consortium created under subsection (4), enter into an agreement
   80  with the consortium to share deidentified patient data.
   81         (f)Upon the completion of the pilot program, the institute
   82  shall provide a report to the Governor, the President of the
   83  Senate, and the Speaker of the House of Representatives.
   84         (4)(a)The Sunshine Genetics Consortium is established to
   85  create a network of clinical and academic research
   86  professionals, geneticists, and physicians from state
   87  universities and the state’s children’s hospitals to collaborate
   88  with leaders in the genetic industry and build and support a
   89  culture of collaborative research and the development of
   90  cutting-edge genetic and precision medicine in the state. The
   91  consortium shall:
   92         1.Integrate state-of-the-art genomic sequencing
   93  technologies.
   94         2.Create a biorepository network and database for ongoing
   95  and future research.
   96         3.Leverage advancements in artificial intelligence
   97  utilization in genomics.
   98         4.Develop educational opportunities for clinicians on
   99  genomic tools.
  100         5.Support the growth and education of geneticists to meet
  101  demand.
  102         6.Raise funds from nonprofits, private industry, and
  103  others to expand the pilot program under subsection (3).
  104         7.Promote patient care to support families with children
  105  diagnosed with genetic disorders.
  106         (b)1.The consortium shall be administered at the institute
  107  by an oversight board and shall meet periodically.
  108         2.The oversight board for the consortium shall serve 2
  109  year terms and consist of the following voting members:
  110         a.One member from the Florida State University to be
  111  appointed by the Dean of the College of Medicine.
  112         b.One member from the University of Florida to be
  113  appointed by the Dean of the College of Medicine.
  114         c.One member from the University of South Florida to be
  115  appointed by the Dean of the College of Medicine.
  116         d.One member from the University of Miami to be appointed
  117  by the Dean of the College of Medicine.
  118         e.One member appointed by the Governor.
  119         f.One member appointed by the President of the Senate.
  120         g.One member appointed by the Speaker of the House of
  121  Representatives.
  122         3.The board shall be responsible for the technical
  123  performance and financial management of the consortium.
  124         (c)The consortium shall annually provide a report to the
  125  Governor, the President of the Senate, and the Speaker of the
  126  House of Representatives.
  127         Section 2. For the 2025-2026 fiscal year, the sum of $5
  128  million in recurring funds is appropriated from the General
  129  Revenue Fund to the Florida Institute for Pediatric Rare
  130  Diseases.
  131         Section 3. For the 2025-2026 fiscal year, the sum of $20
  132  million in nonrecurring funds is appropriated from the General
  133  Revenue Fund to the Florida Institute for Pediatric Rare
  134  Diseases to launch and execute whole genome sequencing at
  135  birthing centers.
  136         Section 4. This act shall take effect July 1, 2025.