Florida Senate - 2025 CS for SB 1356 By the Committee on Education Postsecondary; and Senator Burton 589-02481-25 20251356c1 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 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 and release in the pilot program; defining 14 the term health care practitioner; providing 15 reporting requirements for the pilot program; 16 establishing the Sunshine Genetics Consortium for 17 specified purposes; requiring the consortium to be 18 administered at the institute by an oversight board; 19 providing for the membership and terms of the board; 20 providing meeting and reporting requirements for the 21 consortium; providing appropriations; providing an 22 effective date. 23 24 Be It Enacted by the Legislature of the State of Florida: 25 26 Section 1.Section 1004.4211, Florida Statutes, is created 27 to read: 28 1004.4211The Florida Institute for Pediatric Rare 29 Diseases; the Sunshine Genetics Pilot Program; the Sunshine 30 Genetics Consortium. 31 (1)The Florida Institute for Pediatric Rare Diseases is 32 established within the Florida State University College of 33 Medicine as a statewide resource for pediatric rare disease 34 research and clinical care. The purpose of the institute is to 35 improve the quality of life and health outcomes for children and 36 families affected by rare diseases by advancing knowledge, 37 diagnosis, and treatment of pediatric rare diseases through 38 research, clinical care, education, and advocacy. 39 (2)The goals of the institute are to: 40 (a)Conduct research to better understand the causes, 41 mechanisms, and potential treatments for pediatric rare 42 diseases, including leveraging emerging research methods. 43 (b)Develop advanced diagnostic and genetic screening tools 44 and techniques to enable health care providers to identify rare 45 diseases in newborns and children more rapidly, accurately, and 46 economically. 47 (c)Provide comprehensive multidisciplinary clinical 48 services and care for children with rare diseases. Such care may 49 include, but is not limited to, patient, family, and caregiver 50 support and resources to help navigate the challenges associated 51 with these conditions, support groups, and patient advocacy. 52 (d)Educate and train health care professionals, including, 53 but not limited to, genetic counselors, pediatricians, 54 scientists, and other specialists in the field of pediatric rare 55 diseases. 56 (e)Establish collaborations with other research 57 institutions, medical centers, patient and family advocacy 58 organizations, and government agencies whenever deemed 59 appropriate by the institute director to share expertise, raise 60 awareness, and promote a collective effort to tackle pediatric 61 rare diseases. 62 (3)(a)The institute shall establish and administer the 63 Sunshine Genetics Pilot Program to be administered for a period 64 of 5 years. The pilot program shall provide newborn genetic 65 screening, including, but not limited to, whole genome 66 sequencing. Genetic screening shall be performed by the 67 institute and institutional members of the oversight board upon 68 approval of the oversight board. 69 (b)The institute may establish partnerships with Florida 70 universities and colleges and health care service providers to 71 promote and assist in the implementation of the pilot program. 72 (c)The pilot program shall be an opt-in program and a 73 parent of a newborn must provide consent to participate in the 74 pilot program. 75 (d)The institute and institutional members of the 76 oversight board shall release clinical findings of a newborns 77 screening to the newborns health care practitioner and the 78 newborns parent. As used in this paragraph, the term health 79 care practitioner means a physician or physician assistant 80 licensed under chapter 458; an osteopathic physician or 81 physician assistant licensed under chapter 459; an advanced 82 practice registered nurse, registered nurse, or licensed 83 practical nurse licensed under part I of chapter 464; a midwife 84 licensed under chapter 467; a speech-language pathologist or 85 audiologist licensed under part I of chapter 468; a dietitian or 86 nutritionist licensed under part X of chapter 468; or a genetic 87 counselor licensed under part III of chapter 483. 88 (e)The institute shall: 89 1.Maintain a secure database to collect and store all 90 pilot program data, including, but not limited to, newborn 91 genomics sequence data and deidentified newborn data. 92 2.Provide deidentified newborn data to members of the 93 consortium pursuant to a data sharing agreement to support 94 ongoing and future research. 95 (f)By December 1, 2030, the institute shall provide a 96 report on the Sunshine Genetics Pilot Program to the Governor, 97 the President of the Senate, and the Speaker of the House of 98 Representatives. The report must include, at a minimum: 99 1.Study population and enrollment metrics. 100 2.Whole genome sequencing metrics. 101 3.Clinical and public health impact. 102 4.Cost effectiveness and economic benefits. 103 (4)(a)The Sunshine Genetics Consortium is established to 104 create a network of clinical and academic research 105 professionals, geneticists, and physicians from state 106 universities and the states childrens hospitals to collaborate 107 with leaders in the genetic industry and build and support a 108 culture of collaborative research and the development of cutting 109 edge genetic and precision medicine in the state. The consortium 110 shall: 111 1.Integrate state-of-the-art genomic sequencing 112 technologies. 113 2.Advance research and the development of cutting edge 114 genetic and precision medicine. 115 3.Leverage advancements in artificial intelligence 116 utilization in genomics. 117 4.Develop educational opportunities for clinicians on 118 genomic tools. 119 5.Support the growth and education of geneticists to meet 120 demand. 121 6.Solicit and leverage funds from nonprofits, private 122 industry, and others for the purpose of expanding the Sunshine 123 Genetics Pilot Program and to support genetic screenings by 124 institutional members of the oversight board. 125 7.Promote patient care that supports families with 126 children diagnosed with genetic disorders. 127 8.Report on the use of deidentified newborn data by 128 members of the consortium. 129 (b)1.The consortium shall be administered at the institute 130 by an oversight board. The board shall convene at least once 131 every 6 months. 132 2.The oversight board for the consortium shall consist of 133 the director of the institute who shall serve as chair and the 134 following voting members who shall serve 2-year terms: 135 a.One member nominated by the dean of the University of 136 Floridas College of Medicine and approved by the universitys 137 president. 138 b.One member nominated by the dean of the University of 139 South Floridas College of Medicine and approved by the 140 universitys president. 141 c.One member nominated by the dean of the University of 142 Miamis School of Medicine and approved by the universitys 143 president. 144 d.One member appointed by the Governor. 145 e.One member appointed by the President of the Senate. 146 f.One member appointed by the Speaker of the House of 147 Representatives. 148 3.The board shall be responsible for the promotion and 149 oversight of the consortium, including, but not limited to, the 150 nomination and appointment of members of the consortium. 151 (c)Beginning October 15, 2026, and annually thereafter, 152 the consortium shall provide a report to the Governor, the 153 President of the Senate, and the Speaker of the House of 154 Representatives on research projects, research findings, 155 community outreach initiatives, and future plans for the 156 consortium. 157 Section 2.For the 2025-2026 fiscal year, the sum of $5 158 million in recurring funds is appropriated from the General 159 Revenue Fund to the Florida Institute for Pediatric Rare 160 Diseases. 161 Section 3.For the 2025-2026 fiscal year, the sum of $20 162 million in nonrecurring funds is appropriated from the General 163 Revenue Fund to the Florida Institute for Pediatric Rare 164 Diseases for the implementation of the Sunshine Genetics Pilot 165 Program established in s. 1004.4211, Florida Statutes. 166 Section 4.This act shall take effect July 1, 2025.