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 1004.4211 The 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.