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 1004.4210 The 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.