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.