This docum ent does not reflect the intent or official position of the bill sponsor or House of Representatives.
STORAGE NAME: h1387b.HRS
DATE: 4/4/2023
HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: CS/HB 1387 Department of Health
SPONSOR(S): Healthcare Regulation Subcommittee, Porras
TIED BILLS: IDEN./SIM. BILLS: SB 1506
REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY CHIEF
1) Healthcare Regulation Subcommittee 17 Y, 0 N, As CS Osborne McElroy
2) Health Care Appropriations Subcommittee
3) Health & Human Services Committee
SUMMARY ANALYSIS
CS/HB 1387 makes numerous changes to programs under the Department of Health (DOH) and health care professions
regulated by the Division of Medical Quality Assurance within DOH.
Gain-of-function research involves experimentation that may produce an enhanced potential pandemic pathogen (PPP). An
enhanced PPP is a potential pandemic pathogen which has been modified to increase transmissibility or virulence. The bill
prohibits any such research from being conducted in the state. The bill also requires researchers applying for state or local
funding must disclose in the application for funding whether the research involves enhanced PPPs.
DOH is responsible for ensuring medical marijuana products are safe for human consumption, not attractive to children and that
medical marijuana treatment centers (MMTC) meet all background screening requirements, among others. The bill prohibits
MMTCs from advertising or producing products that are attractive to children or that promote recreational use. The bill also
revises background screening requirements for MMTCs and certified medical marijuana testing laboratories.
The Office of Vital Statistics (Office), under direction of the state registrar, is housed within DOH and facilitates the uniform and
efficient registration, compilation, storage, and preservation of all vital records in the state. The bill specifies that vital records
may be filed electronically with DOH’s electronic registration system. The bill specifies the timeframe under which the courts
must electronically transmit certain records to DOH. The bill also raises the age at which birth certificates become public record
from 100 to 125 years.
Brain death occurs when a person’s respiratory and circulatory functions are maintained by artificial means of support, but there
is irreversible cessation of the functioning of the entire brain including the brain stem. Under current law, two physicians must
certify brain death. The bill authorizes autonomous advanced practice registered nurse practitioners to certify brain death if they
are the patient’s treating health care practitioner. In such cases, brain death must also be certified by two physicians.
Emergency medical technicians (EMTs) and paramedics must complete training programs that meet requirements set in statute
and by DOH, pass a certification exam, and apply to DOH under oath. The bill revises the application process for EMTs and
paramedics, and deletes obsolete language regarding DOH administration of certification exams. The bill revises requirements
for EMTs and paramedics performing health care tasks in a nonemergency environment.
In 2022, the US Food & Drug Administration finalized a rule establishing a new category for over-the-counter (OTC) hearing aids
and specifying what constitutes an OTC hearing aid. The rule prohibits state and local governments from interfering with the
servicing, marketing, sale, dispensing, use, customer support, or distribution of OTC hearing aids The bill amends statute to
align with the requirements of this rule.
Certified Nursing Assistants (CNAs) provide care and assist individuals with tasks relating to the activities of daily living. A CNA
performs services under the general supervision of a registered nurse or licensed practical nurse. CNAs are certified by the
Board of Nursing within DOH. In order to be certified as a CNA, an applicant must pass the Certified Nursing Assistant
Examination (exam) which consists of a clinical skills test and a written test. CS/HB 1387 exempts individuals who have
successfully completed a board-approved CNA training program within six months of applying for licensure from the clinical skills
portion of the exam.
The bill has an insignificant, negative fiscal impact on DOH, which current resources are adequate to absorb. The bill has no
fiscal impact on local governments.
The bill provides an effective date of July 1, 2023, except for those sections which take effect upon becoming law.
FULL ANALYSIS STORAGE NAME: h1387b.HRS PAGE: 2
DATE: 4/4/2023
I. SUBSTANTIVE ANALYSIS
A. EFFECT OF PROPOSED CHANGES:
Enhanced Potential Pandemic Pathogen Research
Current Situation
Gain-of-function (GOF) research involves experimentation that aims to increase a pathogen’s
transmissibility and/or ability to cause damage to a host (known as virulence).
1
Such research can
improve our understanding of pathogens, their interactions in the human body and potential to cause
pandemics, with the ultimate goal of informing public health and preparedness efforts and the
development of medical countermeasures.
2
GOF research may involve “potential pandemic pathogens” (PPPs), infectious agents with known or
likely efficient transmission among humans, with significant virulence, and for which there is limited
population immunity.
3
An enhanced PPP is a PPP which has been modified to increase transmissibility
or virulence. Naturally occurring PPPs are not considered enhanced, regardless of their pandemic
potential.
4
The primary concern over PPPs is that they could be accidentally or deliberately released
and spread rapidly due their high transmissibility.
5
GOF research first gained public notice in 2012 after a study was published regarding increased
transmissibility of a specific strain of influenza.
6
In 2014, the federal government paused funding for
GOF research projects, specifically those involving influenza, SARS, and MERS viruses while new
gain-of-function research policy addressing the risks involved was developed.
7
In 2017, the White
House Office of Science and Technology Policy published new guidance for federal agencies regarding
federally funded research that is anticipated to create, transfer, or use enhanced PPPs.
8
The US
Department of Health and Human Services is the only federal agency that has reported GOF research
funding involving enhanced PPPs.
9
Federal agencies have been criticized for insufficient oversight of
grant-funded projects, including those involving naturally occurring pathogens and enhanced PPPs.
10
There are currently no known labs in Florida that are capable of conducting enhanced PPP research.
11
1
Selgelid, M. (2016). Gain-of-Function Research: Ethical Analysis. Science & Engineering Ethics, 22(4), 923–964.
https://doi.org/10.1007/s11948-016-9810-1.
2
Id.
3
Lipsitch, M., & Galvani, A. P. (2014). Ethical alternatives to experiments with novel potential pandemic pathogens. PLoS Medicine,
11(5). https://link.gale.com/apps/doc/A382807145/AONE?u=statelibraryfl&sid=bookmark-AONE&xid=41e75a11 (last visited March 29,
2023).
4
Congressional Research Service, Oversight of Gain of Function Research with Pathogens: Issues for Congress (2022). Available at
https://crsreports.congress.gov/product/pdf/R/R47114 (last visited March 29, 2023).
5
Supra, note 3.
6
See, Herfst, S., et al. (2012). Airborne transmission of influenza A/H5N1 virus between ferrets. Science (New York, N.Y.), 336(6088),
1534–1541. https://doi.org/10.1126/science.1213362
7
Office of Science and Technology Policy, U.S. Government Gain-of-Function Deliberative Process and Research Funding Pause on
Selected Gain-of-Research Involving Influenza, MERS, and SARS Viruses (2014). Available at
https://www.phe.gov/s3/dualuse/documents/gain-of-function.pdf (last visited March 29, 2023).
8
White House Office of Science and Technology Policy, Recommended Policy Guidance for Departmental Development
of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (P3CO) (2017). Available at
https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/p3co-finalguidancestatement.pdf (last visited
March 29, 2023).
9
Supra, note 4.
10
Office of Inspector General, US Department of Health and Human Services, The National Institutes of Health and EcoHealth Alliance
Did Not Effectively Monitor Awards and Subawards, Resulting in Missed Opportunities to Oversee Research and Other Deficiencies
(2023). Available at https://oig.hhs.gov/oas/reports/region5/52100025.pdf (last visited March 29, 2023).
11
In order to conduct research on highly infectious agents, a laboratory must meet the safety equipment and procedure requirements of
Biosafety Levels (BSL) 3 or 4 as established by the CDC. The BSL required for a project depend upon the specific research being
conducted. There are no known BSL 3 or 4 labs in Florida. See, Global Biolabs. Available at https://global-biolabs.github.io/ (last visited
March 29, 2023). See also, Centers for Disease Control and Prevention, Biosafety in Microbiological and Biomedical Laboratories, 6
th
Edition (2020). Available at https://www.cdc.gov/labs/pdf/SF__19_308133-A_BMBL6_00-BOOK-WEB-final-3.pdf (last visited March 29,
2023). STORAGE NAME: h1387b.HRS PAGE: 3
DATE: 4/4/2023
Effect of Proposed Changes – Enhanced Potential Pandemic Pathogen Research
CS/HB 1387 prohibits research that may be reasonably anticipated to create, transfer, or use potential
pandemic pathogens that result from enhancing a pathogen’s transmissibility or virulence in humans,
known as enhanced potential pandemic pathogen research, from being conducted in the state. The bill
also requires researchers applying for state or local funding must disclose in the application for funding
whether the research it intends to conduct is enhanced potential pandemic pathogen research. The bill
does not affect research funded or conducted prior to the bill taking effect.
The bill authorizes the Florida Department of Health (DOH) to utilize its enforcement authority under s.
381.0012, F.S., to enjoin violations of this section.
This provision is effective upon becoming law.
Medical Marijuana
Current Situation
Marijuana for Medical Use
Section 381.986, F.S., authorizes patients with any of the following debilitating medical conditions to
obtain medical marijuana from Medical Marijuana Treatment Centers (MMTC):
Cancer
Epilepsy
Glaucoma
Positive status for human immunodeficiency virus
Acquired immune deficiency syndrome
Post-traumatic stress disorder
Amyotrophic lateral sclerosis
Crohn’s disease
Parkinson’s disease
Multiple sclerosis
Medical conditions of the same kind or class as or comparable to those enumerated above
To obtain marijuana for medical use from a MMTC, and maintain the immunity from criminal
prosecution, the patient must obtain a physician certification from a qualified physician
12
and an
identification card from DOH.
Advertising
MMTCs are currently prohibited from engaging in advertising that is visible to members of the public
from any street, sidewalk, park, or other public place, except they may:
13
Have a sign on the outside or hanging in the window of the premises which identifies the
dispensary by the licensee’s business name, a department-approved trade name, or a
department-approved logo, as long as the trade name and logo does not contain wording or
images commonly associated with marketing targeted toward children or which promote the
recreational use of marijuana; and
Engage in Internet advertising and marketing under the following conditions:
o All advertisements are approved by the DOH;
o An advertisement’s content does not specifically target individuals under the age of 18;
12
To certify patients for medical use of marijuana, a physician must hold an active, unrestricted license as an allopathic physician under
chapter 458 or as an osteopathic physician under chapter 459 and comply with certain physician education requirements. See ss.
381.986(1)m, F.S. and 381.986(3)(a), F.S.
13
S. 381.986(8)(h), F.S. STORAGE NAME: h1387b.HRS PAGE: 4
DATE: 4/4/2023
o An advertisement is not an unsolicited pop-up advertisement; and
o Any opt-in marketing includes an easy and permanent opt-out feature.
Regulation of Edibles
Current law regulates the manner in which edibles may be produced. Edibles may not be:
Attractive to children;
Manufactured in the shape of humans, cartoons, or animals;
Manufactured in a form that bears any reasonable resemblance to products available for
consumption as commercially available candy; or contain any color additives.
Medical Marijuana Background Screening
Section 381.986, F.S., requires any person who registers as a qualified patient’s caregiver, as well as
the owners, operators, board members, managers, and employees of a MMTC, to pass a level 2
background screening. In addition to the disqualifying offenses included in s. 435.04, F.S., the section
adds an arrest awaiting final disposition for, being found guilty of, regardless of adjudication, or entering
a plea of nolo contendere or guilty to an offense under chapter 837,11 chapter 895,12 or chapter 89613
or similar law of another jurisdiction.
Section 381.988, F.S., establishes requirements for persons or entities seeking to be certified as a
CMTL. Among the requirements, s. 381.988(1)(d), F.S., requires all owners and managers, but not
employees, of a CMTL to pass a level 2 background screening.
Effect of the Bill – Medical Marijuana
The bill makes edible production regulations applicable to all marijuana products
The bill prohibits an MMTC’s logo, trade name, and advertisements from containing wording, images,
or content that is attractive to children or promotes recreational use of marijuana.
The bill expands DOH’s rulemaking authority to authorize any “rules it deems necessary to protect the
health and safety of qualified patients and minors, including, but not limited to, standards to ensure that
medical marijuana treatment centers operate in a manner consistent with the provision of medical
products and rules to discourage the diversion and illicit use of marijuana.”
The bill amends ss. 381.986 and 381.988, F.S., to prohibit exemptions from disqualification due to a
failed background screening from applying to these sections and to require that a caregiver, an MMTC,
or a CMTL bear the costs of the background screening, as applicable. The bill also adds the
requirement that all employees of a CMTL pass a level 2 background screening and makes the
disqualifying offenses for CMTLs consistent with those for MMTCs. Specifically, the bill adds that
disqualifying offense in s. 435.04, F.S., apply and adds that a person is disqualified if they have an
arrest awaiting final disposition for an offense under chs. 837, 895, or 896, F.S.
Florida Vital Statistics
Current Situation
Electronic Filing of Records
The Office of Vital Statistics (Office), under direction of the state registrar, is housed within DOH and
facilitates the uniform and efficient registration, compilation, storage, and preservation of all vital STORAGE NAME: h1387b.HRS PAGE: 5
DATE: 4/4/2023
records in the state.
14
The state registrar Office appoints local registrars in each of Florida’s 67
counties; local registrars are responsible for making and preserving a local record of each birth, death,
or fetal death certificate registered in the county, and transmitting these records to DOH.
15
The state
registrar and local registrars are the only individuals authorized to issue an original certificate of live
birth, death, or fetal death;
16
however, DOH has a current Memorandum of Understanding with the
Florida Tax Collectors Association and Highway Safety and Motor Vehicles to issue birth records in
agreement with the local county health departments.
17
Current law outlines processes for the filing of paper records by local registrars;
18
however, since 2009,
the Office has primarily relied upon an electronic registration system.
19
Certificates for each live birth in
the state are required to be filed by with the local registrar within five days of the birth.
20
Death and fetal
death records must be filed with DOH or the local registrar by the funeral director who first assumes
custody of the dead body or fetus, or a specified health care practitioner in attendance at or after the
death.
21
The court system is responsible for ensuring that all court records relevant to the maintenance of vital
statistics in the state are transmitted to DOH. This includes all court proceedings which may require a
new birth certificate to be issued, such as those regarding adoption, annulment of adoption, affirmation
of parental status, or determination of paternity, which must be forwarded to DOH within 30 days after
the final disposition.
22
The courts must also provide DOH with all new, endorsed marriage licenses and
dissolution-of-marriage records on a monthly basis.
23
Current law does not specify that vital records may be filed electronically with DOH.
Brain Death
Brain death occurs when a person’s respiratory and circulatory functions are maintained by artificial
means of support, but there is irreversible cessation of the functioning of the entire brain including the
brain stem.
24
Under current law, brain death must be determined by two physicians, one of which must
be the patient’s treating physician, the other must be a board-eligible or board-certified neurologist,
neurosurgeon, internist, pediatrician, surgeon, or anesthesiologist.
25
Centenarian Birth Records
Under current law, birth records over 100 years of age are considered public record and may be
produced upon a public records request.
26
The average life expectancy in the US has increased
significantly over the last century, leading to a much larger number of individuals surviving past the age
of 100 than in earlier decades. The number of centenarians living in the US increased from
14
S. 382.003, F.S.
15
S. 382.005, F.S.
16
S. 382.025(4), F.S.
17
Florida Department of Health, Agency Analysis for HB 1387 (2023), p. 5. On file with the Healthcare Regulation Subcommittee.
18
Id.
19
Id.
20
S. 382.013, F.S.
21
S. 382.008, F.S.
22
S. 382.015, F.S.
23
Ss. 382.021 and 382.023, F.S.
24
S. 382.009, F.S.
25
Id.
26
S. 382.025, F.S. STORAGE NAME: h1387b.HRS PAGE: 6
DATE: 4/4/2023
approximately 29,000 in 1990
27
to 89,000 in 2021.
28
The 2010 Census data showed that Florida had
4,090 residents 100 years of age or older at the time;
29
under current law the birth records of such
individuals are subject to public records requests.
Effect of the Bill – Florida Vital Statistics
Electronic Filing of Records
The bill requires local registrars to electronically file all live birth, death, and fetal death records
occurring within their jurisdiction in DOH’s electronic registration system. The bill requires local
registrars to make blank paper forms available to be completed and filed with DOH should the
electronic registration system be unavailable. The bill specifies processes for the managing of paper
records by the local registrars.
The bill specifies that death and fetal death records and birth certificates are to be filed electronically
and makes conforming changes throughout Ch. 382, F.S.
The bill requires court orders and proceedings that may result in the issuance of a new birth certificate
to be forwarded electronically to DOH. The bill requires that the courts electronically transmit all original
marriage licenses to DOH on a weekly basis, or submit the preceding month’s records by the fifth day
of each month. The courts may submit dissolution-of-marriage records electronically to DOH on a
weekly basis, or submit the preceding month’s records by the 10
th
day of each month.
The bill authorizes DOH to appoint persons to be authorized to issue certificates of live birth, death, or
fetal death, in addition to the state and local registrars.
Brain Death
The bill authorizes an autonomous advanced practice nurse practitioner registered under s. 464.0123,
F.S., to certify brain death if they are the patient’s treating practitioner. In such cases, the brain death
must also be certified by two licensed physicians who are board-eligible or board-certified in one of the
following specialties: neurology, neurosurgery, internal medicine, pediatrics, surgery, or anesthesiology.
Birth Records
The bill extends the length of time that birth records are exempt from public record from 100 years to
125 years. This change will prevent the birth records of living centenarians from being released under a
public records request.
Emergency Medical Services
Current Situation
Emergency Medical Responder Certification
Emergency medical responders, formerly known as first responders, include paramedics and
emergency medical technicians (EMTs) certified by DOH. EMTs are certified to provide basic life
27
Krach, C. & Velkoff, V. (1999). Centenarians in the United States – Current Population Reports. U.S. Census Bureau. Available at
https://www2.census.gov/library/publications/1999/demographics/p23-199rv.pdf (last visited March 30, 2023).
28
Boston University, Centenarian Statistics (2023). Available at
https://www.bumc.bu.edu/centenarian/statistics/#:~:text=USA%20number%20of%20centenarians.,or%20a%20prevalence%20of%200.
27%25. (last visited March 30, 2023).
29
Huriash, L. & Maines, J. (2017) 100 Years and Counting: South Florida Centenarians Honored for Lives Well Lived. South Florida Sun
Sentinel. Available at https://www.sun-sentinel.com/local/broward/fl-tamarac-residents-centenarian-celebration-20170127-story.html
(last visited March 30, 2023). STORAGE NAME: h1387b.HRS PAGE: 7
DATE: 4/4/2023
support (BLS), while paramedics are certified to provide both basic and advanced life support (ALS) to
patients.
BLS refers to any emergency medical service that uses only basic life support techniques.
30
BLS
includes basic non-invasive interventions to reduce morbidity and mortality associated with out-of-
hospital medical and traumatic emergencies.
31
The services provided may include stabilization and
maintenance of airway and breathing, some pharmacological interventions, trauma care, and
transportation to an appropriate medical facility.
32
ALS refers to any emergency medical or non-transport service that uses advanced life support
techniques.
33
ALS includes the assessment or treatment of a person by a qualified individual, such as a
paramedic, who is trained in the use of techniques such as the administration of drugs or intravenous
fluid, endotracheal intubation, telemetry, cardiac monitoring, and cardiac defibrillation.
34
To be certified as an EMT, a person must complete an approved Florida EMT training course, submit
an application to DOH, and pass the National Registry for Emergency Medical Technicians (NREMT)
EMT certification examination.
35
To be certified as a paramedic, a person must complete an approved
Florida Paramedic training course, submit an application to DOH, and pass the NREMT paramedic
certification examination.
36
Under current law, EMTs and paramedics are required to apply under
oath,
37
and paramedics must certify under oath that they are not addicted to any substances and free of
any physical or mental defect that could impede their duties as a paramedic.
38
DOH has reported that
this is an obstacle to the electronic application process.
39
Current law requires DOH to offer monthly certification examinations,
40
and outlines provisions for walk-
in eligibility and same-day grading of exams,
41
however, DOH transitioned from state-developed exams
to the NREMT certification examinations in 2016.
42
NREMT examinations are held daily at testing
centers throughout the state.
Emergency Medical Service (EMS) Training Programs
Certification as an EMT or paramedic requires the completion of a DOH-approved EMS training
program. In order for a program to be approved they must apply to DOH with documentation of the
following:
43
Compliance with any applicable Florida Department of Education requirements;
An affiliation agreement with a hospital;
An affiliation agreement with a current EMS provider licensed in Florida who is responsible for
the field experience portion of the program;
Faculty including a medical director
44
and program director; and
Curriculum meeting the standards set in statute and by the National EMS Education Standards.
30
S. 401.23(8), F.S.
31
S. 401.23(7), F.S., and U.S. Department of Transportation, National Highway Safety Administration, National EMS Scope of Practice
Model 23-24. Available at www.nhtsa.gov/people/injury/ems/pub/emtbnsc.pdf (last visited March 29, 2023).
32
Id.
33
S. 401.23(2), F.S.
34
S. 401.23(1), F.S.
35
Florida Department of Health, Licensing. Available at https://www.floridahealth.gov/licensing-and-regulation/emt-
paramedics/licensing/index.html (last visited March 29, 2023).
36
Id.
37
S. 401.27(3), F.S.
38
S. 401.27(4), F.S.
39
Supra, note 17.
40
S. 401.027(5), F.S.
41
S. 401.34, F.S.
42
Supra, note 39. See also, s. 465.017(1), F.S., DOH was required by statute to use national certification exams whenever such an
exam was available and prohibited from developing their own exam when an acceptable national certification exam was available.
43
S. 401.2701, F.S.
44
See also, s. 401.265, F.S., and rule 64J-1.004, a medical director must be a licensed physician and is responsible for the medical
performance of the EMTs and paramedics under their supervision. STORAGE NAME: h1387b.HRS PAGE: 8
DATE: 4/4/2023
Current law requires EMS training programs to maintain an affiliation agreement with a licensed EMS
provider.
45
This has been interpreted as prohibiting EMS providers from also being approved EMS
training providers and providing training internally.
46
Current law requires that DOH use the United States Department of Transportation and Medical
Services: First Responder Training Course as the minimum standard for emergency medical service
training;
47
however, The National Emergency Medical Service Education Standards (EMS Standards)
replaced the First Responder Training Course as the national standard in 2009.
48
DOH has since
transitioned to using the EMS Standards as the basis for EMT and paramedic training programs.
49
Emergency Medical Services Community Health Care
Under current law, EMTs and paramedics are authorized to perform health care tasks outside of an
emergency medical setting and in partnership with a county health department.
50
The purpose of this is
to encourage more effective utilization of the skills of EMTs and paramedics.
51
Paramedics and EMTs are authorized to perform health promotion and wellness activities and blood
pressure screening in a nonemergency environment.
52
Paramedics with sufficient training and
experience may administer immunizations under the direction of a medical director and in collaboration
with a county health department.
53
The physician must have a written agreement with a county health
department establishing the protocols, policies, and procedures under which the paramedic must
operate.
54
In 2022, the Legislature authorized paramedics to provide BLS and ALS to patients receiving acute and
post-acute hospital care at home as specified in a paramedic’s supervisory relationship with a physician
or in accordance with standing orders.
55
A physician who supervises or provides medical direction to a
paramedic for acute hospital care at home is liable for any act or omission of the paramedic when
performing ALS and BLS services in such setting.
56
Effect of Proposed Bill – Emergency Medical Services
Emergency Medical Responder Certification
The bill removes the requirement that EMTs apply under oath. The bill also removes the requirement
that paramedics attest under oath that they are not addicted to any substances and free of any physical
or mental defect that could impede their duties as a paramedic. EMT and paramedics must still attest to
these items but now may do so electronically.
The bill also deletes provisions relating to the frequency, grading, and required fees for the certification
exam as administered by DOH. These provisions are obsolete as DOH no longer develops or
administers the exam.
Emergency Medical Service Training Programs
45
S. 401.2701, F.S.
46
Supra, note 39.
47
S. 401.435, F.S.
48
National Highway Traffic Safety Administration, 2021 National Emergency Medical Services Education Standards. Available at
https://www.ems.gov/assets/EMS_Education-Standards_2021_FNL.pdf (last visited March 30, 2023).
49
Rule 64J-1.008, F.A.C.
50
S. 401.272(1), F.S.
51
Id.
52
S. 401.272(2), F.S.
53
Id.
54
Id.
55
S. 401.272(2)(c), F.S., see also, ss. 401.265, 458.348, and 459.025, F.S. regarding standing orders.
56
S. 401.272(2), F.S. STORAGE NAME: h1387b.HRS PAGE: 9
DATE: 4/4/2023
The bill authorizes licensed EMS providers with permitted transport vehicles to be approved by DOH as
an EMS training program without an affiliation agreement with an outside EMS provider. The bill also
updates statute to reflect the current national education standards for paramedics and EMTs, the US
Department of Transportation’s National Emergency Medical Services Education Standards for the
Emergency Medical Responder, and deletes references to the First Responder Training Course. The
bill also changes “first responders” to “emergency medical responders” in statute.
Emergency Medical Services Community Health Care
The bill removes language requiring that EMTs and paramedics “partner” with county health
departments when performing health care tasks outside of an emergency environment. The bill
removes references to “blood pressure screenings” in the descriptions of health care tasks that an EMT
or paramedic pay perform. Such screenings may be presumed to be included in the “health promotion
and wellness activities,” that are permitted in statute.
The bill authorizes paramedics to administer immunizations under the medical direction of a physician,
rather than a medical director affiliated with an EMS provider. The physician supervising a paramedic in
the administration of immunizations must have a written agreement with a county health department or
DOH establishing the protocols, policies, and procedures under which the paramedic must operate.
The bill stipulates that EMTs and paramedics must operate under the medical direction of a physician
through two-way voice communication or pursuant to standing orders or protocols and within the scope
of their training when they are performing health care tasks in a nonemergency environment or when
transporting a patient to a facility other than an emergency department or hospital as defined in s.
395.002, F.S.
Certified Nursing Assistants
Present Situation
Certified Nursing Assistants (CNAs) provide care and assist individuals with tasks relating to the
activities of daily living, such as those associated with personal care, nutrition and hydration,
maintaining mobility, toileting, safety and cleaning, end-of-life care, cardiopulmonary resuscitation and
emergency care.
57
A CNA performs services under the general supervision
58
of a registered nurse or
licensed practical nurse.
59
CNAs are certified by the Board of Nursing (Board) within DOH.
60
To be certified as a CNA, an applicant must pass the Certified Nursing Assistant Examination (exam)
which consists of a clinical skills test and a written test.
61
Under current law, completion of a board-
approved training program is not required to take the exam and be certified as a CNA, so long as the
applicant is over 18 years of age and has a high school diploma or its equivalent.
62
Applicants who
have completed a 120-hour, board-approved training program, or curriculum developed under the
Enterprise Florida Jobs and Education Partnership Grant are required to pass the same exam in order
to be certified as a CNA.
63
DOH has contracted with Prometric for the development and administration of the exam.
64
The written
and clinical skills portions of the exam are administered separately and are effectively two different
tests for the applicant. The written portion of the exam requires the candidate pay a $35 fee, and is
57
S. 464.201(6), F.S.
58
Under general supervision, the registered nurse or licensed practical nurse does not need to be present but must be available for
consultation and advice, either in person or by a communication device. Rule 64B9-15.001(5), F.A.C
59
Rule 64B9-15.002, F.A.C.
60
S. 464.203, F.S.
61
S. 464.203(1), F.S.
62
Id. See also, Florida Board of Nursing, Certified Nursing Assistant (CNA) by Examination. Available at
http://floridasnursing.gov/licensing/certified-nursing-assistant-examination/ (last visited March 29, 2023).
63
S. 464.203(1), F.S.
64
Prometric, Candidate Information Bulletin, State of Florida, Certified Nursing Assistant Examination. Available at
https://www.prometric.com/sites/default/files/2023-03/FL_CNA_CIB.2.27.23.pdf (last visited March 29, 2023). STORAGE NAME: h1387b.HRS PAGE: 10
DATE: 4/4/2023
administered using a computerized testing system at designated testing sites.
65
The clinical skills
portion of the exam requires a separate $120 fee, and is an in-person test of five clinical skills relevant
to the role of a CNA.
66
The skills portion is administered by Nurse Aid Evaluators who observe
candidates perform each skill and compare performance to the checkpoints for the specified skill. DOH
reports that on average, two Nurse Aid Evaluators are required to proctor each clinical skills test; and
that due to illness or workforce shortages, there have been cancellations of the required clinical skills
test, which have resulted in a delay of licensure.
67
Applicants who have failed any part of the exam three times must complete a board-approved training
program before they are eligible to attempt the exam again.
68
In order to maintain certification, a CNA
must biennially complete 24 hours of in-service training.
69
In response to the COVID-19 Public Health Emergency, the State Surgeon General issued Emergency
Order 20-008 which waived the skills demonstration portion of the exam for applicants who successfully
completed a board approved CNA training program within the prior 6 months.
70
DOH reports that during
the effective period of the executive order, there were no adverse incidents, disciplinary cases, or
complaints that resulted from this waiver.
71
The executive order expired on June 26, 2021.
72
Effect of Proposed Changes – Certified Nursing Assistants
The bill codifies the provisions of Emergency Order 20-008 regarding CNA certification. Specifically, the
bill exempts individuals who have successfully completed a board-approved CNA training program
within six months of applying for licensure from the clinical skills portion of the exam.
Hearing Aids
Present Situation
Hearing Loss
A person who is not able to hear as well as someone with normal hearing – hearing thresholds of 20
decibels or better in both ears – is said to have hearing loss.
73
There are four types of hearing loss:
74
Conductive Hearing Loss – Occurs when something prevents sounds from getting through the
outer or middle ear.
Sensorineural Hearing Loss - Occurs when there is a problem in the way the inner ear or
hearing nerve works.
Mixed Hearing Loss - Hearing loss that includes both a conductive and a sensorineural
hearing loss.
65
Id.
66
Id.
67
Supra, note 17, at p. 6.
68
Supra, note 62.
69
S. 464.203(7), F.S.
70
Florida Department of Health, Emergency Order DOH No. 20-008 (May 28, 2020). Available at https://floridahealthcovid19.gov/wp-
content/uploads/2020/05/DOH-EO-20-008.pdf (last visited March 29, 2023).
71
Supra, note 17.
72
Id.
73
World Health Organization, Deafness and Hearing Loss, Mar. 2, 2021, available at https://www.who.int/news-room/fact-
sheets/detail/deafness-and-hearing-loss (last visited March 30, 2023). “Disabling hearing loss” refers to hearing loss greater than 35
decibels in the better hearing ear.
74
Centers for Disease Control and Prevention, Types of Hearing Loss, available at https://www.cdc.gov/ncbddd/hearingloss/types.html
(last visited on March 30, 2023). STORAGE NAME: h1387b.HRS PAGE: 11
DATE: 4/4/2023
Auditory Neuropathy Spectrum Disorder - Hearing loss that occurs when sound enters the
ear normally, but because of damage to the inner ear or the hearing nerve, sound is not
organized in a way that the brain can understand.
In the United States, approximately 15% of adults (37.5 million) report some difficulty hearing and 29
million adults could benefit from hearing aids.
75
In 2019, there were 372,111 people with a hearing
disability in Florida.
76
Hearing loss in adults is generally a result of aging or noise exposure, but the
causes of hearing loss in children are much more varied and may be associated with other medical
conditions that require medical evaluation.
77
A hearing aid is a small electronic device that goes in or behind an individual’s ear to make sounds
louder so the person can listen, communicate, and participate more fully in daily activities.
78
Most
hearing aids work through air-conduction wherein they bring amplified sound into the ear canal. Certain
types of hearing loss necessitate a bone-conduction hearing aid which sends sound through the skull to
reach the inner ear.
79
Despite the high prevalence of hearing loss in the US, only one-fifth of the people who could benefit
from a hearing aid use one.
80
Barriers to hearing aid use include high cost, access to health care and
hearing specialists, social stigma, perceived value of the devices, and certain state and federal
regulations.
81
High initial purchasing cost and continued maintenance costs are primary barriers to
access; the average cost of a single hearing aid is over $2,000, or $4,000 for a pair.
82
Under current law, consumers purchasing hearing aids are guaranteed certain rights relating to the
purchase. For example, the prospective purchaser must be provided an itemized list of hearing aid
prices,
83
they must receive a written notice of a 30-day trial period with a money-back guarantee,
84
and
they reserve the right to return the hearing aid within 60 days of purchase if they consult with a
physician who determines that the use of the hearing aid is not beneficial.
85
Audiologists
The Board of Speech-Language Pathology & Audiology within DOH is responsible for licensing,
monitoring, disciplining and educating audiologists.
86
The practice of audiology includes the application
of principles, methods, and procedures for the prevention, identification, evaluation, consultation,
habilitation, rehabilitation, instruction, treatment, and research, relative to hearing and the disorders of
hearing. There are currently 1,193 licensed audiologists in Florida.
87
75
United States Department of Health and Human Services, National Institute of Deafness and Other Communication Disorders, Quick
Statistics About Hearing, available at https://www.nidcd.nih.gov/health/statistics/quick-statistics-hearing (last visited on March 30, 2023).
76
Florida Department of Health – FLHealthCHARTS Community Health Assessment Resource Tool Set, Census Population Under 18
with Hearing Disability, Census Population 18-64 with Hearing Disability, Hearing Disability 65-74, and Hearing Disability 75+, available
at http://www.flhealthcharts.com/charts/SearchResult.aspx (last visited Mar. 29, 2021).
77
US Food & Drug Administration. Hearing Aids and Personal Sound Amplification Products: What to Know. (2023). Available at
https://www.fda.gov/consumers/consumer-updates/hearing-aids-and-personal-sound-amplification-products-what-know (last visited
March 30, 2023).
78
Id.
79
Id.
80
US Food & Drug Administration, FDA Issues Landmark Proposal to Improve Access to Hearing Aid Technology for
Millions of Americans (2021). Available at https://www.fda.gov/news-events/press-announcements/fda-issues-landmark-
proposal-improve-access-hearing-aid-technology-millions-
americans#:~:text=However%2C%20despite%20the%20high%20prevalence%20and%20public%20health,the%20device
s%20or%20certain%20state%20and%20federal%20regulations. (last visited March 31, 2023).
81
Id.
82
Anderson, C. & Predith, A., (2016). FDA Takes Action to Deliver Lower-Cost, Innovative Hearing Aids to Millions More
Americans. Obama White House Archives. Available at https://obamawhitehouse.archives.gov/blog/2016/12/07/fda-takes-
action-deliver-lower-cost-innovative-hearing-aids-millions-more-americans (last visited March 31, 2023).
83
S. 468.1245, F.S.
84
S. 468.1246, F.S.
85
S. 468.1255, F.S.
86
S. 468.1185, F.S.
87
Supra, note 17 at p. 7. STORAGE NAME: h1387b.HRS PAGE: 12
DATE: 4/4/2023
In addition to conducting and interpreting hearing tests and dispensing hearing aids a licensed
audiologist may also:
88
Offer, render, plan, direct, conduct, consult, or supervise certain services to individuals who
have or are suspected of having hearing disorders, including:
o Identification;
o Evaluation;
o Treatment;
o Consultation;
o Habilitation;
o Rehabilitation;
o Instruction; and
o Research.
Participate in hearing conservation, evaluation of noise environments, and noise control.
Habilitate and rehabilitate, including, but not limited to, hearing aid evaluation, prescription,
preparation, fitting, assistive listening device selection and orientation, auditory training, aural
habilitation and rehabilitation, speech conservation, and speechreading;
Fabricate ear molds;
Evaluate tinnitus; and
Provide speech and language screening, limited to a pass/fail determination for identifying
individuals with disorders of communication.
Audiologists are required to follow certain minimum procedures and conduct certain tests when fitting a
patient for a hearing aid, including:
89
Pure tone audiometric testing by air and bone to determine the type and degree of hearing
deficiency when indicated;
Effective masking when indicated; and
Appropriate testing to determine speech reception thresholds, speech discrimination scores, the
most comfortable listening levels, uncomfortable loudness levels, and the selection of the best
fitting arrangement for maximum hearing aid benefit when indicated.
All audiometric tests must be conducted in a testing room that has been certified by DOH not to exceed
certain sound pressure levels and specified frequencies.
90
An audiologist is required to perform a final
fitting for a patient to ensure the physical and operational comfort of the hearing aid when indicated.
91
Hearing Aid Specialists
The Board of Hearing Aid Specialists within DOH is responsible for licensing, monitoring, disciplining
and educating hearing aid specialists. There are currently 1,035 licensed hearing aid specialists in
Florida.
92
A licensed hearing aid specialist may practice the dispensing of hearing aids, which
includes:
93
Conducting and interpreting hearing tests for purposes of selecting suitable hearing aids;
Making ear molds or ear impressions;
Providing appropriate counseling; and
All acts pertaining to the selling, renting, leasing, pricing, delivery, and warranty of hearing aids.
88
S. 468.1125(6)(b), F.S.
89
S. 468.1225(1), F.S.
90
S. 468.1225(6), F.S.
91
S. 468.1225(3), F.S.
92
Supra, note 17 at p. 7.
93
S. 484.045, F.S. STORAGE NAME: h1387b.HRS PAGE: 13
DATE: 4/4/2023
Hearing aid specialists are required to follow certain minimum procedures and conduct certain tests
when fitting a patient for a hearing aid, including:
94
Pure tone audiometric testing by air and bone to determine the type and degree of hearing
deficiency;
Effective masking when indicated; and
Appropriate testing to determine speech reception thresholds, speech discrimination scores, the
most comfortable listening levels, uncomfortable loudness levels, and the selection of the best
fitting arrangement for maximum hearing aid benefit.
All audiometric tests must be conducted in a testing room that has been certified by DOH not to exceed
certain sound pressure levels and specified frequencies.
95
A hearing aid specialist is required to
perform a final fitting for a patient to ensure the physical and operational comfort of the hearing aid.
96
Over-the-Counter Hearing Aids
The US Food & Drug Administration (FDA) regulates hearing aids to ensure they provide reasonable
assurance of safety and effectiveness.
97
In the FDA Reauthorization Act of 2017 (FDARA), Congress
directed the FDA to establish a category of over-the-counter (OTC) hearing aids which could be
purchased without a medical exam, prescription, or fitting adjustment by a practitioner through in-
person transactions, by mail, or online.
98
FDARA also incorporated Federal preemption provisions
prohibiting state and local governments from interfering with the servicing, marketing, sale, dispensing,
use, customer support, or distribution of OTC hearing aids.
99
On August 17, 2022, the FDA finalized a rule revising 21 CFR Parts 800, 801, and 874, as directed by
FDARA, with the goal of improving access to and reducing the cost of hearing aids for Americans
100
The FDA’s new rule establishes a new category for OTC hearing aids for adult consumers with
“perceived mild to moderate hearing impairment who wish to buy lower cost hearing aids not bundled
with professional services and not requiring professional advice, fitting, adjustment, or maintenance.”
101
Consumers are now able to purchase specified hearing aids directly from retailers, without the need for
a prescription from their physician or other medical professional. The rule became effective on October
17, 2022.
102
The FDA rule includes provisions for simplified labeling, output limits, maximum insertion depth, and
conditions for sale and distribution for both OTC and prescription hearing aids.
103
The FDA rule defines
OTC hearing aids as a hearing aid that does not require implantation or other surgical intervention and
is intended for use by a person 18 years of age or older to compensate for perceived mild to moderate
hearing impairment. The rule prohibits states from requiring the order, involvement, or intervention of a
licensed person for consumers to access over the counter hearing aids, a licensed person may service,
market, sell, dispense, provide customer support for, or distribute OTC hearing aids.
104
Florida law does not currently distinguish between OTC and prescription hearing aids,
105
nor does it
contemplate the sale of hearing aids online. Under current law, the dispensing of hearing aids to
consumers by mail is prohibited and subject to criminal penalties.
106
94
S. 484.0501(1), F.S.
95
S. 484.0501(6), F.S.
96
S. 484.0501(3), F.S.
97
Supra, note 77.
98
FDA Reauthorization Act of 2017 s. 709. Regulation of Over-the-Counter Hearing Aids.
99
Id.
100
Supra, note 80.
101
See, Federal Register, Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids.
Available at https://www.govinfo.gov/content/pkg/FR-2022-08-17/pdf/2022-17230.pdf (last visited March 31, 2023).
102
Id.
103
Id.
104
Id.
105
See, s. 484.041, F.S.
106
S. 468.1265, F.S. STORAGE NAME: h1387b.HRS PAGE: 14
DATE: 4/4/2023
Effect of Proposed Changes – Hearing Aids
The bill defines “over-the-counter hearing aid” to mean an air-conduction hearing aid that does not
require implantation or other surgical intervention and is intended for use by a person 18 years of age
or older to compensate for perceived mild to moderate hearing impairment. The bill specifies that a
“prescription hearing aid” is any hearing aid that is not considered an OTC hearing aid.
The bill amends statute regulating the distribution of hearing aids by hearing aid specialists and
audiologists to specify that the regulations apply exclusively to the dispensing of prescription hearing
aids. The bill exempts individuals dispensing exclusively OTC hearing aids from regulation. This aligns
statute with the federal rule which specifies that states may not establish regulatory measures or
require licensure for individuals who dispense OTC hearing aids.
107
The bill makes conforming changes
throughout Chs. 468 and 464 to specify that regulations apply only to prescription hearing aids.
The bill specifies that the consumer protections under current law only apply to the purchase of
prescription hearing aids, and do not pertain to the purchase of OTC hearing aids. The bill also
specifies that the restriction on the distribution of hearing aids by mail applies only to prescription
hearing aids.
The bill deletes obsolete references to rulemaking deadlines which have already been met.
Effective Date
The bill provides an effective date of July 1, 2023, except for those sections which take effect upon
becoming law.
B. SECTION DIRECTORY:
Section 1: Creates s. 381.875, F.S., relating to enhanced potential pandemic pathogen research
prohibited.
Section 2: Amends s. 381.986, F.S., relating to medical use of marijuana.
Section 3: Amends s. 381.988, F.S., relating to medical marijuana testing laboratories; marijuana
tests conducted by a certified laboratory.
Section 4: Amends s. 382.005, F.S., relating to duties of local registrars.
Section 5: Amends s. 382.008, F.S., relating to death, fetal death, and nonviable birth registration.
Section 6: Amends s. 382.009, F.S., relating to recognition of brain death under certain
circumstances.
Section 7: Amends s. 382.013, F.S., relating to birth registration.
Section 8: Amends s. 382.015, F.S., relating to new certificates of live birth; duty of clerks of court
and department.
Section 9: Amends s. 382.021, F.S., relating to department to receive marriage licenses.
Section 10: Amends s. 382.023, F.S., relating to department to receive dissolution-of-marriage
records; fees.
Section 11: Amends s. 382.025, F.S., relating to certified copies of vital records; confidentiality;
research.
Section 12: Amends s. 401.27, F.S., relating to personnel; standards and certification.
Section 13: Amends s. 401.2701, F.S., relating to emergency medical services training programs.
Section 14: Amends s. 401.272, F.S., relating to emergency medical services community health
care.
Section 15: Amends s. 401.34, F.S., relating to fees.
Section 16: Amends s. 401.435, F.S., relating to first responder agencies and training.
Section 17: Amends s. 464.203, F.S., relating to certified nursing assistants; certification
requirement.
Section 18: Amends s. 468.1225, F.S., relating to procedures, equipment, and protocols.
Section 19: Amends s. 468.1245, F.S., relating to itemized listing of prices; delivery of hearing aid;
receipt; guarantee; packaging; disclaimer.
107
Supra, note 101. STORAGE NAME: h1387b.HRS PAGE: 15
DATE: 4/4/2023
Section 20: Amends s. 468.1246, F.S., relating to thirty-day trial period; purchaser’s right to cancel;
notice; refund; cancellation fee.
Section 21: Amends s. 468.1255, F.S., relating to cancellation by medical authorization; purchaser’s
right to return.
Section 22: Amends s. 468.1265, F.S., relating to sale or distribution of hearing aids through mail;
penalty.
Section 23: Amends s. 468.1275, F.S., relating to place of business; display of license.
Section 24: Amends s. 484.0401, F.S., relating to purpose.
Section 25: Amends s. 484.041, F.S., relating to definitions.
Section 26: Amends s. 484.042, F.S., relating to Board of Hearing Aid Specialists; membership;
appointment, terms.
Section 27: Amends s. 484.044, F.S., relating to authority to make rules.
Section 28: Amends s. 484.0445, F.S., relating to training program.
Section 29: Amends s. 484.045, F.S., relating to licensure by examination.
Section 30: Amends s. 484.0501, F.S., relating to minimal procedures and equipment.
Section 31: Amends s. 484.051, F.S., relating to itemization of prices; delivery of hearing aid; receipt,
packaging, disclaimer, guarantee.
Section 32: Amends s. 484.0512, F.S., relating to thirty-day trial period; purchaser’s right to cancel;
notice; refund; cancellation fee; criminal penalty.
Section 33: Amends s. 484.0513, F.S., relating to cancellation by medical authorization; purchaser’s
right to return.
Section 34: Amends s. 484.053, F.S., relating to prohibitions; penalties.
Section 35: Amends s. 484.054, F.S., relating to sale or distribution of hearing aids through mail;
penalty.
Section 36: Amends s. 484.059, F.S., relating to exemptions.
Section 37: Relating to the effective date of this act.
Section 38: Provides an effective date of July 1, 2023, except for where otherwise specified.
II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT
A. FISCAL IMPACT ON STATE GOVERNMENT:
1. Revenues:
None.
2. Expenditures:
The bill may have an insignificant negative fiscal impact on DOH relating to rulemaking
necessitated by the bill which can be absorbed within current resources.
B. FISCAL IMPACT ON LOCAL GOVERNMENTS:
1. Revenues:
None.
2. Expenditures:
None.
C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR:
None.
D. FISCAL COMMENTS:
None. STORAGE NAME: h1387b.HRS PAGE: 16
DATE: 4/4/2023
III. COMMENTS
A. CONSTITUTIONAL ISSUES:
1. Applicability of Municipality/County Mandates Provision:
Not applicable. The bill does not appear to affect county or municipal governments.
2. Other:
None.
B. RULE-MAKING AUTHORITY:
The bill provides sufficient rule-making authority to implement the provisions of the bill.
C. DRAFTING ISSUES OR OTHER COMMENTS:
None.
IV. AMENDMENTS/COMMITTEE SUBSTITUTE CHANGES
On April 3, 2023, the Healthcare Regulation Subcommittee adopted two amendments and reported the bill
favorably as a committee substitute. The amendments:
Revised the types of health care practitioners authorized to certify brain death; and
Changed the frequency a court must send marriage licenses and dissolution-of-marriage records to
DOH.
The analysis is drafted to the committee substitute passed by the Healthcare Regulation Committee.