To conform with 21 C.F.R. 800.30.

 

DEPARTMENT OF HEALTH

Board of Hearing Aid Specialists

RULE NOS.:RULE TITLES:

64B6-7.002Guidelines for Disposition of Disciplinary Cases

64B6-7.004Fraudulent, False, Deceptive or Misleading Advertising

PURPOSE AND EFFECT: To conform with 21 C.F.R. 800.30.

SUMMARY: To conform with 21 C.F.R. 800.30.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: During discussion of the economic impact of this rule at its Board meeting, the Board concluded that this rule change will not have any impact on licensees and their businesses or the businesses that employ them. The rule will not increase any fees, business costs, personnel costs, will not decrease profit opportunities, and will not require any specialized knowledge to comply. This change will not increase any direct or indirect regulatory costs. Hence, the Board determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 484.044, 456.47(7), 456.079 FS.

LAW IMPLEMENTED: 456.47, 456.079, 760.27, 484.056(1)(f) FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Ashleigh Irving, Executive Director, Board of Hearing Aid Specialists, 4052 Bald Cypress Way, Bin # C08, Tallahassee, Florida 32399-3258.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

64B6-7.002 Guidelines for Disposition of Disciplinary Cases.

(1) No Change.

(2) Violations and Range of Penalties. For applicants, all violations are sufficient for refusal to certify an application for licensure. For licensees or trainees, the imposition of probation as a penalty shall ordinarily require compliance with conditions such as restitution, continuing education and/or training, indirect or direct supervision by a Board-approved monitor, restrictions on practice, submission of reports, appearances before the Board, and/or hours of community service. As appropriate, such conditions of probation also shall be required following any period of suspension. In addition to any other discipline imposed, the Board shall assess the actual costs related to the investigation and prosecution of a case. In imposing discipline pursuant to Sections 120.57(1) and 120.57(2), F.S., the Board shall act in accordance with the following disciplinary guidelines and shall impose a penalty as authorized by Section 456.072(2), F.S., within the range corresponding to the violations set forth below. Pursuant to Section 456.47, F.S., disciplinary guidelines for registered out-of-state telehealth providers may include suspension or revocation of the provider’s registration or the issuance of a reprimand or letter of concern. A suspension may be accompanied by a corrective action plan as determined by the board.  The verbal identification of offenses are descriptive only; the full language of each statutory provision cited must be consulted in order to determine the conduct included:

(a) through (o) No Change.

(p) Section 484.056(1)(p), F.S.: Implying that use of a prescription hearing aid will improve or preserve hearing or retard impairment.

	MINIMUM	MAXIMUM
FIRST OFFENSE	Reprimand and $250 fine.	$2,500 fine, 1 year probation.
SECOND OFFENSE	Reprimand and $500 fine, 1 year probation.	$5,000 fine, 1 year suspension.
ADDITIONAL OFFENSES	Reprimand and $5,000, 1 year suspension.	$10,000 fine, revocation.
TELEHEALTH REGISTRANTS
	MINIMUM	MAXIMUM
FIRST OFFENSE	Reprimand, 6 months suspension.	Revocation.
SECOND OFFENSE	Reprimand and 1 year suspension, corrective action plan.	Revocation.
ADDITIONAL OFFENSES	Reprimand and 2 years suspension, corrective action plan.	Revocation.

(q) Section 484.056(1)(q), F.S.: Making any statement regarding cure or cause of an impairment by use of a prescription hearing aid.

	MINIMUM	MAXIMUM
FIRST OFFENSE	Reprimand and $250 fine.	$2,500, 1 year probation.
SECOND OFFENSE	Reprimand and $500 fine, 1 year probation.	$5,000 fine, 1 year of suspension.
ADDITIONAL OFFENSES	$5,000, 1 year suspension.	$10,000, revocation.
TELEHEALTH REGISTRANTS
	MINIMUM	MAXIMUM
FIRST OFFENSE	Reprimand, 6 months suspension.	Revocation.
SECOND OFFENSE	Reprimand and 1 year suspension, corrective action plan.	Revocation.
ADDITIONAL OFFENSES	Reprimand and 2 years suspension, corrective action plan.	Revocation.

(r) through (mm) No Change.

(3) through (6) No Change.

Rulemaking Authority 456.47(7), 456.079 FS. Law Implemented 456.47, 456.079, 760.27 FS. History–New 2-11-87, Amended 2-16-89, Formerly 21JJ-7.005, Amended 8-18-93, 9-22-94, Formerly 61G9-7.005, Amended 11-11-02, 6-23-10, 10-21-12, 11-14-21, __________________.

64B6-7.004 Fraudulent, False, Deceptive or Misleading Advertising.

An advertisement or advertising is fraudulent, false, deceptive or misleading if it:

(1) through (2) No Change.

(3) Is misleading or deceptive because its content or the context in which it is presented makes only a partial disclosure of relevant facts.

(a) No Change.

(b) Furthermore, it is misleading and deceptive to advertise, or permit to be advertised, the price of a specifically identified prescription hearing aid, if more than one prescription hearing aid appears in the same advertisement, without an accompanying price.

(4) through (6) No Change.

Rulemaking Authority 484.044 FS. Law Implemented 484.056(1)(f) FS. History–New 8-12-87, Amended 10-15-90, Formerly 21JJ-7.007, 61G9-7.00, Amended 11-16-04, ________________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Hearing Aid Specialists

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Hearing Aid Specialists

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: January 27, 2023

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: February 24, 2023