The proposed rule amendments are intended to update the language.

 

DEPARTMENT OF HEALTH

Board of Medicine

RULE NO.:RULE TITLE:

64B8-56.002Equipment and Devices; Protocols for Laser and Light-Based Devices

PURPOSE AND EFFECT: The proposed rule amendments are intended to update the language.

SUMMARY: To update the language.

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: 458.331(1)(v), 478.43(1), (4) FS.

LAW IMPLEMENTED: 458.331(1)(v), 458.348(3), 478.42(5), 478.43(1), (3), (4) 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: Allen Hall, Executive Director, Board of Medicine Electrolysis Council, 4052 Bald Cypress Way, Bin # A04, Tallahassee, Florida 32399-3253.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B8-56.002 Equipment and Devices; Protocols for Laser and Light-Based Devices.

(1) No Change.

(2) An electrologist may use laser or light-based devices for hair removal or reduction only if they:

(a) through (b) No Change.   

(c) Are operating under the direct supervision and responsibility of a physician properly trained in hair removal and licensed pursuant to the provisions of Chapter 458 or 459, F.S.

1. For the purposes of this rule direct supervision and responsibility shall require the supervising physician be on the premises where laser hair removal is being performed or supervising the electrologist by means of telehealth as defined by section 456.47(1)(a), F.S., provided that:

a. The physician supervising by means of telehealth is located within 150 miles of the electrologist; and

b. The supervision is conducted in such a way as to allow continuous synchronous communication between the electrologist and the supervising physician.

2. Any electrologist who has been previously disciplined by the Board of Medicine shall not be eligible for supervision by means of telehealth until permitted to do so by Order of the Board of Medicine upon demonstration by the electrologist that they are able to practice safely with supervision by means of telehealth.

(3) No Change.

(4)(a) The supervising physician and the electrologist shall develop jointly written protocols regarding;

1. Tthe medical condition for individuals to receive laser and light-based hair removal or reduction treatment;

2. Sspecific conditions and the procedure for identifying conditions that require direct evaluation or specific consultation by the physician;

3. Ttreatment of routine minor problems resulting during or from laser and light-based hair removal or reduction;

4. Health issues or other conditions which would disqualify the use of supervision by means of telehealth for individual patients;

5. Safety limits and processes to ensure that direct supervision via telehealth is done in a safe manner; and

6. Ddetailed procedures to be followed in the event of emergency situations developing during the performance of or as a result of laser and light-based hair removal or reduction, including emergency procedures to use when supervision is conducted by means of telehealth.

(b) These written protocols must be signed, dated, and maintained in a readily available location on the premises where the electrologist practices. One copy shall be maintained by the supervising physician and one copy must be filed with the Department of Health. The written protocols which are kept on the premises of the electrologist will be readily available for inspection and review by agents of the Department of Health. The parties to a protocol must notify the Department within 30 days of the termination of their professional relationship.

(c)(b) The written protocol shall include and require that the initial consultation with each patient must include an examination and assessment by a physician licensed pursuant to Chapter 458 or 459, F.S.

(5) No Change. 

(6) Any physician who provides supervision to an electrologist must keep the Board informed of the number of electrologists the physician is supervising. No physician is authorized to supervise more than four (4) electrologists at any one time whether in person or by means of telehealth.

Rulemaking Authority 458.331(1)(v), 478.43(1), (4) FS. Law Implemented 458.331(1)(v), 458.348(3), 478.42(5), 478.43(1), (3), (4) FS. History–New 9-12-01, Amended 2-28-02, 7-23-06, 3-12-08, 11-4-14, 2-15-17, 3-14-19, 11-10-19,                        .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Medicine Electrolysis Council

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Medicine Electrolysis Council

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: December 4, 2020

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: July 24, 2020