2019 -- H 5463

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LC001495

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2019

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A N   A C T

RELATING TO HEALTH AND SAFETY -- THE CONSUMER PROTECTION IN EYE CARE

ACT

     

     Introduced By: Representatives Jacquard, Lima, and McNamara

     Date Introduced: February 14, 2019

     Referred To: House Corporations

     It is enacted by the General Assembly as follows:

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     SECTION 1. Title 23 of the General Laws entitled "HEALTH AND SAFETY" is hereby

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amended by adding thereto the following chapter:

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CHAPTER 95

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THE CONSUMER PROTECTION IN EYE CARE ACT

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     23-95-1. Short title.

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     This act shall be known and may be cited as the "Consumer Protection in Eye Care Act."

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     23-95-2. Definitions.

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     As used in this chapter:

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     (1) "Automated computer program" means automated equipment or application designed

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to be used on a telephone, a computer, or an Internet-accessible device that can be used either in

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person or remotely to conduct an eye assessment.

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     (2) "Contact lens" means any lens placed directly on the surface of the eye, regardless of

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whether or not it is intended to correct a visual defect. Contact lenses are medical devices and

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include, but are not limited to, any cosmetic, therapeutic, or corrective lenses.

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     (3) "Delegate" means a person tasked by a provider to assist in the examination of the

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eyes and adnexa or in the development of a prescription for spectacles and/or contact lenses as

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part of a provider's utilization of an automated computer program or other eye examination

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equipment.

 

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     (4) "Department" means the Rhode Island department of health.

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     (5) "Dispense" means the act of furnishing spectacles or contact lenses to a patient.

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     (6) "Established treatment site" means a location where a patient shall seek care where

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there is a provider present and sufficient technology and equipment to allow for an adequate

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physical evaluation as appropriate for the patient's presenting complaint, and requires a provider

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in-person patient relationship.

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     (7) "Eye assessment" means an eye care service including, but not limited to, vision test

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or screening that produces prescription or prescription renewals for contact lenses, spectacles, or

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other ophthalmic goods.

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     (8) "Eye examination" means a physical assessment of the ocular health and visual or

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refractive status of a patient that does not consist solely of objective refractive data or information

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generated by an automated testing device, including an autorefractor, in order to establish a

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medical or refractive diagnosis or for the correction of vision disorders.

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     (9) "Eye examination equipment" means computerized or manual medical devices used to

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measure refractive status and/or ocular health of the patient, including, but not limited to,

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Internet-based or local computer programs, automated examination equipment, manual

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examination equipment, cameras, scanning lasers, automated refracting devices, non-contact or

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contact tonometers.

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     (10) "In-person evaluation" means a patient evaluation conducted by a provider who is at

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the same physical location as the location of the patient.

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     (11) "Prescription" means a provider's handwritten or electronic order for spectacles or

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contact lenses based on an eye examination.

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     (12) "Provider" means a health care professional licensed under chapter 35.1 or 37 of title

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5.

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     (13) "Spectacles" means an optical instrument or device worn or used by an individual

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that has one or more lenses designed to correct or enhance vision addressing the visual needs of

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the individual wearer, commonly known as "glasses" or "eyeglasses", including spectacles that

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may be adjusted by the wearer to achieve different types or levels of visual correction or

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enhancement. Spectacles does not include an optical instrument or device that is not intended to

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correct or enhance vision or is sold without consideration of the visual status of the individual

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who will use the optical instrument or device.

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     (14) "Supervision" means overseeing the utilization of a delegated automated computer

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program or other eye examination equipment and shall be provided by a provider. The utilization

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of an automated computer program or other eye examination equipment by a delegate may be

 

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performed if the examination has been delegated and the delegating provider provides appropriate

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on-site supervision and the delegate has met necessary training requirements.

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     23-95-3. Dispensing; Prescriptions.

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     (a) Except as provided for by § 5-35.1-10, no person may dispense contact lenses or

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spectacles in this state to a patient without a valid prescription from a provider.

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     (b) A prescription for spectacles or contact lenses:

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     (1) Shall contain an expiration date of not less than one year from the date of the eye

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examination, unless the provider determines that it is medically appropriate for the prescription to

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expire sooner. If the expiration date is less than one year from the date of the eye examination, the

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provider shall inform the patient of the reasoning, and document the reasoning in the provider's

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medical records for the patient.

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     (2) Shall not be made based solely on information about the human eye generated by an

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automated computer program.

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     (3) Shall take into consideration any medical findings and any refractive error discovered

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during the eye examination.

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     (4) Shall include the name, non-urgent and emergency contact information, state license

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number and physical location of provider issuing the prescription.

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     (c) No contact lenses may be sold or dispensed in this state except pursuant to a

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prescription which:

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     (1) Conforms to state and federal regulations governing such forms and includes the

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name, address, and state licensure number of a prescribing practitioner;

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     (2) Explicitly states the number of refills; provided, however, that the number of refills

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shall be sufficient for, and not excessive of, the provision of the requisite number of contact

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lenses under normal use until the expiration date of the prescription;

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     (3) Explicitly states that it is for contact lenses and indicates the lens brand name and

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type, including all specifications necessary for the ordering or fabrication of lenses; and

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     (4) Is kept on file by the person selling or dispensing the contact lenses for at least

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twenty-four (24) months after the prescription is filled.

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     (d) Anyone who fills a prescription bears the full responsibility of the accuracy of the

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contact lenses or spectacles provided under the prescription.

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     (e) At no time, without the direction of a prescriber, shall any changes or substitutions be

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made in the brand or type of lenses the prescription calls for with the exceptions of tint change if

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requested by the patient. However, if a prescription specifies "only" a specific color or tinted lens,

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those instructions shall be observed.

 

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     (f) All sales of and prescriptions for contact lenses in this state shall conform to the

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Federal Fairness to Contact Lens Consumers Act, Pub. L. 108-164, 15 U.S.C. § 7601, et seq. The

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provisions of this chapter shall be construed in aid of and in conformity with said federal act.

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Civil proceedings to enforce the provisions of this chapter may be brought by any board created

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under the Rhode Island department of health or by any other interested person through injunction

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or other appropriate remedy.

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     23-95-4. Emergent technologies.

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     No person shall operate or utilize eye assessments generated from an automated computer

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program or other eye examination equipment to conduct an eye assessment or to generate a

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prescription for contact lenses or spectacles, unless:

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     (1) Diagnostic information and data, including photographs and scans, gathered by the

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automated computer program are read and interpreted by a provider;

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     (2) The provider who reads and interprets the diagnostic information and data, including

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photographs and scans, gathered by the automated computer program or delegate, has performed

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at least one in-person evaluation of the patient that satisfies the standard of care for an eye

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examination as provided for in the general laws and the rules and regulations promulgated by the

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department thereunder, at an established treatment site;

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     (3) The provider can verify the identity of the patient requesting treatment via the

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automated computer program or other eye examination equipment;

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     (4) The automated computer program or other eye examination equipment complies with

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all the applicable state and federal laws and regulations;

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     (5) The name, non-urgent and emergency contact information, state license number and

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physical location of providers who read and interpret diagnostic information and data are filed

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with the department and disclosed on a publicly accessible website maintained by the owner or

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operator of the automated computer program;

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     (6) Prior to conducting an eye assessment through an automated computer program, any

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entity providing such service shall present to the consumer a disclaimer stating that the automated

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computer program is not a substitute for a comprehensive eye health examination, and that the

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consumer should consult an optometrist or an ophthalmologist for a complete eye health and

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vision examination. The consumer must acknowledge receipt of the disclaimer before proceeding

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with the automated computer program; and

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     (7) The provider maintains medical malpractice insurance consistent with § 42-14.1-2

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and the rules and regulations promulgated thereunder.

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     (b) No person shall operate an automated computer program or attempt to provide remote

 

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vision correction services, or to conduct an eye assessment to generate a spectacle or contact lens

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prescription for any individual under the age of eighteen (18) years old.

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     (c) A provider utilizing an automated computer program to generate a spectacle or

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contact lens prescription shall conform to the standard of care expected of in-person care.

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     23-95-5. Delegation.

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     (a) Prior to delegating the performance of eye care services, including, but not limited to

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refractive eye care services, the delegating provider shall inform the patient of:

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     (1) The name, training and qualifications of the individual who will perform the eye care

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services;

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     (2) The inherent limitations of the service being delegated and any device being used to

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perform the service; and

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     (3) A description of appropriate care and proper follow-up, including a plan to ensure that

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the service meets standards of care.

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     (b) A delegate may only perform those services delegated by and under the supervision of

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a provider who shall be immediately available to respond promptly to any question or problem

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that may arise as a result of the service being provided.

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     23-95-6. Violations; Penalty.

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     (a) Any person who believes a violation of this chapter or the rules and regulation

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adopted pursuant thereto has occurred or been attempted may file a complaint with the

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department in writing. If, upon reviewing the complaint, the department determines there is a

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reasonable basis to believe a violation or attempted violation has occurred, the department shall

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investigate. The department may, on its own initiative or otherwise, initiate an investigation if it

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has a reasonable basis to believe a violation of the act or the rules and regulations has occurred or

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been attempted. Nothing in this chapter shall be deemed to require the department to wait until

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human harm has occurred to initiate an investigation of a violation of this chapter. As part of the

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investigation under this section, the department may hold hearings, administer oaths, and take

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testimony in person or by deposition. Such hearings shall be conducted pursuant to chapter 35 of

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title 42 ("the administrative procedures act"). The findings of the investigation and any hearings

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held pursuant to the investigation shall be in writing.

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     (b) If, as a result of an investigation pursuant to this section the department finds that a

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person has violated or attempted to violate this chapter, it may impose a civil penalty of not more

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than one thousand dollars ($1,000) for each violation. If the department finds that a violation or

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attempted violation occurred and did not result in significant harm to human health, the

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department may issue a warning instead of imposing a civil penalty.

 

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     (c) Nothing in this section shall restrict the department from enforcing disciplinary action

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against a provider pursuant of chapter 35.1 and 37 of title 5, and any rules and regulations

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promulgated thereunder.

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     23-95-7. Rules and regulations.

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     The department, in conjunction with the boards established by §§ 5-35.1-13 and 5-37-1.1,

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may adopt and promulgate reasonable rules and regulations to carry out the provisions of this

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chapter.

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     23-95-8. Severability.

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     If any provision of this chapter, any rule or regulation made under this chapter, or the

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application of this chapter to any person or circumstance is held invalid by any court of

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competent jurisdiction, the remainder of the chapter, rule, or regulation, and the application of the

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provision to other persons or circumstances shall not be affected.

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     SECTION 2. This act shall take effect upon passage.

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LC001495

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO HEALTH AND SAFETY -- THE CONSUMER PROTECTION IN EYE CARE

ACT

***

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     This act would provide for consumer protection in eye care services by developing

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standards and enforcement protocols related to the utilization of emergent technologies in the

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provision of eye care services, as well as for the delegation of eye care services by providers.

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     This act would take effect upon passage.

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