DAR File No. 39639

Commerce, Occupational and Professional Licensing

Section R156-41-602

Form of Written Informed Consent

Notice of Proposed Rule

(Amendment)

DAR File No.: 39639
Filed: 09/03/2015 01:33:16 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

H.B. 112, which was passed during the 2015 General Session, added a requirement that sellers of hearing aids obtain informed consent from their clients on a form approved by the Division in collaboration with the Board. This proposed rule change establishes the approved form for clients of speech-language pathologists and audiologists to acknowledge informed consent.

Summary of the rule or change:

Section R156-41-602 is added to establish the approved form for clients of hearing aid sellers to acknowledge informed consent.

State statutory or constitutional authorization for this rule:

• Section 58-51-1
• Subsection 58-1-106(1)(a)
• Subsection 58-1-202(1)(a)

Anticipated cost or savings to:

the state budget:

The Division will incur minimal costs of approximately $75 to print and distribute the rule once the proposed amendments are made effective. Any costs incurred will be absorbed in the Division's current budget.

local governments:

The proposed amendments apply only to licensed speech-language pathologists and audiologists and applicants for licensure in those classifications. As a result, the proposed amendments do not apply to local governments.

small businesses:

The proposed amendments will have a very minor compliance cost for businesses where hearing aids are sold. These businesses were already required to make certain disclosures to clients. The new statute added a requirement that the form of disclosure and informed consent, to those disclosures, be on a form approved by the Division and the Board. There is no anticipated added cost for complying with this rule beyond what was already contemplated in the passage of H.B. 112 (2015).

persons other than small businesses, businesses, or local governmental entities:

The proposed amendments will have a very minor compliance cost for speech-language pathologists and audiologists who are sellers of hearings aids. These licensees were already required to make certain disclosures to clients. The new statute added a requirement that the form of disclosure and informed consent, to those disclosures, be on a form approved by the Division and the Board. There is no anticipated added cost for complying with this rule beyond what was already contemplated in the passage of H.B. 112 (2015).

Compliance costs for affected persons:

The proposed amendments will have a very minor compliance cost for speech-language pathologists and audiologists who are sellers of hearings aids. These licensees were already required to make certain disclosures to clients. The new statute added a requirement that the form of disclosure and informed consent, to those disclosures, be on a form approved by the Division and the Board. There is no anticipated added cost for complying with this rule beyond what was already contemplated in the passage of H.B. 112 (2015).

Comments by the department head on the fiscal impact the rule may have on businesses:

As stated in the rule analysis, this filing responds to legislative action (H.B. 112, 2015), which required licensed speech-language pathologists and audiologists to obtain informed consent from clients prior to providing hearing aids. The rule specifies the contents of the consent form. No fiscal impact to businesses is anticipated beyond that considered by the legislature in determining to require the disclosure.

Francine A. Giani, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:

Commerce
Occupational and Professional Licensing
HEBER M WELLS BLDG
160 E 300 S
SALT LAKE CITY, UT 84111-2316

Direct questions regarding this rule to:

• Jana Johansen at the above address, by phone at 801-530-6621, by FAX at 801-530-6511, or by Internet E-mail at janajohansen@utah.gov

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

11/02/2015

Interested persons may attend a public hearing regarding this rule:

• 10/06/2015 08:30 AM, Heber Wells Bldg, 160 E 300 S, Conference Room 475, Salt Lake City, UT

This rule may become effective on:

11/09/2015

Authorized by:

Mark Steinagel, Director

R156. Commerce, Occupational and Professional Licensing.

R156-41. Speech-Language Pathology and Audiology Licensing Act Rule.

R156-41-602. Form of Written Informed Consent.

(1) In accordance with Section 58-41-17, a speech-language pathologist or audiologist licensed under this chapter who offers to sell a hearing aid to a consumer shall include the patient's informed consent in substantially the following form.

 

TABLE

ACKNOWLEDGEMENT OF INFORMED CONSENT

  
As a consumer of a hearing aid, you are required to be informed
  
of certain information as provided in Section 58-41-17 of the
  
Utah Code.
  

  
1.  I (the consumer) have been informed regarding hearing aids
  
that work with assistive listening systems that are compliant
  
with the ADA Standards for Accessible Design adopted by the
  
United States Department of Justice in accordance with the
  
Americans with Disabilities Act, 42 U.S.C. Sec. 12101 et seq.
  

  
2.  I (the consumer) have been provided with a written receipt
  
or a written contract that provides the consumer with a 30-day
  
right to cancel the purchase and to obtain a refund if the
  
consumer returns the hearing aid to the seller in the same
  
condition as when purchased, excluding ordinary wear and tear.
  

  
I hereby acknowledge being informed of the above and consent
  
to the receive the hearing aid.
  
Patient's Signature and Date
  

  
Patient's Authorized Representative Signature and Date
  
Relationship to Patient

 

(2) A patient's informed consent form shall meet the following requirements:

(a) The 30-day written receipt or contract shall be written in at least 12-point font.

(b) The 30-day right to cancel shall commence from the date the hearing aid is originally delivered to the consumer or the date the written receipt or contract is delivered to the consumer, whichever is later.

(c) The 30-day period shall be tolled for any period during which the hearing aid seller, dealer, or fitter has possession or control of the hearing aid after its original deliver.

(d) Upon exercise of the 30-day right to cancel a hearing aid purchase, the seller of the hearing aid is entitled to a cancellation fee equal to the actual cost that will be incurred by the seller in order to return the hearing aid to the manufacturer, provided that the written receipt or contract states the exact amount that will be retained by the seller as a cancellation fee.

 

KEY: licensing, speech-language pathology, audiology

Date of Enactment or Last Substantive Amendment: [September 21, 2010]2015

Notice of Continuation: November 29, 2011

Authorizing, and Implemented or Interpreted Law: 58-1-106(1)(a); 58-1-202(1)(a); 58-41-1