STATE OF WISCONSIN
Dentistry Examining Board
IN THE MATTER OF RULEMAKING
PROCEEDINGS BEFORE THE
DENTISTRY EXAMINING
BOARD
PROPOSED ORDER OF THE
DENTISTRY EXAMINING BOARD
ADOPTING RULES
(CLEARINGHOUSE RULE)
PROPOSED ORDER
An order of the
Dentistry Examining Board
to
create DE Chapter
14
relating to
informed consent
.
Analysi
s prepared by the Department of
Safety and Professional Services
.
ANALYSIS
Statutes interpreted:
Statutory authority:
Explanation of agency authority:
Section
15.08
(5)
(b)
, Stats.
Each examining board shall promulgate rules for its own guidance and for the guidance of the trade or profession to which it pertains, and define and enforce professional conduct and unethical practices not inconsistent with the law relating to the particular trade or profession.
Section
227.11 (2) (a)
, Stats., provides that “[e]ach agency may promulgate rules interpreting the provisions of any statute enforced or administered by the agency, if the agency considers it necessary to effectuate the purpose of the statute, but a rule is not valid if the rule exceeds the bounds of correct interpretation.”
Section
447.02
(2)
(i)
, Stats.
The examining board shall promulgate rules specifying the provisions for implementing s.
447.40
.
Related statute or rule:
Plain language analysis:
The duty of certain health care professionals, other than physicians, to obtain informed consent from their patients before conducting treatment had not been codified as a statuto
ry duty prior to the passage of
2013 Wisconsin Act 345
. Act 345 sets f
orth the dentist
s
’
duty to obtain informed consent from their patients and institutes the reasonable
dentis
t standard as the standard for informing patients regarding their treatment options. The reasonable
dentist
standard requires disclosure only of the inf
ormation that a reasonable dentist
would know and disclose under the circumstances.
Summary of, and comparison with, existing or proposed federal regulation:
Although several federal agencies require investigators to obtain informed consent of human subjects participating in investigative trials, there are no specific federal regulations regarding
dentists
obtaining informed consent from their patients or the reasonable
dentist
standard.
Comparison with rules in adjacent states:
Illinois
:
Illinois A
dministr
ative Code
is silent with regards to
dentists’
duty to obtain informed consent (68 Il. Admin. Code pt. 1220).
Iowa
:
Iowa Administrative Code regarding record keeping states that dental records must include, at a minimum, documentation of informed consent that includes a discussion of procedures, treatment options, potential complications, and known risks, and patient’s consent to proceed with treatment (Iowa
Admin. Code r.
650-27.11
).
Michigan
:
Michigan Administrative Code is silent with regards to dentists’ duty to obtain informed consent (Mich. Admin. Code r.
338.11101 - 338.11821
)
.
Minnesota:
Minnesota Administrative Code
requires
that dental records must include a notation that
the dentist, advanced dental therapist, or dental therapist discussed with the patient the treatment options and the prognosis, benefits, and risks of each; and the patient has consented to the treatment chosen (Minn. R. 3100.9600 subp. 9)
.
Summary of factual data and analytical methodologies:
No factual data or analyt
ical me
thodologies
were used in dra
fting the proposed rule due to the
proposed rule being prompted by the passage of
2013 WI Act 345
.
Adjacent states’ requirements were reviewed.
Analysis and supporting documents used to determine effect on small business or in preparation of economic impact
analysis
:
The rule
was
posted for public comment on the economic impact of the proposed rule, including how this proposed rule may affect businesses, local government units, and individuals, for a period of 14 days.
No comments were received.
Fiscal Estimate and Economic Impact Analysis:
The Fiscal Estimate and Economic Impact Analysis document is attached.
Effect on small business
:
These proposed rules do not have an economic impact on small businesses, as defined in s.
227.114 (1)
, Stats. The Department’s Regulatory Review Coordinator may be contacted by email at
Eric.Esser@wisconsin.gov
, or by calling (608) 267-2435.
Agency contact person
:
Katie
Vieira (
Paff
)
, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 1400 East Washington Avenue, Room 151, P.O. Box 8935, Madison, Wisconsin 53708; telephone 608-
261-4472; email at
Kathleen.Vieira
@wisconsin.gov
.
Place where comments are to be submitted and deadline for submission
:
Comments may be submitted to Katie Paff, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 1400 East Washington Avenue, Room 151, P.O. Box 8366, Madison, WI 53708-8935, or by email to
Kathleen.Paff@wisconsin.gov
.
Comments
must be received on or before the public hearing to be held on September
2, 2015
to be included in the record of rule-making proceedings.
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TEXT OF RULE
Section
1
.
Chapter
DE 14
is created to read:
INFORMED CONSENT
(2)
Purpose.
The purpose of the rules is to defi
ne the obligation of a dentis
t to communicate alternate modes of treatment to a patient.
DE
14
.02 Informed consent.
Any dent
ist who treats a patient shall inform the patient about the availability of reasonable alternate modes of treatment and about the benefits and risks of these treatments. The reasonable
denti
st standard is the standard for informing a patient under this
section. The reasonable dent
ist standard requires disclosure only of information that a reasonable
dent
ist would know and disclose under the circumstances.
DE 14
.03 Exceptions to communication of alternate modes of treatment.
The dent
ist's duty to inform the patient under this section does not require disclosure of any of the following:
(1)
Detailed technical information that in all probability a patient would not understand.
(2)
Risks apparent or known to the patient.
(3)
Extremely remote possibilities that might falsely or detrimentally alarm the patient.
(4)
Information in emergencies where failure to provide treatment would be more harmful to the patient than treatment.
(5)
Information in cases where the patient is incapable of consenting.
(6)
Information about alternate modes of treatment for any condition the dentist has not included in his or her diagnosis at the time the dentist informs the patient.
DE 14
.04 Recordkeeping.
A dentis
t’s patient record shall include documentation that alternate modes of treatment have been communicated to the patient and informed consent has been obtained from the patient in keeping wit
h
ch.
DE 8
.
Section
2.
EFFECTIVE DATE.
The rules adopted in this order shall take effect on the first day of the month following publication in the
Wisconsin
administrative register, pursuant to s.
227.22 (2) (intro.)
, Stats.
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(END OF TEXT OF RULE)
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