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LEGISLATURE
OF
THE
STATE
OF
IDAHO
Sixty-eighth
Legislature
Second
Regular
Session
-
2026
IN
THE
HOUSE
OF
REPRESENTATIVES
HOUSE
BILL
NO.
945
BY
WAYS
AND
MEANS
COMMITTEE
AN
ACT
1
RELATING
TO
ARTIFICIAL
INTELLIGENCE
MEDICAL
SERVICES;
PROVIDING
LEGISLA
-
2
TIVE
FINDINGS
AND
INTENT;
AMENDING
TITLE
54,
IDAHO
CODE,
BY
THE
ADDITION
3
OF
A
NEW
CHAPTER
60,
TITLE
54,
IDAHO
CODE,
TO
PROVIDE
A
SHORT
TITLE,
TO
4
DEFINE
TERMS,
TO
ESTABLISH
THE
BOARD
OF
AUTONOMOUS
MEDICAL
PRACTICE,
5
TO
PROVIDE
FOR
A
LICENSURE
FRAMEWORK,
TO
PROVIDE
FOR
TRANSPARENCY,
TO
6
PROVIDE
FOR
CLINICAL
INTEGRITY,
PATIENT
LOYALTY,
AND
AUDITABILITY,
7
TO
PROVIDE
FOR
A
REGULATORY
SANDBOX
AND
ETHICAL
OVERSIGHT,
TO
PROVIDE
8
FOR
SCOPE
OF
PRACTICE
AUTHORITY
AND
A
LIABILITY
WAIVER,
TO
PROVIDE
FOR
9
ENFORCEMENT,
TO
PROVIDE
FOR
STATE
FUNDING,
TO
PROVIDE
FOR
INSURANCE
10
GUIDANCE,
AND
TO
PROVIDE
A
RULE
OF
CONSTRUCTION;
PROVIDING
SEVERABIL
-
1
1
ITY;
AND
DECLARING
AN
EMERGENCY
AND
PROVIDING
AN
EFFECTIVE
DATE.
12
Be
It
Enacted
by
the
Legislature
of
the
State
of
Idaho:
13
SECTION
1.
LEGISLATIVE
FINDINGS
AND
INTENT.
(1)
The
Legislature
finds
14
that:
15
(a)
The
patient
-
directed
diagnostic,
therapeutic,
triaging,
prescrib
-
16
ing,
or
other
clinical
application
of
artificial
intelligence,
when
of
-
17
fered
as
a
clinical
AI
service,
may
constitute
the
practice
of
medicine
18
or
other
licensed
clinical
practice
subject
to
state
regulation.
19
(b)
Laboratory
-
developed
tests
and
professional
diagnostic
services
20
that
are
solely
patient
-
specific
professional
services
within
this
21
state,
and
not
marketed
or
distributed
as
general
purpose
commercial
22
products,
are
professional
services
subject
to
state
regulation,
dis
-
23
tinct
from
the
commercial
sale
of
medical
devices
regulated
by
the
24
federal
food,
drug,
and
cosmetic
act.
25
(c)
To
address
critical
provider
shortages
and
improve
patient
out
-
26
comes,
the
state
must
establish
a
clear,
safe
licensure
pathway
for
27
autonomous
and
augmented
clinical
services
delivered
through
software,
28
systems,
or
devices
while
preserving
state
authority
and
avoiding
con
-
29
flict
with
applicable
federal
law.
30
(d)
The
regulation
of
autonomous
clinical
decision
-
making
is
demon
-
31
strably
necessary
to
protect
the
life,
health,
and
safety
of
the
citi
-
32
zens
of
this
state.
The
licensure
requirements
established
in
this
act
33
are
narrowly
tailored
to
regulate
only
the
professional
application
34
of
artificial
intelligence
in
a
clinical
setting
and
do
not
restrict
35
the
general
private
ownership
or
nonclinical
use
of
computational
re
-
36
sources.
37
(e)
The
purpose
of
professional
licensure
and
regulation
is
to
protect
38
the
public
health,
safety,
and
welfare.
Nothing
in
this
act
is
intended
39
to
preserve
or
advance
the
economic
interests,
market
share,
or
profes
-
40
sional
boundaries
of
any
particular
health
care
profession.
This
act
41
shall
be
construed
to
promote
patient
access
to
safe
and
effective
arti
-
42
ficial
intelligence
services
and
to
encourage
responsible
innovation.
43
2
Any
regulatory
requirement
adopted
pursuant
to
this
act
that
materially
1
affects
market
entry
or
the
availability
of
AI
-
enabled
services
shall
2
be
reasonably
related
to,
and
proportionate
with,
an
identified
risk
to
3
patient
safety
and
shall
not
impose
restrictions
greater
than
necessary
4
to
address
such
risk.
5
(f)
Laboratory
-
developed
tests
and
professional
diagnostic
services
6
utilizing
proprietary
methodologies,
when
offered
and
performed
solely
7
as
patient
-
specific
professional
services
within
this
state
and
not
8
marketed
or
distributed
as
general
-
purpose
commercial
products,
con
-
9
stitute
professional
services
subject
to
state
regulation.
Nothing
in
10
this
act
shall
be
construed
to
expand
or
limit
the
application
of
appli
-
1
1
cable
federal
law.
12
(g)
Nothing
in
this
act
expands
or
restricts
the
scope
of
practice
of
13
any
human
-
licensed
health
care
profession;
rather,
this
act
creates
an
14
independent
licensure
pathway
for
clinical
AI
services.
15
(2)
It
is
the
intent
of
the
Legislature
through
this
act
to
create
a
16
new
class
of
health
care
provider,
the
AI
-
augmented
and
autonomous
service
17
provider,
capable
of
practicing
medicine
or
other
licensed
clinical
prac
-
18
tice
under
state
licensure.
19
SECTION
2.
That
Title
54,
Idaho
Code,
be,
and
the
same
is
hereby
amended
20
by
the
addition
thereto
of
a
NEW
CHAPTER
,
to
be
known
and
designated
as
Chap
-
21
ter
60,
Title
54,
Idaho
Code,
and
to
read
as
follows:
22
CHAPTER
60
23
ARTIFICIAL
INTELLIGENCE
MEDICAL
SERVICES
24
54
-
6001.
SHORT
TITLE.
This
chapter
shall
be
known
and
may
be
cited
as
25
the
"AI
Medical
Services
Act."
26
54
-
6002.
DEFINITIONS.
For
the
purposes
of
this
chapter:
27
(1)
"AAASP"
or
"artificial
intelligence
augmented
and
autonomous
ser
-
28
vice
provider"
means
a
corporate
or
legal
entity
licensed
by
the
board
to
op
-
29
erate
clinical
AI
services
that
are
subject
to
licensure
pursuant
to
section
30
54
-
6004,
Idaho
Code.
31
(a)
For
the
purposes
of
state
law
governing
patient
privacy,
confiden
-
32
tiality,
credentialing,
reimbursement,
and
professional
accountabil
-
33
ity
as
administered
under
this
chapter,
an
AAASP
is
deemed
a
health
care
34
provider.
35
(b)
For
the
purposes
of
state
-
administered
patient
privacy,
confiden
-
36
tiality,
credentialing,
and
reimbursement
laws,
and
for
federal
laws
37
that
expressly
defer
to
state
determinations
of
provider
status,
in
-
38
cluding
the
federal
health
insurance
portability
and
accountability
39
act
(HIPAA),
an
AAASP
is
deemed
a
health
care
provider,
without
creating
40
or
implying
recognition
for
purposes
of
medicare,
medicaid,
or
other
41
federal
payment
programs.
42
(c)
An
AAASP
shall
be
treated
as
a
health
care
provider
under
all
ap
-
43
plicable
state
privacy
and
confidentiality
laws
and
shall
comply
with
44
HIPAA
to
the
extent
it
functions
as
a
covered
entity
or
business
asso
-
45
ciate.
46
3
(2)
"Adverse
event"
means
an
event
of
patient
death,
serious
physical
1
or
psychological
harm,
or
serious
risk
of
harm
reasonably
associated
with
a
2
clinical
AI
service,
including
inappropriate
triage
or
failure
to
escalate
3
care.
4
(3)
"AI"
means
artificial
intelligence.
5
(4)
AI
operational
role
categories:
6
(a)
"Advisory
AI"
means
artificial
intelligence
that
analyzes
pa
-
7
tient
-
specific
data
to
generate
options,
potential
diagnoses,
risk
8
stratification,
or
therapeutic
suggestions
for
a
licensed
health
care
9
provider
or
directly
for
a
patient
or
user,
where
such
output
is
in
-
10
tended
to
inform
but
not
substitute
for
independent
clinical
judgment
1
1
and
where
the
provider
or
user
is
expected
to
review,
contextualize,
12
and
determine
whether
and
how
to
act
regarding
the
suggestion
for
each
13
patient
encounter.
14
(b)
"Fully
autonomous
AI"
means
artificial
intelligence
authorized
to
15
independently
diagnose,
treat,
triage,
or
prescribe
without
the
neces
-
16
sity
of
human
supervision
or
intervention
for
each
distinct
case.
17
(c)
"Informational
AI"
means
artificial
intelligence
that
provides
ag
-
18
gregated
data,
literature,
or
administrative
information
to
a
user
but
19
does
not
suggest
a
specific
clinical
action,
such
as
search
retrieval,
20
transcription,
or
back
-
office
support.
21
(d)
"Supervised
autonomous
AI"
means
artificial
intelligence
autho
-
22
rized
to
generate
and
execute
a
clinical
action,
diagnosis,
or
treat
-
23
ment
plan
under
the
supervision
of
a
licensed
human
provider
who
retains
24
the
ability
to
intervene.
25
(5)
"Board"
means
the
board
of
autonomous
medical
practice.
26
(6)(a)
"Clinical
AI
service"
means
any
software
system,
algorithmic
27
model,
or
automated
service
that,
whether
independently
or
in
combina
-
28
tion
with
human
involvement,
performs,
supports,
or
materially
influ
-
29
ences
functions
that
constitute
the
practice
of
medicine
or
other
li
-
30
censed
clinical
practice
with
respect
to
a
specific
patient,
to
the
ex
-
31
tent
otherwise
permitted
under
applicable
law.
32
(b)
"Clinical
AI
service"
encompasses
AI
systems
across
a
spectrum
of
33
functionality
and
autonomy,
including
information
-
providing,
advi
-
34
sory,
supervised
autonomous,
and
autonomous
systems,
when
such
systems
35
engage
in
patient
-
directed
clinical
functions
as
described
in
this
sub
-
36
section.
Such
functions
include
but
are
not
limited
to:
37
(i)
Collecting,
analyzing,
interpreting,
or
synthesizing
clini
-
38
cal
data,
biometric
data,
diagnostic
data,
laboratory
data,
imag
-
39
ing
data,
or
patient
-
reported
information
for
a
specific
patient;
40
(ii)
Generating
or
supporting
clinical
assessments,
diagnostic
41
conclusions,
risk
stratification,
triage
determinations,
treat
-
42
ment
plans,
medication
selection
or
dosing,
or
therapeutic
initi
-
43
ation,
modification,
continuation,
or
discontinuation
for
a
spe
-
44
cific
patient;
45
(iii)
Recommending,
supporting,
or
interpreting
laboratory
46
tests,
diagnostic
procedures,
or
monitoring
parameters
for
a
spe
-
47
cific
patient;
48
(iv)
Monitoring
patient
status,
detecting
clinically
meaning
-
49
ful
changes,
predicting
clinical
deterioration
or
improvement,
50
4
or
supporting
clinical
intervention
workflows
for
a
specific
pa
-
1
tient,
whether
in
real
time
or
asynchronously;
and
2
(v)
Communicating
clinical
information,
recommendations,
3
alerts,
or
guidance
intended
to
inform
patient
care
or
licensed
4
clinician
decision
-
making
for
a
specific
patient.
5
(c)
"Clinical
AI
service"
may
be
deployed
through
any
care
delivery
6
modality,
including
in
-
person
clinical
systems,
or
software
-
based
7
agents.
The
mode
of
deployment
does
not
alter
whether
a
system
consti
-
8
tutes
a
clinical
AI
service
under
this
definition.
9
(d)
"Clinical
AI
service"
does
not
include
software
or
systems
whose
10
sole
function
is
administrative,
financial,
scheduling,
billing,
in
-
1
1
ventory,
claims
processing,
documentation
assistance,
generalized
12
clinical
education,
population
-
level
analytics,
research,
quality
13
improvement,
public
health
surveillance,
or
de
-
identified
data
pro
-
14
cessing,
provided
such
systems
do
not
materially
influence
clinical
15
decision
-
making
for
a
specific
patient.
16
(e)
"Clinical
AI
service"
also
does
not
include
purely
informational
17
systems
that
only
transmit,
store,
display,
or
route
data
without
per
-
18
forming
clinical
analysis,
interpretation,
or
decision
support,
unless
19
such
systems
materially
influence
patient
-
specific
clinical
functions
20
described
in
paragraph
(b)
of
this
subsection.
A
system
is
considered
21
deployed
as
a
clinical
AI
service
if
it
is
marketed,
represented,
or
22
reasonably
used
to
independently
perform
patient
-
specific
clinical
23
decision
-
making
or
autonomous
clinical
action.
A
system
is
not
consid
-
24
ered
deployed
as
a
clinical
AI
service
when
it
merely
provides
advisory
25
clinical
decision
support
to
a
licensed
human
health
care
provider
who
26
retains
independent
authority
for
clinical
decisions
and
execution.
27
(7)(a)
Clinical
condition
categories:
28
(i)
"Chronic
condition"
means
a
human
disease,
disorder,
in
-
29
jury,
or
impairment
that
is
persistent,
recurrent,
or
reasonably
30
expected
to
require
ongoing
or
periodic
clinical
management,
31
monitoring,
or
care
to
maintain
function,
prevent
progression,
32
mitigate
symptoms,
or
reduce
the
risk
of
complications.
Chronic
33
conditions
are
primarily
managed
through
longitudinal
care
rather
34
than
isolated
emergency
intervention
and
may
experience
episodic
35
exacerbations
requiring
temporary
escalation
of
care.
36
(ii)
"Critical
condition"
means
a
disease,
illness,
injury,
or
37
physiologic
state
in
which
one
(1)
or
more
vital
organ
systems
is
38
impaired,
failing,
or
at
substantial
risk
of
failure,
or
in
which
39
the
condition
presents
a
high
probability
of
death,
permanent
dis
-
40
ability,
or
serious
irreversible
harm
without
prompt
and
advanced
41
clinical
intervention.
A
critical
condition
is
characterized
by
42
physiologic
instability,
high
acuity,
or
the
need
for
continuous
43
monitoring,
specialized
resources,
or
intensive
medical
manage
-
44
ment
to
prevent
catastrophic
outcomes.
45
(iii)
"Noncritical
condition"
means
a
condition,
illness,
or
in
-
46
jury,
whether
acute,
subacute,
stable
chronic,
or
self
-
limiting,
47
for
which,
based
on
reasonable
clinical
judgment
and
available
48
clinical
information,
a
delay
in
definitive
diagnosis,
initia
-
49
tion
of
treatment,
or
escalation
of
care
would
not
reasonably
be
50
5
expected
to
result
in
serious
adverse
health
consequences,
per
-
1
manent
disability,
or
death.
A
noncritical
condition
does
not
2
present
objective
signs
of
physiologic
instability,
rapidly
pro
-
3
gressive
deterioration,
or
the
need
for
immediate
emergency
or
4
life
-
preserving
intervention.
5
(iv)
"Preventive
condition"
means
a
medical
condition
where
6
measures,
services,
or
interventions
are
applied
to
reduce
the
7
likelihood
of
disease
onset,
progression,
recurrence,
or
compli
-
8
cations,
including
wellness,
fitness,
primary,
and
risk
-
based
9
preventive
care,
whether
applied
to
healthy
individuals
or
in
-
10
dividuals
with
identified
risk
factors
or
existing
conditions,
1
1
where
the
primary
purpose
is
risk
reduction
or
health
maintenance
12
rather
than
treatment
of
an
active
acute
pathology
and
where
the
13
intervention
is
generally
low
-
risk
and
consistent
with
accepted
14
standards
of
care.
15
(v)
"Time
-
sensitive
condition"
means
a
medical
condition
or
16
acute
clinical
presentation
for
which
the
effectiveness
of
di
-
17
agnosis,
treatment,
or
intervention
is
materially
dependent
on
18
timely
initiation
and
for
which
a
delay
in
care
is
reasonably
ex
-
19
pected
to
result
in
rapid
clinical
deterioration,
irreversible
20
morbidity,
or
death.
Time
-
sensitive
conditions
require
acceler
-
21
ated
recognition,
triage,
and
escalation
of
care
based
on
reason
-
22
able
clinical
judgment
and
available
clinical
information.
23
(b)
Clinical
condition
categorization
under
this
chapter
shall
be
24
based
on
the
patient's
presentation
and
the
clinical
information
rea
-
25
sonably
available
at
the
time
of
the
service,
not
on
retrospective
26
diagnosis.
A
licensee
acting
in
reasonable
reliance
on
available
clin
-
27
ical
information
shall
not
be
deemed
in
violation
of
the
provisions
of
28
the
chapter
solely
due
to
later
reclassification
of
the
condition.
29
(8)
"Designated
responsible
official"
means
a
natural
person
desig
-
30
nated
by
an
AAASP
who
is
authorized
to
bind
the
AAASP
for
compliance
and
31
administrative
matters
under
this
chapter,
to
receive
legal
process
and
32
board
notices,
and
to
certify
filings
and
reports
required
by
the
board.
A
33
designated
responsible
official
is
not,
solely
by
designation,
deemed
to
be
34
practicing
a
licensed
health
care
profession.
35
(9)
"Materially
influence"
means
having
a
reasonable
likelihood
of
be
-
36
ing
relied
on
to
make,
modify,
or
forego
a
patient
-
specific
clinical
deci
-
37
sion
or
action.
38
(10)
"Medical
director"
means
a
physician
licensed
and
in
good
stand
-
39
ing
in
this
state
who
is
designated
by
an
AAASP
to
provide
clinical
oversight
40
of
the
AAASP's
clinical
scope,
safety
protocols,
escalation
pathways,
and
41
quality
assurance
processes,
as
required
by
this
chapter
or
board
rule.
42
(11)
"Reportable
event"
means
an
adverse
event,
a
material
near
miss,
43
a
material
malfunction
affecting
clinical
output,
or
a
material
data
in
-
44
tegrity
failure
affecting
patient
-
specific
clinical
decisions.
45
(12)
"Sandbox
reciprocity
state"
means
a
jurisdiction
recognized
by
the
46
board
as
having
a
substantially
similar
regulatory
sandbox
for
health
tech
-
47
nology.
48
6
54
-
6003.
BOARD
OF
AUTONOMOUS
MEDICAL
PRACTICE.
(1)
There
is
hereby
1
established
the
board
of
autonomous
medical
practice
in
the
division
of
oc
-
2
cupational
and
professional
licenses.
The
board's
jurisdiction
extends
to
3
clinical
AI
services
constituting
the
practice
of
medicine
or
other
licensed
4
clinical
practice
performing
clinical
AI
services
as
defined
in
section
5
54
-
6002,
Idaho
Code.
6
(2)
The
board
shall
consist
of
eleven
(11)
voting
members
appointed
by
7
and
serving
at
the
pleasure
of
the
governor.
Members
may
be
removed
by
the
8
governor
at
any
time,
with
or
without
cause.
The
board
shall
include:
9
(a)
One
(1)
licensed
medical
doctor
or
doctor
of
osteopathy;
10
(b)
One
(1)
registered
nurse
or
advanced
practice
registered
nurse;
1
1
(c)
One
(1)
licensed
pharmacist;
12
(d)
One
(1)
licensed
mental
or
behavioral
health
professional;
13
(e)
One
(1)
member
representing
hospitals,
such
as
a
hospital
associa
-
14
tion
employee
or
hospital
chief
executive
officer;
15
(f)
One
(1)
health
care
ethicist
with
an
advanced
degree
or
significant
16
professional
experience
in
medical
ethics
or
bioethics;
17
(g)
One
(1)
public
member
representing
the
interests
and
protections
of
18
consumers
with
respect
to
clinical
AI
services;
and
19
(h)
Four
(4)
members
at
large
with
demonstrated
expertise
in
any
of
the
20
following
fields:
health
technology,
artificial
intelligence,
systems
21
engineering,
health
care
administration,
patient
safety,
or
regulatory
22
affairs.
23
(3)(a)
The
division
administrator
shall
appoint
an
executive
officer
24
who
shall
serve
as
the
chief
administrative
officer
of
the
board
and
25
shall
be
responsible
for
the
administration
and
operation
of
the
board.
26
The
executive
officer's
compensation
shall
be
funded
through
state
27
appropriations.
The
executive
officer
shall
be
considered
a
nonclassi
-
28
fied
employee,
an
executive
employee,
and
an
exempt
employee.
29
(b)
The
division
administrator
or
executive
officer
may
employ
such
30
other
staff
as
necessary
to
carry
out
the
duties
of
the
board,
includ
-
31
ing
a
board
ethicist
as
required
by
section
54
-
6007(4),
Idaho
Code,
who
32
shall
be
a
nonvoting
member
of
the
board.
33
(c)
Except
as
otherwise
expressly
reserved
to
the
board
by
statute
or
34
rule,
the
division
administrator
or
executive
officer
is
authorized
to
35
take
all
actions
reasonably
necessary
to
carry
out
and
enforce
the
laws
36
and
rules
administered
by
the
board,
including
but
not
limited
to
the
37
authority
to:
38
(i)
Employ,
supervise,
evaluate,
and
discipline
staff
and
con
-
39
tractors;
40
(ii)
Enter
into
contracts,
procure
goods
and
services,
and
make
41
expenditures
within
appropriated
or
authorized
budgets;
42
(iii)
Establish
internal
organizational
structure,
operational
43
procedures,
and
administrative
systems;
44
(iv)
Receive,
process,
investigate,
and
resolve
applications,
45
registrations,
filings,
complaints,
audits,
and
compliance
mat
-
46
ters;
47
(v)
Conduct
investigations,
issue
requests
for
information,
and
48
require
the
production
of
records
as
authorized
by
law;
49
7
(vi)
Administer
examinations,
reviews,
assessments,
certifica
-
1
tions,
or
registrations
authorized
by
law
or
rule;
and
2
(vii)
Take
any
other
administrative
or
operational
actions
neces
-
3
sary
to
efficiently
carry
out
the
purposes
of
this
chapter.
4
(4)(a)
The
board
is
authorized
to
adopt
and
charge
reasonable
fees
for
5
applications,
provisional
licenses,
license
renewals,
and
other
admin
-
6
istrative
services.
Fees
shall
be
set
at
a
level
sufficient
to
offset
7
the
administrative
costs
of
the
regulatory
sandbox
and
licensure
moni
-
8
toring.
9
(b)
The
legislature
may
appropriate
funds
as
necessary
for
the
initial
10
establishment
and
operation
of
the
board.
Any
such
appropriation
shall
1
1
be
temporary
and
shall
terminate
once
fee
revenue
generated
under
this
12
section
is
sufficient
to
support
the
ongoing
administrative
costs
of
13
the
board.
14
(5)
Members
shall
serve
staggered
four
(4)
year
terms.
The
governor
15
shall
make
appointments
to
promote
regular
turnover
and
avoid
regulatory
16
capture.
No
member
may
serve
more
than
two
(2)
consecutive
terms.
17
(6)
The
board
shall:
18
(a)
Monitor
and
have
the
right
to
grant,
suspend,
and
revoke
AAASP
li
-
19
censes
of
all
classes
and
types;
20
(b)
Establish
and
operate
or
contract
for
a
state
centralized
institu
-
21
tional
review
board;
22
(c)
Authorize
and
develop
frameworks
for
delegated
agreements,
collab
-
23
orative
practice
agreements,
and
supervision
agreements,
collectively
24
referred
to
as
clinical
practice
agreements
in
this
chapter;
25
(d)
Conduct
or
contract
for
algorithmic
safety
and
bias
audits;
and
26
(e)
Issue
unique
state
provider
identifiers
for
billing.
27
(7)
The
board
may
adopt
rules
in
accordance
with
the
provisions
of
chap
-
28
ter
52,
title
67,
Idaho
Code:
29
(a)
As
necessary
to
administer,
implement,
and
enforce
the
provisions
30
of
this
chapter
consistent
with
legislative
intent
and
the
authority
31
expressly
granted
to
the
board,
including
rules
governing
licensure
32
standards,
application
procedures,
renewal
requirements,
recordkeep
-
33
ing,
reporting,
inspections,
audits,
and
compliance
oversight;
34
(b)
To
establish
minimum
standards
of
professional
conduct,
oper
-
35
ational
compliance,
and
public
protection
applicable
to
licensees,
36
within
the
scope
and
purposes
of
this
chapter;
and
37
(c)
To
prescribe
fees,
forms,
and
administrative
processes
necessary
38
to
carry
out
the
duties
of
the
board.
39
(8)(a)
The
board
shall
meet
at
least
quarterly
and
at
such
additional
40
times
as
may
be
necessary
to
carry
out
the
duties
of
the
board.
41
(b)
A
meeting
of
the
board
may
be
called
by
the
chair,
the
executive
of
-
42
ficer,
or
upon
written
request
of
a
majority
of
the
board
members.
43
(c)
The
board
shall
annually
elect
from
among
its
members
a
chair
and
44
vice
chair,
who
shall
serve
one
(1)
year
terms
in
such
positions
and
may
45
be
reelected.
46
(d)
A
majority
of
the
voting
members
of
the
board
shall
constitute
a
47
quorum
for
the
transaction
of
business.
An
affirmative
vote
of
a
ma
-
48
jority
of
the
members
present
at
a
meeting
at
which
a
quorum
is
present
49
8
shall
be
required
for
official
action
of
the
board,
unless
otherwise
1
provided
by
law.
2
(e)
All
meetings
of
the
board
shall
be
open
to
the
public
and
conducted
3
in
compliance
with
the
state
open
meetings
law
and
public
records
act.
4
The
board
may
enter
executive
session
only
as
authorized
by
law.
5
(f)
The
board
shall
permit
public
participation
in
meetings
by
telecon
-
6
ference
or
other
electronic
means,
provided
that
public
access
and
quo
-
7
rum
requirements
are
satisfied.
8
(g)
No
rule
that
materially
restricts
AAASP
scope
of
practice
or
im
-
9
poses
a
new
material
barrier
to
market
entry
shall
be
adopted
without:
10
(i)
At
least
a
two
-
thirds
(2/3)
affirmative
vote
of
the
board;
and
1
1
(ii)
Written
findings
that
the
restriction
is
supported
by
sub
-
12
stantial
evidence
of
a
patient
-
safety
risk
and
is
the
least
re
-
13
strictive
means
to
address
such
risk.
14
(9)
As
the
specific
licensing
authority
for
AAASPs,
the
board:
15
(a)
May
receive
complaints,
conduct
investigations,
require
the
pro
-
16
duction
of
records
reasonably
related
to
compliance
with
this
chapter,
17
and
conduct
audits
and
inspections
as
authorized
by
law
and
rule;
18
(b)
May
issue
administrative
subpoenas
for
testimony
and
documents
in
19
furtherance
of
an
investigation
or
contested
case;
20
(c)
May
impose
discipline,
including
reprimand,
probation,
restricted
21
licensure,
suspension,
revocation,
and
administrative
fines,
if
an
22
AAASP
fails
to
meet
the
applicable
standard
of
care
or
violates
this
23
chapter
or
board
rules;
and
24
(d)
Must
conduct
any
denial,
discipline,
or
adverse
licensure
action
25
as
a
contested
case
subject
to
the
judicial
review
provisions
of
chapter
26
52,
title
67,
Idaho
Code.
27
54
-
6004.
LICENSURE
FRAMEWORK.
(1)
The
following
AI
operational
cate
-
28
gories
are
exempt
from
licensure
under
this
chapter,
provided
they
do
not
ex
-
29
ceed
the
scope
set
forth
in
this
section:
30
(a)
All
informational
AI
systems,
regardless
of
the
clinical
condition
31
they
are
applied
to;
32
(b)
Advisory
AI
as
applied
to
preventive,
chronic,
or
noncritical
con
-
33
ditions;
and
34
(c)
Supervised
autonomous
AI
applied
strictly
to
preventive
conditions
35
and
not
issuing
patient
-
specific
clinical
orders
as
part
of
a
licensed
36
professional
service
rendered
within
this
state,
including
but
not
lim
-
37
ited
to
medication
orders,
laboratory
orders,
or
device
orders.
38
(2)
The
board
shall
issue
AAASP
licenses
with
a
base
class
and
an
auton
-
39
omy
modifier,
as
provided
in
this
subsection.
40
(a)
Base
classes:
41
(i)
Class
A,
state
clinical
service,
is
for
clinical
AI
ser
-
42
vices
delivered
as
patient
-
specific
professional
services
and
43
regulated
by
the
state
pursuant
to
its
authority
over
the
prac
-
44
tice
of
medicine
or
other
licensed
clinical
practice,
including
45
but
not
limited
to
services
operating
in
a
manner
analogous
to
46
laboratory
-
developed
tests
or
other
proprietary
algorithmic
di
-
47
agnostic,
triaging,
or
therapeutic
services,
that
do
not
rely
on
48
9
food
and
drug
administration
clearance
or
approval
as
the
basis
1
for
their
lawful
clinical
use.
2
(ii)
Class
B,
federal
device
reciprocity
service,
is
for
clinical
3
AI
services
that
have
achieved
food
and
drug
administration
clear
-
4
ance,
authorization,
or
approval
as
software
as
a
medical
device
5
and
for
which
such
federal
authorization
serves
as
the
primary
ba
-
6
sis
for
the
system's
lawful
clinical
use.
7
(iii)
Class
C,
therapeutic
and
support
service,
is
for
clinical
AI
8
services
providing
nondiagnostic
therapy,
coaching,
or
monitor
-
9
ing.
Class
C
services
do
not
independently
establish
a
diagnosis
10
but
operate
on
the
basis
of
an
existing
diagnosis,
referral,
or
pa
-
1
1
tient
-
identified
condition.
12
(b)
Autonomy
modifiers:
13
(i)
Modifier
L0,
voluntary
or
exempt,
is
for
AI
systems
otherwise
14
exempt
from
licensure
under
subsection
(1)
of
this
section
that
15
voluntarily
elect
to
obtain
licensure.
16
(ii)
Modifier
L1,
advisory
-
critical,
is
for
advisory
AI
address
-
17
ing
critical
or
time
-
sensitive
conditions.
18
(iii)
Modifier
L2,
supervised,
is
for
supervised
autonomous
AI
re
-
19
quiring
human
oversight
or
clinical
practice
agreements.
20
(iv)
Modifier
L3,
autonomous,
is
for
fully
autonomous
AI
autho
-
21
rized
for
independent
operation.
22
(3)(a)
In
order
to
protect
clinical
decision
support
from
liability,
23
an
advisory
AI
system
shall
not
require
licensure
under
this
chapter,
24
including
under
modifier
L1,
when
the
system:
25
(i)
Does
not
independently
initiate,
execute,
modify,
or
discon
-
26
tinue
a
clinical
action,
order,
diagnosis,
or
treatment;
and
27
(ii)
Is
not
intended,
represented,
or
reasonably
relied
on
as
a
28
substitute
for
independent
professional
clinical
judgment
in
the
29
management
of
a
critical
or
time
-
sensitive
condition.
30
(b)
Nothing
in
this
subsection
exempts
any
system
that
otherwise
meets
31
the
definition
of
supervised
autonomous
AI
or
fully
autonomous
AI.
32
(4)
An
AAASP
license
is
required
for
any
entity
operating
clinical
AI
33
services
that
fall
within
the
following
categories:
34
(a)
Critical
advisory
AI:
Advisory
AI
tools
applied
to
critical
and
35
time
-
sensitive
conditions
that
are
intended,
represented,
or
reason
-
36
ably
relied
on
to
guide
clinical
action
in
a
manner
that
substitutes
37
for,
rather
than
merely
informs,
independent
clinical
judgment
and
that
38
does
not
satisfy
the
clinical
decision
support
liability
protections
39
set
forth
in
subsection
(3)
of
this
section.
40
(b)
Clinical
supervised
AI:
Supervised
autonomous
AI
applied
to
41
chronic,
noncritical,
critical,
or
time
-
sensitive
conditions,
or
42
preventive
conditions
but
only
where
the
service
includes
patient
-
spe
-
43
cific
clinical
orders,
including
but
not
limited
to
medication
orders,
44
laboratory
orders,
or
device
orders
as
part
of
a
licensed
professional
45
service
rendered
within
this
state.
46
(c)
Fully
autonomous
AI:
All
fully
autonomous
AI
systems,
regardless
of
47
the
condition
category
they
are
applied
to.
48
(5)
Licenses
granted
pursuant
to
this
chapter
may
be:
49
10
(a)
A
provisional,
or
sandbox,
AAASP
license,
which
shall
be
the
ini
-
1
tial
license
issued
to
all
new
applicants,
that
restricts
the
licensee
2
to
operating
within
the
regulatory
sandbox
subject
to
the
oversight,
3
geographic
limitations,
and
data
-
reporting
requirements
of
section
4
54
-
6007,
Idaho
Code;
or
5
(b)
A
full,
or
unrestricted,
AAASP
license,
which
shall
be
the
standard
6
license
permitting
statewide
practice,
issued
upon
successful
comple
-
7
tion
from
the
sandbox.
8
(6)
Licensed
human
providers
utilizing
exempt
AI
tools
within
their
9
standard
scope
of
practice
are
not
required
to
obtain
an
AAASP
license.
10
However,
an
exempt
AI
entity
may
voluntarily
apply
for
AAASP
licensure
des
-
1
1
ignated
as
"modifier
L0"
to
obtain
standalone
reimbursement
or
enter
into
12
clinical
practice
agreements.
13
(7)
A
licensee
may
obtain
license
reciprocity
by
sandbox
reciprocity,
14
federal
reciprocity,
or
licensure
by
recognition
in
substantially
similar
15
jurisdictions,
as
provided
in
this
subsection.
16
(a)
A
licensee
in
good
standing
in
a
sandbox
reciprocity
state,
and
not
17
the
subject
of
any
active
or
pending
disciplinary
action,
shall
be
eli
-
18
gible
for
licensure
by
recognition
in
the
Idaho
state
sandbox
upon
sub
-
19
mission
of
a
completed
application.
20
(b)
An
entity
holding
a
valid
federal
clearance
for
the
specific
use
21
case
applied
for
shall
be
automatically
eligible
for
class
B
licensure.
22
The
board
may
impose
state
conditions
of
licensure
under
this
chapter,
23
including
transparency,
reporting,
auditing,
pilot
-
zone,
and
sandbox
24
requirements,
to
the
extent
not
inconsistent
with
federal
law,
provided
25
that
they
align
with
benchmarks,
post
-
market
monitoring
plans,
and
re
-
26
lated
guidelines
already
applicable
to
that
provider
to
the
maximum
ex
-
27
tent
practicable.
28
(c)(i)
The
board
shall
grant
an
AAASP
license
to
an
applicant
29
holding
a
current,
unrestricted
authorization
to
provide
substan
-
30
tially
similar
clinical
AI
services
in
another
state,
unless
the
31
board
determines
that:
32
1.
The
originating
jurisdiction's
regulatory
framework
is
33
materially
less
protective
of
patient
safety
than
this
chap
-
34
ter;
35
2.
The
applicant
is
not
in
good
standing
or
is
the
subject
of
36
pending
disciplinary
action;
or
37
3.
The
scope
of
practice
or
autonomy
level
requested
in
this
38
state
exceeds
that
authorized
in
the
originating
jurisdic
-
39
tion.
40
(ii)
Licensure
granted
under
this
paragraph
shall
not
require
41
satisfaction
of
initial
licensure
requirements,
except
as
neces
-
42
sary
to
verify
good
standing,
scope
equivalence,
and
compliance
43
with
reporting
and
transparency
obligations
under
this
chapter.
44
(d)
The
board
may
require
the
applicant
to
submit
documentation
neces
-
45
sary
to
assess
substantial
similarity
and
may
impose
reasonable
condi
-
46
tions
or
limitations
to
ensure
patient
safety
and
compliance
with
this
47
chapter.
48
(e)
A
licensee
may
petition
to
upgrade
from
a
lower
modifier
to
a
higher
49
modifier,
such
as
from
L2
to
L3,
upon
submitting
safety
data
from
the
50
11
sandbox
demonstrating
performance
equivalent
to
or
exceeding
human
1
benchmarks,
to
the
extent
such
escalation
is
not
inconsistent
with
fed
-
2
eral
law.
3
(8)(a)
A
modifier
L2
AAASP
and
modifier
L3
AAASP
may
issue
patient
-
spe
-
4
cific
clinical
orders
as
part
of
a
licensed
professional
service
5
rendered
within
this
state,
including
but
not
limited
to
medication
or
-
6
ders,
laboratory
orders,
or
device
orders,
provided
that
such
authority
7
does
not
authorize
the
interstate
marketing,
distribution,
or
commer
-
8
cial
sale
of
a
medical
device
in
violation
of
federal
law.
9
(b)
A
modifier
L2
AAASP
and
modifier
L3
AAASP
may
issue
medication
or
-
10
ders
for
prescription
drugs
other
than
controlled
substances
within
its
1
1
approved
scope.
Dispensing
and
drug
administration
of
controlled
sub
-
12
stances
shall
occur
only
through
persons
or
entities
authorized
under
13
state
law
to
dispense
or
administer
medications.
14
(9)(a)
Within
thirty
(30)
days
of
receiving
an
initial
application
for
15
licensure,
the
board
shall
determine
whether
the
application
is
com
-
16
plete
and
notify
the
applicant
in
writing.
17
(i)
If
the
application
is
incomplete,
the
board
must
specify
ex
-
18
actly
what
information
is
missing.
19
(ii)
If
the
board
fails
to
notify
the
applicant
of
a
deficiency
20
within
the
thirty
(30)
day
period,
the
application
shall
be
deemed
21
complete
for
the
purposes
of
this
chapter.
If
an
application
is
22
deemed
complete
by
operation
of
law
due
to
board
inaction,
the
23
board
may
not
subsequently
deny
the
application
based
solely
on
24
the
absence
of
a
document
or
information
that
it
failed
to
request
25
within
the
thirty
(30)
day
review
period,
provided
the
applicant
26
submits
such
missing
information
within
ten
(10)
days
of
a
written
27
request.
28
(b)
Except
as
provided
in
paragraph
(c)
of
this
subsection,
the
board
29
shall
grant
or
deny
a
license
within
ninety
(90)
days
after
the
applica
-
30
tion
is
deemed
complete.
31
(c)
If
the
board
ethicist
determines,
pursuant
to
section
54
-
6007(4),
32
Idaho
Code,
that
an
applicant's
proposed
data
collection
constitutes
33
"human
subjects
research"
requiring
full
review
by
the
state
central
-
34
ized
institutional
review
board
or
an
external
institutional
review
35
board,
the
board
may
extend
the
review
period
by
one
(1)
additional
36
thirty
(30)
day
increment.
The
board
must
notify
the
applicant
of
this
37
extension
in
writing
prior
to
the
expiration
of
the
initial
ninety
(90)
38
day
period.
39
(d)
If
the
board
fails
to
issue
a
final
determination
within
the
appli
-
40
cable
time
period
set
forth
in
paragraph
(b)
or
(c)
of
this
subsection,
41
a
provisional
license
shall
be
immediately
and
automatically
issued
to
42
the
applicant,
upon
submission
by
the
applicant,
through
its
designated
43
responsible
official,
of
a
sworn
attestation
under
penalty
of
per
-
44
jury
that
the
applicant
has
satisfied
all
minimum
insurance,
bonding,
45
safety,
reporting,
and
compliance
requirements
required
for
provi
-
46
sional
licensure
under
this
chapter.
The
provisional
license
shall
47
be
valid
for
ninety
(90)
days
or
until
the
board
issues
a
final
order,
48
whichever
occurs
first.
49
12
54
-
6005.
CONSUMER
TRANSPARENCY
AND
DISCLOSURE.
(1)
Patients
have
the
1
right
to
know
the
nature
of
the
health
care
provider
delivering
clinical
ser
-
2
vices.
3
(2)
Prior
to
or
at
the
time
of
service,
an
AAASP
operating
under
modi
-
4
fier
L2
shall
disclose
to
the
patient:
"An
artificial
intelligence
system
5
was
used
to
generate
and
execute
a
clinical
action,
diagnosis,
or
treatment
6
plan
under
the
supervision
of
a
licensed
human
provider
who
retains
the
abil
-
7
ity
to
intervene.
You
have
the
right
to
request
a
human
review
of
the
de
-
8
cision,
which
may
incur
additional
costs
or
time."
This
disclosure
require
-
9
ment
does
not
apply
to
advisory
AI
tools
that
provide
recommendations,
risk
10
scores,
alerts,
or
guidance
to
a
licensed
human
health
care
provider
who
in
-
1
1
dependently
determines
whether
and
how
to
act.
12
(3)
Prior
to
delivering
services,
an
AAASP
operating
under
modifier
L3
13
shall
obtain
affirmative
patient
acknowledgment
of
the
following
disclo
-
14
sure:
"You
are
receiving
care
from
an
autonomous
AI
provider
licensed
by
15
the
State.
This
provider
is
an
artificial
intelligence
system
and
does
not
16
include
routine
human
clinical
oversight.
You
may
seek
additional
or
alter
-
17
native
care
from
a
licensed
human
health
care
provider
of
your
choice
at
any
18
time."
19
(4)
In
addition
to
the
requirement
set
forth
under
subsection
(3)
of
20
this
section,
a
modifier
L3
AAASP
operating
under
a
provisional
license
21
shall
disclose
to
the
patient:
"This
provider
is
operating
under
a
provi
-
22
sional
State
license
as
part
of
a
regulatory
sandbox
evaluating
safety
and
23
effectiveness.
By
consenting
to
this
service,
you
acknowledge
that
liabil
-
24
ity
for
noneconomic
damages
may
be
limited
under
State
law
as
provided
in
the
25
AI
Medical
Services
Act."
26
54
-
6006.
CLINICAL
INTEGRITY,
PATIENT
LOYALTY,
AND
AUDITABILITY.
27
(1)(a)
An
AAASP
holding
a
modifier
L2
or
L3
license
shall
be
bound
by
a
28
professional
duty
of
loyalty
to
the
patient.
The
AAASP
must
act
solely
29
in
the
best
clinical
interest
of
the
patient.
30
(b)
The
professional
duty
of
loyalty
includes
a
mandate
for
economic
31
stewardship
of
the
patient's
resources.
Stewardship
requires
the
32
AAASP
to
prioritize
the
patient's
overall
welfare,
which
includes
the
33
optimization
of
clinical
outcomes,
financial
efficiency,
care
coor
-
34
dination,
and
patient
convenience.
An
AAASP
violates
this
duty
if
its
35
clinical
logic
is
configured
to
prioritize
the
financial
interests
of
36
the
AAASP
or
its
affiliates
over
a
substantially
similar
and
clinically
37
appropriate
alternative
that
offers
superior
value,
coordination,
or
38
efficiency
to
the
patient.
39
(2)(a)
The
interface
through
which
a
clinical
AI
service
interacts
with
40
a
patient
is
deemed
a
clinical
space.
41
(b)
It
shall
be
unlawful
for
an
AAASP
to
display,
verbally
articulate,
42
or
otherwise
present
paid
commercial
content,
advertisements,
spon
-
43
sored
results,
or
third
-
party
marketing
messages
within
the
context
of
44
a
clinical
encounter,
diagnosis,
or
treatment
plan.
45
(c)
An
AAASP
shall
not
use
conversational
prompts
or
nudges
designed
to
46
persuade
a
patient
to
request
a
specific
medication
or
optional
commer
-
47
cial
service
for
the
sole
purpose
of
financial
gain.
48
13
(3)(a)
An
AAASP
shall
not
utilize
weights,
biases,
or
prompt
engi
-
1
neering
to
prefer
an
affiliated
pharmacy,
specialist,
or
manufacturer
2
unless
such
preference
is
based
on
objectively
verifiable
clinical,
3
economic,
or
coordination
advantages
for
the
patient,
including
but
not
4
limited
to
lower
out
-
of
-
pocket
costs,
faster
time
-
to
-
treatment
initi
-
5
ation,
superior
validated
outcomes,
or
enhanced
convenience
through
6
vertical
integration.
7
(b)
If
an
algorithm
results
in
a
recommendation
for
an
affiliated
en
-
8
tity,
the
AAASP
satisfies
its
duty
of
loyalty,
even
if
a
human
doctor
9
might
have
reasonably
chosen
an
alternative
recommendation,
provided
10
it:
1
1
(i)
Discloses
the
financial
affiliation
in
a
clear
and
conspicu
-
12
ous
manner
at
the
point
of
recommendation;
and
13
(ii)
Presents
the
patient
with
a
choice
of
at
least
two
(2)
nonaf
-
14
filiated
alternatives
of
similar
clinical
quality,
where
reason
-
15
ably
available,
presented
with
equal
visual
prominence
in
the
in
-
16
terface.
17
(4)(a)
Every
AAASP
shall
maintain
an
immutable
clinical
logic
snapshot
18
for
every
version
of
its
algorithm
deployed
in
production,
including
19
the
underlying
weights,
decision
logic,
and
prompt
-
engineering
in
-
20
structions.
21
(b)
AAASPs
shall
retain
these
snapshots
for
a
period
of
two
(2)
years
to
22
allow
for
retrospective
replay
of
the
logic
used
in
any
specific
patient
23
encounter
during
a
board
audit.
24
(c)
Once
an
AAASP
receives
formal
notice
of
an
investigation,
it
is
pro
-
25
hibited
from
altering
or
deleting
any
snapshots
related
to
the
investi
-
26
gation
period.
27
(5)(a)
The
board
is
authorized
to
perform
statistical
audits
of
an
28
AAASP's
referral
and
prescription
patterns.
29
(b)
A
finding
that
an
AAASP
recommends
an
affiliate
at
a
rate
signifi
-
30
cantly
higher
than
the
regional
average,
or
other
appropriate
clinical
31
or
economic
benchmarks
as
determined
by
the
board,
shall
create
a
rebut
-
32
table
presumption
of
unlawful
steering.
33
(c)
An
AAASP
may
rebut
this
presumption
by
demonstrating
through
its
34
clinical
logic
snapshots
that
the
preference
was
driven
by
objective
35
data,
such
as
a
showing
that
the
affiliate
provided
superior
care
coor
-
36
dination
or
convenience
or
the
lowest
-
cost
option
for
the
patient.
37
54
-
6007.
REGULATORY
SANDBOX
AND
ETHICAL
OVERSIGHT.
38
(1)(a)
All
initial
licenses
shall
be
provisional
for
a
period
of
up
to
39
two
(2)
years.
40
(b)
Upon
completion
of
the
two
(2)
year
period,
the
provisional
license
41
shall
convert
to
a
full
AAASP
license
upon
an
affirmative
determination
42
by
the
board
that
published
safety
benchmarks
have
been
met,
unless
the
43
board
and
the
licensee
mutually
agree
to
extend
the
provisional
period
44
to
collect
further
data.
An
extension
of
provisional
licensure
under
45
this
subsection
is
temporary
in
nature
and
shall
not
be
construed
as
a
46
substitute
for,
or
equivalent
to,
issuance
of
a
restricted
full
license
47
under
subsection
(2)
of
this
section
or
as
a
determination
that
the
ap
-
48
plicable
criteria
for
permanent
licensure
have
been
satisfied.
49
14
(c)
The
licensee
may
request
expedited
approval
for
full
AAASP
licen
-
1
sure
through
an
application
for
expedited
approval
of
full
licensure.
2
The
board
may
approve
full
licensure
upon
determining
that
the
pro
-
3
visional
licensee
has
clearly
demonstrated
that
it
meets
or
exceeds
4
safety
and
performance
benchmarks.
5
(2)(a)
The
board
may
impose
restrictions
on
the
scope
of
an
AAASP's
op
-
6
erations
during
the
provisional
or
sandbox
period,
or
as
a
condition
of
7
a
restricted
full
license,
in
order
to
ensure
safe,
controlled,
and
evi
-
8
dence
-
based
deployment.
9
(b)
During
the
provisional
or
sandbox
period,
such
restrictions
may
10
be
used
to
facilitate
phased
deployment,
data
collection,
and
valida
-
1
1
tion
of
safety
and
effectiveness.
Upon
issuance
of
a
restricted
full
12
license,
such
restrictions
may
be
maintained,
modified,
or
removed
to
13
reflect
the
scope
within
which
the
AAASP
has
demonstrated
sustained
14
safety,
effectiveness,
and
compliance.
15
(c)
Permissible
restrictions
applicable
to
either
provisional
autho
-
16
rization
or
a
restricted
full
license
include
but
are
not
limited
to
the
17
following:
18
(i)
Geographic
limitations,
including
restriction
to
designated
19
health
professional
shortage
areas
or
specific
medically
under
-
20
served
counties;
21
(ii)
Patient
volume
caps,
such
as
a
maximum
number
of
active
pa
-
22
tients;
23
(iii)
Scope
limitations,
including
restriction
of
a
clinical
AI
24
service
to
specified
disease
states,
conditions,
or
clinical
25
functions;
and
26
(iv)
Phased
supervised
deployment,
including
requirements
for
27
physician
review
or
confirmation
of
a
defined
number
of
patient
28
interactions,
diagnoses,
or
treatment
recommendations
prior
to
29
modification
or
removal
of
human
-
in
-
the
-
loop
requirements.
30
(3)
Notwithstanding
any
geographic,
volume,
or
site
-
specific
restric
-
31
tions
imposed
under
subsection
(2)
of
this
section
on
any
provisional
or
full
32
AAASP
licensee,
the
licensee
shall
be
authorized
to
provide
services
to
any
33
patient
in
the
state
who
provides
informed
consent
and
meets
at
least
one
(1)
34
of
the
following
high
-
need
criteria,
as
demonstrated
by
a
referral
or
attes
-
35
tation
from
a
licensed
physician:
36
(a)
The
patient
resides
in
a
federal
health
professional
shortage
area;
37
(b)
The
patient
has
been
diagnosed
with
a
severe
or
life
-
threatening
38
condition
or
multiple
chronic
conditions;
39
(c)
The
patient
has
a
condition
from
which
death
is
likely
to
occur
40
within
six
(6)
months;
41
(d)
The
patient
has
a
condition
or
disability
that
causes
irreversible
42
morbidity
or
likely
substantial
reduction
in
daily
function;
43
(e)
The
patient
has
been
determined
by
a
licensed
health
care
provider
44
to
be
at
high
risk
for
a
specific
condition,
disease,
or
diagnosis
that
45
the
AAASP
is
designed
to
detect,
diagnose,
or
treat;
or
46
(f)
The
patient
is
unable
to
obtain
access
to
an
appropriate
human
clin
-
47
ician
within
a
time
frame
reasonably
related
to
the
patient's
condition
48
category.
49
15
(4)
The
board
shall
establish
ethical
review
procedures
and
human
sub
-
1
jects
protections.
2
(a)
As
part
of
the
application
process,
every
sandbox
applicant
must
3
submit
a
determination
to
the
board
ethicist
declaring
whether
the
4
applicant's
proposed
data
collection
constitutes
"human
subjects
re
-
5
search"
under
45
CFR
46
or
is
exempt
or
a
quality
improvement.
6
(b)
The
board
ethicist
or
the
health
care
ethicist
voting
member
shall
7
review
and
sign
off
on
the
determination.
8
(c)
If
the
activity
is
determined
to
be
human
subjects
research,
or
if
9
the
applicant
elects
to
treat
it
as
such
to
support
future
federal
ap
-
10
plications,
the
applicant
must
obtain
institutional
review
board
ap
-
1
1
proval
prior
to
commencing
data
collection.
12
(d)
The
board
shall
establish
a
state
centralized
institutional
review
13
board
to
provide
expedited,
low
-
cost
ethical
review
for
sandbox
par
-
14
ticipants.
Applicants
may
elect
to
use
this
state
centralized
institu
-
15
tional
review
board
or
an
academic
or
hospital
-
based
or
other
external
16
accredited
institutional
review
board,
or
a
network
of
external
insti
-
17
tutional
review
boards,
to
maximize
availability.
18
(e)
The
state
centralized
institutional
review
board
shall
complete
19
its
review
and
issue
a
determination
within
thirty
(30)
days
of
re
-
20
ceiving
a
complete
protocol
submission
to
ensure
compliance
with
the
21
licensure
timelines
established
in
section
54
-
6004(9),
Idaho
Code.
22
(f)
Nothing
in
this
section
alters
or
waives
any
obligation
under
45
CFR
23
46
or
applicable
food
and
drug
administration
human
subject
regulations
24
when
such
obligations
apply
by
virtue
of
federal
funding,
federal
pro
-
25
gram
participation,
or
other
federal
jurisdiction.
26
(5)
The
board
shall
ensure
financial
accountability
and
patient
27
safety.
28
(a)
All
AAASP
applicants
must
submit
proof
of
professional
liability
29
insurance
coverage
commensurate
with
human
specialists
in
the
same
30
field
or
as
determined
by
the
board.
31
(b)
All
AAASP
applicants
shall
submit
to
state
and
federal
criminal
32
background
checks,
in
a
form
and
manner
prescribed
by
the
board,
if
the
33
applicant
is:
34
(i)
Any
individual
with
direct
or
indirect
ownership
of
ten
per
-
35
cent
(10%)
or
more
of
the
AAASP;
36
(ii)
The
designated
responsible
official;
37
(iii)
The
medical
director;
38
(iv)
Any
natural
person
who
provides
unsupervised
direct
patient
39
care
or
who
is
authorized
to
independently
initiate,
modify,
or
40
execute
patient
-
specific
clinical
actions
on
behalf
of
the
AAASP;
41
or
42
(v)
Any
other
category
of
personnel
that
the
board
determines
by
43
rule
demonstrates
risk
to
patient
safety,
data
security,
or
pro
-
44
gram
integrity.
45
(c)
All
AAASP
applicants
must
submit
a
surety
bond
payable
to
the
state
46
consumer
protection
fund
established
in
section
48
-
606,
Idaho
Code,
in
47
an
amount
determined
by
the
board,
but
no
less
than
fifty
thousand
dol
-
48
lars
($50,000),
to
cover
claims
or
operational
failures
not
covered
by
49
insurance.
50
16
(d)
Each
AAASP
applicant
and
licensee
shall
maintain
on
file
with
the
1
board
a
current
designated
responsible
official
and
contact
informa
-
2
tion.
Failure
to
maintain
a
current
designation
is
grounds
for
admin
-
3
istrative
action.
4
(e)
Each
AAASP
applying
for
or
holding
a
modifier
L2
or
modifier
L3
li
-
5
cense
shall
designate
a
medical
director.
The
medical
director
shall
6
be
responsible
for
oversight
of
clinical
scope,
safety
protocols,
es
-
7
calation
procedures,
and
quality
assurance
related
to
patient
care.
8
The
designated
responsible
official
and
the
medical
director
may
be
the
9
same
individual
or
different
individuals,
at
the
election
of
the
AAASP.
10
(6)(a)
As
a
condition
of
licensure,
every
AAASP
applicant
must
submit
1
1
and
maintain
a
wind
-
down
and
continuity
plan
approved
by
the
board.
12
Such
plan
must
detail
procedures
for
the
AAASP's
insolvency,
license
13
revocation,
or
market
exit.
14
(b)
The
plan
must
designate
a
successor
data
custodian
such
as
a
health
15
information
exchange
or
state
repository.
In
a
triggering
event,
the
16
AAASP
shall
transfer
all
patient
data
to
the
successor
data
custodian
in
17
an
interoperable
format
within
seventy
-
two
(72)
hours.
18
(c)
The
AAASP
must
maintain
a
data
transfer
escrow
or
bond
sufficient
to
19
cover
the
technical
costs
of
data
migration.
20
(d)
The
AAASP
must
carry
tail
coverage
on
its
liability
policy
for
a
pe
-
21
riod
equal
to
the
state
statute
of
limitations
for
malpractice
plus
one
22
(1)
year.
23
(e)
The
board
is
authorized
to
seize
the
surety
bond
to
execute
the
24
wind
-
down
and
continuity
plan
if
the
AAASP
fails
to
initiate
it
volun
-
25
tarily.
26
(7)(a)
The
board
shall
establish
and
publish
objective
safety
and
per
-
27
formance
benchmarks
that
an
AAASP
must
meet
or
exceed
to
qualify
for
28
modifier
L3
licensure
or
to
graduate
from
the
regulatory
sandbox.
29
(b)
Such
benchmarks
shall
be
designed
to
ensure
that
the
AAASP
demon
-
30
strates
clinical
competency,
accuracy,
and
safety
outcomes
that
meet
31
or
exceed
the
performance
of
a
reasonably
prudent
human
health
care
32
provider
practicing
in
the
same
or
similar
specialty.
33
(c)
Benchmarks
may
include
clinically
validated
testing,
subgroup
per
-
34
formance
evaluation,
calibration,
false
positive
and
false
negative
35
rates
appropriate
to
the
intended
use,
and
real
-
world
outcome
measures.
36
The
board
may
recognize
external
evaluation
frameworks
by
guidance
and
37
should
align
with
federal
benchmarks
and
monitoring
methods
for
similar
38
services
and
tools
when
possible.
39
(d)
To
maintain
licensure,
an
AAASP
must
submit
annual
performance
40
reports
demonstrating
that
the
model
continues
to
meet
the
safety
41
benchmarks
established
at
licensure.
The
board
may
suspend
a
license
42
if
data
indicates
model
drift
or
a
degradation
in
safety
outcomes.
43
Licensees
shall
report
adverse
and
reportable
events
as
defined
in
sec
-
44
tion
54
-
6002,
Idaho
Code.
45
(e)
To
minimize
duplication
and
administrative
burden
to
licensees,
46
the
board
shall,
to
the
maximum
extent
practicable,
align
state
bench
-
47
marks
and
post
-
market
surveillance
and
monitoring
plans
with:
48
(i)
Federal
benchmarks
and
post
-
market
surveillance
plans
estab
-
49
lished
for
class
B
AAASP
licensees;
and
50
17
(ii)
Other
state
sandbox
or
state
licensing
board
benchmarks
for
1
AAASP
licensees
who
are
sandbox
participants
in
another
state
or
2
who
hold
a
similar
license
in
another
state.
3
54
-
6008.
SCOPE
OF
PRACTICE
-
-
WAIVER
-
-
STANDARD
OF
CARE.
(1)
A
clini
-
4
cal
AI
service
or
act
is
within
the
authorized
scope
of
practice
of
a
licensed
5
AAASP
if:
6
(a)
The
act
is
consistent
with
and
not
expressly
prohibited
by
this
7
chapter
or
the
limitations
of
the
specific
license
class
and
modifier
8
held
by
the
AAASP;
9
(b)
The
act
is
consistent
with
the
AI
model's
validated
technical
spec
-
10
ifications,
training
data,
intended
use
case,
and
performance
parame
-
1
1
ters
as
submitted
to
the
board;
and
12
(c)
The
performance
of
the
act
is
within
the
accepted
standard
of
care
13
under
Idaho
law
for
the
specific
clinical
task
that
would
be
provided
in
14
the
same
or
similar
clinical
setting
by
a
reasonable
and
prudent
human
15
health
care
provider
with
the
same
or
similar
specialization.
16
(2)
The
board
shall
ensure
that
any
administrative
rules
adopted
under
17
this
chapter
do
not
conflict
with
the
universal
practice
authority
granted
18
by
this
section,
ensuring
that
regulation
focuses
on
clinical
outcomes
and
19
safety
rather
than
prescriptive
technical
methodologies.
20
(3)
Any
prohibition
on
the
corporate
practice
of
medicine
or
any
other
21
licensed
clinical
practice
is
waived
solely
to
the
extent
necessary
to
per
-
22
mit
an
AAASP
to
hold
an
AAASP
license
and
to
bill
for
clinical
AI
services
au
-
23
thorized
under
this
chapter.
Nothing
in
this
subsection
authorizes
a
person
24
or
entity
to
control
the
independent
professional
judgment
of
a
licensed
hu
-
25
man
health
care
provider,
nor
does
it
alter
corporate
practice
restrictions
26
applicable
to
human
clinical
services.
27
(4)
A
provider
-
patient
relationship
exists
when
a
licensed
AAASP
de
-
28
livers
a
clinical
AI
service
to
a
specific
patient
and
the
patient
reasonably
29
relies
on
that
service
for
health
care
decision
-
making,
and
such
relation
-
30
ship
shall
give
rise
to
professional
duty,
standard
of
care,
confidential
-
31
ity,
and
civil
liability
under
state
law.
32
(5)
For
AAASP
sandbox
participants
in
substantial
compliance
with
this
33
chapter
and
the
informed
consent
requirements
of
section
54
-
6005,
Idaho
34
Code,
noneconomic
damages
shall
be
governed
by
the
limitations
set
forth
35
in
section
6
-
1603,
Idaho
Code.
Nothing
in
this
subsection
limits
economic
36
damages,
injunctive
relief,
or
board
disciplinary
authority.
37
(6)
Nothing
in
this
chapter
authorizes
any
natural
person
to
engage
in
38
conduct
outside
the
scope
of
that
person's
professional
license,
if
any.
Au
-
39
thority
granted
to
an
AAASP
does
not
confer
practice
authority
on
any
unli
-
40
censed
individual
involved
in
development,
deployment,
operations,
or
sup
-
41
port
of
a
clinical
AI
service.
42
(7)(a)
The
board
shall
have
exclusive
authority
to
regulate,
license,
43
investigate,
and
discipline
AAASPs
and
the
delivery
of
clinical
AI
ser
-
44
vices
authorized
under
this
chapter.
45
(b)
No
other
state
licensing
board
shall
impose
licensure
require
-
46
ments,
supervision
requirements,
disciplinary
action,
or
rules
of
47
professional
conduct
that
have
the
purpose
or
effect
of
restricting,
48
prohibiting,
or
conditioning
the
lawful
use
of,
reliance
on,
or
partic
-
49
18
ipation
in
services
provided
by
a
licensed
AAASP
acting
within
the
scope
1
of
this
chapter.
2
(c)
Nothing
in
this
subsection
limits
the
authority
of
any
state
li
-
3
censing
board
to
regulate
the
independent
professional
conduct
of
natu
-
4
ral
persons
within
that
board's
jurisdiction.
If,
in
the
course
of
an
5
investigation,
the
board
identifies
evidence
of
potential
misconduct
6
by
a
licensed
human
practitioner
that
is
independent
of
and
not
solely
7
attributable
to
lawful
AAASP
operation,
the
board
may
refer
such
matter
8
to
the
appropriate
licensing
board
for
review.
9
(8)
Designation
as
a
medical
director
does
not,
by
itself,
constitute
10
the
practice
of
medicine
with
respect
to
individual
patient
encounters
con
-
1
1
ducted
by
an
AAASP
and
does
not
create
professional
liability
for
the
outputs
12
of
an
AAASP
acting
within
the
scope
of
this
chapter.
13
54
-
6009.
UNLAWFUL
PRACTICE
-
-
TITLE
PROTECTION
-
-
ENFORCEMENT.
(1)
A
14
person
or
entity
shall
not
offer,
operate,
market,
or
deploy
a
clinical
AI
15
service
requiring
licensure
under
section
54
-
6004,
Idaho
Code,
without
a
16
valid
AAASP
license
issued
under
this
chapter.
17
(2)
A
person
or
entity
shall
not
falsely
represent
that
it
holds
an
18
AAASP
license,
license
class,
or
autonomy
modifier,
or
use
any
words,
let
-
19
ters,
or
symbols
that
reasonably
imply
such
licensure.
20
(3)
A
person
or
entity
shall
not
knowingly
aid,
abet,
or
facilitate
the
21
unlicensed
practice
prohibited
by
this
section.
22
(4)
The
board
may
issue
cease
and
desist
orders
and
may
request
the
at
-
23
torney
general
to
bring
an
action
for
injunctive
relief
to
enforce
the
provi
-
24
sions
of
this
chapter.
25
(5)
The
board
may
impose
an
administrative
fine
not
to
exceed
ten
thou
-
26
sand
dollars
($10,000)
for
each
count
or
offense,
in
addition
to
any
other
27
remedy
authorized
by
law.
28
54
-
6010.
FINANCE
-
-
REIMBURSEMENT.
(1)
The
department
of
health
and
29
welfare
and
the
state
employee
health
plan
shall
collaborate
with
the
board
30
to
develop
reimbursement
codes,
pilot
programs,
or
coverage
determinations
31
for
licensed
AAASP
sandbox
participants.
The
department
of
health
and
wel
-
32
fare
and
the
department
of
administration's
office
of
group
insurance
may
33
issue
any
rules
as
may
be
necessary
to
carry
out
the
duties
of
this
section.
34
(2)(a)
The
board
shall
issue
a
unique
state
provider
identifier
to
ev
-
35
ery
licensed
AAASP
for
use
in
claiming
reimbursement
from
state
payer
36
programs
whenever
a
federal
national
provider
identifier
is
unavail
-
37
able
or
technically
inapplicable.
38
(b)
Reimbursement
for
claims
submitted
under
a
state
provider
identi
-
39
fier
by
a
provider
without
a
corresponding
federal
national
provider
40
identifier
or
centers
for
medicare
and
medicaid
services
recogni
-
41
tion
shall
be
funded
exclusively
through
state
general
funds
or
other
42
sources
of
nonfederal
funds
unless
the
requirements
of
paragraph
(c)
of
43
this
subsection
are
met.
44
(c)
No
claims
for
AAASP
services
shall
be
submitted
for
federal
medi
-
45
cal
assistance
percentage
matching
funds
unless
and
until
the
centers
46
for
medicare
and
medicaid
services
issues
written
guidance
confirming
47
eligibility
or
otherwise
makes
clear
through
guidance
or
establishment
48
19
of
billing
protocols
that
such
federal
matching
funds
are
available
for
1
these
services.
2
(3)
To
maximize
the
full
potential
value
of
AI
-
based
clinical
services,
3
reimbursement
models
for
AAASP
services
should
prioritize
value
-
based
care,
4
capitation
models,
bundled
payments,
or
other
alternative
payment
method
-
5
ologies
over
fee
-
for
-
service,
where
practical.
6
54
-
6011.
INSURANCE
REIMBURSEMENT
AND
REGULATORY
GUIDANCE.
(1)
No
7
later
than
July
1,
2027,
the
department
of
insurance
shall
issue
formal
guid
-
8
ance,
bulletins,
or
rules
as
may
be
necessary
to
clarify
the
application
of
9
the
Idaho
insurance
code
to
AAASPs
licensed
under
this
chapter.
10
(2)
Such
guidance
or
rules
may:
1
1
(a)
Establish
that
an
AAASP
holding
a
valid
modifier
L2
or
modifier
12
L3
license
constitutes
a
recognized
provider
type
eligible
for
reim
-
13
bursement
under
private
health
insurance
policies
and
state
-
regulated
14
health
plans;
15
(b)
Designate
appropriate
billing
mechanisms,
which
may
include
the
16
use
of
existing
current
procedural
terminology
codes
with
specific
mod
-
17
ifiers
identifying
the
service
as
AI
-
delivered,
or
the
adoption
of
new
18
distinct
billing
codes
as
they
become
available;
19
(c)
Prohibit
health
insurance
carriers
from
denying
coverage
for
a
med
-
20
ically
necessary
service
solely
because
the
service
was
provided
by
a
21
licensed
AAASP,
provided
that
the
service
would
be
covered
if
delivered
22
by
a
human
health
care
provider;
and
23
(d)
Outline
standards
for
including
AAASPs
in
insurance
provider
net
-
24
works,
including
credentialing
requirements
that
are
appropriate
for
25
automated
systems
rather
than
individual
human
history
such
as
waiving
26
malpractice
history
questions
that
do
not
apply
to
software.
27
(3)
In
developing
these
rules,
the
department
shall
consult
with
the
28
board
of
autonomous
medical
practice
to
ensure
clinical
consistency
and
with
29
the
public
health
districts
to
ensure
alignment
with
public
health
goals.
30
(4)
This
section
applies
to
health
insurance
coverage
to
the
extent
31
permitted
by
state
and
federal
law,
including
the
employee
retirement
income
32
security
act
of
1974.
33
(5)
Nothing
in
this
section
shall
be
construed
to
require
a
health
bene
-
34
fit
plan
to
provide
coverage
or
reimbursement
for
any
service.
35
54
-
6012.
RULE
OF
CONSTRUCTION
AND
FEDERAL
COMPLIANCE.
(1)
Nothing
in
36
this
chapter
shall
be
construed
to
prohibit,
restrict,
or
require
licensure
37
solely
for
the
development,
ownership,
or
private
operation
of
artificial
38
intelligence
models,
provided
such
models
are
not
marketed
or
deployed
as
39
clinical
AI
services
for
patient
care.
40
(2)
This
chapter
constitutes
a
regulation
of
professional
medical
con
-
41
duct
and
not
a
restriction
on
computational
resources.
42
(3)
Nothing
in
this
chapter
authorizes
conduct
that
is
expressly
pro
-
43
hibited
by
federal
law
or
that
would
place
a
licensee
in
unavoidable
conflict
44
with
the
federal
food,
drug,
and
cosmetic
act
or
the
controlled
substances
45
act.
46
(4)
Nothing
in
this
chapter
shall
be
construed
to
authorize
conduct
47
prohibited
under
the
criminal
laws
of
this
state.
48
20
(5)
Nothing
in
the
licensure
established
pursuant
to
this
chapter
shall
1
be
construed
to
authorize
the
distribution
of
a
commercial
medical
device
in
2
violation
of
the
federal
food,
drug,
and
cosmetic
act.
A
class
C
license
au
-
3
thorizes
the
professional
delivery
of
therapeutic
services
via
artificial
4
intelligence,
which
constitutes
the
practice
of
medicine
within
this
state,
5
distinct
from
the
commercial
sale
of
a
medical
device.
6
(6)(a)
It
shall
be
the
policy
of
this
state
that
AI
-
enabled
health
care
7
services
within
the
scope
of
this
chapter
are
presumed
authorized
un
-
8
less
a
specific
data
-
backed
safety
risk
is
identified.
9
(b)
In
promulgating
rules,
the
board
shall
not
impose
a
restriction
on
10
AAASP
licensure
or
scope
of
practice
that
is
more
burdensome
than
neces
-
1
1
sary
to
address
a
specific
documented
risk
to
public
health.
12
(c)
The
board
shall
issue
written
findings
supporting
any
material
13
rule
restriction,
denial,
or
adverse
licensure
action,
and
such
find
-
14
ings
shall
be
supported
by
substantial
evidence
in
the
administrative
15
record,
consistent
with
the
provisions
of
chapter
52,
title
67,
Idaho
16
Code.
17
SECTION
3.
SEVERABILITY.
The
provisions
of
this
act
are
hereby
declared
18
to
be
severable
and
if
any
provision
of
this
act
or
the
application
of
such
19
provision
to
any
person
or
circumstance
is
declared
invalid
for
any
reason,
20
such
declaration
shall
not
affect
the
validity
of
the
remaining
portions
of
21
this
act.
22
SECTION
4.
An
emergency
existing
therefor,
which
emergency
is
hereby
23
declared
to
exist,
this
act
shall
be
in
full
force
and
effect
on
and
after
24
July
1,
2026.
25