4. Failure to conform to the appropriate
standards of care or professional ethics while using telemedicine may subject
the
licensee to potential
discipline by the
board.
(1)
Definitions. As used in
this
rule:
"Asynchronous store-and-forward transmission "
means the collection of a patient's relevant health information and the
subsequent transmission of the data from an originating site to a health care
provider at a distant site without the presence of the patient.
"Board" means the Iowa board of
medicine.
"In-person encounter" means that the physician
and the patient are in the physical presence of each other and are in the same
physical location during the physician-patient encounter.
"Licensee " means a medical physician or
osteopathic physician licensed by the board.
"Telemedicine" means the practice of medicine
using electronic audio-visual communications and information technologies or
other means, including interactive audio with asynchronous store-and-forward
transmission, between a licensee in one location and a patient in another
location with or without an intervening health care provider. Telemedicine
includes asynchronous store-and-forward technologies, remote monitoring, and
real-time interactive services, including teleradiology and telepathology.
Telemedicine shall not include the provision of medical services only through
an audio-only telephone, e-mail messages, facsimile transmissions, or U.S. mail
or other parcel service, or any combination thereof.
"Telemedicine technologies" means technologies
and devices enabling secure electronic communications and information exchanges
between a licensee in one location and a patient in another location with or
without an intervening health care provider.
(2)
Practice guidelines. A
licensee who uses telemedicine shall utilize evidence-based telemedicine
practice guidelines and standards of practice, to the degree they are
available, to ensure patient safety, quality of care, and positive outcomes.
The board acknowledges that some nationally recognized medical specialty
organizations have established comprehensive telemedicine practice guidelines
that address the clinical and technological aspects of telemedicine for many
medical specialties.
(3)
Iowa medical license required. A physician who uses
telemedicine in the diagnosis and treatment of a patient located in Iowa shall
hold an active Iowa medical license consistent with state and federal laws.
Nothing in this rule shall be construed to supersede the exceptions to
licensure contained in 653-subrule 9.2(2).
(4)
Standards of care and
professional ethics. A licensee who uses telemedicine shall be held to
the same standards of care and professional ethics as a licensee using
traditional in-person encounters with patients. Failure to conform to the
appropriate standards of care or professional ethics while using telemedicine
may be a violation of the laws and rules governing the practice of medicine and
may subject the licensee to potential discipline by the board.
(5)
Scope of practice. A
licensee who uses telemedicine shall ensure that the services provided are
consistent with the licensee's scope of practice, including the licensee's
education, training, experience, ability, licensure, and
certification.
(6)
Identification of patient and physician. A licensee who uses
telemedicine shall verify the identity of the patient and ensure that the
patient has the ability to verify the identity, licensure status,
certification, and credentials of all health care providers who provide
telemedicine services prior to the provision of care.
(7)
Physician-patient
relationship.
a. A
licensee who uses
telemedicine shall establish a valid
physician-patient relationship with the
person who receives telemedicine services. The
physician-patient relationship
begins when:
(1) The person with a
health-related matter seeks assistance from a licensee;
(2) The licensee agrees to undertake
diagnosis and treatment of the person; and
(3) The person agrees to be treated by the
licensee whether or not there has been an in-person encounter between the
physician and the person.
b. A valid
physician-patient relationship may
be established by:
(1) In-person encounter.
Through an in-person medical interview and physical examination where the
standard of care would require an in-person encounter;
(2) Consultation with another licensee.
Through consultation with another licensee (or other health care provider) who
has an established relationship with the patient and who agrees to participate
in, or supervise, the patient's care; or
(3) Telemedicine encounter. Through
telemedicine, if the standard of care does not require an in-person encounter,
and in accordance with evidence-based standards of practice and telemedicine
practice guidelines that address the clinical and technological aspects of
telemedicine.
(8)
Medical history and physical
examination. Generally, a licensee shall perform an in-person medical
interview and physical examination for each patient. However, the medical
interview and physical examination may not be in-person if the technology
utilized in a telemedicine encounter is sufficient to establish an informed
diagnosis as though the medical interview and physical examination had been
performed in-person. Prior to providing treatment, including issuing
prescriptions, electronically or otherwise, a licensee who uses telemedicine
shall interview the patient to collect the relevant medical history and perform
a physical examination, when medically necessary, sufficient for the diagnosis
and treatment of the patient. An Internet questionnaire that is a static set of
questions provided to the patient, to which the patient responds with a static
set of answers, in contrast to an adaptive, interactive and responsive online
interview, does not constitute an acceptable medical interview and physical
examination for the provision of treatment, including issuance of
prescriptions, electronically or otherwise, by a licensee.
(9)
Nonphysician health care
providers. If a
licensee who uses telemedicine relies upon or
delegates the provision of telemedicine services to a nonphysician health care
provider, the
licensee shall:
a. Ensure that
systems are in place to ensure that the nonphysician health care provider is
qualified and trained to provide that service within the scope of the
nonphysician health care provider's practice;
b. Ensure that the licensee is available in
person or electronically to consult with the nonphysician health care provider,
particularly in the case of injury or an emergency.
(10)
Informed consent. A
licensee who uses telemedicine shall ensure that the patient provides
appropriate informed consent for the medical services provided, including
consent for the use of telemedicine to diagnose and treat the patient, and that
such informed consent is timely documented in the patient's medical
record.
(11)
Coordination of
care. A licensee who uses telemedicine shall, when medically
appropriate, identify the medical home or treating physician(s) for the
patient, when available, where in-person services can be delivered in
coordination with the telemedicine services. The licensee shall provide a copy
of the medical record to the patient's medical home or treating
physician(s).
(12)
Follow-up
care. A licensee who uses telemedicine shall have access to, or
adequate knowledge of, the nature and availability of local medical resources
to provide appropriate follow-up care to the patient following a telemedicine
encounter.
(13)
Emergency
services. A licensee who uses telemedicine shall refer a patient to an
acute care facility or an emergency department when referral is necessary for
the safety of the patient or in the case of an emergency.
(14)
Medical records. A
licensee who uses telemedicine shall ensure that complete, accurate and timely
medical records are maintained for the patient when appropriate, including all
patient-related electronic communications, records of past care,
physician-patient communications, laboratory and test results, evaluations and
consultations, prescriptions, and instructions obtained or produced in
connection with the use of telemedicine technologies. The licensee shall note
in the patient's record when telemedicine is used to provide diagnosis and
treatment. The licensee shall ensure that the patient or another licensee
designated by the patient has timely access to all information obtained during
the telemedicine encounter. The licensee shall ensure that the patient
receives, upon request, a summary of each telemedicine encounter in a timely
manner.
(15)
Privacy and
security. A
licensee who uses telemedicine shall ensure that all
telemedicine encounters comply with the privacy and security measures of the
Health Insurance Portability and Accountability Act to ensure that all patient
communications and records are secure and remain confidential.
a. Written protocols shall be established
that address the following:
(1)
Privacy;
(2) Health care personnel
who will process messages;
(3)
Hours of operation;
(4) Types of
transactions that will be permitted electronically;
(5) Required patient information to be
included in the communication, including patient name, identification number
and type of transaction;
(6)
Archiving and retrieval; and
(7)
Quality oversight mechanisms.
b. The written protocols should be
periodically evaluated for currency and should be maintained in an accessible
and readily available manner for review. The written protocols shall include
sufficient privacy and security measures to ensure the confidentiality and
integrity of patient-identifiable information, including password protection,
encryption or other reliable authentication techniques.
(16)
Technology and
equipment. The
board recognizes that three broad categories of
telemedicine technologies currently exist, including asynchronous
store-and-forward technologies, remote monitoring, and real-time interactive
services. While some telemedicine programs are multispecialty in nature, others
are tailored to specific diseases and medical specialties. The technology and
equipment utilized for telemedicine shall comply with the following
requirements:
a. The technology and equipment
utilized in the provision of telemedicine services must comply with all
relevant safety laws, rules, regulations, and codes for technology and
technical safety for devices that interact with patients or are integral to
diagnostic capabilities;
b. The
technology and equipment utilized in the provision of telemedicine services
must be of sufficient quality, size, resolution and clarity such that the
licensee can safely and effectively provide the telemedicine services;
and
c. The technology and equipment
utilized in the provision of telemedicine services must be compliant with the
Health Insurance Portability and Accountability Act.
(17)
Disclosure and functionality of
telemedicine services. A
licensee who uses telemedicine shall ensure
that the following information is clearly disclosed to the patient:
a. Types of services provided;
b. Contact information for the
licensee;
c. Identity, licensure,
certification, credentials, and qualifications of all health care providers who
are providing the telemedicine services;
d. Limitations in the drugs and services that
can be provided via telemedicine;
e. Fees for services, cost-sharing
responsibilities, and how payment is to be made, if these differ from an
in-person encounter;
f. Financial
interests, other than fees charged, in any information, products, or services
provided by the licensee(s);
g.
Appropriate uses and limitations of the technologies, including in emergency
situations;
h. Uses of and response
times for e-mails, electronic messages and other communications transmitted via
telemedicine technologies;
i. To
whom patient health information may be disclosed and for what
purpose;
j. Rights of patients with
respect to patient health information; and
k. Information collected and passive tracking
mechanisms utilized.
(18)
Patient access and feedback. A
licensee who uses telemedicine
shall ensure that the patient has easy access to a mechanism for the following
purposes:
a. To access, supplement and amend
patient-provided personal health information;
b. To provide feedback regarding the quality
of the telemedicine services provided; and
c. To register complaints. The mechanism
shall include information regarding the filing of complaints with the board.
(19)
Financial
interests. Advertising or promotion of goods or products from which
the licensee(s) receives direct remuneration, benefit or incentives (other than
the fees for the medical services) is prohibited to the extent that such
activities are prohibited by state or federal law. Notwithstanding such
prohibition, Internet services may provide links to general health information
sites to enhance education; however, the licensee(s) should not benefit
financially from providing such links or from the services or products marketed
by such links. When providing links to other sites, licensees should be aware
of the implied endorsement of the information, services or products offered
from such sites. The maintenance of a preferred relationship with any pharmacy
is prohibited. Licensees shall not transmit prescriptions to a specific
pharmacy, or recommend a pharmacy, in exchange for any type of consideration or
benefit from the pharmacy.
(20)
Circumstances where the standard of care may not require a licensee to
personally interview or examine a patient. Under the following
circumstances, whether or not such circumstances involve the use of
telemedicine, a
licensee may treat a patient who has not been personally
interviewed, examined and diagnosed by the
licensee:
a. Situations in which the licensee
prescribes medications on a short-term basis for a new patient and has
scheduled or is in the process of scheduling an appointment to personally
examine the patient;
b. For
institutional settings, including writing initial admission orders for a newly
hospitalized patient;
c. Call
situations in which a licensee is taking call for another licensee who has an
established physician-patient relationship with the patient;
d. Cross-coverage situations in which a
licensee is taking call for another licensee who has an established
physician-patient relationship with the patient;
e. Situations in which the patient has been
examined in person by an advanced registered nurse practitioner or a physician
assistant or other licensed practitioner with whom the licensee has a
supervisory or collaborative relationship;
f. Emergency situations in which the life or
health of the patient is in imminent danger;
g. Emergency situations that constitute an
immediate threat to the public health including, but not limited to, empiric
treatment or prophylaxis to prevent or control an infectious disease
outbreak;
h. Situations in which
the licensee has diagnosed a sexually transmitted disease in a patient and the
licensee prescribes or dispenses antibiotics to the patient's named sexual
partner(s) for the treatment of the sexually transmitted disease as recommended
by the U. S. Centers for Disease Control and Prevention; and
i. For licensed or certified nursing
facilities, residential care facilities, intermediate care facilities, assisted
living facilities and hospice settings.
(21)
Prescribing based solely on an
Internet request, Internet questionnaire or a telephonic evaluation -
prohibited. Prescribing to a patient based solely on an Internet
request or Internet questionnaire (i.e., a static questionnaire provided to a
patient, to which the patient responds with a static set of answers, in
contrast to an adaptive, interactive and responsive online interview) is
prohibited. Absent a valid physician-patient relationship, a licensee's
prescribing to a patient based solely on a telephonic evaluation is prohibited,
with the exception of the circumstances described in subrule
13.11(20).
(22)
Medical
abortion. Nothing in this
rule shall be interpreted to contradict or
supersede the requirements established in
rule
653-13.10
(147,148,272C).
This rule is intended to implement Iowa Code chapters 147, 148
and 272C.