Iowa Administrative Code › Agency 653 - Medicine Board › Chapter 13 - Standards of Practice and Principles of Medical Ethics › Rule 653-13.11 - Standards of Practice-telemedicine

Current through Register Vol. 47, No. 3, July 24, 2024
This rule establishes standards of practice for the practice of
				medicine using telemedicine.
1. The
			 board recognizes that technological advances have made it possible for
			 licensees in one location to provide medical care to patients in another
			 location with or without an intervening health care provider.
2. Telemedicine is a useful tool that, if
			 applied appropriately, can provide important benefits to patients, including
			 increased access to health care, expanded utilization of specialty expertise,
			 rapid availability of patient records, and potential cost savings.
3. The board advises that licensees using
			 telemedicine will be held to the same standards of care and professional ethics
			 as licensees using traditional in-person medical care.
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.