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WHITE PAPER

Photo Courtesy of Specialists on Call

TELEMEDICINE RISK
MANAGEMENT
A PRACTICAL GUIDE FOR
UNDERSTANDING AND
MITIGATING PATIENT
SAFETY RISK AND
MALPRACTICE EXPOSURE

Paul Hildebrand, MD
Associate Director
TeamHealth Patient Safety Organization

Amidst ongoing challenges and changes within the healthcare industry,


telemedicine is emerging as an increasingly attractive tool for delivering
quality medical services. This white paper provides an overview of the
potential patient safety and malpractice risks associated with telemedicine,
explores the risks in several specific applications of telemedicine, and offers
strategies and tactics for mitigating those risks.
Amidst ongoing challenges and changes within
the healthcare industry, telemedicine is emerging
as an increasingly attractive tool for delivering
quality medical services.
For geographically remote hospitals and
communities, telemedicine can provide access to
specialists who help on-site practitioners reach a
patient diagnosis and develop a treatment plan,
thus eliminating the need for patients to either
travel great distances at great expense or forgo a

with the demand for specialty physician on-call


coverage now far exceeding the supply of
specialists in urban areas, telemedicine is
becoming a more common solution for not-soremote facilities, too. In addition to specialist
referral services and patient consultations,
telemedicine can offer solutions for remote
inpatient or outpatient monitoring within the
hospital and even followAccording to the American Telemedicine
Association (ATA), approximately 2,000 medical

institutions participate in an estimated 200


telemedicine networks across the United States
that link tertiary care hospitals and clinics with
outlying health centers. Of those 200 networks,
about half provide patient care services via
telemedicine on a daily basis.i Those services
span a variety of clinical specialties, including
radiology, neurology, psychiatry, dermatology,
intensive care and emergency medicine.
For hospitals considering telemedicine solutions,
available research shows that telemedicine can
provide quality care in an efficient, cost-effective
TELEMEDICINE DEFINED
The Centers for Medicare and Medicaid Services
(CMS) defines telemedicine as a two-way, realtime interactive communication between a patient
and a physician or practitioner at a distant site
through telecommunications equipment that
includes, at a minimum, audio and visual
equipment. iii The ATA more broadly defines
exchanged from one site to another via electronic
communications for the health and education of
the patient or health care provider and for the
purpose of improving patient care, treatment and
i

manner in some cases saving hospitals


thousands of dollars while also improving
outcomes.ii Unfortunately, if not well managed,
telemedicine can also generate opportunities for
less than optimal care, exposing physicians and
hospitals to new potential liabilities.
This white paper provides an overview of the
potential patient safety and malpractice risks
associated with telemedicine, explores the risks in
several specific applications of telemedicine, and
offers strategies and tactics for mitigating those
risks.
radiology providers in question faced lawsuits
resulting from negative patient outcomes.
Patients reading this or similar articles may
use of telemedicine. Obviously, we in healthcare
need to understand the various categories of risk
with telemedicine and have specific strategies
that will mitigate that risk.
The following are the general categories of risk v
associated with telemedicine:

Generally, the global term of telemedicine refers


to any medical activity that occurs at a distance
and utilizes some form of telecommunication. In
some states, telemedicine encompasses
exchanges by telephone, fax and email.

participating in telemedicine have the


same obligation of responsibility for the
privacy and security of patient information
as those providing face-to-face care, and
they must abide by the rules of HIPAA
and the HITECH Act.vi Healthcare
institutions should verify the security of a

GENERAL CATEGORIES OF RISK


As anyone who has ever misread an email can
attest, electronic communications are not always
as clearly delivered and received as face-to-face
interactions. For hospitals, the potential pitfalls of
telecommunications can create serious problems,
iv
Doctor reading your XThe
story describes several examples of delayed and
missed diagnoses associated with teleradiology. It
cites alleged lack of adequate clinical and
contextual information necessary for
teleradiologists to interpret scans and suggests a
possible lack of teamwork between the originating
facility and distant site personnel. It further claims
an apparent disregard for certain red flags,
indicating that a qualified radiologist had not
interpreted the films. The hospitals and/or

Privacy, Security and Patient


Confidentiality. Healthcare providers

operations in order to protect their


physicians should also be wary of
unencrypted communication platforms
such as Skype or Google Talk, which do
not allow for providers to protect against
breaches.vi

Credentialing. Hospitals must ensure that


telemedicine providers who are
credentialed on the staff of a different
hospital, or whose licenses are from
another state or country, are legally
permitted to provide services to the
the Medicare Conditions of Participation

requiring that hospitals fully credential all


practitioners in the same manner,
including those who provide telemedicine
services from a distant site.vii But in the
revised CoP released in 2011, CMS
attempted to ease some of the
credentialing burden. (This is discussed in
more detail below.)

patient with chest pain or high fever),


though providing telemedicine advice to
the bedside clinician would be
appropriate.

Although physicians consult with patients


over the phone on a regular basis, there

Informed Consent. Patients must be


aware of, and consent to, the potential
benefits and risks associated with
telemedicine, including delays that could
result from deficiencies or failures of
telecommunications equipment and the
potential for security breaches.viii
Physicians should discuss the benefits
and risks of telemedicine with patients
before obtaining a signed consent form.
Proof of informed consent should be

system in place for phone calls to be


triaged by a skilled clinical person who can
document all clinically relevant
information. In addition, two or more calls
for the same condition within a finite
period should prompt face-to-face
interaction. And when the provider is not
available by phone, the voicemail greeting
should provide an alternative contact
number for patients who need immediate
assistance.

Maintaining Continuity of Care. As with


face-to-face encounters, documentation of
telemedicine encounters must be
included in the ongoing medical record of
the patient. This documentation ensures
an accurate and complete patient history
that can be referenced by subsequent
physicians.

Ensuring Reliability of the Technology.


Should technology fail during a critical
moment of a patient encounter, the
patient or physician may receive incorrect
information. Standard vendor contracts
disclaim liability in such instances.
Hospitals should seek a reliable vendor,
and legal advisors also recommend

COP RULES AND RISK EXPOSURES


As stated above, CMS revised its CoP rules in
July 2011 to ease some of the burden typically
associated with credentialing telemedicine
physicians. Facilities offering telemedicine
services can now rely on credentialing and
privileging decisions of a distant site hospital that
facilities and telemedicine providers be familiar
with the specific provisions of CMS revised CoP.
Specifically, the revised CoP requires that:

and that healthcare providers


negotiate some form of vendor
responsibility in their contracts to motivate
the vendor to a high level of performance.

Providing the Oldest Form of


Telemedicine Telephone Advice.

Choosing the Appropriate Clinical Context.


Telemedicine is effective in two major
areas of healthcare delivery: acute primary
care and care of patients with chronic
conditions. It is not appropriate, for
example, for a telemedicine provider to
give trauma or surgical advice in a case
that requires bedside assessment. And
telemedicine does not replace the role of
the physician in attendance for escalating
medical conditions (e.g., evaluation of a

The distant site hospital offering


telemedicine services to patients in
another location must be a Medicare
participating hospital or meet all applicable
CoP, including Medicare credentialing
standards.
The practitioner providing telemedicine
services on behalf of a hospital must be
privileged at the distant site hospital or
entity where he or she routinely works.
The telemedicine physician must hold a
license issued or recognized by the state
in which the hospital whose patients are
receiving care is located.
The hospital receiving the telemedicine
services must review the services
provided to its patients by telemedicine
physicians covered under the agreement.
The hospital must also provide written
feedback to the distant site hospital or

entity, addressing at a minimum, adverse


events and patient complaints arising from
the telemedicine services.

services due to equipment failure or other


reasons.

RISK MANAGEMENT MITIGATION TACTICS


Although telemedicine poses risks beyond those
associated with face-toface delivery of
patients to receive
healthcare, it can be a
medically necessary
meaningful solution for
interventions in a more
patients in need of
specialty care when it is
not locally available, and
follow-up in the
it is possible for
management of
hospitals to create an
chronic disease
appropriate risk
management strategy
to mitigate these risks.
Compliance with the
Proactive risk, quality,
CoP, however, will not
and compliance
eliminate all risk.
activities are vital to
According to risk
Photo Courtesy of Specialists on Call
avoiding mishaps
management
related to telemedicine
brokerage firm Parker,
and
any
negative
public
exposure
that could
Smith & Feek, some related risk exposures to
ix
follow.
consider include:
According to the rule, its goals are to remove

Reliance on a written agreement between


the hospital and distant-site telemedicine
entity may not release the hospital
receiving the telemedicine services from a
negligent credentialing allegation if the
facility providing the telemedicine service
is noncompliant with Medicare
credentialing standards.
Informed consent may not be
comprehensive, allowing patients the
choice to accept or decline telemedicine
care.
Non-physicians participating in
telemedicine services may exceed the
scope of their certification or licensure,
resulting in unmet standards of care.
Peer review protections may not extend
to information shared between the
originating hospital and the remote
telemedicine site, requiring that the
structure of the program be revised in
order to maintain quality improvement
protections for shared data.
Existing professional liability and other
insurance may not adequately cover
exposures inherent to telemedicine, such
as errors & omissions of a telemedicine
practice, negligent credentialing, privacy
breaches, and disruption of telemedicine

Consider the following tactics as part of your


telemedicine risk management program:x

Ensure credentialing standards of the


facility/entity providing the telemedicine
practitioner meet the CoP.

Verify that the provider entity is qualified


to do business in all states where it
intends to conduct business and that all
owners of the entity are properly licensed
in each of those states. (Some states
prohibit the delivery of professional
medical services through a partnership,
corporation or LLC not wholly owned by
professionalsx licensed in the state).

Incorporate CMS standards into medical


staff bylaws and rules/regulations.

Develop a process to maintain an up-todate list of telemedicine providers.

Confirm that the performance of the


telemedicine providers meets compliance
and credentialing standards, as well as
quality of care standards, as determined
through a peer-review process.

Memorialize the scope of practice


protocols for non-physicians who
participate in the telemedicine program

(e.g. advanced practice clinicians, RNs,


radiology techs, etc.)

with the practice of telemedicine, it is helpful to


explore risk management in specific applications.

Review general and specialized consent


forms for inclusion of patient authorization
for telemedicine services.

Tele-ICU

Ensure physicians know informed consent


requirements for telemedicine. Confirm
they can point out the difference in the
patient-physician relationship via
telemedicine and understand the need to
establish a rapport and trust remotely.

Establish guidelines regarding the sharing


of medical information with telemedicine
providers and monitor documentation as
an ongoing process.

Require that any EHR access by or with


telemedicine providers is secure and
compliant with HIPAA.

Create or review existing telemedicine


agreements for compliance with the CoP
and modify as needed if the facility
decides to rely on the credentialing of the
distant site telemedicine facility.

Review insurance provisions of your


telemedicine agreement for mutual hold
harmless and indemnification provisions,
as well as ensure adequate insurance
coverage.

Ensure professional liability insurance


provides coverage for telemedicine
services and that the insurance carrier is
licensed to write coverage for a broad
geographical area or whether you need to
obtain insurance in more than one state.
(Where services are deemed to be
rendered may be significant to claims
coverage, so you may need both foreign
and state specific liability coverage.)x

Verify that, in addition to the clinical notes


and recommendations, documentation for
a telemedicine session includes the mode
of service delivery, sites that were linked,
attendee names and any technical
ability to carry out the consultation.viii

RISK MANAGEMENT IN SPECIFIC TELEMEDICINE


APPLICATIONS
To better understand some of the risks associated

In the intensive care unit, telemedicine allows for


a centralized or remotely based critical care team
to connect with the bedside ICU team and
patients via audiovisual communication and
computer systems. The tele-ICU team can provide
surveillance and support for the on-site care team,
providing improved safety through redundancy
and helping to enhance outcomes through
standardization.x This model has become
increasingly popular due to a shortage of
intensivists and data that shows ICUs perform
better when managed by an intensive care
specialist.xi
However, the tele-ICU team may be perceived as
intrusive by on-site staff or patients and family.
being monitored instead of supported may speak
in a dismissive manner about the service in front
of patients. To minimize risks associated with teleto earn buy-in from staff in the
ICU so they cooperate with and communicate
freely with the tele-ICU staff and provide them
with a sense of the ICU environment that may not
be discernible via the camera. On the other hand,
the tele-ICU physicians must be held to the same
standard as the ICU physician in attendance at the
bedside, and they must look not just at the data,
but also at the patient to observe any health
warning signs.xii

Telepsychiatry
The number of patients presenting to emergency
departments with mental health issues is
growing. These patients can place a great burden
on already busy emergency departments because
they are often difficult to manage and observe,
and the shortage of available psychiatric consults
or psychiatric beds may cause long waits for
appropriate treatment.xiii Telepsychiatry offers a
solution to expedite the treatment process for
these patients and improve patient flow in
emergency departments.
According to the American Psychiatric
Association, telepsychiatry allows for diagnosis
and assessment, medication management, and
individual and group therapy. It also provides an
opportunity for consultative services between
psychiatrists, primary care physicians and other
healthcare providers; and it is also being used to

provide patients with second opinions in areas


where only one psychiatrist is available. xiv
In the case of telepsychiatry, it is best for the
telepsychiatrist to be assisted by a skilled mental
health staff member on-site so that subtle clues,
such as odors, details of grooming, reactive facial
expressions or body language responses will be
communicated to the telemedicine physician. The
staff member should remain with the patient
throughout the encounter and be familiar with the
working of the telemedicine technology at least
enough to turn on and test the equipment before
the encounter to avoid system failure or the need
to adjust the technology during the patient
encounter, which can lead to loss of confidence
by the patient, staff or telemedicine provider.
The on-site facility or practice should also ensure
that the capabilities of the telemedicine
equipment meet any state licensing board
standards and determine if there are any licensing
board regulations
requiring in-person
examination by a
practitioner prior to
telepsychiatry
consultation. The onsite staff should also
determine whether
patients are appropriate
or inappropriate for
telepsychiatric
consultation before
engaging the service.
And, as in tele-ICU,

providing rapid response to neurological


emergencies in places and situations where
access would not otherwise exist.xvii There are
multiple examples of this model currently in
practice, including at academic institutions such as
The University of Miami, which is partnering with
telemedicine provider Specialists On Call for
teleneurology service for stroke care.xviii
In addition, hospitalist services may benefit from
teleneurology services if a neurology consultation
is not available, particularly for inpatients who
develop stroke symptoms and signs while
admitted, or inpatients with complex neurological
disorders.
The risks associated with teleneurology are similar
to those with tele-ICU: Teleneurologists are
unable to check reflexes, feel muscle tone,
perform a detailed sensory exam, do a fundus
exam, or examine for a stiff neck. That makes
teleneurology a good fit for emergency situations,
but less appropriate for
routine consults.xix On
the other hand,
teleneurology may also
help lower the
malpractice risk for
some emergency
physicians. According
to a 2008 study in the

Annals of Emergency
Medicine,xx the vast
majority of strokerelated lawsuits
involved a patient suing

telepsychiatry providers
an emergency
Photo Courtesy of Specialists on Call
must be held to the
physician who failed to
same standards as psychiatrists treating at the
make, or delayed, a stroke diagnosis with the
bedside.xv,xvi
patient not receiving tPA (drugs to break up or
dissolve blood clots). Teleneurology mitigates this
Teleneurology
risk.
Teleneurology is especially useful in consultation
Tele-emergency medicine
for stroke care and other emergency neurological
consultations for hospitals and emergency
Tele-emergency medicine involves providing
departments not staffed by American Board of
emergency service consultation to outlying
Emergency Medicine (ABEM)-certified specialists
hospitals. (The previously discussed applications
in emergency medicine. The challenge for these
of telemedicine are often used in emergency
hospitals is that they need specialists with
departments as well.) Academia began to
expertise and training in stroke care, and roundembrace tele-emergency medicine by the late
the-clock availability historically has not been a
-affiliated medical school
major area of interest for neurologists.
programs in states across the country. Looking
Teleneurology by stroke care specialists fills the
forward, there is opportunity for tele-emergency
need by preventing disruption of office hours with
emergency calls, relieving the on-call burden, and
ABEM-certified physicians in an academic

nurse practitioners and/or certified physician


departments in rural or underserved areas.xxi For
example, the University of Mississippi has a
working program with hospitals in rural
communities.xxii
When it comes to risks, tele-emergency medicine
faces exposures similar to the previously
discussed applications. Special consideration

physicia

advanced practice clinicians at

There is also a need for rigorous quality assurance


and continuing education for advanced practice
clinicians. The participating facilities may want to
consider periodically rotating the
advanced practice clinicians
emergency department for greater emergency
medicine knowledge and procedure training and
credentialing. Facilities may even want to consider
an advanced fellowship in emergency medicine
advanced practice clinicians.

TELEMEDICINE MALPRACTICE CASE LAW


Despite all the risks associated with telemedicine,
there have been relatively few malpractice claims
to date (compared to general malpractice claims),
given that telemedicine is still a relatively new
tool. According to a 2009 Report from the Center
for Telehealth and e-Health Law,xxiii the majority of
legal actions that have been brought against
telemedicine providers proceeded as a result of

prescribing medications over the Internet, rather


than actions brought because care was
negligently administered through telemedicine.
Ultimately, however, telemedicine claims will be
judged similarly to other malpractice claims
based on alleged negligence in the practice of
medicine, which happens to occur via
telemedicine instead of face-to-face medicine.
Telemedicine providers are held to the same
standard of care as those who administer
healthcare services in a traditional setting, but
they may find that they will be subject to
additional procedural and jurisdictional rules.

Some legal issues to consider related to


telemedicine and malpractice include:xxiv

require the defendant (physician) to


state. In cases involving medical
malpractice, the court will consider the
personal jurisdiction in deciding whether

home state.

govern the case. In telemedicine cases


spanning state lines, neither the
defendant nor plaintiff should assume the
laws of the state where the case is being
heard will govern the case.

CONCLUSION
Telemedicine is emerging as an increasingly sought-after tool for addressing some of the challenges and
changes within the healthcare industry, including poor physician access in remote areas and high demand for
specialists in both rural and urban areas. This relatively new healthcare delivery mode comes with new risks
that hospitals and physicians must consider when entering into a telemedicine agreement, designing their
telemedicine programs, and providing care via telemedicine. However, adhering to strategies that can
mitigate those risks can help hospitals lower their exposure to negative events while providing quality care to
their patients.

BROUGHT TO YOU BY

www.TeamHealth.com I 800.818.1498

Telemedicine Defined. American Telemedicine Association.


http://www.americantelemed.org/i4a/pages/index.cfm?pageid=3333.
ii
Patel, Mihir. Innovative Telemedicine Programs Offer Quality Plus Cost Savings, Med Health World.
http://www.medhealthworld.com/?p=1822
iii
Telemedicine. Medicaid.gov. http://www.medicaid.gov/Medicaid-CHIP-Program-Information/ByTopics/Delivery-Systems/Telemedicine.html.
iv
Elban, Kathleen. Is a Doctor reading your X-Rays? Maybe not, NBCNews.com, 26 October 2011.
http://www.msnbc.msn.com/id/44949425/ns/health-cancer/t/doctor-reading-your-x-rays-maybenot/#.ULzpSIawX3E.
v
Managing the Risks of Practicing Telemedicine, Massachusetts Medical Society Online Continuing
Education.
http://www.massmed.org/AM/Template.cfm?section=Communication4&Template=/CM/HTMLDisplay.cfm&Co
ntentID=72998.
vi
Youngstrom, Nina. With the Use of Telehealth Expected to Grow, Hospitals Confront Fraud, HIPAA
Pitfalls, AIS Health. 21:11, 19 March 2012. http://aishealth.com/archive/rmc031912-02.
vii
CMS Issues Final Regulations on Telemedicine Credentialing Conditions of Participation. Bricker & Eckler,
3 May 2011. http://www.bricker.com/publications-and-resources/publications-and-resourcesdetails.aspx?Publicationid=2165.
viii
Risk Management for Telemedicine Providers, Risk Management Services report. MDA National, Autumn
2006.
ix
Hall, Sharon. Telemedicine: Avoiding a Risk Management Nightmare, Parker, Smith & Feek, Nov 2011.
x
Goran, Susan F. A Second Set of Eyes: An Introduction to Tele-ICU. Crit Care Nurse August 2010; 30(4):
46-55. http://ccn.aacnjournals.org/content/30/4/46.full#.
xi
Clinical and Financial Evidence for Improving Quality and Efficiency in Your ICU, Philips VISICU, Inc.
January 2009.
http://www.americantelemed.org/files/public/membergroups/teleicu/Clinical%20and%20Financial%20Evidenc
e%20for%20Improving%20Quality%20and%20Efficiency%20in%20the%20ICU.pdf.
xii
Ahn, et al. Perspectives on the Electronic ICU, ICU Director March 2012 3(2): 64-69.
xiii
B. A. Nicks and D. M. Manthey, The Impact of Psychiatric Patient Boarding in Emergency Departments,
Emergency Medicine International, vol. 2012, Article ID 360308, 5 pages, 2012. doi:10.1155/2012/360308
http://www.hindawi.com/journals/emi/2012/360308/
xiv
Telepsychiatry. American Psychiatric Association. http://www.psychiatry.org/practice/professionalinterests/underserved-communities/telepsychiatry
xv
Emergency/Crisis Telepsychiatry Services. Insight Telepsychiatry LLC. http://www.insight.net/content/services/emergency_dept.asp.
xvi
Myers K, Cain S. Practice Parameters for Telepsychiatry with children and adolescents, J Am Acad Child
Adolesc Psychiatry. 2008; 47(12):1468-1483.
xvii
Rubin, Mitchell J. Viewpoints Teleneurology Report Card: Proof of Concept. Practical Neurology. June
2011. http://bmctoday.net/practicalneurology/2011/06/article.asp?f=viewpoints-teleneurology-report-cardproof-of-concept
xviii
Miller School, Telemedicine Firm Collaborating in Teleneurology. University of Miami Miller School of
Medicine. 1 Dec. 2009.
http://ww2.med.miami.edu/mednews/news_page/miller_school_telemedicine_firm_collaborating_in_teleneurol
ogy
xix
Rubin, Mitchell J. Viewpoints Teleneurology Report Card: Proof of Concept. Practical Neurology. June
2011. http://bmctoday.net/practicalneurology/2011/06/article.asp?f=viewpoints-teleneurology-report-cardproof-of-concept
xx
Empirical Characteristics of Litigation Involving Tissue Plasminogen Activator and Ischemic Stroke. Liang,
BA et al. Annals of Emergency medicine, August 2008, 52 (2):160-164.
xxi
Strategies for Emergency Medicine, Delivery System Reform Task Force, American College of
Emergency Physicians, Dennis Beck, MD and Bruce Auerbach, MD, co-chairs. October, 2012.
xxii
Special Report, Telemergency Medicine: Rural EDs Shining Star, Emergency Medicine News, November
2012, p19
xxiii
Natoli, Christa M. Summary of Findings: Malpractice and Telemedicine. Center for Telehealth and EHealth Law. December 2009.

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