Sponsored by: The NORCAL Group of companies includes NORCAL Mutual Insurance Company, along with its subsidiary companies Medicus Insurance Company, FD Insurance Company, NORCAL Specialty Insurance Company and its affiliate Preferred Physicians Medical RRG.
NORCAL Mutual Insurance Company is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
For questions, please call the Risk Management Department at 855.882.3412.
Method and Medium
To obtain CME credit, read the article then take the quiz and fill out the evaluation form. You can print or email your CME certificate from this application.
Please complete and submit the online quiz by the expiration date indicated below:
Original Release Date: January 15, 2018
Expiration Date: February 1, 2020
Learning Objectives
By reviewing medical professional liability claims and/or emerging topics in healthcare risk management, this enduring material series will support your ability to:
Assess your practice for risk exposures.
Apply risk management best practices that increase patient safety and reduce medical professional liability claims.
Target Audience
Physicians, healthcare staff and administrators
Credit Designation Statement
NORCAL Mutual Insurance Company designates this enduring material for a maximum of 1 AMA PRA Category 1 CreditTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Disclosure Policy
As an ACCME accredited provider, NORCAL Mutual Insurance Company requires planners, reviewers or authors who influence or control the content of a CME activity to disclose financial relationships (of any amount) they have had with commercial interests associated with this CME activity during the year preceding publication of the content.
Any identified conflicts of interest are resolved prior to the commencement of the activity.
Disclosures
Individuals involved in the planning, reviewing or execution of this activity have indicated they have no relevant financial relationships to disclose.
Telemedicine is gaining momentum. Third-party payment for telemedicine is increasing, state medical boards are working to make practicing in multiple states less onerous for physicians, and patients are demanding it.
The implications for patient safety and risk management are still uncertain. At the current time, the number of NORCAL liability claims directly related to the use of telemedicine is low. In claims that involve telemedicine, the technology has been a peripheral issue that has little effect on the cause of injury. However, as the number of telemedicine encounters increases, patient injuries and malpractice claims directly associated with it will likely increase.1
This month's publication primarily draws case study fact patterns from policyholders' calls to the Risk Management Department. Over the past few years, policyholder calls to the Risk Management Department about telemedicine have been concentrated in a few different areas:
Physicians who want to join a virtual care network (e.g., American Well, MDLive, Doctor on Demand and Teladoc)
Physicians who want to treat established patients who have moved out of state (or country)
Physicians who want to offer telemedicine services to existing patients in the same venue
Practices/groups that want to engage a specialist to provide telemedicine consultations to their patients (e.g., teledermatology, teleneurology), or a specialist who wants to provide virtual consults or second opinions
Physicians who want to know if they can use a particular technology/platform to provide medical advice (e.g., Skype, FaceTime, Grand Rounds, HealthTap)
These queries align with potential risk exposure issues, including:
Recordkeeping: Virtual care vendor patient recordkeeping protocols can impact contracting physicians' ability to comply with recordkeeping laws, patient safety standards and risk management recommendations.
Physician-Patient Relationship: When the physician-patient relationship is created and ends may be ambiguous in virtual care arrangements.
Quality of Care:Telehealth platforms may make providing quality care complicated. Clinicians need to determine when the patient needs to be seen in person, whether a diagnosis can be made without touching or smelling the patient and whether the patient has the capacity to engage via telemedicine.
Informed Consent: In addition to the risks, benefits and alternatives associated with the treatment being contemplated, the patient should be educated about the risks, benefits and alternatives associated with telemedicine.
Technology: The technology used on both ends of the encounter needs to be adequate for the medical care contemplated. Internet connectivity, power outages, bandwidth issues and inadequate technology support during a consult can cause diagnosis delays, errors and patient dissatisfaction.
HIPAA: Telehealth technology needs to maintain the privacy and security of patient health information (PHI).
Licensure: Clinicians need to be licensed in the state in which the patient is receiving care, as well as in the state in which the physician is physically located.
Contracts: Telemedicine company contracts may impact quality of care, compliance with healthcare laws and defense of liability claims.
It is important for individual physicians to understand how the telehealth platform affects their ability to provide quality care and manage risk. There can be tremendous pressure on physicians to achieve excellent patient ratings and attract a new generation of patients that wants fast, efficient and "no hassle" care by offering virtual care. Vendors may pitch telemedicine as an easy way to increase revenue, reduce burnout, increase patient access and improve patient well-being. However, physicians must not be swept up in the tide of excitement without a risk management and patient safety plan in place.
Defining Telemedicine
Telemedicine and telehealth are often used interchangeably. In the broadest sense, they both refer to the use of technology to deliver healthcare at a distance.i According to the American Telemedicine Association, telehealth is a delivery tool or system, while telemedicine is healthcare that utilizes telecommunications technologies.ii Telemedicine can be thought of as any type of patient care that involves telecommunication, including videoconferencing, transmission of still images and other data, e-health (patient portals, websites), m-health (mobile healthcare service), remote monitoring and medical call centers.ii
Resource
i. Health and Public Policy Committee of the American College of Physicians, Daniel H, Sulmasy LS. Policy Recommendations to Guide the Use of Telemedicine in Primary Care Settings: An American College of Physicians Position Paper. Ann Intern Med. 2015;163(10)787-789. Available at: annals.org/... (accessed 1/10/2018).
ii. ATA Standards and Guidelines Committee. Core Operational Guidelines for Telehealth Services Involving Provider-Patient Interactions. 2014. Available at: www.uwyo.edu/... (accessed 1/10/2018).
Risk Issues Associated with Synchronous Virtual Care
Virtual care is not inherently riskier than seeing a patient in the office. However, limitations with the current state of technology and the existence of a third-party virtual care vendor serving as a conduit between clinician and patient can increase patient safety and liability risk. Physicians can become involved in virtual care through different pathways. Many healthcare systems that offer virtual visits contract with one of the major virtual care companies and then brand the virtual care platform under their own name. Patients in the healthcare system frequently have access to physicians in their own healthcare system, but may also have access to the virtual care company's panel of physicians.2 Small private practices that have historically lacked the technical infrastructure for virtual care are also starting to have opportunities to provide virtual care to their patients with the major virtual care companies.2,3 Finally, physicians can choose to join a virtual care physician panel as independent contractors. This option is often presented to physicians as a way to make extra income or as an alternative way to practice medicine.
The NORCAL Risk Management Department has received numerous calls from policyholders who are considering joining the physician panel of a synchronous virtual care provider (e.g., American Well, MDLive, Doctor on Demand and Teladoc). Physicians calling were ready to enter into virtual care agreements without realizing the unique patient safety and liability risks associated with this new care delivery methodology. The following case studies are drawn from those calls.
Virtual Care Recordkeeping
In the virtual care arrangement contemplated in the following case, the physician did not know how he could comply with medical record retention, security, access, and release regulations, or whether he would have access to a complete copy of all records in the event of a lawsuit.
Case One
Issue:
The physician had not thoroughly considered the unique recordkeeping issues associated with virtual care.
The physician's group was planning to contract with a second-opinion virtual care company. According to the physician, the vendor described the process as follows: patients filled out an intake form, uploaded their medical records and requested a second opinion. The virtual care company then chose a physician from the company panel of contracted physicians. If the chosen physician agreed to provide the second opinion, the patient and physician were connected and communication took place via the company's virtual care platform. The physician would provide a written opinion that was uploaded to the system, where the patient could access it.
Virtual Care Recordkeeping
Physicians own the physical medical record, while patients own the information in the record (for the most part). The era of electronic medical records - by adding a vendor to the equation - has changed the thinking around ownership and control of medical records and patient information. Telehealth will further change the dialogue, because the telehealth platform vendor controls so much of the transaction between the physician and patient. Virtual care platform designers may not consider medical record documentation and accessibility by physicians a priority; however, physicians who use telehealth modalities must document, retain and provide patient access in a manner consistent with current laws and regulations governing healthcare recordkeeping. It will be important for physicians contemplating virtual care to carefully review contracts to ensure their appropriate access to patient records.
Virtual Recordkeeping
Because a virtual care encounter may be conducted entirely through a third-party, it is important to know how to comply with various recordkeeping regulations and patient record access expectations. Consider the following recommendations:2
Have a clear mechanism to access, supplement and amend patient information.
Know how the patient obtains a copy of the virtual care consultation record.
Ensure the patient's ability to access a copy of the record is consistent with state and federal law.
Obtain assurances that a complete legal record of the virtual care consultation will be made available to you if it is needed to defend care in a malpractice action or regulatory matter, such as a board of medicine inquiry.
Establish who on the patient's healthcare team should receive reports of the encounter.
Telemedicine Encounter Documentation
Documenting a virtual care encounter requires additional details. If an unexpected outcome occurs as a result of a telemedicine encounter, it is important to know the cause, for both risk management and quality improvement. Without clear documentation, it can be difficult to determine the cause of an unanticipated outcome. In addition to clinical information, documentation should include: 4,5,6
The exact time when you were contacted to provide a consult, the time that you were connected to the patient, and, if it is an emergency, the time that you recommended treatment and when the treatment was provided.
Your location and the location of the patient.
The names and contact information for everyone involved in the encounter, including the person who requested the examination and the telepresenter (a person in the remote location assisting with the consultation), if there is one.
Patient authentication: Will you be able to ensure you are examining and prescribing for the correct person? Some ways to authenticate the patient include:
Asking the patient to hold up a driver's license to the camera and comparing the information on the identification card to the information provided by the patient.
Running an insurance eligibility check, confirming the patient's name, address, date of birth and Social Security number.
If the patient has been seen before, asking a series of questions on prior medical history to determine if the patient responses match what is in the medical records.
The informed consent process and confirmation, including that the patient agrees to and understands that you may determine telemedicine may not be appropriate for the diagnosis and treatment of his or her condition.
Who provided observations associated with a component of a physical examination; for example, if the telepresenter assessed the strength or tone of the patient, add to the documentation "per telepresenter."
Ancillary reports that contributed to the examination - if the reports are not available in the file, identify the clinician who read the report to you.
Any technical issues that interfered with, delayed or complicated the telemedicine encounter, for example, poor internet connectivity or signal quality, camera or device malfunction, telepresenter unavailability, patient inability to manage technical aspects of the exam, or peripheral device unavailability.
Patients Recording or Posting Virtual Care Encounters
Whether patients are allowed to record a virtual care encounter can be analogized to patients creating sound or video recordings with their smartphones during in-person examinations. There are pros and cons associated with allowing patients to record healthcare encounters. On the pro side, patients can play the recording when they forget the details of treatment recommendations or the risks, benefits and alternatives associated with proposed treatment. However, the posting of an examination to social media is an entirely different matter in which the cons will most likely outweigh the pros, since it is difficult to determine how posting the visit to social media would enhance the quality of care. Another concern is that the recording could be used in future litigation against the clinician, and that the recording could be altered to favor the plaintiff.
Whether a patient is legally permitted to record a patient encounter (video and/or audio) depends primarily on state wiretapping/eavesdropping laws, which designate whether all parties or just one party must consent to the recording of a conversation. For example, in one-party-consent states, a patient could record an examination without the physician's knowledge or consent. In the other states, recordings without the consent of the physician would be illegal. Currently, 39 of the 50 states and Washington, D.C. are one-party-consent states. The remaining 11 states are all-party-consent states.iii However, there may be other state laws that also affect whether recording a telemedicine encounter would be legal. For example, in Vermont, which is a one-party consent state, telemedicine law prohibits recording telemedicine encounters either by the physician or the patient.iv Consequently, it is important to understand the state laws affecting wiretapping/eavesdropping and telemedicine encounter recordings when creating patient recording policies. Information about state laws on recording can be accessed at www.mwl-law.com/... (accessed 12/1/2017).
The bottom line is: Patients may record and post their virtual care encounters regardless of whether a physician consents to it. Surreptitious recording can't be controlled, but lack of a physician's consent to the recording may affect whether the recording would be admissible as evidence in future litigation. Physicians who do not want to be recorded should develop clearly written policies for consultation recordings and the appropriate response to recording that occurs covertly. If a patient is resistant, offer a summary of the visit, discharge information sheet, educational pamphlets or tools, and/or remind patients to take notes during the encounter and summarize these points with them at the end of the encounter. It is important to clearly document your refusal to consent to the recording.
Physicians affiliated with third-party virtual care vendors who want to make virtual care recordings available to patients must additionally determine whether the recording is allowed by the vendor. If legal or contractual issues do not prohibit recording, it will be important to coordinate and store the various streams of patient data and recordings, and determine how and to what extent this data will be shared and how privacy will be protected. If virtual care recordings are shared with patients, consider entering into an agreement with the patient that limits sharing all or portions of the recording with the general public (e.g., on social media).
Resource
iii. Glyn Elwyn, Paul James Barr, Mary Castaldo. Can Patients Make Recordings of Medical Encounters? What Does the Law Say?. JAMA. 2017;318(6):513-514.
iv. Lacktman NM, Ferrante TB. Vermont's New Telemedicine Law Expands Insurance Coverage, Bans Recording. 2017. Healthcare Law Today. Available at: www.healthcarelawtoday.com/... (accessed 12/4/2017).
The Beginning and End of the Virtual Patient-Physician Relationship
In virtual care, the starting point of the physician-patient relationship may be difficult to determine. In either traditional or virtual healthcare, the relationship is established when the physician agrees to treat the patient and the patient agrees to be treated.7 With virtual care, the telemedicine vendor can play a significant role in the creation of the patient-physician relationship. For example, the virtual care company may match the patient to the physician, or the patient may choose the physician from a selection provided by the company. When the vendor is in the middleman role, it can delay the communication of physician or patient agreement to enter into a treatment relationship. There also may be ambiguity over when the relationship ends, which can expose the physician to allegations of abandonment.
In the following case study, the physician asking for advice about joining a virtual care company as a panel physician had not considered the following issues:
What expectations will patients have for the physician-patient relationship?
Is the limited nature of the relationship described/agreed to by both parties?
Is there any expectation by the patient for an ongoing relationship beyond the virtual visit?
Who is responsible if a patient in need of services selects a physician, but the vendor fails to promptly connect patient and physician, causing a delay in treatment or diagnosis?
Case Two
Issue:
The physician had not considered unique physician-patient relationship issues associated with virtual care.
A family practice physician wanted to contract with a virtual care company. The process for providing a virtual consultation was described to her as follows: She would indicate her availability to conduct virtual visits through the virtual care platform. Her profile would only be made available to patients located in her state who were in need of basic family medicine acute illness care. When a patient chose her, she would be notified through the platform. She would then be given access to information the patient had entered into his or her profile and the patient and physician would be connected virtually through the platform. The consultation would take place using the patient's and physician's webcams.
Although these issues are not settled, it could be argued that the physician-patient relationship begins when the patient chooses the physician from the online panel, particularly if the patient has a reasonable expectation of the relationship beginning at that point, based on the information provided to the patient by the vendor. The physician may have little control over lag time between the patient requesting the consultation and the vendor notifying the physician of the patient request. Some virtual care physician contracts include a waiver of liability. Consequently, if the company causes a delay that results in a patient injury, the physician may be held responsible for negligent delay of treatment that was out of his or her control.
Another unsettled issue is physician-patient relationship termination. If the patient believes he or she has a continuing relationship with the virtual care physician, but the virtual care platform does not support a continuing physician-patient relationship, the physician could be accused of abandoning the patient. Finally, physicians should consider how to handle assignment of virtual care patients whose healthcare needs require in-person consultation or exceed the virtual care physician's scope of practice.
Consider the following recommendations:
Ask the virtual care vendor about the time frame from patient request to physician notification, and consider whether you are willing to accept the risks associated with any anticipated delays.
Understand and confirm or adjust the patient's expectations for his or her relationship with you.
If the expectation is for only one virtual encounter with no continuing relationship, obtain consent from the patient prior to the examination.
Obtain virtual care vendor patient information to determine what the vendor is offering patients.
Ensure there is an appropriate method for referring patients who need in-person care, or treatment by a specialist that terminates the physician-patient relationship between you and the referred patient.
Ensure your ability to follow-up on patient compliance with recommendations and your ability to follow-up with the patient to ensure the condition has resolved.
Understand vendor expectations of your availability and response time. If you do not want to be available 24/7, it is important to ensure you are in control of your schedule.
Patient Selection
Patient selection for virtual care is extremely important in managing risk and ensuring patient safety. For example, writing a prescription for Viagra® or diagnosing pink eye in a toddler via webcam is fairly straightforward, but consulting with a suicidal teenager in a rural area, or with a patient with an unreliable internet connection, or with a patient for whom managing the technology will be challenging involves an entirely different risk/benefit analysis when determining whether telemedicine is an appropriate option. Oftentimes, receiving unsupervised telehealth services requires the patient to take an active and cooperative role in the consultation. Consequently, part of the patient selection process should be assessing the patient's ability to engage in a telehealth encounter without help. Another important consideration will be the probability of the patient requiring emergency services and how quickly he or she can access them. Geographically isolated patients, who stand to gain significantly from telemedicine, often have the poorest infrastructure, resources and capabilities to receive it.6
Consider the following recommendations:6
Ensure the patient has the organizational and cognitive capacity to receive telehealth services.
Ensure the patient has the technology and connectivity necessary to be adequately examined.
The patient may only have access to a cellphone or a computer lacking the bandwidth necessary or connectivity required by the telehealth platform.
Ensure the patient's condition can be appropriately examined via available telehealth equipment. For example:
If you are asked to do an atypical lesion assessment, can you see the lesion clearly enough to make a diagnosis?
If you are asked to assess a patient for dizziness, can the camera angle accommodate an appropriate gait assessment?
Have a patient health emergency protocol.
Particularly for behavioral health patients, it's important to know how to get crisis intervention or police involved.
Informed Consent
In addition to informing a patient about the risks, benefits and alternatives associated with a proposed treatment, some states require the patient to also be educated about the risks, benefits and alternatives associated with telemedicine.8
Ensuring the patient understands the limitations and benefits of telemedicine is a good idea, even if the law doesn't require it. Consider the following recommendations:6
In addition to the risks, benefits and alternatives associated with treatment, include in the telemedicine informed consent
Consultation structure and timing
Triggers for discontinuing the consultation and referring the patient to in-person care
Protocols for contacting you following the consultation
Patient medical record access, correction, etc., in compliance with HIPAA and any local patient information laws
Confidentiality and the limits of confidentiality when communicating via an electronic medium
Reassurances that reasonable precautions are being taken to ensure privacy, security of PHI and HIPAA compliance, but it is the responsibility of the patient to ensure a private environment on their end of the virtual consultation to the extent that it is important to the patient
Emergency plan
Potential for technical failure
Care coordination and specialist referral policies
Provide consent information in language that can be easily understood by the patient, particularly information that refers to technical issues like encryption or the potential for technical failure.
If the telemedicine platform being used has the consent for telemedicine built into the process, make sure that the elements noted above are addressed.
Confirm that local laws allow electronic signatures on the consent form.
Document the consent process in the medical record.
Professionalism
Virtual care encounters require a different communication approach than an office visit. Some physicians may appear perfectly natural to patients who see them on their computer screens and may be able to seamlessly move back and forth between live and virtual patient care. Other physicians' body language or preoccupation with technology may give the impression of a lack of empathy or incompetence. Physicians who treat a virtual health consult too much like a telephone consult, or who fail to set the appropriate stage in their telemedicine office may also make a poor impression. Patients notice when professionalism is lacking. For example, in the comments section of a virtual care website, a patient complained that the physician appeared to be in an office with family and company in another room who kept passing in the hallway behind him. Another patient was upset that her physician appeared to be reading something from the internet while she was explaining her symptoms.9 NORCAL Risk Managers have fielded questions from policyholders that raise similar concerns. For example, an intensivist who worked for a tele-ICU company called to ask if he could continue monitoring patients from his hotel room while he was vacationing with his family. Another caller planned to take calls in his car while he and his wife commuted to and from work. Although telemedicine is often seen as a way for physicians to consult with patients more conveniently, maintaining a professional virtual care environment is an important consideration.
Professionalism should be the same for office and virtual visits. Consider the following recommendations:6
Be comfortable with the telemedicine technology you are using and have access to technical assistance when needed.
If legal or contractual issues do not prohibit recording, review recordings of your telemedicine consults and determine whether there are aspects of your "on-screen" presence that could be changed to enhance the patient's experience.
Provide virtual consultations from an environment that is comparable to a professional patient consultation setting.
Choose a simple background, without distracting images or objects.
Close the door to your office during virtual consultations.
Avoid conducting virtual consultations in public places.
Take measures to reduce the potential for interruptions during periods while you are doing virtual care.
Set up your camera and encourage the patient to set up his or her camera in a way that facilitates seeing each other's faces.
Place your camera on a stable platform in order to transmit a steady image.
Appropriately light yourself and your surroundings.
Virtual Care Production Quality Resources
With registration, the American Telemedicine Association (ATA) provides guidance on improving quality during a virtual care encounter. For example, the ATA articles, "Let there be Light: A Quick Guide to Telemedicine Lighting," and "A Concise Guide for Telemedicine Practitioners Human Factors: Quick Guide Eye Contact," can both be accessed through the ATA website at: www.americantelemed.org/home (accessed 12/1/2017).
Quality of Medicine
In general, the quality of telemedicine should be at least equivalent to in-person healthcare for a particular patient presentation. Various issues should be considered when determining whether a patient can be appropriately treated in a virtual manner. Even minor medical complaints, like upper respiratory infection or sore throat, may require hands-on evaluation. For example, one virtual care provider was asked to provide a hand examination for a patient who had throbbing pain in her index and middle finger of her right hand. She described no other symptoms. Her acrylic nails were elaborately decorated for the holiday season. It was only after observing an erythematous and inflamed perionychial area on the left index finger, that the physician got the patient to admit that her nails were emitting a foul odor. She was then able to diagnose abscesses under the nail beds of the right hand. This would require removal of the elaborate acrylic nails, which the patient was trying to avoid. Had the physician been examining this patient in person, the odor of the infection would have made diagnosis relatively simple.
Technology on either end of the consultation may prohibit quality care. Even if the technology meets the standards necessary, inadequate training can create the basis for a malpractice claim. Additionally, inability to obtain information, either through past medical records or ordered labs, studies or consults, may impact a physician's ability to provide treatment consistent with the standard of care. Finally, quality assessment can be difficult if the telemedicine vendor does not allow access to patient complaints and satisfaction surveys. These are all issues that should be considered when considering whether telemedicine is appropriate for a particular patient.
Consider the following recommendations:6,10
Ensure the patient can be adequately assessed without information normally obtained during an office visit. For example:
Does the diagnosis and treatment recommendation require temperature, pulse, blood pressure, throat swab, ear drum examination, palpation, urine sample, strength assessment, reflexes, etc.?
Do not be tempted to guess about appropriate treatment if information that would usually be gathered in person is unavailable.
Be explicit with a patient who needs to follow up with an in-person clinician and explain the risks of failing to do so.
Ensure additional patient records can be obtained if necessary for reaching a diagnosis and proposing appropriate treatment.
Consider how studies, labs or referrals will be accomplished.
Determine whether the patient has mobility and is able to comply with referral recommendations.
Be familiar with the patient's prescription and medication dispensation options.
Ensure a method to report and coordinate telemedicine consultations with the patient's primary care physician.
Refer to guidelines to determine whether telemedicine is appropriate in a particular situation or with a particular patient.
Telemedicine Guidelines
Various organizations have published guidelines to assist physicians in the provision of quality telemedicine. For example, the ATA has published "Core Operational Guidelines for Telehealth Services Involving Provider-Patient Interactions." The ATA also has published guidelines for various telemedicine specialty practices, including guidelines for telepathology, teleICU, teledermatology, telemental health and telerehabilitation, which can be accessed through the ATA website at: www.americantelemed.org/home (accessed 12/1/2017). In addition to the ATA, various medical specialty societies also have published clinical practice guidelines related to telemedicine, including:
American College of Radiology, "White Paper on Teleradiology Practice" Available at: www.jacr.org/... (accessed 12/1/2017)
American Academy of Dermatology, "Teledermatology Toolkit" Available at: www.aad.org/... (accessed 12/1/2017)
American Academy of Pediatrics, "Telemedicine: Pediatric Applications" Available at: pediatrics.aappublications.org/... (accessed 12/1/2017)
American Academy of Neurology, "Resources on Teleneurology" Available at: www.aan.com/... (accessed 12/1/2017)
Privacy and Confidentiality
Many forms of interactive audio-visual technology (IAVT) (e.g., Skype, FaceTime) are readily available, inexpensive and provide an opportunity to videoconference via computer, tablet or smartphone. Unfortunately, many popular IAVT tools were not designed for doctor-patient interactions, and can compromise your obligation as a covered entity to comply with HIPAA. IAVT companies may encrypt information that travels through their platforms, but some do not sign business associate agreements, do not provide audit trails, do not ensure security of backup files and do not offer notification in the event of a breach or a security incident. IAVT services that do not perform these functions jeopardize a covered entity's HIPAA compliance and would therefore not be appropriate for providing telehealth services.11
Consider the following recommendations:6
Ensure your telemedicine platform/software/mobile device app secures all data transmissions with point-to-point encryption that meets recognized government standards.
More information on encryption standards is available at: www.hhs.gov/... (accessed 12/4/2017).
Ensure IAVT software is not set to allow outside access to teleconsultation with patients. For example, some platforms may default to create a video "chat room" that allows other users of the platform to enter at will.
Determine whether videoconference transmission data is inadvertently stored on computer hard drives or smartphones. If so, protect storage security with disk encryption, remote wipe functions and pre-boot authentication. A better strategy is not storing PHI on portable devices.
Take appropriate precautions to keep others from hearing or seeing PHI (e.g., close the office door; do not conduct telemedicine in public).
Ask the patient to do the same.
Licensure and Choice of Law
Obtaining appropriate licensure should be a major consideration for any physician contemplating the practice of telemedicine across state lines. Consulting with patients in distant states without proper licensure may be "practicing medicine without a license," which can have harsh penalties, including criminal prosecution, civil litigation or administrative action. Some states require full licensure while others provide a special limited license through reciprocity. Recent efforts to simplify physician licensing across state lines have been somewhat successful. For example, the Federation of State Medical Boards (FSMB) Physician Licensure Compact provides an expedited licensing pathway for physicians who wish to be licensed in numerous states. More information about the compact is available at: www.licenseportability.org (accessed 12/2/2017).
In addition to ensuring appropriate licensure, clinicians should also consider the healthcare laws applicable in the patient's location. Standards of care and informed consent laws vary from state to state and may be more or less favorable to clinicians in the event of a medical liability claim.
For example, tort reform measures might not apply when a patient is located in a state without them. Additionally, mandatory reporting and related ethical requirements, such as duty to notify, are tied to the jurisdiction where the patient is receiving services.6
State medical associations, medical boards and other healthcare organizations provide state-specific telemedicine law summaries. The ATA's "State Telemedicine Gaps Analysis: Physician Practice Standards & Licensure," which is available at: www.americantelemed.org/... (accessed 12/2/2017), compares the telemedicine laws in all 50 states. The Center for Connected Health Policy has an interactive US map available at: www.cchpca.org/... (accessed 12/2/2017), which details telemedicine law and policies by state.
Technology
Technology is a major aspect of telehealth that impacts most risk management and patient safety recommendations in some way. Consider the following recommendations:6,12
Establish technological standards for providing telehealth services.
Match the technology to the complexity and needs of the situation. For example, a surgeon who is performing robotic surgery from a remote location will have different bandwidth, image resolution and uptime requirements, etc., than a therapist conducting a behavioral health session.
When using a personal computer, use professional-grade or high-quality cameras and audio equipment at both ends, when necessary.
Use up-to-date telehealth software and services that will support HIPAA compliance.
Have a backup plan in place for technology failures (e.g., internet connectivity, power outage and bandwidth issues can be addressed with back-up generators, redundant equipment and other clinicians on-call who can step in if necessary).
Have a process in place for physicians and patients to report technical insufficiencies (e.g., poor resolution of images, transmission delays, malfunctioning equipment, etc.).
Communicate the plan to the patient prior to beginning the consultation, including termination of the session, if technical difficulties become insurmountable.
Regularly test equipment and connectivity to ensure functionality.
Use the most reliable connection method possible to access the internet (i.e., use wired connections when possible, and use videoconference software that will adapt to changing bandwidth environments without losing the connection).
Ensure all members of the telehealth team are complying with technology policies.
Contracts with Telemedicine Vendors
Contracts between telemedicine vendors and physicians may cover many of the issues already addressed in this article, including patient access to medical records, HIPAA compliance, obtaining patient consent, responsibility for technology functionality, paying for telecommunication connection and tech support, credentialing, referrals and indemnification for liability. Physicians should not assume that a telemedicine contract takes into account a physician's duty to comply with various healthcare laws, medical ethical standards, patient safety guidelines or professional liability coverage arrangements. Indemnification language in a contract can shift liability to a physician signatory, even though a patient injury was caused by a telemedicine company. Additionally, the contract's definition of confidential information may be too broad to allow compliance with various laws and guidelines. Finally, verbal promises made to physicians by the company or vendor that conflict with language in the contract will most likely be difficult, if not impossible, to enforce.6
Consider the following recommendations:13
Carefully review all telehealth contracts and strongly consider having a healthcare attorney provide a review.
Do not agree to a term in a contract if you do not understand the effect it will have on you, your practice or your business.
Do not ignore an indemnity clause and assume it can be resolved at a future date. In general, it is more difficult to negotiate the terms of a contract after it has been signed.
Have an attorney review any contract containing the terms "indemnity," "hold harmless" or anything similar. (An indemnity clause does not have to include the terms "indemnity" or "hold harmless" to shift indemnification to you.)
Review any liability policies for exclusionary language that may apply to any contract being considered.
Determine how reimbursement will be managed and ensure it is compliant.
Remote Patient Monitoring
The use of remote patient monitoring by physicians and healthcare entities continues to increase.14 Remote patient monitoring is using digital technology to collect health data from a patient in one location and electronically transmit that information to a clinician in a different location for assessment. Patient data such as vital signs, weight, blood pressure, blood sugar, blood oxygen levels, heart rate and electrocardiogram can be transmitted from hospitals to monitoring centers such as teleICU units, or from a patient's home to a hospital or primary care unit. Patients can be remotely monitored from home using a variety of different devices. For example, the University of Pittsburgh Medical Center (UPMC) provides congestive heart failure patients with kits containing a pulse oximeter, blood pressure cuff, weight scale and a 4G tablet that uploads data to UPMC nurses who monitor the data.15
The following case, which is based on a NORCAL closed claim, involves a different remote patient monitoring scenario. In the following case, the obstetrician on call was monitoring patients using an iPhone app that allowed her to review laboring patient fetal heart monitor (FHM) tracings remotely. Reviewing the case in retrospect, the ability to review the FHM tracings online seemed to lull the physician into a false sense of security about fetal well-being.
Case Three
Allegation:
The on-call OB, who was watching the patient's fetal monitor tracings on her cellphone app, negligently delayed delivery.
At midnight, an OB nurse called the on-call OB and asked her to come in to examine a high-risk patient and update the care plan. The OB brought up the FHM tracings on her smartphone, and informed the nurse they were not concerning to her. She told the nurse that she would continue to monitor the tracings from her home. She then updated the electronic health record (EHR) from her home computer, noting category 2 tracings and no fetal distress.
By 2:30 a.m., when the OB arrived at the hospital, the FHM tracings were showing repetitive decelerations and the biophysical profile was 2/8. A C-section was called at 3:00 a.m. and started at 3:50 a.m. The infant was delivered with APGARs of 0/0 and could not be revived. Placental pathology showed placental abruption. The mother filed a wrongful death lawsuit against the OB.
OB experts who reviewed this case could not support the delay in delivery. They believed the FHM tracings started to look concerning at 1:30 a.m. and were ominous by 2:00 a.m. According to one expert, a jury wouldn't be impressed by the OB's capacity to monitor from home. They would focus on her failure to present to the hospital after the nurse expressed her concern about fetal well-being. Another issue that arose during litigation was the patient's perception that she was being ignored by the OB. The nurse had advised the patient that the physician was monitoring her from home, but the patient considered the off-site monitoring inferior and unsatisfactory. Whether the remote monitoring app inaccurately represented the FHM tracings could not be established.
Consider the following recommendations:14,16
Be appropriately responsive to the nurse or other patient attendant who is directly observing a patient whom you are remotely monitoring.
Be sensitive to potential differences in the accuracy of the data generated by remote monitoring devices (e.g., how does the stethoscope plugged into the patient's home computer compare to a stethoscope in person?).
Regularly ensure the remote monitoring device/software is functioning appropriately.
Understand the extent of your responsibility for reviewing remote data - will you be responsible for noticing that the patient is having an adverse event at 3:00 a.m., when your practice is to review overnight data at 8:00 a.m. the following morning?
Have a system for recognizing when patient data is indicating a downward trend.
Identify patients for whom remote monitoring will be most beneficial (e.g., patients with chronic disease that are most likely to be readmitted to the hospital). Remote monitoring for every patient who requests it may not be appropriate.
Take into account the potential for patient dissatisfaction with remote monitoring when the patient expects bedside or in-person evaluation, and adequately explain how it works and why it is an appropriate alternative to in-person evaluation.
Clinician Adjustment to New Telehealth Modalities
There may be a period of adjustment while telepresenters/generalists adjust to their new role as conduits of a more specialized or complex practice. In the following case, a rural hospital started using a teleneurology "telestroke robot" when neurologists were not available for consultation. The negligence allegations were not associated with the teleneurology, per se, but rather with the ED physician's and hospitalist's failure to utilize the technology to diagnose the patient's stroke in a timely manner, when it could have been treated. Consider how the following outcome may have been different if the ED physician and hospitalist had been more familiar with the teleneurology policies and protocols.
Case Four
Allegation: The ED physician should have obtained a teleneurology consultation.
At 8:00 p.m., a 25-year-old man arrived by ambulance to the ED. He was obtunded, could not speak and was not responsive. His wife described him as otherwise healthy before he had lost consciousness, although he had been complaining of a headache for the past week. The ED physician considered stroke in her differential, but her index of suspicion for stroke was not high enough to trigger a stroke alarm, which she understood was the requirement for telestroke robot utilization. Therefore, the ED physician ordered a battery of tests and studies, which revealed no obvious reason for the patient's nearly comatose status.
She decided to have the patient admitted for further testing. The hospitalist who admitted the patient ordered a neurology consult for the following day when a neurologist would be rounding on patients.
The following day, the neurologist who examined the patient concluded he had suffered a stroke. By this time, the patient's brain damage was extensive. The patient filed a lawsuit against the hospital, ED physician and hospitalist alleging he should have immediately received a teleneurology consultation and, had this been done, his stroke would have been diagnosed, tPA and/or other interventions would have been undertaken and his outcome would have been significantly better.
The American Academy of Neurology supports teleneurology as an effective tool for rapid evaluation of patients in isolated and urban areas with too few available neurology specialists. Particularly when stroke is in the differential, teleneurology consultation can significantly reduce the risk of patient injury when a neurologist is not available.17 In this case, experts believed the ED physician needed to immediately seek consultation from a neurologist when she was unable to determine the etiology of the patient's neurological status. She could have done this using the telestroke robot, but she misunderstood the policy for using teleneurology, assuming it was only to be used to determine whether to administer tPA.
The hospital's policy for using the teleneurology system did not limit use of the teleneurology system to suspected stroke patients; however, the policy was somewhat unclear, as it consistently referred to the "telestroke robot" and "telestroke policy." Consequently, although experts believed the ED physician was personally liable for her failure to act, the hospital shared responsibility for the poor outcome because the policies and procedures were not effective. Experts believed hospital administrators had a duty to ensure the teleneurology system was being used appropriately before it was made widely available to patients.
Hospital administrators in this case had no idea that their telestroke robot policies were unclear until it came up in litigation. Consider the following recommendations:
Clinicians and Telepresenters
Understand the appropriate use of telemedicine in your workplace.
Stay abreast of telemedicine upgrades and changes in your workplace.
Comply with telemedicine policies and protocols when appropriate.
If some aspect of a policy or protocol is unclear, seek clarification.
Take advantage of telemedicine training resources and request additional training when necessary.
Resist being pulled outside of the scope of your license or specialty by telemedicine policies or protocols.
Administrators
Before rolling out a new telemedicine program, ensure clinicians understand how and when to use telemedicine.
Train clinicians on the telemedicine modalities and the policies and protocols for its use.
Ensure the wording of telemedicine policies and protocols is not misleading or ambiguous.
Define general guidelines for telemedicine-appropriate conditions and complaints, but then refine the guidelines as practice indicates.
Ensure telemedicine modalities are being utilized appropriately.
Update telemedicine policies and procedures as technology is updated.
Telemedicine laws, technology and guidelines continue to develop and change, which will inevitably result in questions about how to provide telemedicine in a manner that complies with state and federal laws, ethical guidelines and patient safety standards. Understanding and mastering telemedicine-specific patient safety and liability risk issues will be important as telemedicine becomes more ubiquitous in the healthcare arena. With all of the excitement over new technologies and opportunities, it can be difficult to remember that telemedicine, at its core, is simply a means to providing healthcare. Clinicians must be able to comply with the standard of care, and if that is impossible because the physician and patient are in different places, then the patient consultation should take place in person. The strategies and suggestions introduced in this article are presented to help clinicians determine when telemedicine is appropriate and ease the adjustment to this new methodology for practicing medicine.
The NORCAL documents referenced in this article, along with many other Risk Management Resource documents and past editions of the Claims Rx, are available in the Risk Solutions area of MyACCOUNT, or by policyholder request at 855.882.3412.
Ksiazek MC. Telemedicine - Are There Increased Risks With Virtual Doctor Visits? Nat Law Rev. 2017. Available at: www.natlawreview.com/... (accessed 12/5/2017).
Loeb S. How Does Health Tap Make Money? Vatornews. 2017. Available at: vator.tv/news/... (accessed 12/5/2017).
Govindarajan, RR, et al. Developing an outline for teleneurology curriculum: AAN Telemedicine Work Group recommendations. Neurology. 2017;89(9):951-959.
Goedert J. Telemedicine Consults Require Care in Confirming Patient Identity. Health Data Manage. 2017. Available at: www.healthdatamanagement.com/... (accessed 12/5/2017).
American Telemedicine Association. Practice Guidelines for Video-Based Online Mental Health Services. 2013. Available at: www.integration.samhsa.gov/... (accessed 12/5/2017).
Kentucky Board of Medicine. Board Opinion Regarding the Use of Telemedicine Technologies in the Practice of Medicine. 2014. Available at: kbml.ky.gov/... (accessed 12/5/2017).
Lacktman NM. Joint Commission Introduces New Accreditation Standards for Telehealth Services. Health Care Law Today. 2017. Available at: www.healthcarelawtoday.com/... (accessed 12/5/2017).
State Medical Boards' Appropriate Regulation of Telemedicine (SMART) Workgroup. Federation of State Medical Boards Model Policy for the Appropriate Use of Telemedicine Technologies in the Practice of Medicine. 2014. Available at: www.fsmb.org/... (accessed 12/5/2017).
Greve P. Telemedicine Law and Liability: 2015. Willis Towers Watson Wire. Available at: blog.willis.com/... (accessed 12/5/2017).
Armer WD. Indemnification in Healthcare Contracts: Concepts, Coverage and Clauses. 2016 Nov. Available at: www.dallasbar.org/... (accessed 12/5/2017).
Irfan A. Virtual Care Trend Watch. Telemedicine Magazine. 2017. Available at: www.telemedmag.com/... (accessed 12/5/2017).
University of Pittsburgh Schools of the Health Sciences. Remote Monitoring Telemedicine. 2017. Available at: www.upmc.com/... (accessed 12/5/2017).
Chesanow N. Do Virtual Patient Visits Increase Your Risk of Being Sued? Medscape. 2014. Available at: www.medscape.com/... (accessed 12/5/2017).
McCormick T. Teleneurology: Why It Works Today. Telehealth and Medicine Today. 2017:(2)5. Available at: www.telhealthandmedtoday.com/... (accessed 12/5/2017).
2018