The growing use of telemedicine is putting more pressure on risk managers to develop appropriate processes for informed consent. This modality requires an emphasis on making sure patients understand the limitations of telemedicine at the same time it is being promoted as the new, modern way to interact with healthcare professionals.

Telemedicine applications and evolving technologies are changing the consent process, says Fay A. Rozovsky, JD, MPH, president of The Rozovsky Group in Williamsburg, VA. The changes include what information should be discussed with the patient and how the consent for a telemedicine encounter should be documented, she says.

There are a variety of applications for telemedicine, Rozovsky notes. Care providers may use telemedicine to interpret diagnostic imaging, pathology samples, electrocardiology, and fetal monitoring tracings. The findings may be sent to the ordering care provider in an electronic report, she notes. In urgent situations, the findings may be the subject of a real-time phone or secure email discussion.

Telemedicine also may involve a distant care provider interacting directly with a patient, either with telemetry or telepsychiatry, telepsychology, internal medicine, or specialist interactions. In those instances in which the discussion involves imaging or tracing results shared via telemedicine, the specialist can refer to and share the content with the patient during the discussion, she notes.

Another telemedicine technology enables remote care providers to see real-time diagnostic information and speak to onsite healthcare professionals and patients. One example of such technology is e-ICU.

Consent forms for “legacy processes” involving consent are unlikely to be sufficient to document a successful telemedicine consent communication, Rozovsky says.

“Although some may see telemedicine as an item that can be added to a general admission consent form, such an approach may be a setup for failure. It is prudent to consider utilizing specific consent communications and documentation for telemedicine and telehealth services,” Rozovsky says.

“It should be recognized that some states have specific requirements for telemedicine and telehealth consent. It is important, too, to examine recent legislative changes in which states have added specific consent requirements for certain types of telemedicine and telehealth services such as treatment of substance abuse disorders.”

State legislative changes notwithstanding, legacy processes may not be consistent with national guidelines or standards that have evolved for telemedicine and telehealth services, Rozovsky says.

Examples include the American Telemedicine Association’s “Practice Guidelines for Live, On-Demand Primary and Urgent Care” and the Federation of State Medical Boards’ “Model Policy for the Appropriate Use of Telemedicine Technologies in the Practice of Medicine.” Rozovsky says it also is important to consider accreditation standards.

Telemedicine and telehealth are technologies that may engender some liability risks, Rozovsky says. In addition to the failure to follow applicable state laws on telemedicine or telehealth consent, she notes these risks:

• violation of scope of practice and/or licensure laws regarding which care providers can participate in such services;

• substandard practice leading to patient injury;

• delays resulting in patient injury;

• negligent treatment;

• negligent credentialing of care providers involved in telemedicine or telehealth services (note that there is a federal regulation on use of remote provider credentialing);

• breach of information security;

• breach of patient privacy;

• identity theft;

• billing and coding;

• breach of contract;

• providing unauthorized telemedicine or telehealth services;

• lack of liability, technical errors and omissions, cyberinsurance coverage.

Healthcare is increasing the pace at which it is adopting telemedicine and telehealth services, so healthcare risk managers should develop appropriate consent policies and processes for them, Rozovsky says. Working with legal counsel, risk management professionals can identify state-specific requirements, she says, and national guidelines and standards also can be incorporated into updated processes.

Aside from well-recognized core elements of consent, Rozovsky says telemedicine and telehealth discussions and documentation should address these items:

• an explanation of the process;

• who will be involved in the process;

• the limitation of telemedicine or telehealth;

• the option to seek in-person services;

• access to records by the patient and other care providers;

• any costs to the patient associated with requests to share images or reports with other care providers;

• measures taken to prevent the risk of hacking telehealth and telemedicine information;

• costs of telemedicine and telehealth services not covered under the individual’s health insurance plan, especially for out of network providers, imaging, or telepathology;

• the potential for delays in interpretation or communication of results and care provider-patient discussion due to technical problems;

• specific authorizations for other uses of telemedicine and telehealth images or information in education, research, or publications.

“It cannot be emphasized enough that since many states have or are enacting laws on telemedicine and telehealth, it is important to tailor consent communication and documentation to conform to such requirements,” Rozovsky says. “Additionally, in developing telemedicine and telehealth policies, there are other considerations. Regulations on credentialing remote providers and billing and coding merit review with legal counsel and financial officials.”

Most states have requirements for informed consent in telehealth, and some go so far as to dictate the required language, notes Lisa Schmitz Mazur, JD, partner with the law firm of McDermott Will & Emery in Chicago. Some also specify that the consent must be obtained in writing, while others allow for verbal consent, she notes.

“Even in the states where there is no specific telehealth requirement for informed consent, I still advise healthcare providers to develop a process of informed consent specific to that type of care,” Mazur says.

“It gives the healthcare provider an opportunity to educate the patient on telehealth, which is good because even though it has been around a long time, it is still new to many individual patients. You can explain what the technology is, what is appropriate for, and what is not appropriate for, so that you’re all on the same page from the beginning.”

State issues regarding consent are especially important in telemedicine, says Jacob Harper, JD, an attorney with the Morgan Lewis law firm in Washington, DC. State approaches to telemedicine vary widely, he says, and it is important to comply not only with the state in which your organization resides but possibly with another state’s laws as well, he says.

“Some states emphasize educating the patient about how this is not an in-person consultation and there are sometimes things that can get lost in translation,” Harper says. “There is a difference in telehealth — no matter how valuable it is in the greater scheme of healthcare — and seeing a physician face-to-face. States can be particular about how they want you to explain that in the consent process.”

The technology itself can present liability challenges, Harper says.

“I’ve seen situations where a patient tried to upload photos to show the doctor something about his condition, the pictures didn’t upload for some reason, and the physician chose to proceed with the treatment without that information,” Harper says. “That can create potential risk, and risk managers need to avoid those situations where care can be compromised. It’s one thing where everything is working great and there are no hiccups, but everyone knows that technology can fail at the worst times.”

Even when an organization determines that there is a need for specific telehealth consent, that consent process can be included in the intake along with other types of consent, Mazur notes. It it not necessary to wait until a telehealth session is scheduled to go ahead and educate the patient about that process, she says, although it may also be prudent to go over the material again for future telehealth appointments.

Mazur notes that some of the same concerns with video telehealth can apply when data is transmitted from the patient’s home but without any audiovisual interaction. This may apply for telemetry of patient vitals and other data. There also can be unique concerns with telemetry.

“It’s very important when you’re talking about remote patient monitoring to provide the patient with information about when the doctor is going to review the data,” Mazur says. “You want the patient to understand that the doctor is going to review this data, but they may not be reviewing it in real time on a consistent and constant basis. If a cardiac monitor records a cardiac arrhythmia, the doctor may not see that until the next patient visit. You don’t want the patient thinking that is constantly monitored in real time.”

The goals for telemedicine consent should be similar to any other type of consent, hinging on good communication and documentation, says Richard Cahill, JD, vice president and associate general counsel with The Doctors Company, a liability insurer in Napa, CA. However, that does not mean that a standard, traditional consent process for treatment is sufficient for telemedicine, he says.

He notes that the Federation of State Medical Boards (FSMB) has developed a model policy for telemedicine consent, addressing such concerns as establishing a doctor-patient relationship remotely.

“State licensure is a key concern and physicians should be educated on this, as it applies even if the patient is out of state on vacation,” he says.

The FSMB’s “Model Policy For The Appropriate Use of Telemedicine Technologies in the Practice of Medicine” outlines six specific consent issues that should be addressed. (The model policy is available online at: https://bit.ly/2RSkTNW.)

As with all consent processes, informed consent for telehealth must be carried out by the physician and cannot be delegated, Cahill says.

“Patients need to be advised of the material facts, based upon their actual circumstances, based on community standards, in a way and using terminology that the patient can reasonably understand,” Cahill says. “The standards for informed consent are not diminished in any way because the care is being provided in a telehealth setting, though there are additional challenges that also must be addressed.”

Consent issues arise whenever there is a new way to deliver healthcare, notes Samuel J. Louis, JD, an attorney with the Clark Hill law firm in Houston. Telehealth presents challenges for risk managers not because it is new, but because it is now becoming more widely used than ever before, Louis says.

“Whenever there is some new aspect of delivery systems for healthcare, it is important to make sure the patient has a clear understanding of what services are being provided, what the risks are, and that therefore their consent is knowing and voluntary,” Louis says.

The limitations of telemedicine are particularly important in the consent process, Louis says. Patients must understand that the physician is unable to conduct assessments they might see in a traditional face-to-face office visit.

“In a traditional encounter, the physician relies not only on what the patient is saying but there also is the opportunity to examine the patient and conduct various hands-on assessments, whereas in telemedicine you don’t have that option,” Louis explains. “The physician is limited in the ability to determine the root cause of the patient’s problem, but the patient may have a true physical encounter with a physician later who makes a different assessment, or the lack of that physical assessment may lead to the patient suffering some type of harm. The patient who accepts a telemedicine encounter must understand those limitations so that the liability is limited for the provider.”

SOURCES

• Richard Cahill, JD, Vice President and Associate General Counsel, The Doctors Company, Napa, CA. Phone: (800) 421-2368.

• Jacob Harper, JD, Morgan Lewis, Washington, DC. Phone: (202) 739-5260. Email: jacob.harper@morganlewis.com.

• Samuel J. Louis, JD, Clark Hill, Houston. Phone: (713) 951-5604. Email: sam.louis@clarkhillstrasburger.com.

• Lisa Schmitz Mazur, JD, Partner, McDermott Will & Emery, Chicago. Phone: (312) 984-3275.

• Fay A. Rozovsky, JD, MPH, President, The Rozovsky Group, Williamsburg, VA. Phone: (860) 242-1302.