The COVID-19 pandemic has transformed the global health care system, highlighting both gaps in allocation and shortcomings in the delivery of care. Domestically, health care is more highly regulated at every level of government than any other industry, including the famed military-industrial complex that is primarily regulated at the federal level.
However, the public health emergency has pushed traditional models of health care to virtual settings, forcing patients and practitioners to interface through telehealth platforms.
The successes and pitfalls of moving health care to these virtual models highlight a host of legal issues that practitioners and their counsel should be aware of to help avoid the harsh consequences of the changing regulatory landscape as a result of the public health emergency.
As the world grapples with the COVID-19 pandemic, the use of telemedicine, or telehealth, has become a popular tool for patients who must abide by social distancing requirements but who still need care.
Telemedicine is the use of telecommunication and other information technologies in order to provide clinical health care at a distance. In the modern era, this regularly includes cross-border consultations or even remote procedures, which utilize robotic instrumentation.
According to the World Health Organization, telemedicine “holds great potential for reducing the variability of diagnoses as well as improving clinical management and delivery of health care services worldwide by enhancing access, efficiency, and cost-effectiveness.”
The most significant gains are seen among typically underserved populations, notably those in rural communities. From an international standpoint, cultural differences, credentialing, compliance with the applicable community standard of care, and adherence to health care facilities’ policies and procedures pose significant hurdles to practitioners and patients alike.
One of the most obvious hurdles for health care professionals and patients teleconferencing is not directly a legal issue, but rather are cultural miscommunications that can lead to significant liability.
A major concern arises out of language differences and the availability, or lack thereof, of translators. In addition, medical professionals from industrialized communities may not understand the infrastructure, both physical and social, from which their patients are seeking care.
For instance, a lack of computer literate workers, availability of health care staff to assist patients on site with technological difficulties, and gender norms between patients and practitioners can significantly affect access and quality of care.
The presence or absence of national policy agendas that either include or exclude telemedicine as a means of accessing health care likewise has a profound effect on both intra- and inter-border communication between patients and their doctors.
In addition to the traditional international trade terms that are applicable to any agreement for services on an international level, and that are quite different than a domestic transaction, it is important that any agreement to provide such services address cultural realities and has mechanisms to handle communication effectively.
Specifically, regardless of whether the practitioner is based in the U.S. and is providing services in a foreign country, or vice versa, the practitioner should not operate in a silo. A practitioner who can physically still lay hands on a patient may be a necessary part of the medical team to ensure appropriate care.
Consider reinforcing policies and procedures, especially those dealing with employee training related to sexual harassment and other appropriate conduct. For foreign doctors emigrating to the U.S., it may be appropriate to include a chaperone for a period of time to overcome any cultural issues.
The more complex issue deals with ancillary practices that may not directly involve hands-on medical care. For example, radiologists are now based around the world and regularly review images and then provide a written report. The ability for a treating practitioner to fully rely on those remote services without quick communication may lead to repeat images.
As referenced, these communications could be hampered due to cultural differences or language barriers. This has multiple legal consequences associated with timing of care, medical necessity for the multiple images and readings, and other supervision issues.
Many agreements ignore these real issues of cross-border telemedicine and attempt to apply a domestic risk shifting tactic utilizing intermediaries to work through such issues. Instead, consider addressing the communication and cultural issues up front in the agreement or accompanying protocols.
Further, along with the credentialing process discussed below, health care facilities should consider mandated training to address cross-border services and provide mechanisms to resolve any issues to avoid cultural misunderstandings becoming legal liabilities.
Credentialing and Privileging
While a distant site provider will not have the same privileges with a health care facility as an onsite provider, it is prudent that those responsible for credentialing and privileging determine whether the foreign telehealth practitioner is legally allowed to provide the type and scope of care for the particular patient population he or she serves.
In the U.S., the Centers for Medicare and Medicaid Services “requires each hospital to have a credentialing and privileging process for all practitioners providing services to its patients.”
The process as applied to distant site providers, known as credentialing by proxy, permits hospitals and critical access sites to provide telemedicine services “to their patients through written agreements with a distant-site hospital or a distant-site telemedicine entity.”
Still, it is important for providers and facilities to be aware of the different licensing and credentialing requirements as set forth by the state(s) in which they hold a license(s) and the federal government.
For instance, in the past, CMS rules required telehealth practitioners to be physically located within the U.S. to treat patients for Medicare-covered services. However, on Dec. 1, 2020, the Centers for Medicare and Medicaid Services issued guidance regarding emergency declaration blanket waivers for health care providers.
This declaration permits physicians “whose privileges will expire to continue practicing,” allows for “telemedicine services to be furnished to the hospital’s patients through an agreement with an off-site hospital,” and waives the requirement that doctors be physically located in a critical access hospital to “provide medical direction, consultation, and supervision for the services provided.”
However, it cannot be assumed that the practitioner is properly credentialed. Health care facilities that utilize such out-of-state services must still review and document that the practitioner providing remote services is properly credentialed and meet the skill requirements to meet the applicable standard of care.
Although this credentialing review is at times shifted to the staffing or third-party group providing services, the facility should consider ensuring that mechanisms are in place to individualize the approval process for each practitioner providing telehealth services to patients.
Patient location is typically the primary factor when considering which country’s licensing and credentialing schemes apply. That is, if a U.S.-based physician were interfacing with a non-U.S. patient in the non-U.S. jurisdiction, that foreign country would typically require the U.S. physician to have a foreign license if patient interaction is for the purpose of making a diagnosis and planning a course of treatment. However, some jurisdictions have more liberal regulations when it comes to medical licensing.
Medical institutions may have to be qualified in a non-U.S. jurisdiction as a health services establishment or medical center in order for their physicians to offer telemedicine services or for the provider to have diagnostic or treatment privileges for his or her patients.
In some cases, the U.S.-based practitioner is only consulting with a foreign practitioner, and it is the foreign practitioner that is solely responsible for making diagnosis decisions and implementing treatment plans. Of course, this raises compensation issues for the services provided by U.S. practitioners and potential liability concerns when the foreign practitioner does not adhere to a U.S.-based consultation.
U.S. entities utilizing foreign independent contractors should also be cognizant of foreign employment laws. For example, health care systems using foreign recruiter or procurement agents may believe that the standard independent contractor language provides adequate protection from foreign taxes or employment laws.
However, that is not always the case. As such, if a system decides to terminate a relationship with an agent, they can be liable for severance payments or other taxation that were not anticipated. In addition, the venue and choice of law provisions are just as important in addressing dispute issues.
Liability: Physician-Patient Relationship and Standard of Care
In any medical malpractice case, a plaintiff must first establish that a physician owed her a legal duty to act according to certain professional standards. Historically, courts have found that physician-patient relationships can be formed even from simple telephone conversations.
In 2011, the Supreme Court of Vermont in White v. Harris found that a 90-minute video conference consultation between a physician and individual along with a subsequent written consultation assessment and treatment plan was sufficient to create a doctor-patient relationship. It is not the duration of the doctor-patient relationship that creates a duty, but rather the “doctor’s responsibility for the services provided.”
The setting and formality of the interaction is becoming less important. What courts will likely focus on is whether the physician gave advice and whether the patient relied on it.
Public policy considerations of tort law and physician’s responsibilities to do no harm underly the broadening definition of what constitutes a physician-patient relationship and it seems exceedingly likely that as more patients and providers interface via telehealth platforms that the formality of a physician-patient will continue to erode.
Next, the plaintiff must show that the provider breached the standard of care. One issue, however, is that providers have not yet faced the same or similar circumstances that this pandemic has created on such a broad scale. Because the pandemic and virus itself is novel in this age of modern medicine, the law surrounding whether a practitioner has met the standard of care in a telehealth context is playing catch-up to a certain degree.
Moving forward, telemedicine may influence the standard of care analysis if telehealth itself becomes part of the standard. That is, failing to have or use telemedicine, which is becoming an industry standard due to the pandemic, could create liability for providers.
If a physician fails to use a telehealth platform correctly or misreads patient data, diagnosis or imaging, that could certainly create liability for the provider. Having proper safeguards in place for internet security, connectivity, and capacity to store patient data will also be important factors to protect health care entities from malpractice suits.