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The Role of Telehealth Tools in Veterinary Medicine and Legal Compliance
The Role of Telehealth Tools in Veterinary Medicine and Legal Compliance
Sarah Babcock Jessica Chapman
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La disponibilité des outils de télésanté associée à un manque d’accès aux soins médicaux vétérinaires a mis en évidence la nécessité d’évaluer les normes actuelles qui régissent la prestation traditionnelle de soins médicaux vétérinaires. À mesure que les réglementations et les normes régissant la médecine vétérinaire évoluent, il est nécessaire d’évaluer les avantages et les risques potentiels des soins virtuels. La capacité des vétérinaires à exercer un jugement professionnel solide pour assurer un équilibre approprié entre l’accès aux soins et la sécurité des patients est primordiale dans l’examen de l’intégration des outils de télésanté dans la pratique. La disponibilidad de herramientas de telesalud, junto con la falta de acceso a la atención médica veterinaria, ha puesto de relieve la necesidad de evaluar los estándares actuales que rigen la prestación tradicional de atención médica veterinaria. A medida que evolucionan las regulaciones y los estándares que rigen la medicina veterinaria, es necesario evaluar los beneficios y los riesgos potenciales de la atención virtual. La capacidad de los veterinarios para ejercer un juicio profesional sólido para garantizar un equilibrio adecuado entre el acceso a la atención y la seguridad del paciente es primordial en la consideración de incorporar herramientas de telesalud en la práctica.
In response to the Covid-19 pandemic, veterinary medicine adapted its healthcare practices for animal healthcare through the increased use of telehealth. The role of telehealth is critical given that the effect of Covid-19 on traditional approaches will likely persist even after the pandemic subsides. Using telehealth, veterinary practitioners around the world are working to develop a greater depth of expertise and global resources. But this global approach raises unprecedented regulatory concerns. These challenges require the collaboration of veterinary professionals and regulators working together to balance the benefits, potential risks, and regulatory requirements of telehealth to promote both animal health and the consumer safety. In the United States, there are a variety of telehealth and telemedicine service models available to veterinarians and veterinary hospitals. Client-facing telemedicine services may include: (1) using tools that allow a veterinarian to remotely gather all essential veterinary medical information from the animal owner or other caretaker, (2) accessing the patient’s medical records, and (3) conducting a virtual exam of the patient through a real-time video or through digital pictures. For example, VetNow has created a custom toolkit to facilitate the ability of a global network of veterinarians, epidemiologists, and public health experts to consult on cases and public health threats. The kit includes a Bluetooth-enabled stethoscope, digital microscope, electrocardiogram, and pulse oximeter. Based on the patient information provided by a local veterinarian, researchers with the aid of algorithms can use these tools to provide the data required to monitor the patient for patterns in clinical signs and diagnoses, and to earlier detect pathogens with pandemic potential. The indispensable role of law is a key component of erecting the global public health infrastructure. The ability of a jurisdiction to enforce laws and regulations that protect health and ensure safety is essential. In light of Covid-19, state and federal regulators in the United States are evaluating the current regulatory framework of telehealth in vete-
rinary medicine. Today, veterinarians must use telehealth tools in compliance with local regulations and speci¬fically within the context of an established veterinarian-client-patient-relationship (VCPR). And, as in all patient encounters, veterinarians must make reasonable decisions and exert sound professional judgment, regardless of their method of delivery of care.
The Veterinarian-Client Patient Relationship
In the United States, governments have drafted regulations and standards for hands-on delivery of veterinary medical care that govern the veterinary profession. Until recently, one of the most insurmountable hurdles to the use of telehealth tools has been the requirement in most state regulations for a veterinarian to have “sufficient knowledge” of the patient in order to establish and often maintain the VCPR. Most VCPR regulations contain language that requires an in-person examination or a medically appropriate and timely visit to the location where the animal is kept. The use of telehealth tools, by definition, is remote care and does not include an in-person exam or visit to the location where the animal is kept. This places the burden on the veterinarian to determine if there is an exception or some other means to establish or maintain the VCPR in treating the animal.
Each state’s practice act regarding veterinary care defines what constitutes the practice of veterinary medicine for that state. In many states, the practice act details license requirements, provides for exemptions for state licensure, details the disciplinary process for licensees who violated the act, and includes requirements for reporting animal cruelty and potential related immunity for reporting provisions. The state practice act may also define the VCPR. Most jurisdictions that license and authorize the practice of veterinary medicine promulgate regulations that require the establishment of a valid VCPR to provide patient care and prescribe medications. Most states will specify the requirements of the VCPR through general statutory language. This may include specific requirements to establish, maintain, terminate, and define the scope of the relationship and resulting duties, such as medical record-keeping requirements, availability for follow up, and confidentiality. Federal and state laws may not be the same. If a veterinarian is engaging in extra-label drug use or issuing veterinary feed directives and the state does not have a requirement for a VCPR or the requirements are not as stringent as the federal definition, then the federal definition must be satisfied first when engaging in any of the above outlined activities. FDA regulations provide that the VCPR “can exist only when the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal by virtue of examination of the animal and/or by medically appropriate and timely visits to the premises where the animal(s) are kept.” Therefore, traditionally, a veterinarian could not establish a VCPR solely through telemedicine (e.g. photos, videos, or other electronic means that do not involve the examination of the animals) or timely visits to the premises. However, as part of the FDA’s ongoing commitment to combatting the Covid-19 pandemic and providing flexibility across FDA-regulated industries, the agency announced on March 24, 2020 that it will not enforce certain provisions related to the animal examination and premise visit requirement in the VCPR. This relaxed requirement allows veterinarians to better utilize telemedicine to address animal health needs. For example, the owner of a sick dog could share a video with a veterinarian. If necessary, the veterinarian could then prescribe a drug that is not approved for use in dogs or for that illness, meaning extra-label use. As another example, a veterinarian could remotely examine and diagnose a group of food-producing animals with a skin disease, and then authorize the use of certain drugs in the animals’ feed. Despite the relaxed legal requirements, many veterinarians have trouble imagining not being able to touch animal patients in their daily practice. But providers in multiple countries began using telehealth as a consultation tool as early as the start of the Twentieth Century.1 Providers have been using telehealth their entire careers without thinking about its terminology. Communicating with clients or consulting with a specialist over the phone on a case is a practice that has been a part of veterinary medicine long before this pandemic. For instance, clients call their veterinarians to ask for help with feeding a new companion animal, a calf with diarrhea, or a wild baby bird that has fallen from its nest. Until recently, veterinarians have not been required to do a real analysis of the services they provide and how state and federal regulators define that activity and subsequent legal duties.
Definitions of Telehealth Tools
The American Association of Veterinary State Boards (AAVSB) is an association of veterinary medicine regulatory boards whose membership includes licensing bodies in 62 jurisdictions. The AAVSB provides comprehensive information that strategically strengthens the veterinary regulatory community through its membership. While the AAVSB represents veterinary licensing bodies, the American Veterinary Medical Association (AVMA) is the professional association of veterinarians. In addition to caring for
1. See generally Carlton Gyles, “Veterinary telemedicine”, 60 Canadian Veterinary J. 119 (2019).
the nation’s beloved pets – from dogs and cats to birds, horses, reptiles, and more – the AVMA’s 95,000 members encompass every facet of the veterinary profession and serve in medical research, academia, prevention of bio and agroterrorism, food safety, public service, industry, and the uniformed services. The AAVSB defines telehealth as an overarching term that encompasses all uses of technology that is geared to remotely deliver health information or education. “Telehealth encompasses a broad variety of technologies and tactics to deliver virtual medical, health, and education services. Telehealth is not a specific service, but a collection of tools which allow veterinarians to enhance care and education delivery. Telehealth encompasses both telemedicine and general advice administering healthcare services remotely, such as health assessments or consultations, over the telecommunications infrastructure. It allows veterinarians to evaluate, diagnose and treat patients without the need for an in-person visit.”2 A veterinarian must refer to the state under which they are licensed for specific guidance on whether a virtual examination may qualify as a basis on which to establish a VCPR and gain sufficient knowledge of the patient. State veterinary boards are trying to balance the need to safeguard public interest with access to veterinary care through telehealth technology.
Telehealth Logistics and Legal Requirements
Although telehealth differs from in-person veterinary care, it is subject to the same legal and ethical considerations. A veterinarian will need to determine if using telehealth is suitable for a specific patient. This determination requires the veterinarian to ensure an appropriate balance between access to care and patient safety. The veterinarian will need
2. Am. Ass’n of Veterinary St. Boards, “AAVSB Recommended Guidelines for the Appropriate Use of Telehealth Technologies in the Practice of Veterinary Medicine” (Sept. 2018). to decide if they have enough information about a patient to make a competent diagnosis. Pursuant to state and federal governance, even if a veterinarian determines using telemedicine is medically appropriate, they must at minimum, ensure that they are licensed in the state where they are practicing; that they take steps to establish a valid VCPR; obtain consent from the client for the patient’s care and for the use of telemedicine; conduct all necessary patient evaluations consistent with currently acceptable standards of care; maintain meticulous medical records; and complies with the requirements of the jurisdiction in which the veterinarian practices. Veterinarians must ensure that the technology and physical settings they utilize for telemedicine are compliant with jurisdictional and federal requirements. Available digital platforms and applications for veterinarians exist in the event a veterinarian needs to quickly develop the capability to practice telemedicine. However, veterinarians may face obstacles using these tools because of an absence of digital infrastructure or broadband access. Therefore, veterinarians must prepare reliable telehealth infrastructure within their practice before using it to Veterinarians must interact with clients. ensure that the Establishing a VCPR with technology and physical telehealth technology settings they utilize for also requires veterina- telemedicine are compliant rians to (1) obtain infor- with jurisdictional and med consent from their clients, (2) conduct all federal requirements. necessary patient evaluations consistent with currently acceptable standards of care, (3) take precautions to safeguard the confidentiality of a client or patient’s records, and (4) ensure that the client is aware of the veterinarian’s identity, location, jurisdictional license number, and licensure status. Additionally, a provider of telemedicine should give the client a clear mechanism to access, supplement,
and amend client-provided contact information and health information about the patient, as well as a way to register complaints with the appropriate board of veterinary medicine or other regulatory body. An exception to establishing a VCPR with a patient through telemedicine may exist in emergency situations. Distanced emergency care would involve teletriage, which is an emergency form of animal care that veterinarians use for immediate, life-threatening animal health situations such as poison mitigation, animal CPR instructions, and other critical lifesaving treatment or advice.
Veterinary Telehealth Use Outside of the United States
Many veterinarians in Europe, including France and Spain, are interested in using telehealth technology, but have not developed the infrastructure to do so. While countries generally define telehealth and various telehealth tools similarly, globally, there is overall less engagement in telehealth tools in veterinary medicine. The United Kingdom is an outlier and allows veterinarians to conduct remote consultations and write remote prescriptions based on the current risks of Covid-19. The UK’s practice may be the modern trend: 90% of its veterinarians have been giving remote consultations and 70% have used telemedicine for existing and new clients in the wake of the pandemic.3 Most other countries that employ telehealth only allow telemedicine for teletriage. The development of global platforms may aid in the ability of countries to work together to share expertise and resources to improve the ability for quality and continued patient care.
Paths Forward Using Telehealth
The path forward for telehealth has similar considerations. The ongoing regulatory need to balance patient care and safety is paramount. Telehealth tools may lend themselves to ensure veterinary access and help eliminate barriers to veterinary care. Telehealth may likely provide veterinarians additional tools needed to provide care for animals while working with their diminished resources because of Covid19’s economic impact, too. Despite the necessity for telehealth, veterinarians throughout the world are trying to navigate the ethical duties they have towards their clients and patients to ensure each animal receives proper care. This concern, and the potential liabilities that may arise from the use of telehealth tools, such as providing insufficient care (e.g. misdiagnosing illnesses), and causing prolonged animal suffering, will likely be ongoing and change depending on the circumstances of each case. Although remote veterinary care is becoming more acceptable and, in recent times, required, both veterinarians and
3. Josh Loeb, ‘The wind always blows in from the west’: how the UK is leading the way with telemedicine, 186 Veterinary Record 583, 583 (2020). Other countries that employ veterinary telehealth include Canada, supra note i, “Portugal, M. Magalhāes-Sant’Ana et al., What challenges is the veterinary profession facing? An analysis of complaints against veterinarians in Portugal” (Springer, S. & Grimm, H. eds. 2018). animal owners need to remember that a limit exists as to what telemedicine can do. Through the VCPR, veterinarians have developed trust and public confidence in their ability to provide leadership. The communication of science-based practices can help inform and guide individuals’ decisions, which will help patients and clients, and contribute to society in this most vulnerable moment. Veterinarians should talk to their clients about their concerns, the use of telemedicine, and new, alternative approaches for patient care. Telemedicine will not replace a veterinarian’s ability to physically touch animals, and veterinarians will be more reliant on their clients’ ability to communicate patient histories and symptoms. Telemedicine will require an additional effort by veterinarians to communicate empathy, establish trust, and develop the connection that led so many of them to pursue a career in veterinary medicine. Clients will have to ensure they are providing an accurate and complete history and provide the veterinarian with access to medical records. Clients will also have to accept the limitations of telehealth tools and be prepared to act if additional diagnostics are necessary, or help is needed to relieve the suffering of an animal. The shared decision-making process between the veterinarian and the client is more important now than ever, as is the importance of respecting both the VCPR and the human-animal bond.
Conclusion
Veterinarians must always act in ways that ensure their patients’ safety. However, veterinarians must not be afraid of new technology that may provide efficient access to care for animals whom they cannot treat in person. The ability to support and educate clients through multiple platforms is one of the profession’s strongest and most versatile assets. Given the reality that this pandemic is not passing quickly, and that other pandemics will likely occur in the future, the veterinary profession must be nimble and resilient, and develop creative, effective approaches to serve its clients and the public. These approaches include changing veterinarians’ mindsets from “business as usual” to “what works now.” And, what works now will be relative, fluid, and based on each veterinarian’s specific community. Whether a small or large animal practitioner, regulatory, research, or zoo veterinarian, upon being admitted to the profession, all veterinarians swear to use their scientific knowledge and skills to benefit society. Veterinarians should do so in a safe manner and always exercise sound, professional judgment. ■
Sarah BABCOCK, DVM, JD President, Animal & Veterinary Legal Services, PLLC Harrison Township, MI, United States sbabcock@animalandveterinarylaw.com
Jessica CHAPMAN, JD Animal Law LLM Candidate, Lewis & Clark Law School Portland, OR, United States jchapman@lclark.edu