The first step in evaluating how laws impact veterinary medicine is to understand what telemedicine means.
Telemedicine during veterinary practice (also known as tele-veterinary practice) can include:
- A remote consultation when a local veterinarian is not available.
- Typing in a question and waiting for a response from a veterinarian.
- Reviewing medical records about a dog, cat, or any animal by sending them through email or making the records available through the Internet
- Reviewing medical images digitally so they can be enlarged
- Face to pet owner and face-to-pet consultations through video or digital applications
Many other variations of telemedicine for veterinarians are possible.
Telehealth, telemedicine, and teleconsulting are similar in that they both use technology to advance medical services. Telehealth is generally considered the broadest category. mHealth or mobile health is defined as a subcategory of telehealth that employs mobile devices (including wearables).
Telemedicine has been encouraged by many states to help serve rural populations and areas without medical help.
VETERINARY TELEMEDICINE LEGAL ISSUES SIMILAR TO HUMAN TELEMEDICINE
Are pets like humans under telemedicine laws and regulations?
How an attorney can help advise veterinarians about their telemedical practice
The practice of veterinary medicine is governed primarily by the states. Practice owners should consult with an experienced attorney who practices in the state where the veterinary medical practice is located. The lawyer should understand:
- Business. The attorney should understand the various ways a business can be formed such as through a sole-proprietorship, a partnership, a nonprofit, a corporation, or other entities. The lawyer should also understand day-to-day management issues, and how to properly dissolve a business.
- Health. Legal advice includes explaining the different federal and state laws that regulate how medical practices can operate and the state licensing and certification requirements
- Technology. The laws on operating websites, online businesses, and telemedicine practices are evolving. An experienced lawyer explains the current status of the law and works to reasonably help explain how the law may change.
The attorney can review regulatory issues (such as, for example, the necessity of an in-animal exam) and transactional issues (such as the contract between veterinarian and pet owner, contracts with telemedicine or tele-vet company, contracts with suppliers, and so on).
Guidelines for telemedicine veterinary health practices
The American Veterinary Medical Association (AVMA) and the Model Veterinary Practice Act (MVPA) provide legal guidance veterinary practices.
The AVMA guidelines, the Final Report on Telemedicine can be found here – https://www.avma.org/KB/Resources/Reports/Documents/Telemedicine-Report-2016.pdf.
The AVMA guidelines on telemedicine are only intended to be advisory and as a resource.
These guidelines for telemedicine by veterinarians include:
- Veterinary-Client-Patient-Relationship (VCPR). See the example below.
- Practice of veterinary medicine
- VCPR in conjunction with MVPA (Model Veterinary Practice Act)
- Telehealth, telemedicine, and mHealth
- Consultant and veterinarian of VCPA”
- More on Telemedicine including, but not limited to, categories of telemedicine:
- Client-facing telemedicine
- Nonclient, public-facing electronic communications
- Consultant -facing telemedicine
- Pharmacy-facing telemedicine. See the example below.
- Medicated feed-distributor-facing telemedicine
- Regulator-facing telemedicine”
- The drivers of telemedicine such as competition, veterinary professional benefits, and the needs of the public
- Types of technology being used
- Education, public outreach, and advocacy
For example – A Veterinary-client-patient-relationship is defined as follows:
“3.1. Veterinarian-client-patient relationship (VCPR)
The VCPR is the basis for interaction among veterinarians, their clients, and their patients. In addition to the discussion of VCPRs in Section III of the AVMA’s Principles of Veterinary Medical Ethics, below is the AVMA’s current definition of “veterinarian-client-patient relationship” (VCPR) as it appears in subsection 20 of the AVMA Model Veterinary Practice Act.
“Veterinarian-client-patient relationship” means that all of the following are required:
- The veterinarian has assumed the responsibility for making medical judgments regarding the health of the patient and the client has agreed to follow the veterinarian’s instructions.
- The veterinarian has sufficient knowledge of the patient to initiate at least a general or preliminary diagnosis of the medical condition of the patient. This means that the veterinarian is personally acquainted with the keeping and care of the patient by virtue of:
- a timely examination of the patient by the veterinarian, or
- medically appropriate and timely visits by the veterinarian to the operation where the patient is managed.
- The veterinarian is readily available for follow-up evaluation or has arranged for the following:
- veterinary emergency coverage, and
- continuing care and treatment.
- The veterinarian provides oversight of treatment, compliance and outcome.
- Patient records are maintained.
This definition of the VCPR differs from that embodied in federal regulation 21 CFR 530.3(i), among states, and that of the American Association of Veterinary State Boards’ (AAVSB) Practice Act Model.”
Note here that the veterinarian must have met some hurdles such as having “sufficient knowledge” of the pet to “initiate at least a general or preliminary diagnosis,” and that this means, at least “a timely examination” of the pet or “medically appropriate and timely visits” to “the operation where the patient [animal] is managed.”
Another example of the extensive guidance here is the definition of pharmacy-facing telemedicine
4.3.4. Pharmacy-facing telemedicine
Electronic prescribing (aka, e-Rx or e-prescribing) is the electronic transmission of doctors’ orders for medical prescriptions—new or refills. Software platforms designed for e-prescribing may also help reduce transcription and interpretation errors. While e-prescribing is less common in veterinary medicine compared with other health professions, there is an obvious potential for increased use within the veterinary profession, especially as platforms include components more specific to veterinary medicine, such as owner name and patient species.
This signals a recognition that e-prescribing is more and more common, and requires careful consideration.
Note that second opinions that do not involve examination of the animal are discouraged.
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What are some of the dangers involved with a telemedicine veterinary practice protect itself?
There is no magic bullet for avoiding legal claims.
The risks of operating a telemedicine veterinary practice can include:
- Malpractice litigation.
- Increased insurance premiums.
- Loss of license
- Statutory fines and penalties
- Being hold in non-compliance with applicable law
Legal protections begin with making an appointment to see a respected health and business attorney. The lawyer will review the best legal formation issues for protecting your business and the doctors. The attorney will review the applicable laws, regulations, and guidelines that should be followed so that the veterinarian can argue he/she was in compliance. The lawyer will review the insurance needs as well as many other practical and legal options.
Again, legal precautions, insurance, and business practices steps can reduce risk. There’s always the danger that a dissatisfied pet owner may bring a legal claim. For example, normally a healthcare practitioner /licensee cannot disclaim or waive away actual negligence. On the other hand, a good informed consent form can help deflect claims that the pet-owner was not given sufficient information to make a good decision for their pet.
What steps should the veterinarian take with pet owners?
Veterinarians should consult with an experienced telemedicine veterinary attorney before preparing a website and before offering any advice online – either through the website, emails, videoconferences, or any type of digital communication. The lawyer will review some of these items and others with your practice:
- The creation of a doctor-patient relationship. Veterinarians should understand what actions, online and offline, create a doctor-patient relationship.
- The type of advice being given. Pet doctors should make certain that the pet owner or pet business understands the difference between general educational advice and specific clinical advice for a specific dog, cat, horse, bird, or other animal. Educational services are generally protected by the First Amendment while clinical advice is generally subject to the relevant licensing laws.
- Disclaimer and service agreements. Disclaimers are not a magic bullet. And they are subject to various requirements which can vary from state to state and possibly county to county. Some of these requirements include:
- A clause that states the advice is just general advice and does not create the doctor-patient relationship
- A statement that it is recommended (possibly required) that the pet owner physically see the veterinarian in the pet doctor’s office – before beginning any online communications.
- Specific legal requirements such as being prominent or easy to read.
- Additional concerns. Veterinarians offering medical service with the aid of technology should:
- Offer the same standard of medical care as they would if they were examining the animal up-close.
- Keep medical records in the same manner as offline medicine
- Give informed consent – explain the risks and dangers of any treatment
- Be licensed in the appropriate states
What steps should veterinarians takes before consulting with specialists in their field?
Veterinarians who work with other doctors or specialists online need to take many of the same precautions as doctors take when speaking with pet owners. They need to speak with an experienced health lawyer, review the laws and regulations that apply to their practice, understand the risks, and have a legal plan in place before they start communicating online.
For example, a veterinarian may require that that the medical practice they are consulting with acknowledge that you are the primary veterinarian for the pet owner and that advice is being given to the primary veterinarian so the pet owner can be informed about the health of the pet.
Our healthcare lawyers keep abreast of telemedicine legal developments so we can advise clients about their telehealth compliance legal duties. Contact our telemedicine lawyers to discuss your specific legal situation.
Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture.
The post How Do You Navigate Telemedicine Veterinary Legal Issues? appeared first on Michael H Cohen Law Group | Healthcare Lawyers | Life Sciences | FDA & FTC Law.