Position Statement
Published: March 2024
Introduction
The College exists to promote and ensure the safe practice of veterinary medicine on behalf of the public. In doing so, its governing Board, the Council, has a duty to anticipate and understand the future of the delivery of veterinary care and determine what, if any guidance or parameters, will be necessary to consider to assure quality outcomes for animal health and welfare over time. In this age of innovation, where the advancement of technology and the emphasis on precision medicine are at the forefront, the Council takes a principled approach to determining the risks of digital innovation in veterinary practice and aims to provide guidance that supports veterinarians in the accountable experimentation and use of the tools of the future.
Context
The evolution of the delivery of veterinary medicine has been occurring at an increasingly more rapid pace. The present and emerging technological tools utilizing varied and complex digital platforms extend across a continuum from telemetric devices to robotics to electronic record keeping to diagnostics. The most challenging of these advancements is software as a medical device (SaMD) which is fueled by the increasing capability of levels of artificial intelligence and data analytics.
While transformative change is not new, this is without question a next period of great change that will alter the work and the practice of veterinary medicine as it has been understood. While every transformation comes with associated risks, the adoption of new tools will continue to be dependent on the competency and good judgement of the practitioner that chooses to integrate them into the care of animals under their oversight.
Definitions
Software as a Medical Device (SaMD): software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device (e.g., mobile app).
Position
Every licensed veterinarian is accountable for their practise choices and decisions, which is underscored by their societal commitment to do no harm.
In a landscape of rapidly developing tools and processes relying on technological platforms which have no government regulatory oversight, veterinarians are challenged to select options and opportunities that are trustworthy. Risks must be assessed in the choices made and it is the obligation of a veterinarian to use their judgement in the selection of new approaches as they are introduced.
The Council of the College of Veterinarians of Ontario supports and encourages innovation within the veterinary community. The College acknowledges the need to experiment with new models of practice, new models of delivery, new diagnostic tools, and new approaches to treatment. Veterinarians faced with this future need to develop skills that support curiosity, critical analysis, balanced skepticism, and experimentation with the knowledge that this environment is largely unregulated.
Regulation of a profession is not intended to be a barrier to change, but rather to be an avenue which creates safe forward movement. In keeping with its principled approach to profession-based regulation, the College urges veterinarians to consider the following as they make choices to embrace innovation and digital technology:
- transparency of the potential biases which may exist in the analysis of data or the auto-population of clinical assessment (neutrality)
- explainability of the outcomes produced by the tool (basis for prediction, consistency)
- robust and relevant prelaunch testing which gives confidence to the product (evidence informed)
- data privacy and security
Veterinary medicine will and must advance, however, the importance of the benefit and positive outcomes for animal health and welfare must remain paramount in the decisions and choices made at point of care by every veterinarian.
References
Bellamy JE. Veterinary informatics: Why are we dragging our feet? Can Vet J 1999;40:861-863
Bellamy JE Artificial Intelligence in veterinary medicine requires regulation Can Vet J Vol 64, October, 2023
Coglianese, C. AI and the Future of Regulation. Presentation to the International Veterinary Regulatory Network May, 2023
Cohen EB, Gordon IK. First do no harm. Ethical and legal issues of artificial intelligence and machine learning in veterinary radiology and radiation oncology. Vet Radiol Ultrasound 2022;63:840-850
Federation of Medical Regulatory Authorities of Canada, Working Group on Artificial Intelligence and the Practice of Medicine. Summary Statement June 2022
Federation of Medical Regulatory Authorities of Canada, Artificial Intelligence as a Continuum August 2020
Royal College of Physician and Surgeons of Canada Task Force on Artificial Intelligence and Energy Digital Technologies
Forcier M B. Liability issues for the use of artificial intelligence in health care in Canada: AI and medical decision-making. Dalhousie Med J 2020;46:7-11
Government of Canada [Internet]. The Artificial Intelligence and Data Act (AIDA) [updated March 13, 2023]. https://ised-isde.canada.ca/site/innovation-better-canada/en/artificial-intelligence-and-data-act-aida-companion-document
Government of Canada [Internet]. Good Machine Learning Practice for Medical Device Development: Guiding Principles [updated October 26, 2021]. https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/good-machine-learning-practice-medical-device-development.html
Health Canada Software as a Medical Device (SaMD) Definition and Classification December 2019
United Nations Educational, Scientific and Cultural Organization Preliminary Study on the Ethics of Artificial Intelligence February 2019
US Food and Drug Administration Proposed Regulatory Framework for Modifications to Artificial Intelligence / Machine Learning Based Software as a Medical Device: Discussion Paper
US Food and Drug Administration, Health Canada, Medicine and Health Care products Regulatory Agency, Good Machine Learning Practice for Medical Device Development: Guiding Principles, October 2021
Wischmeyer T, Rademacher T, eds. Regulating Artificial Intelligence. Cham, Switzerland; Springer Nature, 2020