To qualify as SaMD, the AI in question must either replace or inform clinical judgment in a way that impacts individual patient care.
By contrast, administrative or operational AI tools, which do not directly influence clinical decisions, are not regulated as SaMD. These include systems designed to automate scheduling, manage billing, or — most relevant here — generate documentation. Health Canada explicitly excludes software that merely supports healthcare providers by organizing, transmitting, or displaying information, as long as it does not analyze medical images or provide clinical interpretation.6
Much of the public and professional attention around AI in healthcare has focused on AI classified as SaMD, and for good reason. Diagnostic AI raises significant legal, ethical, and safety concerns. One frequently cited issue is the so-called “black box” problem, whereby AI systems produce outcomes that cannot be easily explained or audited by human users. This opacity may obscure sources of error and promote systemic biases.7 How these technologies may affect a medical malpractice lawsuit has not yet been tested in Canada, though the experience abroad indicates it is only a matter of time before courts in this country have to grapple with these thorny issues.8
Despite this focus, however, the implementation of clinical AI in Canada remains limited. While high-profile pilot projects and academic studies suggest a future where AI may play a greater role in diagnostics and decision-making, in practice, most healthcare settings continue to rely on traditional methods. The everyday presence of AI in Canadian medicine is far more likely to be found in administrative systems — tools that quietly support, rather than direct, clinical care. One successful and routine implementation of AI are digital scribes, which will be the focus of the remainder of this article.
Digital Scribes in Canadian Healthcare
Physicians in Canada have both a legal and ethical responsibility to maintain accurate, timely, and complete records of all medical care provided. These clinical records not only facilitate continuity of care, but also offer a source of accountability and legal protection. In medical malpractice litigation, charting often becomes the central piece of documentary evidence — sometimes, it is the only record available to reconstruct what transpired during a clinical encounter. Contemporaneous chart entries are routinely considered by the court to be business records admissible in evidence as prima facie proof of the facts stated therein.9 As articulated by Justice Marzari in Gilmore v Love,
“It is well established that documents created at the time of the events themselves can be helpful in providing an accurate reflection of what occurred, in addition to, or even in preference over, the memories of the participants that have aged with the passage of time, hardened through litigation, or been reconstructed.”10
As such, documentation quality has a significant impact on the analysis of whether the defendant’s conduct met the standard of care.
