Are digital health applications venturing into the illegal practice of medicine?

A recent article in the British Medical Journal reported the results of a study of different digital applications aimed at the general public for the assessment and management of health problems, such as Ada, Babylon and Symptomate. This evaluation aimed to compare the results obtained with 8 of these health apps and 7 GPs in terms of the extent of coverage of clinical conditions, the accuracy of the suggested diagnoses and the relevance of the advice given. The overall conclusion of the study: Although there was quite a bit of variability in the performance level of the apps tested and none outperformed the doctors’ results, some of them performed almost as well as these latter.

At the rate of progress observed in artificial intelligence (AI), it is possible to foresee that, eventually, these applications could become so efficient that they would represent a credible option to meet different needs in primary care . This is where the question of compatibility between such applications and the legal framework relating to the practice of medicine and other health professions arises.

Contemporary societies have regularly sought to prevent and suppress “quackery” in the health field, which is reflected today in laws aimed at prohibiting the illegal practice of medicine and other health professions. This is not in itself a question of granting a monopoly to the professionals in question, but rather of protecting the public, by ensuring that only people with the required training and skills can offer the population services with diagnostic or therapeutic purposes.

As a lawyer and teacher in health law and policy at the University of Sherbrooke and professor in health law and technology at the University of Montreal, we are interested in the legal framework for AI, which leads us to ask ourselves this question: can these applications, or more precisely, the companies that offer them, be in a situation of illegal practice of medicine?

“Diagnosis” and “treatment prescription” on a legal level

In Quebec, following the interpretation that the courts generally make of the Medical Act, it is relatively easy to cross the boundary of what constitutes activities reserved for doctors.

For example, here is how the reserved activity of “diagnosis of diseases” was defined in a court case concerning the illegal practice of medicine:

A diagnosis is essentially a process of identifying a disease, pathology or health disorders. This process consists of examining symptoms or examining by apparatus or scientific method. Diagnosis also concerns identifying the nature of a dysfunction or difficulty. Diagnosis also means forecasting probable ailments depending on a person’s condition.

To this definition, we could add that, in Quebec, the evaluation of the physical and mental condition of a symptomatic person corresponds to an activity reserved for nurses, not counting the various evaluation or diagnostic activities reserved for others. professionals.

Read more: The rise of telehealth: is Canada’s legal framework up to the task?

As for the activity of prescribing, whether it concerns medications, other substances or treatments, it must be understood according to the Quebec Court of Appeal as a “therapeutic recommendation”, i.e. a recommendation aimed at treating a given condition. Even if no diagnostic conclusion is communicated to the person requesting the consultation, the courts tend to consider that a diagnosis has been made solely because at the end of a consultation, a treatment is recommended.

Illegal application and practice of medicine

A cursory examination of how some health management applications intended for the general public work suggests that they are based on a more or less varied combination of the following steps:

• Notice to the user that the application is not intended to replace consultation with a health professional or to establish a “medical diagnosis”;

• Collection of user information: gender, age, history, symptoms, etc.;

• Proposal of different diagnostic and treatment hypotheses or appropriate courses of action, usually with advice to consult a physician or other health professional.

As regards the first step, as the courts have already pointed out, the fact that a person who is not an authorised professional communicates an opinion on the limits of a consultation for diagnostic or therapeutic purposes, for example by requiring the signing of a “disclaimer” or by submitting a “self-declaration”, is not sufficient to avoid a finding of illegal practice, nor is the fact that “clinical impressions” are mainly generated by a “device”.

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As for the information gathering stage, it would not, in itself, correspond to the making of a diagnosis. However, it is when, based on this information, diagnostic hypotheses and corresponding therapeutic recommendations are proposed that a doubt may be raised as to legality. According to the definitions already mentioned, it is then possible that the process could correspond to the carrying out of reserved professional activities relating to the diagnosis or assessment of health problems and the prescription of treatment. This could at least be the case in Quebec, as soon as the limit of the dissemination of general health information is crossed and the aim is instead to rule on the specific situation of an individual.

Read more: How AI will transform the healthcare system

By contrast, it is noted that in the Ontario law (s. 27 para. 2), the definition of the reserved activity in matters of diagnosis is more circumscribed, since it supposes “the communication to an individual, or to his representative, of a diagnosis attributing his symptoms to such diseases or disorders, when the circumstances reasonably suggest that the individual or his representative will rely on this diagnosis”.

Such a definition would perhaps be less difficult in the case of an application which, depending on the circumstances of its use and the notices accompanying it, is not intended for the user to rely solely on the resulting assumptions to make processing decisions.

Legally, the situation would perhaps be even less risky in Alberta, even though diagnosis is not identified as a reserved activity in the applicable law (art. 1.3).

Rules to be adapted or clarified

The abundant technological developments of recent years, particularly in AI, teach us that what seems unlikely or desirable one day can quickly change within a society and a profession.

Read more: Three conditions for more responsible digital tools in the context of a health emergency

If the rules surrounding illegal exercise are justified solely by the imperatives of protecting the public, there is no, a priorigood reasons for technology companies to escape them. However, we must also be prepared to reassess the relevance of these same rules if they are no longer justified in light of certain contemporary realities.

It can therefore already be anticipated that in the near future, even more applications or technological services with diagnostic and therapeutic purposes will be made available to the general public, with performance levels that, in certain contexts, could rival those of health professionals. It may then become necessary to adapt, or at least clarify, the rules applicable to the illegal practice of health professions, which were designed at a time when the risks in this area arose exclusively from human interactions.