More and more consumers are using devices as an integral part of their personal health and fitness regimes. In response, businesses are developing and marketing an array of innovative software applications represented for a variety of health-related uses, from monitoring heart rate and tracking step count to calorie counters, nutrition advice and online fitness classes.
As the range of service offerings is continually expanding to address management and prevention of prevalent conditions, including obesity, abnormal cardiac activity, gut health, etc., so is the risk that an application is considered a “medical device” within the meaning of the Medical Devices Regulations.
It is critical that businesses ask the question “will my application, as proposed, be regulated as a medical device?” before marketing the app.
The definition of a “medical device” is quite broad and includes anything that is manufactured, sold or represented for use in “diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms in human beings,” and also in “restoring, modifying or correcting the body structure of human beings or the functioning of any part of the bodies of human beings.” Arguably, under a broad interpretation, a recommended daily step count / tracker may be considered as represented for use in preventing obesity and as such, may be considered a “medical device.”
In practice, Health Canada does not enforce the legislation (Food and Drugs Act) against certain products. In particular, Health Canada has indicated that software applications that meet exclusion criteria detailed in Health Canada guidance on the topic are excluded from regulation as a medical device, notwithstanding that the software may be captured by the legal definition of a “medical device.” The policy rationale behind this administrative stance is based on the view that software apps intended to support or encourage a healthy lifestyle should not be regulated as medical devices. Subject to a case-by-case assessment of the functions, features and claims associated with wellness apps, a case for their exclusion could be made.
Excluding software applications that pose a low risk of potential harm to human health and safety from being regulated as medical devices would also align with Health Canada’s broader compliance and enforcement policy, which prioritizes strict compliance of health products, including medical devices, that pose a higher risk of potential harm to the health and safety of consumers.
It remains critically important to undertake a case-by-case assessment under applicable laws and regulations before marketing new wellness app products or features.
For questions regarding classification as a medical device or risk mitigation strategies in marketing and advertising of new health and fitness applications, please contact Monica Song (monica.song@dentons.com ) and Yulia Konarski (yulia.konarski@dentons.com).
