Your product touches health data. Your contracts should know it.

Mostly privacy, contracts and IP for the product: working out whether PHIPA or PIPEDA applies, a privacy policy and data practices that match what the product does, the agreement clinics sign to use it, AI terms where a model touches clinical information, and IP assignments so the code and clinical content belong to the company. We do this for health tech and med tech startups in Toronto and across Canada.

It depends on who you’re working for. If you handle personal health information for Ontario health information custodians, such as clinics and regulated practitioners, PHIPA usually binds you through that relationship, as an agent or a service provider. A direct-to-consumer app with no custodian involved is generally under PIPEDA, which still treats health information as sensitive.

It can be. Health Canada regulates software as a medical device when it is intended for a medical purpose, such as diagnosing, treating or monitoring a condition, and classifies it from Class I to IV by risk. Class II to IV devices need a medical device licence before they are sold. General wellness and administrative software is generally not a device. What you say the product is for, in your marketing and terms, drives the answer.

The service and its limits, who owns the data and what you may do with it, the safeguards and breach notice PHIPA expects of anyone handling health information for a custodian, where data is hosted, uptime and support, and liability. If a clinician relies on your output, the agreement should say the clinician stays responsible for clinical decisions.

Start with your contracts: many clinic agreements limit you to processing data on the clinic’s behalf. Under PHIPA, using personal health information for a new purpose generally needs consent or a specific exception, and de-identified data must be properly de-identified. Decide your position and state it plainly in your agreements and privacy policy.

Yes. A physician or nurse can own shares in a health tech company personally or through a holding company. Their professional corporation can generally only carry on the practice of the profession and related activities, so startup shares are usually held outside it. Clinician founders should also check their college’s rules on conflicts of interest, such as recommending a product they own to their patients.

Federal privacy law doesn’t require data to stay in Canada, but you remain responsible for it and must protect it by contract. Hospitals, health authorities and other public-sector buyers often require Canadian hosting, by contract or under the privacy law that applies to them, so check before you choose a cloud region.