What steps should be taken in order to legalise and sell medical software?
<p>So I thought about an idea for a medical software and I made just for fun. It wasn't that good but it was much better than what I'd expected to get. Fast forward a couple months, I made the software a lot better, made sure the accuracy is good, and I thought maybe I could actually sell it to doctors (more specifically, GPs and family doctors).</p>

<p>The software is basically as follows: First, you take a picture of a skin lesion. Then, the app would say if the skin lesion is cancerous or not. At first, I thought the accuracy would be pretty bad but it's actually good(it's not 100% but it's pretty close and after talking to a dermatologist and a plastic surgeon and was told that it is good enough as long as it doesn't do some specific things, which my software doesn't. They said it's something they would definitely use).</p>

<p>So I was wondering, what steps am I required to take to be able to sell this software to doctors? Obviously, it has to undergo some tests to make sure the accuracy is good, but I don't know where to begin.</p>

<p><strong><em>EDIT</em></strong></p>

<p>I'm located in New Brunswick, Canada and this is where I'm planning to sell my software and not the rest of Canada.</p>

<p>P.S: I'm a minor, so please bear that in mind.</p>

<p>Thank you so much in advance!</p>

<p>In Canada, you would have to satisfy the requirements of <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/medical-devices/software-medical-device-draft-guidance/document.html" rel="nofollow noreferrer">software as medical device</a>. As a diagnostic device, it would be subject to regulation. <a href="https://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/" rel="nofollow noreferrer">Here</a> is the law: you need to understand and comply with that. §10 requires you to</p>

<blockquote>
  <p>take reasonable measures to (a) identify the risks inherent in the
  device;(b) if the risks can be eliminated, eliminate them; (c) if the
  risks cannot be eliminated, (i) reduce the risks to the extent
  possible, (ii) provide for protection appropriate to those risks,
  including the provision of alarms, and (iii) provide, with the device,
  information relative to the risks that remain; and (d) minimize the
  hazard from potential failures during the projected useful life of the
  device.</p>
</blockquote>

<p>There is an approval process, <a href="https://www.emergobyul.com/resources/canada-process-chart" rel="nofollow noreferrer">here is a link</a> (you need an account). One issue that you will have to sort out is the Class of the device, and <a href="https://www.emergobyul.com/sites/default/files/file/ca_guidance-keyword-index-verify-class.pdf" rel="nofollow noreferrer">there is a long document</a> on that. Let's say that you believe that the device is Class 2 (please note that your beliefs are not what matters, what matters is what the criteria are for class assignment). I chose Class 2 because that seems to be what software is. Then you read <a href="https://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/page-3.html#h-1021513" rel="nofollow noreferrer">this part of the law</a> and see that you have to apply for a license. There will be a review, you will need to satisfy the minister, and it is a completely non-trivial task to license a medical device. Anyhow, this is a starter on the license part.</p>

<p>You also need to study the law of liability, because you might easily get sued for millions of dollars in case something bad happens (or, someone alleges that something bad happened). Also, you need to study copyright law especially w.r.t. software licenses (assuming that you want to maintain any control over the software, but also want somebody to be able to use the software). There are some tax questions that will come up, basically if you make any money, expect to pay taxes.</p>

<p>Another approach would be to find a company that does this stuff and sell them the software. The sticky point for them will be that contracts generally cannot be enforced against a minor. It's not at the moment clear whether a transfer of copyright by a minor would be effective in NB, so if not, that would be a serious bar to selling the software.</p>

software licensing canada