health + tech in law = mixing chalk + cheese
About a year after it convened a Scientific Advisory Panel with respect to Software-as-a-Medical-Device (SaMD), Health Canada has now released a Draft Guidance Document for public comment until March 29, 2019.
According to the Draft Guidance Document, software will generally be considered SaMD if it has and performs one or more intended medical purposes without being part of a hardware medical device. However, SaMD may be used in combination or interfacing with a hardware medical device. SaMD will include medical mobile apps (MMAs). As expected, general wellness apps will be excluded from SaMD.
The Draft Guidance Document really only addresses the questions of whether something is SaMD and its classification. Health Canada is working on other digital aspects of medical device regulations (see my earlier post on cybersecurity), so it will be interesting to see whether Health Canada will address SaMD separately in these other areas or if it will be regulated in a similar manner to the software component of a physical device.
There are already a couple of articles outlining the details the the Draft Guidance Document, so I won’t go into them. Instead, I wanted to make a couple of comments about the approach, which I think shows how dated the laws are and how they are lagging behind other jurisdictions.
My first comment relates to international harmonization, which Health Canada clearly directed its mind to when developing the Draft Guidance Document. The question of diverging regulatory requirements among different countries is important since one might end up with a device that is regulated in one jurisdiction but not another, or that is considered a higher risk (and thus subject to more rules) than in another. This consequence may not be wrong since different countries have different laws, so it is interesting to see that international regulators attempt to interpret laws to arrive at the same or similar results. Ultimately, there is a limit on how far the wording of a statute or regulation can be stretched, and raises the question of whether there is a need for legislative change.
In the case of the Draft Guidance Document, Health Canada took the very Canadian approach of trying to take a little bit from everywhere (made possible by the fact that it is relatively late to the game with respect to a digital health strategy in comparison to the US and Europe). The Appendices to the Draft Guidance Document refer copiously to previous work relating to SaMD at the International Medical Device Regulators Forum (IMDRF), a voluntary group of medical device regulators including Health Canada, which has been working towards medical device regulatory harmonization. However, within the substance of the Draft Guidance Document, there are a couple of pieces that are taken from the US FDA approach.
Perhaps one of the more significant pieces is with respect to Table 1 of the Draft Guidance Document, listing four criteria, which if all met for a particular piece of clinical decision support/patient decision support software, may exclude it from the definition of a device. The four criteria are essentially a paraphrase of section 520(o)(1)(E) of the US Federal Food, Drug, and Cosmetic Act, which was introduced into the legislation in 2016 through the 21st Century Cures Act. Interestingly, following these criteria, a piece of software that the Court of Justice of the European Union (CJEU) in December 2017 considered to be a medical device (C-329/16) would arguably not be a medical device in Canada. In the CJEU case, the software was said to provide “a doctor with the necessary information for the correct prescription of drugs, relating, in particular, to possible contraindications, interaction between different drugs and excessive doses.” The CJEU concluded that the software was a medical device under the relevant law (Directive 93/42) with the following reasons:
The ICCA software provides assistance with particular information so that the doctor prescribes drugs more safely, thereby preventing incorrect prescription. It therefore fulfils instrumentally the objective of ‘prevention, monitoring treatment or alleviation of disease’.
This last objective seems awfully similar to the inclusion criteria in the Draft Guidance Document. Health Canada does note that exclusion criteria are not rigid and other factors may be relevant, but Table 1 makes it seem like Health Canada is leaning towards taking the US approach to this type of software. Given the CJEU case above, there is a question whether this approach is permitted under Canadian law.
My second comment is another indication that the medical device laws need to be updated is from Health Canada’s slightly wacky application of the classification rules as discussed in the Draft Guidance Document. Here harmonization takes a back seat as there are a few noticeable differences between Table 2 (Non-IVD SaMD classification) and the comparable Table developed at the IMDRF.
Health Canada cites Rule 10(1) (in Schedule 1 of the Medical Devices Regulations) then says SaMD could be “an active device because it relies on a source of energy other than energy generated by the human body or gravity” [emphasis added]. In fact, the Rule uses the words “supplies energy”. Technically speaking, the SaMD itself produces no energy since it could be printed out on a piece of paper – it’s the cellphone or laptop or whatever executing the software that is actually supplying the energy. However, it’s not hard to see why Health Canada is taking this position, since there is not really anything specific enough in the Medical Devices Regulations or Rules to allow the agency to properly regulate something that is not tied to a physical device.
In conclusion, the Draft Guidance Document highlights that the whole regulatory scheme needs to be updated – and remember that the definition of “device” in Food and Drugs Act doesn’t even include the word “software”!