Thank you, Madam Chair.
Predictive technologies are a very important innovation in this space. Some of them will become regulated as medical devices, but some of them are a matter of hospital-based research. Identifying predictively when a disease is going to appear or what its symptoms and natural history might look like is very important work. It's frontier work. So if we were bringing it into the regulatory cycle, I think we would need to pay attention to two things. One is how it integrates with presenting treatments, and the other is how much validity and certainty we can get around these new technologies, because a misfire, predictively, could lead someone either to be without the necessary treatment or to have treatment they shouldn't have.
This is something that internationally many regulators are trying to get their minds around. A lot of very important discoveries are being made, but again, bringing them into the regulatory pathway is a matter of study. We want to make sure too that we don't overburden those innovations and remove a certain suppleness from them by requiring too much of the wrong thing. So understanding how you would validate that kind of predictive model in the regulatory cycle is another important discussion. We want to be very practical. We're having more and more discussions, especially in oncology, the area of cancers. A lot of progress is being made on identifying different types of cancers we haven't seen before.
So with regard to what we are to make of this—we're talking with a lot of our research specialists and others to develop technologies that detect those sorts of genetic variations—and to understanding how to bring that in are parts of a very important discussion.
We're also inviting our international regulatory counterparts. There's a lot of work going on in the United States on that as well.