How Regulators are Viewing the Current Landscape of Clinical Technology

ACT: How are the regulators viewing this current “boom” in clinical technology? How has their stance on it changed over the years?

Easy: I think that what we're seeing now is that regulators are developing guidance very specific to support the “boom”—I quite like the “boom”—but I think they're very focused on making sure that anything that's put in place is really about benefiting the patients. There's certainly key areas that they're always going to focus on, and number one has to be patient drug safety. The trend I'm seeing is very much that they're moving from being passive to very active and engaging with the industry and in many areas. We were talking about AI (artificial intelligence) earlier. If I think about AI regulations and what we're seeing—we were joking the other day, some of us how 2023 was the year of GenAI and it was front and center. I don't know anyone that was not having a meeting that started off with something about ChatGPT, whereas now in 2024 I think we've seen several developments, again, not only around safety, but guidance risk mitigation in AI. The White House announced a government-wide AI risk mitigation policy. Then you had the EU have pass the AI Act. The UN and has adopted a US-led AI resolution, UK and US AI Safety Institutes—the fact that these places even exist now—are announcing partnerships, so specifically on research and safety. We're really seeing a shift towards a much more structured landscape—giving the example of AI here—that people need to follow.

To me, what this signals is opportunities and challenges in the life sciences space, especially in clinical trials. Why I say that is, to me, this is a shift, and it really underscores the need for everyone in the industry to urgently and rapidly evolve because they've got to do this focusing on how they strategically use AI and use it responsibly, and then be able to deploy it in line with all of these emerging standards, but what people need to do at the same time is to have a forward-looking view, because some of these regulations might adapt further, so anything you deploy today, you need to know that it is not so structured that it will not meet future guidelines that are given out. There is a nice long answer to your great question.