On May 14, 2025, the U.S. Department of Health and Human Services (HHS) kicked off what it calls the largest deregulatory effort in its history. It’s asking stakeholders across all sectors to weigh in on how to “dramatically deregulate” the Department. And if I’m honest, I find that a little scary.

But also, maybe not entirely bad.

In one way or another, we’ve all felt the strain of outdated requirements, inefficient processes, or documentation practices that no longer reflect today’s realities. The idea of cutting red tape isn’t, in itself, the problem. It’s how we go about it, and what we choose to cut, that matters most.

The problem isn’t that regulations exist; it’s when we fail to distinguish between what needs to be regulated and how those regulations are supported. There’s a world of difference between foundational requirements and the layers of implementation guidance that surround them. That nuance is at risk of being lost when deregulation is approached without thoughtful distinction.

When it comes to core federal regulations, especially in areas like drug development, clinical trials, and data privacy – we need stability. Title 21 of the Code of Federal Regulations exists for a reason. These are the ground rules that protect patients, research subjects, and data integrity. Yes, some parts may be outdated, but most are essential. 

One aspect of Executive Order 14192 that raises concern is its directive for agencies to eliminate ten regulations for every new one introduced. While the broader goals of improving efficiency and reducing unnecessary burden are understandable, this specific metric sets an overly aggressive target. A numbers-driven approach overlooks the importance of thoughtful evaluation. The focus should be on modernizing and improving regulations, not simply reducing their count. Gutting regulations for the sake of numerical reduction would be a serious misstep. 

Sweeping regulatory changes that introduce instability or suggest a lack of structure can make the U.S. a less attractive environment for clinical research. The industry relies on clear frameworks to plan and execute studies. If the U.S. begins to appear inconsistent or reactionary in its approach, research activity could shift elsewhere. This isn’t just about perception, it’s about maintaining an environment that invites investment, innovation, and trust. 

Other countries are also talking about reform, but they’re taking different paths. In the UK, for example, the government is enacting the most significant update to clinical trial regulations in over two decades. Like the U.S., the UK is focused on reducing administrative burden and making it easier to conduct trials. But unlike the sweeping deregulatory tone adopted in the U.S., the UK’s approach is rooted in careful, structured reform. It’s a reminder that modernization doesn’t require dismantling. We all want the same outcome: regulations that protect participants while enabling innovation. The method matters.

Read more about the UK approach to Clinical Trials Reform here. 

There’s room for improvement, no question. Outdated rules should be reviewed with unnecessary complexity trimmed. But we need to approach this moment with perspective, not presumption. Regulations aren’t the enemy, they’re the foundation. Let’s make sure that in the name of deregulation, we don’t pull the rug out from under the systems we depend on.

This effort could bring necessary modernization. But only if we take the time to listen, to think, and to avoid sweeping changes that could lead to unintended consequences, at home and beyond.