OPINION:
Americans are paying more attention to their health than ever before. From scrutinizing ingredient lists to prioritizing sleep and recovery, people across the country are becoming more engaged in their own well-being.
At the center of this movement are wearable health devices.
Products like smartwatches, fitness bands and rings now offer insights that once required a visit to a doctor or specialist. They help answer everyday questions that matter: Did that late-afternoon coffee affect my sleep? Has increasing my activity lowered my resting heart rate? Am I recovering well, or should I take it easy today?
I’ve seen this evolution firsthand. Decades ago, wearable health tech was bulky, expensive, and mostly limited to elite athletes. Today, it fits on your wrist or even your finger and it’s being used by people of all ages. My own mother, now in her 80s, can track her steps and better understand how she’s feeling from one day to the next.
I’m an early adopter myself. I’ve worn a smartwatch for years. It tracks my workouts, heart rate, sleep, respiration and VO2 max, and even estimates a “fitness age” compared to my actual one. These tools don’t replace a doctor but they make me a more informed, engaged patient.
In fact, when I go in for my annual physical, I can hand my phone to my physician and review trends together. Having this data already in hand sparks better conversations, better questions and better decisions.
But as exciting as this progress is, innovation is now moving faster than our regulatory system.
Wearable companies are packing more sensors, features and capabilities into consumer devices at a rapid pace. But Washington’s regulatory framework wasn’t built to keep up with health-focused technology that evolves this quickly.
Technology has a long history of outpacing the federal government. But when regulation lags too far behind, it can delay access to safe, low-risk innovations and discourage the very breakthroughs that have made American products competitive globally.
This is where Congress needs to act.
In the coming weeks, I will introduce legislation to modernize how certain low-risk digital health screening functions on wearables are reviewed and approved. The goal is simple: create a streamlined, tailored regulatory pathway that protects consumers without bogging down innovation.
My bill provides the Food and Drug Administration with clear legislative guidance on how to approach these emerging tools. It encourages collaboration between regulators and device manufacturers, rather than forcing innovators into outdated, one-size-fits-all processes designed for traditional medical devices.
Safety and accuracy remain front and center. But we also need a system that recognizes the difference between high-risk medical interventions and low-risk digital health screeners that help people better understand their own bodies.
This matters not just for patients, but also for the entire health care system. When individuals are more engaged in their health, outcomes improveand costs can come down.
There’s also a bigger picture to consider. The United States leads the world in health innovation, but that leadership isn’t guaranteed. If we fail to modernize our regulatory approach, we risk falling behind while other countries race ahead.
Just as important as innovation is protecting Americans’ personal health information. Consumers deserve confidence that the data generated by their devices is secure, transparent and used responsibly. As this discussion unfolds on Capitol Hill, I will be committed to establishing strong privacy safeguards and clear accountability.
Republican or Democrat, we all want healthier lives for ourselves and our families. Modernizing regulations to keep pace with innovation shouldn’t be controversial; it should be expected. And in 2026, learning more about your health shouldn’t be limited to the four walls of a doctor’s office.
As co-chair of the Congressional Digital Health Caucus, I believe we should use every tool at our disposal to bring care directly to patients, wherever they are, and whenever they need it. With thoughtful, modern regulations, we can empower consumers, support innovators and ensure America remains the global leader in digital health.
• Rep. Troy Balderson represents Ohio’s 12th Congressional District. He serves on the House Energy and Commerce Committee.
Please read our comment policy before commenting.