Early this year, I had the opportunity to explore the latest trends and breakthroughs shaping the health industry at the Digital Health Summit at CES in Las Vegas, USA. It was clear that the pace of innovation has been remarkable, but also that regulatory frameworks are struggling to keep up.
One big announcement in that regard came on Day 1, when FDA introduced a new guidance document for general wellness devices - a long-awaited step toward modernizing how these technologies are regulated. This shift empowers individuals to take a more active role in managing their health, supporting the broader movement toward preventive care.
The update was welcomed by several industry voices, for example, Oura CEO Tom Hale has long advocated for regulations that distinguish between early awareness and medical diagnosis - an essential nuance as wearables evolve. This new regulatory guidance promises to support innovation and speed market access for informative, non-interventional solutions.
Another major announcement during the week - though outside the show floor - came from OpenAI, revealing the new ChatGPT Health feature. Designed to give people a more active role in understanding and managing their health, it represents another step in democratizing health information. For now, the full feature is only available in the U.S.
It is clear that AI-enabled health solutions are reshaping how we think about healthcare. Patients are at the forefront, and the demand for high-quality, fast and convenient care continues to grow.
A recurring theme at CES was the shift of care into the home environment. Speakers emphasized that hospitals - at least as we know them today - are changing. Digital tools now support remote monitoring, longitudinal assessment, and earlier detection. The ability to conduct health measurements in home-environments is particularly valuable for underserved populations, high-risk groups, and non-ambulant patients.
Regulators are also increasingly requesting real-world evidence in clinical trials, acknowledging that traditional clinician-based testing can be biased and unrepresentative (FDA, EMA). Real-world digital measures offer the chance to collect more continuous, meaningful, and context-rich information.
As we shift from episodic measurements to continuous health data, the complexity increases as well. The sheer volume of health data can quickly become overwhelming, both for consumers as well as for health practitioners. Here, AI-driven interpretation is essential for turning data into meaningful and actionable information.
Another theme that resonated was that no single sensor or device can currently capture the full picture of human health. That’s why connecting different data sources, sensors and solutions, and collaborating across companies is crucial for moving toward more preventive, personalized, and inclusive healthcare. CES saw multiple collaboration announcements, and kudos are due to the companies that continue to choose cooperation over competition. When data and ecosystems connect, the whole field becomes stronger altogether benefiting the patients.
The momentum in consumer digital health is visible also in clinical development. We’re already seeing modernisations in clinical trial designs, such as
The regulatory landscape is evolving quickly, and navigating it will require expertise, collaboration, and adaptability. We’re excited to see what the future holds for digital endpoint measures - and we’re here to support partners on that journey.
If you’re planning upcoming studies and want to ensure your digital measures are meaningful, feasible, and regulatory‑ready, let’s connect.
I’ll end with a quote that stayed with me throughout CES: “Digital health measures make the invisible visible” and that visibility has the power to transform human health.
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