As we look back on 2025, it’s clear that digital health has entered a new phase of maturity. The industry is moving beyond early enthusiasm in the promise of technologies such as AI to focus on what truly matters — trust, evidence, and sustainable impact. AI continues to capture attention, but the emphasis has shifted toward accountability and integration into clinical workflows. Regulators are defining clearer rules to distinguish between consumer wellness and medical devices, while pharma is sharpening its focus on measurable ROI, and cybersecurity has become a defining pillar of patient safety. Across every corner of healthcare, the message is consistent: innovation must be matched by responsibility.
In this blog, we look at some of the stories that stood out this year — and why it’s important to reflect on them and the lessons learned as we move into 2026 and beyond.
If 2024 was the year of AI hype in healthcare, 2025 is proving to be the year of AI accountability. The FDA’s Draft Guidance for AI-Enabled Medical Devices, released in early 2025, signaled a maturing regulatory landscape around AI in healthcare, focused on safety, transparency, and real-world performance. The recommendations point to a total product lifecycle (TPLC) mindset, treating data as a living resource requiring continuous stewardship, and providing detailed documentation for every AI-enabled submission. For an industry that has often moved faster than oversight, the message is clear: innovation must now be matched by rigor.
At the same time, as John O’Gorman, Principal Technology Officer – Cybersecurity and Data Analytics at S3 Connected Health, recently noted, AI in healthcare appears to be entering what Gartner calls the “trough of disillusionment.” The initial excitement is giving way to the harder, more necessary work of integration — ensuring these systems actually deliver measurable improvements without compromising safety or clinician performance. Early NHS examples show both the promise and pitfalls: automation can free up scarce clinical resources, but it can also shift accountability and alter behavior in unpredictable ways. The challenge for 2026 and beyond will be embedding AI within workflows, demonstrating sustained benefits, and maintaining trust as the technology becomes an integral part of care delivery.
In July 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter to WHOOP, Inc., asserting that the company’s Blood Pressure Insights (BPI) feature met the definition of a medical device — and therefore required regulatory clearance before marketing. The agency’s reasoning was straightforward: any technology “intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body,” qualifies as a medical device under U.S. law.
This decision reignited a long-running debate in digital health: Where exactly is the line between a wellness product and a medical device? For nearly two decades, wearables have blurred this boundary. What began with early fitness trackers like Fitbit (2007) and Nike FuelBand (2012) has evolved into today’s sophisticated smartwatches and biometric sensors capable of measuring everything from heart rhythm irregularities to sleep stages and blood oxygen saturation. Each technological leap brings greater health insight — and greater regulatory complexity.
The WHOOP vs. FDA moment underscores how that complexity is now coming to a head. As “wellness” devices inch closer to clinical-grade functionality, regulators are being forced to draw clearer lines around intended use, accuracy, and consumer protection. The WHOOP case will likely serve as a precedent-setting moment for digital health in 2025 and beyond. It signals a future where regulatory clarity and clinical credibility will be as essential to innovation as sleek design and user engagement. You can dig deeper into the details in an article that Bill Betten, Director of Solutions - Medtech, S3 Connected Health, published on MDDI: To Be or Not to Be (a Medical Device): FDA Vs. WHOOP
As digital health moves from experimentation to expectation, pharma continues to face one of its biggest hurdles — proving ROI. Despite widespread recognition that connected solutions can improve adherence, outcomes, and patient experience, many companies still struggle to translate these gains into measurable business impact. Without a strong, evidence-based business case, even the most innovative programs can falter when it comes to sustained investment and enterprise alignment.
Our recent whitepaper, Commercial Pharma’s Business Case for Digital Health Solutions, takes a deep dive into this challenge. It explores how pharma can move beyond pilots and align digital initiatives with brand and enterprise priorities. The paper outlines how to overcome revenue barriers, integrate digital early in the drug lifecycle, and tailor strategies for high-value, complex therapies — where connected health can make the biggest commercial and clinical difference.
This theme has been a major focus for us throughout 2025, reflected in a series of thought leadership blogs led by John Mulcahy, VP of Product Management at S3 Connected Health.
The fallout from the Change Healthcare cyberattack in 2024 highlighted just how vulnerable healthcare systems can be — and how quickly a single breach can impact critical services. In an interconnected environment, a compromised system can halt treatments, delay diagnostics, and in the worst cases, threaten lives. For today’s increasingly software-driven and connected medical devices, cybersecurity has evolved from a compliance checkbox to a cornerstone of patient safety and business continuity.
For medical device manufacturers, this is no longer just a technical issue; it’s a strategic and regulatory imperative. A single breach can trigger investigations, recalls, and loss of market access — outcomes that no executive or regulator can ignore. This year, John O’Gorman, Principal Technology Officer for Cybersecurity & Data Analytics at S3 Connected Health, explored this in depth through his two-part blog series:
As 2025 draws to a close, one message is clear: The conversations have evolved from if to how these technologies can deliver sustained impact. Whether it’s the FDA’s push for AI accountability, the scrutiny surrounding the scrutiny around consumer wellness technology and medical device classification pharma’s pursuit of measurable ROI, or the industry-wide commitment to stronger cybersecurity, the sector is uniting around a shared goal: building systems that are safe, evidence-based, and truly patient-centered. The challenge for 2026 and beyond will be maintaining this momentum — turning lessons learned into lasting change and ensuring that every digital innovation enhances care, protects patients, and delivers real value to the people and organizations who depend on it.