If you have been following the regulatory landscape for digital health, you know that the line between a “medical device” and a “workflow tool” has often been blurry — leaving digital health companies unsure of whether their core features require rigorous FDA clearance or fall under enforcement discretion. That ambiguity has stifled innovation.
However, this week, the FDA released updated guidance for its clinical decision support and general wellness policies that reduces the ambiguity. The FDA has now relaxed the prior constraints and provided very specific examples of what the new constraints are. This eases the pathway for healthcare organizations and payers who have been hesitating to innovate at the speed of AI.
For organizations focused on value-based care, these updates are a green light to adopt smarter, more scalable solutions without getting bogged down in unnecessary regulatory hurdles.
Here is what the 2026 guidance means for your digital health strategy.
The "glass box" era of clinical decision support
The FDA’s updated guidance on clinical decision support software reinforces a critical distinction: Software that supports a clinician is different from software that aims to replace them.
Also, the FDA is effectively telling us that if your software allows a provider to “independently review the basis” for a recommendation, it stays out of the medical device regulatory bucket. This signals a shift away from “black box” algorithms toward “glass box” transparency.
It means we can deploy intelligent tools that aggregate patient data, match it against clinical guidelines, and present options to providers … so long as the software explains why.
For healthcare systems and payers, this is an opportunity to elevate your clinical team efficiency and quality, directly impacting your bottom line. This guidance supports the exact type of innovation we have created at Percipio Health: Tools that streamline workflows and automate care plans but keep the clinician in the driver’s seat.
Expanding wellness to chronic care management
The second major update is the “General Wellness: Policy for Low Risk Devices.” The FDA has superseded its 2019 guidance to reflect the reality of 2026. Wellness is no longer just about fitness trackers; it is about chronic disease management.
The FDA confirmed that it does not intend to enforce device requirements for products intended to maintain a general state of health. But crucially, they have expanded the scope to include lifestyle choices that “help to reduce the risk or impact of certain chronic diseases.”
This is massive for population health. It means digital tools can explicitly promote healthy lifestyles to help patients live well with conditions like type 2 diabetes, high blood pressure, and heart disease (provided the connections are well-understood and supported by peer-reviewed science).
The guidance even opens the door for non-invasive optical sensing in wellness products — think estimating blood pressure through a smartphone facial scan using rPPG technology — provided they are solely for wellness uses and don't prompt specific clinical actions, unless recommended by clinicians using this information within their clinical decision support tools.
Strategic takeaways for health systems and payers
The FDA has signaled that it wants to encourage, not hinder, low-risk digital health innovation. For health systems and payers, the message is clear:
Embrace explainable AI-guided decision support: Invest in clinical decision support tools that prioritize plain-language explanations of their data sources and clinical guidelines, enabling a clinician to efficiently review, take action, and document in just a few clicks. This satisfies the FDA's "Criterion 4" and builds trust with your clinicians.
Leverage AI health signals for risk stratification: Use the relaxed wellness guidance to deploy device-free health signal tools for broad-scaled risk assessments with your chronic disease populations, without waiting for a 510(k) clearance, as long as the tools remain low-risk and non-invasive.
At Percipio Health, we believe that turning patient data into actionable risk stratification and automated care plans is the key to sustainable care delivery. These new FDA guideposts make that vision easier to achieve than ever before.