For many years, ASTP/ONC certification focused on a straightforward capability: whether health IT could exchange data. By 2026, that baseline has shifted. Exchange alone is no longer sufficient. Certified health IT is now expected to support the transparent, traceable, and longitudinal use of data, particularly for managing chronic conditions.

This expectation is enforced through existing requirements under HTI-1 and USCDI v3, shaping how certified systems are expected to behave when data is used, acted upon, and reviewed over time.

The change reflects the current state of healthcare operations. Data increasingly informs decisions, drives automation, enhances quality programs, and supports public health workflows. When that happens, systems must be able to explain what they did and why, even months later.

Why ASTP/ONC is Emphasizing Insight in 2026

Practical gaps drive ASTP/ONC’s focus, which it has observed across the ecosystem.

Chronic conditions such as heart disease, kidney disease, diabetes, chronic pain, anxiety, and depression require continuous management rather than episodic documentation. At the same time, health IT systems are increasingly responsible for triggering alerts, supporting population health workflows, and exchanging data across organizations.

ASTP/ONC has seen that while many systems successfully move data, fewer can reliably reconstruct how data was used after the fact. This creates challenges during certification surveillance, information blocking reviews, and cross-program alignment with CMS.

The HTI-1 final rule reinforces expectations around predictable system behavior, traceability, and explainability. These are not theoretical principles. They are operational requirements that apply to certified health IT throughout 2026.

The Role of USCDI v3

USCDI v3 provides the data structure that enables insight.

By expanding standardized data elements related to conditions, assessments, health status, goals, observations, and clinical notes, USCDI v3 enables systems to represent patient care over time rather than as isolated events. This structure is foundational for tracking chronic conditions and understanding change.

ASTP/ONC does not expect systems to infer improvement from unstructured data alone. It expects consistent, reproducible data that can support longitudinal views and cohort logic.

What ASTP/ONC Means by “Insight” Operationally

Although “Insight” is not a formal certification label, the expectation is clear in how compliance is evaluated.

Certified systems are expected to demonstrate the ability to:

Identify patients with specific chronic conditions using consistent logic
Track those patients over time with preserved context
Maintain data provenance, including source and timing
Explain CDS behavior and automated actions
Retain evidence that supports reconstruction during review

ASTP/ONC is not measuring outcomes. It is evaluating whether systems support clear, defensible use of data.

When “Insight” is Missing

The absence of insight rarely causes immediate failure. Instead, it creates friction that compounds over time.

Operationally, issues surface when systems cannot answer basic follow-up questions, such as why a patient appeared in a cohort, which data triggered an alert, or what information was available at the time a decision was made. When context is missing, teams are forced into manual reconstruction or reactive responses.

Over time, this leads to increased support burden, slower certification reviews, and greater difficulty defending data during audits or investigations. ASTP/ONC has been consistent that systems should be able to explain their behavior without relying on guesswork.

Why it Matters More Now

In 2026, these expectations intersect with broader regulatory activity.

HTI-1 requirements are fully in effect. USCDI v3 expands data scope. CMS continues to mature MIPS Value Pathways, which rely on consistent, defensible data. TEFCA broadens exchange across organizations that may not share the same systems or assumptions.

As automation increases, tolerance for opaque system behavior decreases.

Where Darena Health Adds Value

This is where many EHR teams feel the strain, not because they lack technical skill, but because regulatory execution begins to pull focus away from product innovation.

Darena Health tackles the aspects of compliance that are most challenging to operationalize and often underestimated.

We support EHRs by:

Auditing and documentation covering real-world utilization of the §170.315(g)(10) FHIR API
Managing ongoing updates to FHIR and USCDI versions
Keeping production workflows aligned with certification expectations
Preserving traceability and defensible system behavior for ASTP/ONC review

This work is continuous, not episodic. When handled well, it becomes invisible to customers and regulators alike.

The Bottom Line

In 2026, ASTP/ONC expects certified health IT to do more than exchange information. Systems are expected to make data use understandable, traceable, and defensible over time, especially for chronic condition management, where longitudinal context matters.

This expectation is enforced through HTI-1 and USCDI v3, rather than a standalone “Insight” rule. The impact is operational and already influencing certification reviews, surveillance, and audit readiness.

EHRs are not being asked to justify clinical decisions. They are expected to explain system behavior - how data was captured, exchanged, acted upon, and preserved at specific points in time.

EHRs that build insight into their systems spend less time reconstructing evidence for regulators and more time focusing on product improvements. Darena Health takes on the ongoing work required to support this, from FHIR and USCDI updates to real-world API utilization auditing, so EHR teams can stay focused on building and improving their EHRs.