Why Realize-365 is Not a Medical Device

We get asked about this question quite often.

And while the answer is not always straightforward for healthcare AI companies, in our case it is quite clear: Realize-365 is not a medical device under its current intended use.

Realize-365 is designed to help clinicians review medical records more efficiently. It structures, summarizes, searches and source-links information that already exists in the patient record. In other words, it helps clinicians get to the relevant information faster, with a clearer view of the patient history and a direct path back to the underlying source material.

What Realize-365 does not do is just as important.

It does not diagnose patients. It does not suggest diagnoses. It does not recommend treatment plans, calculate risk scores, triage patients, prioritize patients for clinical action, make prescribing recommendations or issue autonomous clinical alerts.

The clinician remains fully responsible for interpreting the record and making any clinical decisions.

A helpful way to think about this is that many things influence clinical thinking. Lab results, referral letters, discharge summaries, EHR search tools and handover notes all influence how clinicians understand a patient. That does not automatically make them medical devices.

The key question is whether the software is intended to make, drive or replace a clinical decision.

Realize-365 does not.

It helps clinicians reach the same record-based understanding they would otherwise reach manually, but faster, more clearly and with better navigation back to the original record.

So, in simple terms: Realize-365 does not tell clinicians what to do. It helps them find and understand the information they already have.