Clinical Informatics Leaders
Design with the end in mind. Clinical informatics already owns the path from evidence and best practice through to the health record. We improve that process so a named person sits between proposal and practice, and so you can walk the output back to sources months later. Outcomes by design here means the workflow and the record are designed together (not a guarantee of clinical outcomes). People, evidence, and AI are all fallible; governance surfaces and mitigates. This is back-office standards work, not a chatbot in the chart. Health informatics is one lane of a multidisciplinary platform.
The 2023 AMDIS CDS conversation asked whether generative AI can author decision support without a clinician in the loop. Work on Evidentia stops until a named person looks. That is architecture, not a memo.
If your 2030 EHR conversation already assumes agents will act, the missing piece is replay: what ran, who approved, what changed. We are that layer for the evidence-to-action process behind the chart.
The 18 August 2026 CDRH paper is a discussion document, not a GenAI device rule. Question 1 asks whether output can be walked back to primary sources. That is the trail. We are not a diagnostic device and we do not claim clearance.
AMDIS is the professional home of this audience. Plexina has supported that community’s digital presence for nearly eighteen years. AMDIS does not endorse this platform. The Plexina mention lives on Plexina’s Health solutions page.
A protocol, a CDS policy draft, an AI-governance charter, or a bibliography. Fixed-price first check; you keep the report. We do not scope a hospital IT project in that conversation.