ECLYPSE
AI
Built for FDA, Medicare, and HIPAA
Deployed inside your own US environment, not routed through a vendor's cloud outside it. The regulatory environment is FDA's credibility framework for AI as a medical device, Medicare/CMS's still-evolving reimbursement pathways, and HIPAA's rules on who may touch patient data and under what agreement.
The regulatory landscape
FDA. Clinical and diagnostic AI typically needs a credibility argument built around a specific context of use, not a one-size-fits-all clearance — the evidence standard scales with what's actually at stake in that use. See the FDA's AI credibility framework.
Medicare / CMS. FDA clearance doesn't automatically unlock reimbursement — CMS has deliberately kept the two processes separate. Getting paid runs through CPT coding, New Technology Add-on Payments, or a regional Medicare contractor's own coverage determination, each with its own evidence bar and timeline. See Medicare reimbursement for AI-enabled healthcare software.
HIPAA. A vendor touching patient data is a business associate the moment it does so, whether or not a contract exists yet — and a signed business associate agreement is what makes that disclosure permitted at all. See what HIPAA actually requires of an AI system.
None of this is legal, regulatory or reimbursement advice — specific clearance, coverage and compliance decisions should be made with qualified counsel for your system and situation. For how governance fits together as one problem rather than three separate compliance exercises, see healthcare AI governance.
Three deployments US teams ask about most.
Validation, classification, audit trails, human oversight and hallucination control as one design — covering what an FDA credibility argument needs without treating it as a separate project from the rest of the deployment. See healthcare AI governance.
Extraction, compliance verification and audit trail for submission-heavy workflows, deployed inside your own environment rather than a hosted platform the documents pass through. See regulatory document automation.
One governed evidence base behind payer value stories and HTA-adjacent submissions, generated on demand rather than rebuilt per request. See market access & HEOR.
See the deployments already live.
Client names, references, and full results available under NDA.
Common questions about Eclypse in the United States.
Does Eclypse have an office or legal entity in the US?
No. Eclypse Pte. Ltd. is registered in Singapore. Deployments run inside your own US infrastructure — sovereign cloud, on-premise, or air-gapped.
Is Eclypse HIPAA-ready?
Yes, at the same posture stated across the site. No PHI moves without a signed business associate agreement; access control, audit logging and scoped retrieval are structural. See what HIPAA actually requires of an AI system.
Does Eclypse handle Medicare billing or coding?
No. Eclypse is a platform vendor, not a billing entity — deployments produce the clinical validation evidence and audit trail a reimbursement conversation needs.
How does this relate to FDA clearance?
The same governance approach used across every deployment — documented intended use, audit trail, human oversight, hallucination mitigation — covers most of what an FDA credibility argument needs.
Tell us which regulatory piece you're scoping — we'll show you how the deployment fits.
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ECLYPSE
AI
Our proprietary AI orchestration platform for healthcare: one engine, a registry of reusable task modules and domain agents, and a governed knowledge base — deployed inside your walls and run by your team.