Healthcare AI Deployment Readiness System

A clinical AI system goes live, and six months later someone on the board asks who evaluated the FDA classification, whether every vendor with PHI access has a Business Associate Agreement on file, and what the override procedure is if the model gets it wrong. The answers are scattered across emails, spreadsheets, and whoever happens to remember the meeting.

Healthcare AI Deployment Readiness System brings those decisions into one structured governance record, so your team can document how a clinical AI deployment was evaluated, where gaps remain, and what needs to happen before deployment.

Built for organizations that have outgrown ad hoc compliance tracking but aren't ready for a $20K+ enterprise GRC platform: regional health systems, multi-site clinical groups, digital health companies scaling past their first enterprise customer, and compliance consultants who serve them.

This self-contained governance workspace covers six interconnected evaluation domains: patient safety, HIPAA and PHI governance, clinical decision support, FDA/SaMD classification, provider governance, and patient consent. No procurement cycle, IT integration, or subscription required.

What's Inside

• Hard-Stop Governance Logic: Critical unresolved conditions can block a Ready determination independently of the overall score, including missing BAA documentation where a vendor has PHI/ePHI access, no clinician override mechanism, unresolved adverse-event reporting, or unresolved FDA/SaMD status.

• Six Weighted Evaluation Domains: Patient Safety, HIPAA & PHI, Clinical Decision Support, FDA/SaMD Classification, Provider Governance, and Patient Consent, with FDA/SaMD evaluation adjusted when the domain does not apply.

• Real-Time Scoring & Evidence Tracking: A weighted assessment score updates as your team works, with evidence indicators showing which determinations have been documented.

• Structured Governance Record: Timestamped audit entries capture saves and key lifecycle changes, creating a centralized record of the assessment process.

• Executive Summary: A concise output showing assessment status, completeness, key blockers, risk areas, and the configured readiness determination.

• Unified Risk Register: Identified gaps flow into a centralized register with severity, owner, date, and remediation fields.

How It Works

1. Complete the Organization and AI System Profile once. The information feeds the scoring and governance logic across the workspace.

2. Work through the six evaluation modules as a cross-functional team, such as Privacy, Security, Medical, Legal/Risk, and IT stakeholders.

3. Generate your Executive Summary, Risk Register, and Audit Trail, along with the configured readiness determination: Ready, Not Ready, or Ready with Conditions.

Who It's For

Cross-functional compliance and clinical governance teams at mid-size and scaling health organizations, plus consultants running structured AI deployment assessments across multiple clients.

Use it when you need a centralized, documented record of the questions, determinations, evidence, risks, and outstanding conditions surrounding a clinical AI deployment.

Move your next AI deployment decision from scattered opinions to a documented governance record.

FAQ

Does this guarantee compliance with FDA, HIPAA, or other regulations?

No. This system is a self-assessment and governance aid. It does not certify compliance, provide legal advice, or approve a clinical AI deployment. Consult qualified legal, regulatory, clinical, and compliance professionals for organization- and jurisdiction-specific determinations.

Does this require internet access or a cloud account?

No. The workspace runs as a self-contained HTML file and does not require an account, server, or internet connection. Workspace data is stored locally in your browser's local storage. Do not enter actual patient-identifying information or unnecessary patient-level PHI into the workspace.

How is data backed up or shared across a team?

The workspace does not connect to a cloud service. You can export your workspace as a JSON backup, optionally encrypted with AES-256-GCM, and then store or transfer that file using your organization's approved network or cloud storage. Exporting the file is separate from the workspace itself.

Is this meant to be completed by one person?

No. It is designed for cross-functional evaluation and can be worked through collaboratively across multiple sessions.

Is this a substitute for an enterprise GRC platform?

It is not intended to replace an enterprise GRC platform where one is already in place. It provides a focused workspace for organizations that need a structured AI deployment assessment without implementing a full enterprise GRC platform.

What does the license cover?

The license covers single-organization internal use. Generated outputs may be used internally for governance and compliance purposes. The system itself may not be redistributed, resold, or sublicensed. Enterprise, multi-client, or consultant licensing is available on request.

License: Single-organization internal use. Redistribution and resale of the system itself are not permitted.