Phase II Q & A
Public-facing answers to the most common Phase II program and transition questions, written for sponsors, partners, and stakeholders.
What is the Phase II objective?
Scale the validated Phase I rehabilitation system into a multi-site VA deployment with longitudinal outcome tracking, while expanding wearable integrations and clinical workflow alignment.
What will be delivered by the end of Phase II?
A VA deployment toolkit, a licensing-ready platform baseline, clinical outcome metrics instrumentation, and transition documentation suitable for Phase III commercialization pathways.
How does Phase II de-risk transition?
Execution is gated by formal acceptance, and financial/operational ramp is governed. Commercial pathways are explicitly coupled to engine-level maturity and measured performance.
What is the milestone plan?
Milestones target a pilot live deployment by Month 6, longitudinal trust/outcome data by Month 12, platform hardening by Month 18, and commercial readiness by Month 24.
How is privacy handled (VA + broader standards)?
Phase II uses privacy-by-design: minimization, explicit consent, controlled access, and auditable governance. The compliance posture is aligned to HIPAA/HITECH expectations and designed to be compatible with EU-grade privacy and data governance standards for interoperability environments.
How is safety and “over-claim” prevented?
Guidance is confidence-aware and bounded by policy constraints. When confidence is insufficient, the system suppresses prescriptive outputs and defaults to advisory-only information with clear uncertainty signaling.
What scale of evaluation is planned?
Phase II expands evaluation cohorts and supports orthopedic and neuro rehabilitation tracks, with longitudinal tracking for trust, adherence, and functional outcome measures.
How does the wearable ecosystem expand?
The plan adds FDA-cleared wearables and continuous monitoring integration where appropriate, maintaining a hardware-agnostic architecture for future partner devices.
What is the staffing model?
A multidisciplinary team supports Phase II: PI oversight, systems engineering, data science for trust modeling, software engineering, clinical SME alignment, and privacy/security SME coverage for HIPAA/NIST and ATO preparation activities.
How is the budget framed externally?
High-level allocation emphasizes labor-intensive execution (majority labor), followed by overhead/fringe, cloud/tools, wearables, and travel/training. Detailed line items remain controlled in program documentation.
Phase II readiness statement
Just State: Phase II is planned as a controlled scale-up of Phase I results, with acceptance-gated transition, governance-first deployment posture, and measurable outcomes supporting VA operations and future Phase III commercialization.