AI DECISIONS THAT HOLD UP UNDER SCRUTINY
Pedone AI Advisors builds defensibility architecture for healthcare and other regulated organizations — the operational layer that makes AI-influenced decisions reconstructable, authoritative, and accountable when challenged by an auditor, regulator, plaintiff, or board.
HOW PEDONE AI ADVISORS APPROACHES THIS
Defensibility architecture rests on three working assumptions.
First, governance is operational infrastructure, not policy documents. Documents do not run. Running infrastructure does. Pedone AI Advisors builds work that operates after the engagement closes, not deliverables that sit on a shelf.
Second, accountability has to be reconstructable, not just present. The question is not whether an organization has AI governance. The question is whether it can reconstruct who authorized the AI, who supervised the output, and what evidence supports the decision when someone asks two years later. Most organizations cannot.
Third, the architecture travels across regulated industries. The gap between AI deployment and AI accountability is structural — same problem in different vocabularies. The framework holds across healthcare, legal, clinical trials, and other regulated domains because it addresses the structure, not the surface.
ENGAGEMENTS
THE 30-DAY DEFENSIBILITY ASSESSMENT
For organizations needing an operational answer in four weeks
A bounded, four-week engagement that documents your AI governance posture against the regulatory frameworks shaping your exposure — ANSI/HSI 2800, FDA, OIG, FCA, and others as relevant — identifies the operational gaps that surface as risk, and produces an actionable roadmap for closing them.
Structured around the operational dimensions that surface in regulatory inspections, litigation discovery, board scrutiny, and audit failures. Examined across the AI deployments and vendors most central to your operations.
Deliverables: written assessment report, operational roadmap, and live walkthrough with leadership.
Sized for situations requiring a 30-day operational answer — regulator inquiry, litigation posture, board update, M&A diligence, internal audit response.
FRACTIONAL CAIGO
Named, accountable governance leadership on a fractional basis
A monthly retainer engagement that provides senior architectural counsel for AI governance — executing the operational roadmap, working alongside your team and existing vendors, and translating an evolving regulatory landscape into the decisions you make every week.
Cadence: weekly working sessions, governance committee participation, board-level reporting on AI risk posture, and direct execution support on the priorities you choose.
Engagement: three-month minimum, six-month preferred, with measurable success criteria established at engagement start.
Outcome: governance infrastructure that operationalizes during the engagement and continues operating after — built into your team's working rhythm, not delivered as documents that need someone to interpret them.
EXPERT WITNESS
Architectural analysis and testimony for active matters
Available to law firms representing clients in healthcare AI litigation, regulatory inquiries, or transactional matters where governance architecture is at issue.
Scope: architectural analysis, expert reports, deposition support, and trial testimony on industry standards, governance sufficiency, operational defensibility, and the interpretation of evolving regulatory frameworks.
Retained directly by counsel under standard expert witness terms. Substantive areas include healthcare AI deployment, ambient AI documentation, AI-influenced billing decisions, vendor accountability, and post-deployment monitoring failures.
THE LANDSCAPE
The standards are active now.
ANSI/HSI 2800:2025 — the first American National Standard for healthcare AI governance — places explicit accountability on Boards and CEOs. Skadden's February 2026 Informed Board memorandum (Vieira & Kerr-Shaw, "No Loopholes for AI") and Norton Rose Fulbright's April 2026 Healthcare IT News analysis establish that directors face personal liability for AI deployment without governance when standards were foreseeable.
The pattern repeats across regulated domains. FDA AIDF for medical devices and AI-enabled clinical decision support. ICH GCP R3 for clinical trial sponsor oversight. HIPAA Security Rule final rule expected May 2026. ABA Model Rules updates governing attorney AI use. ISO/IEC 42001 as the international standard for AI management systems.
The standards are converging on operational requirements that policy documents do not satisfy.
The Black Book 2026 Healthcare AI Governance Study — surveying 384 organizations — documented the operational reality: 76% of health systems cannot reconstruct AI-influenced decision chains. $2M+ in annual supervision costs go untracked. 72% of AI pilots fail operationally, not technically.
The standards are foreseeable. The operational gap is documented. The architecture is what closes it.
THE PRINCIPAL
Jeff Pedone is the founder of Pedone AI Advisors and a Contributing Researcher on the Black Book 2026 Healthcare AI Governance Study.
Before founding Pedone AI Advisors, Jeff spent 30 years in enterprise technology operations across Fortune 100 companies including Red Hat, Cisco, and Oracle. His background is in Customer Success leadership for organizations operating at the intersection of complex technology, regulated environments, and high-stakes accountability.
Defensibility architecture is the discipline that emerged from that work — the operational layer that makes complex systems reconstructable and accountable when challenged.
The practice is built around senior peer-altitude engagement rather than scaled consulting. Jeff works directly with the leaders responsible for AI governance decisions — not through associates, not through layered teams.
Engagements are bounded, defined by measurable success criteria, and structured to leave operating infrastructure behind rather than documents that need someone else to interpret.
Jeff is based in New Jersey and works with regulated organizations across the United States.
