Every AI failure in a regulated institution traces back to the same root cause: the regulatory strategy was built after the solution was chosen — or never built at all.
At RCKCGROUP, regulatory strategy precedes everything. Before we recommend a platform, a use case, or a roadmap, we establish exactly what your compliance obligations require — and what they prohibit.
When AI systems are deployed without proper HIPAA authorization, FedRAMP authorization to operate, or FISMA compliance, regulators halt them publicly. The reputational damage to institutions serving vulnerable populations outlasts the technology failure itself.
Retrofitting regulatory compliance into an AI system costs 3–5× more than building it in from the start. Organizations that skip upfront regulatory strategy often find themselves rebuilding entire architectures after procurement — at the worst possible time in the budget cycle.
AI vendors who are not compliant with your regulatory environment can create contractual, legal, and mission exposure that takes years to unwind. A platform-agnostic regulatory strategy gives procurement teams defensible evaluation criteria — and legal protection when vendors fall short.
When AI systems cause harm in regulated environments, leadership is held accountable — regardless of whether they were involved in technical decisions. A documented regulatory strategy is the difference between institutional accountability and personal liability.
Every regulatory strategy engagement at RCKCGROUP is built on four non-negotiable principles. They are what separates a defensible compliance architecture from a compliance document that nobody reads.
No use case, platform recommendation, or roadmap is produced until we have a complete picture of your applicable regulatory obligations. Most consultants skip this step. We treat it as the only defensible starting point.
Regulatory strategy outputs are written for your legal counsel, compliance officer, and board — not your IT department. Every recommendation is framed in the language of obligation, risk, and defensibility rather than systems architecture.
We have no vendor relationships, no referral arrangements, and no incentive to recommend a specific platform. Our regulatory strategy gives you the evaluation criteria to assess any AI vendor against your specific compliance obligations — and the documentation to enforce those requirements in contracts.
We build regulatory strategy as institutional documentation — not as a consultant's deliverable. When leadership changes, budgets shift, or vendors are replaced, your regulatory strategy remains the authoritative record of how AI decisions were made and why they met your obligations.
Click any framework to see how it applies to AI deployments in your sector and what obligations it creates for your organization.
HIPAA is the foundational compliance framework for any AI system that touches protected health information (PHI). The Privacy Rule, Security Rule, and Breach Notification Rule each create specific obligations for AI systems — from how training data is handled to how AI-generated clinical recommendations are stored and transmitted.
FedRAMP establishes the security authorization requirements for cloud products used by federal agencies. Any AI platform deployed in or connected to a federal environment must either be FedRAMP authorized or be subject to an agency-specific ATO process. The consequences of non-compliance include halted contracts and program termination.
FISMA requires federal agencies to develop, document, and implement an information security program for systems supporting their operations. AI systems are information systems under FISMA — and the law's requirements for categorization, documentation, and continuous monitoring apply directly.
TRICARE is the health care program for uniformed service members, retirees, and their families. AI deployments in military health and behavioral health environments face the intersection of HIPAA privacy requirements, DoD security requirements, and the specific clinical and ethical considerations governing care for military personnel and their families.
NIST's AI RMF is the federal standard for trustworthy AI governance. While currently voluntary for most organizations, it is rapidly becoming an expected baseline — particularly in federal procurement and healthcare AI contexts. It provides the governance, accountability, and risk management structure that HIPAA, FedRAMP, and FISMA assume exists but don't define.
42 CFR Part 2 provides stricter privacy protections for substance use disorder (SUD) treatment records than HIPAA alone. For behavioral health organizations — particularly those serving military populations where SUD intersects with mental health care — AI systems that touch SUD records face a distinct and more stringent compliance layer that most AI vendors are unprepared for.
Every regulatory strategy we build operates across three interdependent layers — governance, operations, and documentation.
The organizational foundation of your regulatory strategy — defining who owns AI decisions, how they are made, and how accountability is documented. Governance architecture establishes the institutional structures that make your compliance posture defensible to regulators, auditors, and legal counsel.
The day-to-day compliance controls that must be embedded into AI system operations — data handling procedures, access controls, audit logging, incident response protocols, and the specific technical safeguards required by each applicable framework. Operational compliance is where most AI deployments fail.
The documentary record that proves your organization met its regulatory obligations — and that leadership made responsible, defensible decisions. Audit-ready documentation is not a retrospective exercise; we build it concurrently with your AI strategy so it exists before you need it.
Every deliverable is built for a specific institutional audience — legal, compliance, executive, and operational — and designed to remain useful beyond the engagement.
A plain-language summary of your compliance obligations mapped to your specific AI use cases — written for legal and compliance review, not technical teams.
A fully drafted AI governance policy tailored to your organization's existing policy framework — covering decision authority, accountability, ethics review, and incident response.
Platform-agnostic scoring criteria for AI vendors that reflect your regulatory requirements — so procurement decisions are defensible and contractually enforceable.
Step-by-step documentation of every internal approval, audit checkpoint, and governance sign-off required before AI deployment — so nothing surfaces in procurement.
A documented data governance framework for your AI systems — covering PHI handling, training data provenance, inference data minimization, and breach notification triggers.
A compiled documentation package that demonstrates your organization met its regulatory obligations — built to survive an OIG audit, HHS review, or IG inquiry without additional preparation.
A focused, principal-led engagement. No junior analysts. No offshore teams. No templates.
Principal-led discovery call. Organizational profile, applicable framework identification, and current compliance posture review. Existing policies and vendor contracts reviewed for gaps.
Detailed analysis of each applicable framework against your use cases and data environment. Exposure points identified, risk levels assigned, and obligation inventory completed.
Governance architecture drafted. Vendor evaluation criteria built. Approval pathway documented. Data handling framework designed. All deliverables reviewed with legal counsel if available.
Full deliverable package transferred. Board briefing delivered. Audit-ready evidence package compiled. 90-day implementation priorities defined. Your team owns everything — no ongoing dependency.
This service is designed for organizations at a compliance inflection point — where the cost of getting AI wrong is institutional, not just operational.
The first conversation is a direct exchange with Richard Kohn — not a discovery call with a sales team. We'll assess your regulatory exposure and tell you exactly what a strategy engagement needs to address.
Know exactly where your organization stands before committing to an AI strategy — across six domains including regulatory, data, and governance readiness.
Modern digital experiences built for adoption, usability, and long-term scale in regulated environments.
20+ years of enterprise AI transformation experience across healthcare, retail, and banking — combined with the agility of AI-native ventures.