AI in Regulated Industries: A Starter Map

AI in Regulated Industries: A Starter Map

AI Compliance Framework: Practical Steps to Govern Generative Models

Create a practical AI compliance framework that reduces risk, protects data, and speeds safe deployment — actionable steps and checklist to get started.

Generative AI brings productivity gains and new risks. This guide lays out a concise, actionable framework to scope projects, assess regulatory impact, govern data, validate models, and manage vendors so you can deploy responsibly.

  • Quick, operational steps to scope an AI project and set objectives.
  • How to map laws and standards, assess risk, and govern data lineage.
  • Validation, documentation, vendor controls, pitfalls, and a ready implementation checklist.

Set scope and objectives

Start by defining what the AI system will do, who benefits, and what “safe success” looks like. Clear scope reduces downstream rework and directs compliance effort.

  • Define business outcomes: productivity metric, customer benefit, or cost reduction.
  • List functional boundaries: allowed inputs, outputs, and prohibited actions.
  • Identify stakeholders: product owner, security, legal, privacy, and operations.
  • Set measurable success and safety criteria: accuracy thresholds, latency, and acceptable error types.

Example: “Customer support triage assistant that drafts replies for agent review, must redact PII and achieve ≥85% intent-match accuracy.”

Quick answer — 1-paragraph summary

To deploy generative AI responsibly, set a clear scope and objectives, map applicable regulations and standards, perform a use-case risk assessment, establish data governance and lineage, validate and document models, and apply rigorous vendor and contract management; follow the implementation checklist to operationalize these steps and avoid common pitfalls like unclear requirements, inadequate data controls, and poor validation.

Map applicable regulations and standards

Identify legal and regulatory regimes that apply to your data, industry, and geography early. This shapes data handling, retention, and disclosure requirements.

  • Regulatory scan: privacy laws (e.g., GDPR-style principles), sector rules (finance, healthcare), consumer protection, copyright, and explainability obligations.
  • Standards and frameworks: ISO/IEC AI standards, NIST AI RMF, SOC 2, and internal security baselines.
  • Risk tolerances set by compliance: permissible data categories, cross-border transfer rules, and required audit trails.

Tip: Create a simple matrix mapping each requirement to project controls (e.g., encryption at rest, PII redaction, audit logging).

Example regulation-to-control mapping
RequirementControlOwner
Personal data minimizationInput filtering & anonymization pipelinePrivacy lead
Auditability / loggingImmutable logs, model version taggingML Ops
Sector-specific consentConsent capture + storage, consent checksLegal

Assess use-case risk and compliance impact

Perform a structured risk assessment focused on harm categories, likelihood, and detectability. Prioritize mitigations where impact and probability converge.

  • Harm categories: privacy breaches, misinformation, discrimination, IP infringement, safety failures.
  • Likelihood factors: model provenance, training data quality, open vs. closed model, user control level.
  • Detectability: how quickly errors surface in production and whether automated monitoring can catch them.

Use a simple scoring grid (Impact 1–5, Likelihood 1–5) to compute a risk score and map to required controls (e.g., human-in-loop, stricter input filters, rejection rules).

Sample risk scoring
Use caseImpactLikelihoodRisk scorePrimary control
Automated legal advice5315 (High)Lawyer review + disclaimers
Internal knowledge search224 (Low)Access controls

Establish data governance, privacy, and lineage

Design a data lifecycle: collection, storage, processing, retention, deletion. Ensure traceability and privacy safeguards for every dataset used in training or inference.

  • Data catalog: tag datasets with sensitivity, source, consent status, and retention rules.
  • Lineage tracking: record transformations, model inputs/outputs, and dataset versions.
  • Privacy controls: PII discovery, masking, synthetic alternatives, and differential privacy where applicable.
  • Access controls and encryption: role-based access, key management, and secure audit logs.

Example requirement: “All datasets with customer PII must be stored in encrypted buckets, accessible only to the ML engineering group with logged access and quarterly review.”

Develop, validate, and document models

Adopt repeatable ML development and validation patterns that include testing for accuracy, fairness, robustness, and safety. Maintain concise but complete documentation for auditability.

  • Model cards and datasheets: record purpose, training data sources, evaluation metrics, limitations, and known failure modes.
  • Testing: unit tests, adversarial tests, bias/fairness tests, and scenario-based safety checks.
  • Validation: independent review by QA, privacy, and legal prior to production release.
  • Versioning: immutable model artifacts, reproducible training pipelines, and rollback capabilities.

Include sample prompts, failure examples, and benchmark results in documentation so reviewers have concrete evidence of behavior.

Manage vendors, procurement, and contracts

Third-party models and services require tailored controls. Contracts must transfer requirements into enforceable obligations and verification rights.

  • Due diligence checklist: security posture, model provenance, training data policies, and prior incident history.
  • Contract clauses: data processing agreement, audit rights, SLAs for availability and security, liability caps, and termination terms.
  • Operational controls: vendor access management, isolation of vendor models from sensitive datasets, and monitoring for drift or misuse.
  • Ongoing reviews: periodic security and compliance assessments, and renewal gating based on performance and risk.

Negotiation tip: require vendors to support redaction or local deployment options when handling regulated data.

Common pitfalls and how to avoid them

  • Unclear objectives — Remedy: set measurable success and safety criteria before development.
  • Poor data lineage — Remedy: implement dataset cataloging and immutable versioning from day one.
  • Insufficient validation — Remedy: include adversarial, bias, and scenario tests in CI pipelines.
  • Over-reliance on vendor claims — Remedy: require evidence, audit rights, and independent testing.
  • No human oversight for high-risk outputs — Remedy: mandate human-in-loop or explicit escalation paths for sensitive decisions.
  • Missing retention and deletion policies — Remedy: enforce lifecycle policies via automated workflows.

Implementation checklist

  • Document scope, stakeholders, and success/safety criteria.
  • Map regulations and create a controls matrix.
  • Complete a use-case risk assessment and assign mitigation owners.
  • Catalog datasets, tag sensitivity, and enable lineage tracking.
  • Define validation tests and produce model cards/datasheets.
  • Negotiate vendor contracts with audit rights and data protections.
  • Deploy monitoring, logging, and an incident response plan.
  • Schedule periodic reviews and re-assess risk post-deployment.

FAQ

How do I choose between an open model vs. vendor API?
Choose based on data sensitivity, control needs, and compliance: local models give more control over data and provenance; vendor APIs are faster but may constrain auditing and increase data exposure.
What minimum documentation should I produce?
At minimum: a model card, dataset inventory with sensitivity tags, validation test results, and a signed risk acceptance by a business owner.
When is human-in-loop mandatory?
Mandate human review where outputs affect legal rights, safety, or significant financial outcomes — or where regulations require human oversight.
How often should I re-evaluate risk?
Reassess on major model changes, after incidents, or at least quarterly for high-risk systems and annually for lower-risk systems.