Tier 1
Standard Review
Professional linguist plus QA score.
Best for
Internal communications, HR materials, training content, and general business documents.
AI Risk & Intelligence Assurance
Defensible AI translation verification for healthcare, financial services, legal, and pharma. Human-validated translation with reviewer credentials, full audit trails, and certification letters built into every job - for the regulated industries where "we used an AI" is not an acceptable answer.
Talk to our teamThe State of AI Translation in Regulated Industries
- The Audience: 25.7M U.S. adults have limited English proficiency, and most regulated industries are required by law to communicate with them (U.S. Census Bureau, 2021).
- The Shortcut: 73% of healthcare organizations already use AI translation to keep up. Only 8% have a formal validation process (CSA Research, 2024).
- The Bill: $71M settlement for one mistranslated word in a Florida ER (Ramirez case). $811M judgment for English-only contracts with Spanish-speaking customers (CFPB v. Libre by Nexus, 2024). AI at scale multiplies the exposure.
Your AI compliance program probably has a translation gap. AI translation is already in your workflow; the audit trail probably is not. Whether that gap surfaces during a CFPB inquiry, a Section 1557 investigation, an FDA submission, or a foreign-language exhibit in discovery, the answer to “how was this translation validated?” needs to be more than the name of an AI tool.
ARIA produces the audit trail, reviewer credentials, and certification letter that your regulators, opposing counsel, and compliance team will accept.
Regulatory Convergence
Why This Matters Now
AI translation is the new default.
Across healthcare, financial services, legal, and pharma, AI-generated translation has moved from pilot to production faster than internal validation policies could catch up.
Regulators are catching up
Section 1557 mandates human expert review of AI translation before clinical use. CFPB cites language barrier exploitation as UDAAP and ECOA. FDA 21 CFR Part 11 requires traceable, signed review. Courts require certification with attestation.
The audit trail is the asset
Reviewer identity, timestamps, tracked edits, and segment-level QA scores are what every emerging AI governance framework - from the NIST AI RMF to the EU AI Act - is converging on as evidence of validation.
Most validation is informal
CSA Research found only 8% of healthcare organizations have a formal AI translation validation process. Most other regulated industries are tracking even less.
Why AI Risk & Intelligence Assurance, Not Just AI
Defensible Translation Models
Unverifiable AI Output
Pure AI translation delivers speed but fails regulatory scrutiny due to the absence of a reviewer of record, measurable QA scoring, and formal certification required for defensible submission.
Non-Scalable Traditional LSPs
Conventional language service providers offer defensibility, but segment-by-segment human review creates throughput constraints that cannot meet the scale of modern regulated content demands.
Internal Review Exposure
In-house review workflows introduce latency without establishing auditability, resulting in undocumented processes that carry equivalent legal and compliance risk as unverified AI output.
ARIA Hybrid Model
ARIA combines AI-driven throughput with qualified human validation and a built-in audit trail, using risk-tiered workflows to align review depth with regulatory exposure while maintaining scale.
Industries we support
Tailored solutions for regulated, high-impact sectors.
Healthcare & Health Systems
Patient-facing and clinical content including communications, consent forms, discharge instructions, IFUs, EHR entries, and member materials. Built to meet HIPAA translation requirements, Section 1557 language access mandates, and The Joint Commission 2026 National Patient Safety Goals.
Financial Services & Insurance
Structured financial content such as member disclosures, EOBs, policy documents, HR materials, and B2B communications. Aligned with General Data Protection Regulation translation standards, California Consumer Privacy Act compliance, UDAAP principles, ECOA requirements, and CMS member communication guidelines.
Legal & Corporate Counsel
High-precision legal documentation including contracts, discovery files, M&A due diligence, immigration filings, and regulatory submissions. Delivered under ISO 17100 processes, ABA-aligned workflows, USCIS-certified translation protocols, and court-admissible formatting.
Pharma, Life Sciences & Medical Devices
Regulated scientific and clinical materials such as IFUs, drug labels, patient leaflets, clinical protocols, trial documentation, and regulatory submissions. Compliant with 21 CFR Part 11 translation standards, EU MDR/IVDR labeling rules, and global GCP/GMP quality frameworks.
Outcomes
Results you can expect
AI Translation at Scale
AI translation at scale across regulated content types and over 200 language pairs.
Risk-Tiered Expert Review
Risk-tiered review by qualified linguists, domain SMEs, and Regulatory SMEs.
Auditable Quality Assurance
Translation quality assurance: full audit trail with reviewer identity, credentials, timestamps, tracked edits, and segment-level QA scores.
Certified Translation Output
Certification letter with translator attestation for regulated-tier output.
ISO-Aligned Workflow
ISO 17100-aligned human review workflow.
Terminology & Memory Control
Translation Memory and domain glossary maintenance across submission cycles.
Secure Delivery Infrastructure
Secure portal and API delivery, BAA available, SOC 2 Type II controls.
Service Tiers
Three review levels, matched to your risk
Tier 2
Technical Review
Domain SME review, risk-flagged tracking, and full audit trail.
Best for
Clinical documentation, contracts, financial disclosures, and regulated B2B content.
Tier 3
Regulatory Review
Clinical, Legal, or Regulatory SME plus ISO 17100 plus certification letter.
Best for
Section 1557 materials, court filings, USCIS submissions, FDA filings, MDR labeling, and CMS-regulated content.
Included with
Every tier
Translation Memory
Maintained across projects
Glossary updates
On every delivery
Secure delivery
SFTP or portal
How It Works
AI scale, human accountability, certified delivery
-
Step 01
AI generates risk scores
Content submitted via portal or API. AI translation runs at scale. Automated QA scores every segment and assigns a Standard, Technical, or Regulatory risk tier.
Automated -
Step 02
Human review, matched to risk level
Professional linguist, domain SME, or Regulatory SME assigned by risk tier. All material changes are tracked and documented with a rationale. No segment bypasses review when risk is flagged.
Expert reviewed -
Step 03
Certified delivery
Final translation, QA report, full audit trail, and certification letter (when applicable) delivered as one package. Ready for the regulatory file, counsel review, or production.
Audit-ready
Compliance Coverage
Built for the most regulated industries on earth.
16
Active certifications
01
Privacy & data protection
- GDPR
- CCPA
- HIPAA / BAA
02
Healthcare & clinical
- Section 1557
- CMS communications
- Joint Commission 2026
03
Legal & translation
- ISO 17100
- USCIS certified
- Court-admissible
- ABA-aligned
04
Life sciences & regulated industries
- FDA 21 CFR Part 11
- EU MDR / IVDR
- GCP / GMP
05
AI & security
- NIST AI RMF
- EU AI Act
- SOC 2 Type II
All certifications maintained continuously.
Schedule a consultationRelated resources
December 16, 2024
2025 Predictions: The Future of Language Services Will be Defined by Generative AI
Read More
November 12, 2024
Can ChatGPT Interpret Legal Documents Effectively? Exploring AI’s Role in Legal Language Services
Read More
March 3, 2025
Certified Medical Interpreters vs. AI Translation: What Hospitals Need to Know
Read More
Next Step
Tell us which content lives in your highest-risk pile.
We will show you what an ARIA audit trail would look like for that specific workflow.
