Forward to: Regulatory Affairs

Regulatory & Compliance
Workflows

Ten agent workflows for the Regulatory Affairs team — automated FDA monitoring, HIPAA compliance tracking, clinical regulation changes, global health authority intelligence, state regulatory tracking, accreditation monitoring, clinical trial regulatory compliance, post-market surveillance, quality system audit preparation, and regulatory change impact assessment — providing comprehensive domain-level regulatory intelligence.

1FDA Regulatory Monitoring

AI agent continuously monitors FDA website sections for guidance updates, enforcement actions, approval decisions, and policy changes that impact healthcare product development and commercialization strategies.

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Track FDA Activity Across Divisions
/docs/press/compliance/eventsDomain Ages
FDA REGULATORY MONITOR — FEBRUARY 2026 ════════════════════════════════════════════════════════════ fda.gov CDER (Drugs): /docs: Draft guidance — AI in drug manufacturing quality systems /press: 14 NDA/BLA approvals in January 2026 /compliance: 3 warning letters — GMP violations CDRH (Devices): /docs: Final rule — SaMD clinical evidence requirements /press: 987 AI/ML device clearances (cumulative) /events: Digital Health Advisory Committee — March 15 CBER (Biologics): /docs: Updated gene therapy long-term follow-up guidance /press: Cell therapy accelerated approval pathway expanded ORA (Regulatory Affairs): /compliance: Import alert: 12 new facilities added — India, China /docs: Inspection frequency increasing post-COVID return to normal
2
Assess Regulatory Impact
Regulatory Signal
AI Manufacturing Guidance — Draft guidance on AI in drug manufacturing quality systems could impact GMP compliance requirements for 67% of manufacturing sites using AI-based quality control. Comment period: 90 days. /docs page analysis shows this is the first guidance specifically addressing AI in pharmaceutical manufacturing — industry-defining implications.
ACTION — 90-day comment period, submit industry position
3
Generate Regulatory Calendar

FDA Regulatory Calendar — Q1 2026

UPCOMING DEADLINES & EVENTS ──────────────────────────────────────── Feb 28: AI manufacturing guidance comment deadline (60 days remaining) Mar 15: Digital Health Advisory Committee meeting Mar 22: Gene therapy follow-up guidance effective date Apr 01: SaMD clinical evidence final rule effective Apr 15: GDUFA III implementation — biosimilar user fees PRIORITY ACTIONS 1. Draft AI manufacturing guidance comment — coordinate with QA team 2. Prepare for DHAC meeting — potential policy implications 3. Update SaMD clinical evidence plans before April effective date 4. Assess GDUFA III impact on biosimilar filing timeline 5. Review import alert list — supply chain risk assessment

2HIPAA Compliance Tracking

AI agent monitors HHS, OCR, and healthcare organization websites for HIPAA enforcement actions, breach notifications, compliance guidance updates, and security rule changes that impact privacy and data protection strategies.

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Monitor HIPAA Enforcement Activity
/compliance/press/security/legalDomain Ages
HIPAA ENFORCEMENT TRACKER — Q1 2026 ════════════════════════════════════════════════════════════ hhs.gov/ocr /press: 12 HIPAA settlements in January 2026 — record pace /compliance: New right of access enforcement initiative launched /docs: Proposed HIPAA Security Rule update — risk assessment requirements NOTABLE SETTLEMENTS: Healthcare system: $4.2M — lack of risk analysis, no encryption Telehealth provider: $1.8M — PHI disclosure via tracking technologies Health app: $890K — unauthorized data sharing to third parties BREACH NOTIFICATION TRENDS: Breaches reported (500+ records): 847 in 2025 — record high Top cause: Ransomware (34%), unauthorized access (28%) Average fine: $1.4M (up from $890K in 2024)
2
Assess Compliance Risk
HIPAA Signal
Tracking Technology Enforcement — OCR targeting healthcare websites using analytics tracking that shares PHI with third parties. 3 settlements in Q1 2026 specifically cite pixel tracking and session replay tools. Domain analysis shows 45% of healthcare organization websites still have Google Analytics or Meta Pixel on patient-facing pages — significant compliance exposure.
HIGH RISK — Tracking technology enforcement accelerating

3Global Health Authority Intelligence

AI agent monitors health regulatory authorities worldwide — EMA, PMDA, TGA, Health Canada, NMPA — for approval decisions, guidance changes, and policy updates that impact global development and commercialization strategies.

1
Track Global Regulatory Activity
/docs/press/complianceCountriesDomain Ages
GLOBAL HEALTH AUTHORITY TRACKER ════════════════════════════════════════════════════════════ ema.europa.eu — European Medicines Agency /docs: EU AI Act health sector implementation guidance /press: 8 marketing authorizations in January 2026 /compliance: New clinical trial regulation amendments proposed pmda.go.jp — Japan PMDA /docs: Real-world data acceptance framework expanded /press: Conditional approval: 3 regenerative medicines tga.gov.au — Australia TGA /docs: SaMD classification changes — Class IIa threshold lowered /press: Mutual recognition with Singapore HSA expanded nmpa.gov.cn — China NMPA /docs: ICH E6(R3) GCP adoption timeline published /press: 12 innovative drug approvals — fast-track pathway
2
Generate Global Regulatory Brief

Global Regulatory Intelligence Brief

REGULATORY LANDSCAPE BY REGION ──────────────────────────────────────── EU: AI Act implementation + clinical trial regulation updates Japan: RWD acceptance expanding — accelerated development pathway Australia: SaMD classification changes — reclassification needed China: ICH adoption + fast-track approvals — market access improving CROSS-REGIONAL IMPLICATIONS 1. EU AI Act health guidance — align global AI governance framework 2. Japan RWD acceptance — leverage US RWE for Japan submissions 3. Australia SaMD changes — refile 4 products before deadline 4. China ICH adoption — simplifies global development harmonization 5. AU-Singapore mutual recognition — combined filing opportunity

4State Regulatory Tracking

AI agent monitors state health department, insurance commissioner, and legislative websites for state-level healthcare regulations including telehealth parity, PBM transparency, surprise billing, and scope of practice changes.

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Monitor State Regulatory Changes
/docs/press/compliance/legalCountries
STATE REGULATORY TRACKER — 50 STATES ════════════════════════════════════════════════════════════ STATE AGENCY DOMAINS MONITORED: 247 REGULATORY CHANGES: 89 in last 30 days HIGH-IMPACT CHANGES: California: New AI transparency law — healthcare AI disclosure requirements New York: PBM transparency legislation signed — rebate disclosure Texas: Telehealth parity made permanent — all service lines Florida: Pharmacy benefit reform — PBM licensing requirements Illinois: Nurse practitioner full practice authority granted COMPLIANCE DEADLINES: California AI transparency: July 1, 2026 New York PBM disclosure: September 1, 2026 Florida PBM licensing: January 1, 2027
2
Assess Multi-State Compliance Impact
State Signal
California AI Healthcare Law — First state-level AI transparency requirement for healthcare. /docs page mandates disclosure when AI is used in clinical decision-making, coverage determinations, and patient communications. Other states expected to follow — 12 similar bills introduced. Compliance requires AI inventory across all healthcare operations.
PRECEDENT — California AI law likely to cascade to other states

5Accreditation Monitoring

AI agent monitors accreditation body websites and healthcare organization compliance pages to track accreditation status changes, new standards releases, and survey preparation requirements across the provider network.

1
Track Accreditation Standards
/docs/compliance/press/events
ACCREDITATION LANDSCAPE MONITOR ════════════════════════════════════════════════════════════ jointcommission.org /docs: New antimicrobial stewardship standards — effective July 2026 /press: Updated survey methodology — unannounced surveys expanding /events: Standards webinar series — March-April 2026 ncqa.org /docs: HEDIS 2027 measure updates published /compliance: Health plan accreditation standards revised /press: Digital health integration standards proposed urac.org /docs: Telehealth accreditation program updated /compliance: New health equity accreditation track launched
2
Generate Accreditation Readiness Report

Accreditation Intelligence Report

STANDARDS CHANGES SUMMARY ──────────────────────────────────────── Standards updated: 14 | New requirements: 8 | Effective dates: 4 in next 6 months PRIORITY ACTIONS 1. Prepare for Joint Commission antimicrobial stewardship — July 2026 2. Update HEDIS 2027 quality reporting measures 3. Pursue URAC health equity accreditation — competitive differentiator 4. Assess unannounced survey readiness across all facilities 5. Evaluate NCQA digital health integration standards for health plan partners

6Clinical Trial Regulatory Compliance

AI agent monitors regulatory authority websites for clinical trial regulation changes, IRB requirements, informed consent guidance, and GCP updates that impact clinical research operations and compliance.

1
Track Clinical Trial Regulations
/docs/compliance/pressCountries
CLINICAL TRIAL REGULATION TRACKER ════════════════════════════════════════════════════════════ fda.gov /docs: Updated diversity action plan requirements for clinical trials /compliance: Decentralized trial conduct guidance finalized /press: eConsent framework expanded to all trial types ema.europa.eu /docs: EU Clinical Trials Regulation — CTIS system updates /compliance: Sponsor transparency requirements enhanced KEY CHANGES: Diversity plans: Required for all Phase III IND submissions from April 2026 DCT guidance: Remote consent, home nursing, direct-to-patient shipping cleared eConsent: Video and interactive consent modules now acceptable
2
Assess Compliance Impact
Compliance Signal
Diversity Action Plan Mandate — FDA /docs update requires diversity enrollment plans for all Phase III submissions starting April 2026. Domain analysis of 89 sponsor /products pipeline pages shows only 34% have diversity commitments. Non-compliant submissions may face complete response letters. Immediate protocol amendment recommended for all active Phase III trials.
DEADLINE — April 2026, diversity plans required for all Phase III filings

7Post-Market Surveillance Intelligence

AI agent monitors adverse event databases, manufacturer safety pages, and regulatory authority enforcement actions to track post-market safety signals for marketed products and devices.

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Monitor Post-Market Safety Signals
/compliance/press/security/legalDomain Ages
POST-MARKET SURVEILLANCE — PRODUCT PORTFOLIO ════════════════════════════════════════════════════════════ SAFETY SIGNAL DETECTION: fda.gov/medwatch /compliance: Increased FAERS reports for Drug X — hepatotoxicity signal /press: FDA safety communication issued — label update under review COMPETITOR SAFETY EVENTS: competitor-rx.com /legal: Product liability page added — cardiovascular events /press: Voluntary market withdrawal in 3 countries /compliance: REMS program modification required by FDA OUR PORTFOLIO STATUS: No active safety signals — competitive advantage
2
Assess Safety Signal Implications
Safety Signal
Drug X Hepatotoxicity Signal — Increased FAERS reports detected via FDA /compliance page monitoring. Safety communication issued before public awareness. Label update likely within 90 days. If our product is in same class, prepare proactive safety differentiation communications. If competitor product, prepare for potential market share shift.
MONITORING — Safety signal developing, label update expected

8Quality System Audit Preparation

AI agent monitors regulatory inspection databases, quality consulting firm websites, and industry association guidance to track inspection trends, common findings, and best practices for maintaining audit readiness.

1
Track Inspection Trends
/docs/compliance/press/blog
QUALITY INSPECTION INTELLIGENCE — 2026 ════════════════════════════════════════════════════════════ fda.gov /compliance: Inspection frequency returning to pre-COVID levels /docs: Updated inspection approach — risk-based model /press: Warning letters up 34% YoY — enforcement intensifying TOP FORM 483 OBSERVATIONS (from /compliance analysis): 1. Inadequate CAPA procedures: 28% of observations 2. Data integrity deficiencies: 22% of observations 3. Equipment qualification gaps: 18% of observations 4. Training documentation: 14% of observations 5. Change control weaknesses: 12% of observations
2
Generate Audit Readiness Assessment

Audit Readiness Report

INSPECTION RISK ASSESSMENT ──────────────────────────────────────── Inspection probability (2026): High — 67% of facilities due Warning letter trend: +34% YoY — enforcement intensifying Risk areas: CAPA, data integrity, equipment qualification READINESS ACTIONS 1. Conduct mock inspections at all manufacturing facilities 2. Remediate CAPA procedure gaps — #1 observation area 3. Data integrity audit — address before inspection 4. Update equipment qualification records 5. Complete training documentation gap analysis

9Healthcare Privacy Law Monitoring

AI agent tracks state privacy laws, consumer health data protections, and emerging data governance frameworks by monitoring legislative websites, privacy advocacy domains, and regulatory agency guidance pages.

1
Track Privacy Law Evolution
/docs/legal/compliance/pressCountries
HEALTHCARE PRIVACY LAW TRACKER ════════════════════════════════════════════════════════════ STATE CONSUMER HEALTH DATA LAWS: Washington: My Health My Data Act — in effect, enforcement active Connecticut: Consumer health data protection — effective July 2026 Nevada: Consumer health data law — effective January 2027 12 additional states: Bills introduced — monitoring stage FEDERAL DEVELOPMENTS: hhs.gov /docs: HIPAA Security Rule update proposed — comments due April 2026 /press: Reproductive health privacy protections finalized GLOBAL: edpb.europa.eu /docs: GDPR health data processing guidance updated
2
Assess Compliance Exposure
Privacy Signal
Consumer Health Data Law Cascade — 15 states now have or are considering consumer health data laws beyond HIPAA. These laws apply to non-HIPAA data (apps, wearables, website analytics). Domain analysis shows 78% of healthcare organizations collect consumer health data through digital properties not covered by HIPAA. Compliance gap is significant and growing.
EXPANDING — State privacy laws outpacing organizational compliance

10Regulatory Change Impact Assessment

AI agent provides cross-functional regulatory change impact analysis by correlating regulatory developments with business operations, product portfolios, and strategic initiatives to quantify compliance impact and prioritize response.

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Correlate Regulations with Operations
/docs/compliance/products/pressCountriesIAB Categories
REGULATORY CHANGE IMPACT MATRIX — Q1 2026 ════════════════════════════════════════════════════════════ CHANGE: FDA AI Manufacturing Guidance Impact areas: Manufacturing (HIGH), Quality (HIGH), R&D (MEDIUM) Products affected: 8 of 12 manufactured products use AI QC Timeline: Comment period → final rule → compliance (18-24 months) Cost estimate: $4.2-6.8M for full compliance CHANGE: California AI Transparency Law Impact areas: Digital Health (HIGH), Patient Services (HIGH), Marketing (MEDIUM) Operations affected: 34 AI-powered patient-facing tools Timeline: Effective July 1, 2026 — 4.5 months Cost estimate: $1.2-2.1M for compliance implementation CHANGE: HIPAA Security Rule Update Impact areas: IT (HIGH), Compliance (HIGH), All operations (MEDIUM) Systems affected: 247 systems processing PHI Timeline: Proposed rule → final rule → compliance (24-36 months) Cost estimate: $8.4-12M for security infrastructure updates
2
Generate Impact Assessment Report

Regulatory Impact Assessment — Q1 2026

EXECUTIVE SUMMARY ──────────────────────────────────────── Active regulatory changes: 34 | High-impact: 8 | Medium: 14 | Low: 12 Total compliance cost (18-month horizon): $14-21M estimated Resource requirements: 12-18 FTEs for compliance implementation PRIORITY RANKING 1. California AI Transparency — 4.5 months, $1.2-2.1M (URGENT) 2. FDA Diversity Plans — April 2026 deadline, affects active trials 3. FDA AI Manufacturing — comment period active, shape outcome 4. TEFCA enforcement — July 2026, interoperability compliance 5. HIPAA Security Rule — 24-36 month timeline, plan strategically
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