AWS Clean Rooms ML for Healthcare Research - HEOR + RWE + Multi-Party

Datavant and Slalom reference AWS Clean Rooms; no vertical healthcare Clean Rooms ML professional services listing exists on AWS Marketplace today. Pharma-R&D + payer HEOR + multi-site clinical research collaboration is uncontested white space, and FDA's 2023 RWE guidance explicitly endorsed privacy-preserving computation / clean rooms as acceptable for regulatory submission.

Healthcare data collaboration has been broken for 20 years. Pharma cannot share patient-level data with payers for HEOR studies because HIPAA, GDPR, and DUAs block direct movement. Payer-pharma HEOR stalls 6–12 months on terms. Tokenization platforms (Datavant, HealthVerity, Komodo, Trinetx) charge $150K–$2M/yr and still require data movement. RWE platforms (Aetion, Flatiron, Trinetx) run $500K–$5M/yr with proprietary data-model lock-in.

AWS Clean Rooms + Clean Rooms ML solves this architecturally. Parties keep raw data in own S3 buckets under Lake Formation; Clean Rooms executes pre-approved analysis against federated datasets with cryptographic isolation, zero PHI egress between parties. Clean Rooms Identity Resolution matches identifiers without revealing them. Differential privacy enforces configurable epsilon budgets; k-anonymity default k ≥ 10; aggregation thresholds per DUA. Clean Rooms ML extends to lookalike + predictive without sharing training data. HealthLake normalizes FHIR R4; Comprehend Medical de-identifies; Macie discovers residual PHI; OMOP CDM via Glue.

Existing AWS Marketplace listings don't close this gap. Data Sharing & Clean Rooms (generic), AMC Clean Room Accelerator by Publicis Sapient (advertising), and Spectus (mobility data) are not healthcare-specific. The only RWE PS listing is a 4-week POC using Redshift + HealthLake + SageMaker, not a multi-party Clean Rooms collaboration. Slalom, Deloitte, Accenture, EY, PwC sell Clean Rooms advisory off-Marketplace at $250K–$1.5M.

Architecture deployed. Clean Rooms collaboration workspace (pharma + payer + CRO/provider + consortium); cryptographic isolation. Clean Rooms ML lookalike + predictive without training-data sharing. Analysis templates pre-approved per DUA; DP epsilon budgets; aggregation thresholds. Data layer: parties keep raw in S3 + Lake Formation tag-based governance. Health data: HealthLake FHIR R4; Comprehend Medical de-id; Macie PHI discovery. OMOP CDM (OHDSI) harmonization via Glue. Identity resolution via Clean Rooms (no identifier reveal). Statistical methodology federated (PSM, IPW, DiD, TTE). DP via Clean Rooms ML configurable epsilon. IRB-ready Common Rule (45 CFR 46) templates; 42 CFR Part 2 controls for SUD. FDA 2023 RWE guidance alignment. CloudTrail + Clean Rooms audit logs + S3 Object Lock (7-yr HIPAA). Lake Formation tag-based policies per party. DUA workflow: Clean Rooms membership + collaboration approval (Kriv reviews technical alignment; legal drafting Customer counsel).

Week-by-week. W1 Scoping + DUA review (party inventory; DUA technical alignment; data inventory; DP budget). W2 Workspace + governance (Clean Rooms setup; party invitation; Lake Formation governance). W3 Ingestion + de-identification (S3 + Lake Formation + OMOP CDM Glue; Comprehend Medical + Macie). W4 Analysis templates + DP config + k-anonymity thresholds. W5 IRB protocols + regulatory alignment (Common Rule; 42 CFR Part 2; FDA RWE memo), Foundation closes (30-day warranty). W6 First collaboration run + DP budget + audit verification. W7 Standard, Clean Rooms ML lookalike + predictive; PSM / IPW / TTE; HealthLake; QuickSight. W8 Standard: production multi-use-case (HEOR + RWE + comparator) (60-day warranty). W9–10 Enterprise , 5+ party consortium; FDA-submission evidence; 90-day hypercare.

Three tiers. Foundation $125K (6 wk; 2-party pharma+payer HEOR; Clean Rooms ML baseline; Entity Resolution; 1 lookalike model; DP; Common Rule template; 30-day warranty). Standard $200K (8 wk; 3–4 party; multi-use-case HEOR + RWE + comparator; HealthLake + Comprehend Medical; lookalike + predictive; 2 IRB templates; QuickSight; 60-day warranty) for mid-pharma RWE, CRO multi-sponsor, regional consortia. Enterprise $300K (10 wk; 5+ party; FDA 2023 RWE submission evidence; 3+ IRB templates; optional tokenization-vendor integration; 90-day hypercare) for large pharma-payer HEOR, multi-sponsor CRO, AMC research networks. Optional Extra Party $50K each.

Important disclosures. Kriv does NOT draft legal DUAs (counsel required). NOT a CRO; does not act as Sponsor, Investigator, or Monitor under 21 CFR Part 312. Does NOT issue IRB approval. No legal / regulatory / clinical / actuarial / expert-witness advice. NOT a HIPAA Covered Entity, operates as BA (BAAs required with all in-scope parties). No FDA RWE submission-acceptance guarantee. No IRB-approval outcome guarantee. AWS + Anthropic + Bedrock + Clean Rooms per-run consumption separate. No Clean Rooms API stability guarantee. Anthropic CPN membership does not constitute endorsement.