AWS Clean Rooms ML for Healthcare Research - HEOR + RWE + Multi-Party
Kriv AI · Cybersecurity & IT
Certification per AWS Marketplace.
Evidence tier Source Confirmed · 4 captures on record
What the publisher says
As described on AWS Marketplace.
**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.
Show the rest of the publisher’s description (6 more lines)
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.
Highlights
Highlighted by the publisher on AWS Marketplace.
First vertical healthcare Clean Rooms ML PS listing on AWS Marketplace — pharma-payer HEOR + RWE + multi-site clinical research + multi-sponsor CRO federations + payer-provider VBC + AMC consortium research.** HEOR studies that used to take 6–12 months on DUAs now run in 6–10 weeks. Competitors: Datavant + Slalom reference Clean Rooms but sell off-Marketplace at $250K–$1.5M; Aetion / Flatiron / Trinetx are $500K–$5M/yr SaaS platforms with proprietary data-model lock-in.
Zero PHI egress between parties, architectural guarantee via AWS Clean Rooms cryptographic isolation + differential privacy + k-anonymity (k ≥ 10 default) + aggregation thresholds per DUA. Clean Rooms ML lookalike + predictive modeling across parties without sharing training data. Clean Rooms Identity Resolution matches identifiers without revealing them. OMOP CDM harmonization via AWS Glue. AWS HealthLake + Amazon Comprehend Medical de-identification + Amazon Macie PHI discovery.
IRB-ready Common Rule (45 CFR 46) protocol templates + 42 CFR Part 2 controls for SUD records + FDA 2023 RWE guidance alignment (privacy-preserving computation explicitly endorsed for regulatory submission).** AWS Select + Databricks + Anthropic CPN. Three tiers: $125K Foundation (2-party pharma+payer HEOR pilot); $200K Standard (3–4 party multi-use-case); $300K Enterprise (5+ party consortium + FDA submission-ready evidence + 90-day hypercare). Extra Party $50K each.
Agent build and provenance
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Compliance
- FedRAMPConfirmedNot listed90%, registry-checkedNo FedRAMP Marketplace entry matched this vendor's domain, checked 2026-08-27registry recordas observed 2026-08-27
Confirmed means matched to a public authoritative registry. Claimed means the vendor or its listing states it, not yet cross-checked. A framework not shown was not found in any source we hold, which is not evidence against it. Not listed means a scoped registry check found no match for this vendor's domain: a No is a scoped registry check, not a compliance judgment. Confidence bands: 95% domain-verified, 90% registry-checked, 80% self-attested, 70% weak signal. Self-attested items marked “vendor's site” are gathered from the vendor's own website and are not verified by us.
Vendor
External enrichment · as of 2026-08-29
Sources
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3 linksLinked repositories
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