Evidence Lens
The patient evidence pharma and care teams can act on. Clinical, claims, multi-omics, and wearable signal joined at patient level, reasoned through by agents.
Real-world evidence is that other half — and it is now the currency. Five modalities join at patient level. An agentic layer reasons across them and returns patient-grade evidence to pharma, diagnostics, providers, and trial sponsors.
Three facts. The category direction is set.
The regulatory verdict
Real-world evidence was cited in 23 to 28% of FDA labeling-expansion approvals across 2022 to 2024, peaking at 27.7% in 2023. Oncology led at 43.6%. The 2018 RWE Framework has been followed by guidance on registries (final December 2023), digital health technologies for clinical investigations (final December 2023), EHR and claims data (final July 2024), external-control trials (draft February 2023, pending finalization), and the medical-device RWE update (December 2025). EMA's DARWIN EU is operational across 16 European countries, covering roughly 180 million patients on a common OMOP model.
The commercial pull
Pharma is paying for linked real-world evidence at unit prices the market has not previously seen. AstraZeneca, Tempus, and Pathos announced a $200M agreement on April 17, 2025 to build a multimodal oncology foundation model on Tempus's de-identified patient records. GSK extended its Tempus partnership at $70M upfront in October 2022 for a three-year minimum, extendable to five. In January 2025, a coalition of US health systems launched the Truveta Genome Project, with the Regeneron Genetics Center as anchor sequencing partner in a $320M collaboration. CMS's Cell and Gene Therapy Access Model is operational across 32 states plus DC and Puerto Rico, with outcomes-based rebates tied to real-world results for Vertex's Casgevy and bluebird bio's Lyfgenia.
The five-modality gap
Clinical, claims, genomic, multi-omic, and wearable data live in four parallel stacks and four standards. Even the leading players show the scarcity of the join at patient level. By the time Tempus unveiled its Fuses foundation-model program in May 2025, the multimodal library had grown past 40 million records, of which more than 1.5 million carry matched clinical and genomic data. Wearable signal is now regulator-grade in tightly scoped settings.
The math
The leak is in the join, not in any single modality.
What the silo costs
Evidence gets reconstructed cohort-by-cohort and study-by-study. Time-to-cohort runs in months. Causal signal is lost at the boundary between modalities. Shadow patient journeys outside the EHR — specialist visits, out-of-network labs, generic prescriptions, lifestyle change — go uncaptured. Every fragmented evidence base is paid for again on the next study.
Why genomics alone is half an answer
AACR's Project GENIE Biopharma Collaborative is a ten-sponsor precompetitive collaboration targeting roughly 50,000 patients with cohorts in various cancers. The target is small for a reason.
Why claims alone is half an answer
Komodo's Healthcare Map covers more than 325 million de-identified patients. The breadth is real and useful. The limit is structural. Claims describe reimbursement, not clinical truth.
Why wearables alone is half an answer
The qualified wearable endpoints work only inside tightly scoped patient populations. Continuous physiology without molecular and clinical context is signal without meaning.
The Blueprint
Four layers. One patient view.
Evidence Lens sits above the existing data estate — EHR, claims platform, sequencer pipeline, wearable ingestion. Four layers harmonize the modalities, store the patient evidence semantically, reason across it, and surface the work to four audiences.
Layer 04 · Surfaces
- Bioinformatician: Research Workbench
- Commercial Lead: Partner-Insight Surface
- Provider: Patient-Journey Console
- Trial Sponsor: Cohort Explorer
Layer 03 · Reasoning
- Agent 01: Cohort Assembly
- Agent 02: Phenotype Enrichment
- Agent 03: Journey Reconstruction
- Agent 04: Evidence Synthesis
Layer 02 · Vectors
- Embeddings · Clinical: Clinical Vector Store
- Embeddings · Genomics: Genomics Vector Store
Layer 01 · Fabric
- Clinical: FHIR R4 / R5
- Claims: OMOP CDM v5.4
- Genomics: GA4GH VRS
Trust posture
Five controls the medical, technology, and privacy office will ask about in the first working session.
- Compliance: HIPAA BAA, SOC 2 Type II controls
- Identity resolution: Patient-level join across modalities via tokenization.
- Deployment model: AWS, Azure, and GCP supported.
- Clinical decision-support stance: The agentic layer informs care.
- Bias and validation: Cohort representation is reported against benchmark populations.
The data foundation
Three tiers of evidence depth. Tier 1 alone no longer answers.
- Tier 01 · Baseline: Clinical + claims
- Tier 02 · Multi-omics: Joined at patient level
- Tier 03 · Wearables · DHT: Continuous signal
The patient is the unit of evidence.
The bet
The patient-level join is the asset. The agentic layer is what makes it usable.
The window
The regulatory and commercial pulls are public. The five-modality join is still rare in 2026.
The risk
What we do not know
We don’t yet know how the agentic layer will perform on your specific cohort until we run it against yours.
What we will not do
The agentic layer informs care. The blueprint does not replace the EHR or other existing systems.
The engagement model
Prove the join first. Ship one use case next.
- Sprint (Weeks 1–2): Prove the join on your own patients.
- Enable (One use case): Ship one use case end-to-end.
- Realize (Cycle over cycle): Scale across use cases.
Commitments
Bounded confidence
One use case in Enable.
Confidence range, not promise
Sprint returns a measured range on what Enable would deliver on your data.
Designed for the loop
The blueprint sits above the systems of record, not inside them.
Next Step
If this looks like the right shape for your evidence question, the next step is a Baseline Assessment.