OM1, Inc.

OM1, Inc. operates an AI outcomes platform built on the PhenOM foundation model, trained on over 1 billion patient-years of healthcare data. The company provides real-world evidence generation, patient phenotyping, outcomes prediction, and clinical registry services primarily for life sciences companies, healthcare providers, and payers. Founded in 2015 and headquartered in Boston, OM1 pioneered digital patient phenotyping technology and launched its first AI model in 2017.

The company's platform combines three core components: the PhenOM foundation model for patient identification and medical event prediction, an Agentic Health Data Framework for automated data processing, and a Real-World Data Cloud covering 350+ million patients with linked longitudinal data from EMR, claims, and specialty networks. OM1 has been awarded 10 AI technology patents covering phenotyping, subtyping, explainability, and outcomes measurement.

OM1 serves major pharmaceutical companies including Amgen, AbbVie, GSK, and Johnson & Johnson, with expertise in regulatory submissions and FDA-ready evidence generation. The company completed what it describes as the largest AI-processed study with a successful regulatory submission for a new label indication, and received Frost & Sullivan's 2025 Technology Innovation Leadership Recognition for real-world evidence solutions in immunology and oncology.

Choose OM1 when your organization requires AI-powered real-world evidence that meets regulatory standards, particularly for FDA submissions or payer coverage decisions. The company excels in complex phenotyping scenarios where traditional data sources lack sufficient granularity, and when predictive capabilities for patient outcomes, disease progression, or treatment response are central to decision-making.

Expect a consultative engagement model combining platform technology with scientific and clinical expertise. OM1's team provides epidemiological design, regulatory strategy, and data science support alongside platform access, making them suitable for organizations that value expert guidance in addition to technology capabilities.

OM1 operates exclusively in healthcare, with 100% focus on outcomes measurement and real-world evidence generation. The company maintains specialized networks in neurology (3+ million patients), immunology, and oncology, with demonstrated expertise in regulatory compliance and FDA submissions. Their platform addresses healthcare-specific challenges including patient phenotyping for rare conditions, treatment effect estimation from observational data, and automated abstraction for quality registries.

The company serves three primary healthcare verticals: life sciences companies requiring real-world evidence for drug development and regulatory submissions, payers needing predictive analytics for member risk assessment and intervention targeting, and provider organizations seeking quality improvement through automated registries and patient identification for care gaps.

The ideal OM1 client is a pharmaceutical company seeking regulatory-grade real-world evidence for label expansions or post-market surveillance, a national payer implementing predictive analytics for population health management, or a large academic health system requiring automated registry solutions. These organizations have complex evidence needs, regulatory requirements, and the resources to implement AI-driven insights into clinical or business operations.