Featured Archives - OMNY Health

The Company Now Offers Insights Across Ten Specialty Areas, Including Dermatology, Respiratory, Cardiovascular, Autoimmune, Gastroenterology, and Neurology

ATLANTA – May 8, 2025 – OMNY Health, the leading healthcare ecosystem for compliant real-world data insights at scale, today announced it has expanded its data network by adding more than 300 clinical assessment measures. These disease-specific measures include information derived from clinical severity indicators, surveys, and questionnaires, such as the Crohn’s Disease Activity Index (CDAI) and the Harvey Bradshaw index for Gastroenterology, as well as the Asthma Control Test and COPD Assessment Test (CAT) for Respiratory. These measures provide a more granular, real-world view of patient health, enhancing the ability to monitor disease progression and treatment impact.

The new measures incorporate data extracted and curated from structured and unstructured sources within OMNY Health’s extensive data pool of electronic health records (EHRs) to enhance the research and insights into medical specialties such as respiratory, cardiovascular, autoimmune, gastroenterology, neurology, and oncology. Adding these new pan-therapeutic measures builds on OMNY Health’s successful data strategy in dermatology, where it first demonstrated the value of leveraging disease-specific measures.

“For some time, OMNY Health has been seen as a dermatology data network, but with our network growth, we are moving beyond that and demonstrating the value of our solutions to the broader healthcare community,” said Dr. Mitesh Rao, CEO and Co-Founder of OMNY Health. “By leveling up research and making more information available across multiple specialties, OMNY Health enables teams to fill information gaps, accelerate research timelines, and make meaningful improvements to patient care.”

OMNY Health’s curated measures offering includes data on:

Longitudinal disease progression, flare-ups, and treatment responses for conditions such as asthma, COPD, Crohn’s disease, ulcerative colitis, rheumatoid arthritis, lupus, epilepsy, and multiple sclerosis
Real-world evidence on risk factors, medication adherence, and patient outcomes for conditions like heart failure and hypertension
Post-surgical recovery tracking, rehabilitation outcomes, and treatment effectiveness for various conditions

By capturing a broader range of clinical information across a larger and diverse set of provider organizations, OMNY Health’s measures provide deeper and more representative insights than traditional disease-specific registries, positioning the company as a go-to source for researchers seeking information and data.

“Democratizing access to longitudinal data that has both breadth and depth has been a longstanding challenge for healthcare researchers like myself,” said Dr. T. Y. Alvin Liu, Inaugural Director of the James P. Gills Jr. MD and Heather Gills Artificial Intelligence Innovation Center at Johns Hopkins Medicine. “As AI begins to leave its mark on the healthcare industry, these new measures from OMNY come at a pivotal time, guaranteeing the highest quality of data to researchers and actionable information to healthcare executives. By taking previously untapped data sources and turning them into resources for better care, we can provide more precise and accurate treatments to patients across care specialties and unparalleled insights for executives to make decisions on a system level.”

OMNY Health’s release of more than 300 new health measures to its data ecosystem follows the company’s announcement in March of the availability of 4 billion unstructured clinical notes. This enabled the company to support its customers in unlocking previously hidden insights, which will drive a better understanding of patient journeys and unleash new innovations in treatment options. For more information on OMNY Health and its data ecosystem, please visit www.omnyhealth.com.

About OMNY Health

OMNY Health™ is a national data ecosystem connecting the world of healthcare to fuel partnerships that improve clinical outcomes and drive patient care. OMNY’s dynamic partnerships with specialty health networks, hospitals, academic medical centers, and integrated delivery networks span all fifty states and cover over 85 million patient lives. The company’s comprehensive data layer powers health tech companies to drive the next generation of innovation. The platform serves as a centralized resource for life sciences and healthcare provider groups to facilitate mutually-beneficial data sharing and research collaboration at scale, fueling innovation where patients need it the most. OMNY Health’s data network now reflects more than eight years of historical data encompassing more than 4 billion clinical notes from 1 billion encounters, 500,000+ providers across 200+ specialties – and is growing. To learn more about how OMNY Health transforms lives and drives patient care by connecting providers and life sciences companies through data, visit www.omnyhealth.com.

Media Contact

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Caroline Rueve

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The pharmaceutical industry is rapidly embracing real-world evidence (RWE) to accelerate drug development and regulatory approvals. External control arms (ECAs), built using real-world data (RWD), are transforming clinical trials by offering an alternative to traditional placebo groups. By reducing recruitment burdens, increasing statistical power, and aligning with regulatory expectations, ECAs have the potential to redefine late-stage drug development.

OMNY Health is at the forefront of this shift, providing research-ready EHR datasets that seamlessly integrate into clinical trial designs. Our recent study demonstrates how EHR-derived control arms can effectively mirror traditional placebo groups, offering a robust and scalable solution for regulatory submissions.

Building an External Control Arm with OMNY Health’s RWD

To evaluate the feasibility of an ECA in a late-stage clinical trial, OMNY Health leveraged six specialty dermatology networks and six integrated delivery networks (2017-2024) from its real-world data platform. The study constructed an ECA for the Phase 3 POETYK PSO-1 trial, which evaluated deucravacitinib versus placebo for moderate-to-severe plaque psoriasis.

The ECA was built using precise patient selection criteria that ensured alignment with the trial’s placebo group. Patients were included if they met physician global assessment (PGA) score eligibility, ensuring comparable disease severity. Baseline treatment history was carefully controlled, and topical medication use was restricted prior to the index severity visit to reflect treatment-naïve status. By tracking patients longitudinally, we assessed week-16 outcomes using structured EHR data, mirroring the trial’s methodology.

While some demographic differences were observed—ECA patients were older, more likely to be female, and had a different racial distribution compared to the placebo arm—the disease severity and baseline clinical characteristics were well matched.

Key Findings: OMNY Health’s ECA vs. Trial Placebo Arm

The real-world ECA demonstrated a significantly higher response rate compared to the traditional placebo arm, reinforcing its validity as a comparator.

18.5% of ECA patients achieved PGA 0/1 (clear or almost clear skin), versus only 7.2% in the placebo arm.
Despite differences in age, gender, and race, disease burden and severity scores aligned closely between the ECA and placebo group.
Stratification by prior biologic use, systemic therapy history, and weight showed no notable impact on outcomes.

One notable finding was racial disparities in achieving the primary endpoint within the ECA, suggesting that differences in patient demographics between the ECA and placebo group may have contributed to the observed differences in response rates. Further research could explore adjustments such as population weighting to refine ECA comparability even further.

These results confirm that OMNY Health’s real-world dataset can be used to generate ECAs that replicate clinical trial placebo groups, while also revealing new insights into patient diversity, treatment history, and long-term outcomes.

Why OMNY Health’s Data is a Game-Changer for External Control Arms

Traditional clinical trials face high recruitment costs, ethical concerns over placebo use, and long enrollment timelines. OMNY Health helps to eliminate these barriers by offering regulatory-grade EHR data that aligns with clinical trial endpoints.

With 85M+ patients, 1B+ encounters, and 4B+ unstructured clinical notes, our dataset provides a scalable and statistically powerful alternative to traditional control groups. By incorporating structured disease severity scores, prescribing patterns, and physician-reported outcomes, our ECAs offer more efficient and cost-effective alternative to prospectively collected placebo data.

Beyond reducing recruitment time, OMNY Health’s real-world ECAs improve trial generalizability, capturing diverse patient populations often underrepresented in traditional studies. As the FDA increasingly endorses RWD for regulatory decision-making, the ability to integrate ECA’s into pivotal trials is becoming a competitive advantage for pharmaceutical companies.