OMNY Health, the leading healthcare ecosystem for compliant real-world data insights at scale, today announced it has become the first electronic health record (EHR) company to offer its real world data (RWD) dataset on Datavant Connect powered by AWS Clean Rooms through its Lighthouse Partner Program.
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.
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.
The real-world ECA demonstrated a significantly higher response rate compared to the traditional placebo arm, reinforcing its validity as a comparator.
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.
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.
Pruritus, or chronic itch, is one of the most common symptoms reported in dermatology, yet real-world treatment patterns remain poorly characterized. While topical therapies are typically the first-line approach, severe cases often require systemic interventions. But how do clinicians determine when to escalate therapy? OMNY Health conducted a real-world evidence study leveraging research-ready EHR data from six specialty dermatology networks to examine how itch intensity, a critical but underutilized measure, influences real-world prescribing patterns. By integrating structured and unstructured clinical data, OMNY provides new insights into the relationship between symptom severity and treatment decisions.
While pruritus is a symptom, its severity can significantly impact quality of life and treatment choices. This study focused on patients with a documented 10-point itch intensity score, captured through physician assessments and patient-reported outcomes. The dataset included 7,330 patients with 8,115 encounters, capturing the following structured severity measures:
By leveraging EHR-derived severity assessments, the study provides a more granular understanding of how treatment decisions align with symptom burden.
Findings revealed a clear relationship between itch severity and systemic therapy use, while topical therapies were prescribed at consistent rates across all levels of severity.
The increasing use of sedative antihistamines in severe cases suggests a reliance on limited systemic options, leaving a gap in alternative therapies for patients with refractory pruritus.
The underutilization of structured itch severity scores in real-world studies has historically limited the ability to quantify treatment impact. Our findings reinforce why itch intensity should be a standard measure in both clinical decision-making and drug development. For clinicians, understanding real-world prescribing trends tied to symptom severity can optimize treatment pathways and inform escalation decisions. For researchers and trial sponsors, itch intensity scores provide an opportunity to refine patient segmentation, support cohort identification, and assess real-world treatment responses. For drug developers, the limited use of alternative systemic therapies highlights a need for novel treatments, particularly for patients with refractory pruritus.
This EHR-based study provides new insights into how structured itch intensity measures correlate with real-world prescribing behavior. By integrating structured severity assessments with prescribing data, OMNY Health’s research-ready datasets offer a unique lens into treatment trends, patient stratification, and disease burden.
In dermatology, real-world data plays a crucial role in understanding disease progression and optimizing treatment strategies. Actinic keratosis (AK), a common precancerous skin condition, requires tailored management approaches based on disease severity. OMNY Health’s vast dermatology dataset provides new insights into AK treatment patterns by leveraging structured electronic health records, including lesion count and patient-reported pain scores.
One of the unique aspects of OMNY Health’s dataset is the inclusion of real-world AK disease activity measures. Traditionally, treatment decisions for AK have been guided by lesion count, but OMNY’s data also incorporates pain scores using the 0-10 Visual Analogue Scale (VAS). This dual-measure approach provides a more comprehensive understanding of how AK severity impacts treatment decisions.
Analyzing data from six specialty dermatology networks within the OMNY Health platform (2017-2024), researchers examined how lesion count and pain VAS influence real-world treatment strategies. The study included 334,410 patients with 704,665 assessments, highlighting distinct trends in treatment selection.
Key findings include:
These findings emphasize the value of structured EHR measures in refining dermatological treatment strategies. By incorporating both lesion count and pain VAS, OMNY Health’s dataset enables providers and researchers to:
OMNY Health continues to enhance its dermatology RWD offerings by integrating unstructured clinical notes and refining disease activity metrics. Future analyses could leverage clinical notes to provide richer insights into treatment rationale and long-term outcomes.
As dermatology evolves, real-world evidence will be essential in bridging the gap between clinical research and everyday patient care. OMNY Health’s commitment to data-driven insights ensures that providers have access to the most comprehensive, research-ready EHR datasets to inform their decisions.
We at OMNY Health are thrilled to announce that the OMNY Health Platform has successfully achieved HITRUST e1 Certification, a landmark achievement in our ongoing commitment to foundational cybersecurity controls and information risk management in healthcare.
HITRUST e1 Certification focuses on foundational cybersecurity and the most critical set of controls for essential cybersecurity hygiene. This certification demonstrates that OMNY’s Ecosystem Platform has a comprehensive set of rigorous controls and best practices in place for essential for cybersecurity hygiene and protecting sensitive information.
“The HITRUST e1 Validated Assessment is a good tool for cyber-aware organizations like OMNY HEALTH that want to build assurances and progressively demonstrate due diligence around information security and privacy,” said Robert Booker, Chief Strategy Officer at HITRUST. “We applaud OMNY HEALTH for their commitment to cybersecurity and successful completion of their HITRUST e1 Certification.”
Achieving HITRUST Certification is no small feat. It represents countless hours of hard work, meticulous attention to detail, and an unwavering commitment to excellence from our entire team. This certification validates our robust approach to data security and privacy, covering 19 domains of information security.
“The HITRUST e1Certification is more than just a badge of honor – it’s a rigorous, comprehensive validation of our security practices,” said Dr. Maik Lindner, OMNY’s Chief Information Security Officer. “This achievement demonstrates that we’ve implemented a robust set of controls that meet the unique challenges of protecting sensitive healthcare data. It’s a reflection of our proactive approach to security and our commitment to staying ahead of evolving cyber threats in the healthcare industry.”
For our health system partners, the HITRUST Certification of our platform offers several key benefits:
“Achieving HITRUST certification is a testament to our unwavering commitment to data security and privacy in healthcare. This milestone reflects the dedication of our entire team and reinforces our position as a trusted partner in the healthcare data ecosystem. We’re proud to offer our health system partners the highest level of assurance in data protection, allowing them to focus on what matters most – improving patient outcomes,” said Dr. Mitesh Rao, CEO.
At OMNY, we view this certification not as a final destination, but as a milestone in our ongoing journey of excellence. We are committed to:
As we celebrate this achievement, we want to thank our dedicated team and our valued partners for their trust and support. We look forward to continuing our mission of advancing healthcare through secure, innovative data solutions.
Knee replacement surgery has advanced significantly over the years, with innovations in implant design aimed at improving patient mobility and long-term outcomes. However, when it comes to single-radius (SR) vs. multi-radius (MR) femoral implants, how much of an impact does design really have on patient recovery and healthcare utilization? While clinical trials provide controlled comparisons, real-world evidence offers a broader perspective on outcomes across diverse patient populations.
To better assess these differences, OMNY Health analyzed real-world data from its orthopedic-focused medtech dataset, evaluating clinical, functional, and economic outcomes in TKA patients.
This study leveraged data from the OMNY Health Medical Device Database (2017-2021), examining 1,464 patients who underwent unilateral TKA. Patients were categorized into SR (N=1,135) and MR (N=329) cohorts, allowing for direct comparisons of key outcomes.
Patient Demographics:
Despite prior speculation that implant design could significantly impact outcomes, this real-world analysis found that SR and MR implants performed similarly across key measures.
Clinical Outcomes:
Functional Outcomes:
Economic & Utilization Outcomes:
The findings suggest that implant design alone does not significantly impact clinical or functional outcomes in TKA patients. Instead, factors such as surgical technique, rehabilitation protocols, and patient-specific factors play a more substantial role in determining recovery and long-term success.
For healthcare providers and medtech companies, these results highlight the value of real-world data in refining orthopedic product development and post-market surveillance. While MR designs have been thought to provide more natural knee movement, this study suggests that real-world functional outcomes do not differ significantly between SR and MR implants.
Additionally, the slight difference in cost between implant types warrants further investigation to determine cost-effectiveness in value-based care models.
By integrating structured EHR data with curated clinical measures, OMNY Health provides real-world insights into medical device performance. This data-driven approach enables:
With orthopedics as a key therapeutic area for medtech innovation, leveraging real-world evidence is essential for ensuring high-quality, cost-effective decision-making in TKA and beyond.
At OMNY Health, we believe that unlocking the full potential of healthcare data means going beyond structured fields in Electronic Health Records (EHRs). By combining EHR data with unstructured clinical notes, we can uncover insights that truly reflect the complexities of patient care—insights that are often hidden in claims or EHR data alone.
Our recent study on Inflammatory Bowel Disease (IBD) treatment patterns highlights the unique value of integrating EHR data with clinical notes. Using Large Language Models (LLMs), we analyzed over 10.6 million clinical notes from our health systems to explore why IBD patients switch or discontinue biologic treatments. This approach gave us a comprehensive, real-world view of treatment decisions. We identified 7 distinct reasons for treatment alteration across 7 biologics.
While traditional EHRs track structured data like medication prescriptions and diagnoses, they often miss the “why” behind treatment decisions. Our study revealed seven key reasons why biologic treatments are altered, based on unstructured notes that provide deeper context:
Figure 1. Reasons for Biologic Switching in IBD
| Biologic | Adverse Drug Event (%) | Drug-Disease Interaction (%) | Symptom Resolution (%) | Finance Related (%) | Patient Related (%) | Not Effective (%) | Obstetric (%) |
|---|---|---|---|---|---|---|---|
| Infliximab | 28.26 | 1.92 | 2.87 | 24.42 | 8.62 | 14.37 | 0.48 |
| Adalimumab | 26.82 | 2.87 | 1.44 | 12.93 | 8.14 | 2.87 | 1.92 |
| Golimumab | 0.96 | 0 | 0.48 | 1.44 | 0.48 | 0 | 0 |
| Certolizumab | 1.92 | 0 | 0 | 0.96 | 0 | 0 | 0 |
| Vedolizumab | 16.28 | 0.96 | 4.31 | 7.18 | 6.70 | 1.44 | 1.92 |
| Ustekinumab | 11.01 | 0.48 | 0 | 3.83 | 2.39 | 0 | 0 |
| Risankizumab | 0.96 | 0 | 0 | 0 | 0.48 | 0 | 0 |
By analyzing clinical notes, OMNY Health’s AI models identified reasons for treatment alterations with 94.5% accuracy. This level of insight isn’t typically captured in structured EHR fields, and it has significant implications for improving patient care.
Understanding the real-world reasons behind treatment changes is essential for refining treatment strategies, improving adherence, and ultimately achieving better patient outcomes. For IBD patients, this means more personalized care tailored to their unique circumstances—whether that’s a financial hurdle, an adverse drug reaction, or a need for a more effective therapy.
At OMNY Health, we’re excited about the future of healthcare data. By integrating EHRs with unstructured clinical notes and leveraging the power of AI, we can identify patterns that were previously overlooked. This approach not only improves our understanding of IBD treatment but also has the potential to transform how we approach care across a wide range of conditions.
New Studies on the Use of These Medications in Adult and Pediatric Populations are Supported by the Data Network
Atlanta, Georgia – August 27, 2024 – OMNY Health, the leading healthcare ecosystem known for facilitating compliant cross-industry data partnerships, today announced the launch of its Glucagon-Like Peptide-1 (GLP-1) data network, further cementing the company’s commitment to democratizing healthcare data across industries. This new data network comprised already of over half a million patients will supply its life sciences and health system partners, as well as its AI-driven health tech partners, with additional knowledge of GLP-1 use, related social determinants of health (SDOH), and patient demographics to better inform generative AI tools, researchers, and clinicians and improve patient outcomes.
Despite a staggering amount of healthcare data being generated across health systems and life sciences companies, 97% of this data goes unused. This underutilization is particularly crucial as the usage of GLP-1 agonists surge, driven by their effectiveness in treating chronic conditions such as type 2 diabetes and obesity. The growing demand for these medications has sparked an urgent need for more comprehensive data that evaluates their effectiveness and long-term effects for other conditions like cardiovascular disease, liver disease, and skin disorders.
“GLP-1 therapies are transforming the treatment landscape across multiple conditions beyond diabetes and obesity in profound ways. The systemic impact of these medications underlines the need for more comprehensive data to fully understand how these therapies affect patients as a whole,” said Dr. Mitesh Rao, CEO of OMNY Health. “By democratizing data partnerships between life sciences companies and health systems, we can enable more in-depth clinical research that will fuel healthcare innovation and revolutionize the potential impact of GLP-1’s for years to come.”
OMNY’s GLP-1 data network consists of curated EMR data from more than 645,000 patients representing a broad set of demographic characteristics, including age ranges, race/ethnicity, region of care delivery, as well as provider and payer types. The data network supported two recent studies that address gaps in understanding GLP-1 therapies, particularly within pediatric and patient populations impacted by SDOH factors enabling partner companies to better understand and apply findings to patient treatments.
Pediatric use of GLP-1s was not approved by the FDA until December 2022, making data on these use-cases extremely limited despite the prescriptions of GLP-1RAs for children and adolescents increasing by 594.4% from 2020 to 2023. OMNY’s GLP-1 network contains valuable information on pediatric GLP-1 use, enabling a study that found the median age of users was 16 years and the majority were female in gender (72%).
“We are able to deliver more equitable clinical outcomes when the research is backed by data from diverse populations,” said Dr. Sameer Badlani, Fairview Health Services’ Executive Vice President, and Chief Strategy Officer. “With access to data that factors in SDOH for diverse populations we learn valuable insights in service of providing resources and clinical care that is differentiated by excellence in quality, safety, experience and health equity for every consumer who trusts us with their wellness and care.”
OMNY’s network also provides critical information on SDOH factors, including economic insecurity, food insecurity, and social isolation often documented in clinician notes. With many of these factors accounting for up to 50% of the variation in health outcomes in the US, it was crucial that the SDOH status of patients receiving GLP-1 treatment be made available. A second study by OMNY found that GLP-1 patients were half as likely to have SDOH economic burden issues noted in their EHR record as compared the population of non-users.
OMNY’s data network enables companies to diversify their patient populations for clinical trials, better understand medication interactions, and strengthen treatment outcomes.
This announcement follows OMNY’s partnerships with QuantHealth, the leading AI-driven clinical trial design company, and ArisGlobal, a technology company at the forefront of life sciences and the creator of LifeSphere®. OMNY Health is committed to AI-enabled healthcare improvement and supporting research programs that aim to improve clinical care. To learn more about how OMNY Health is transforming lives and driving patient care by connecting providers and life sciences companies through data, visit www.marketing-dev.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, healthcare systems, academic medical centers, and integrated delivery networks span all fifty states and cover over 75 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 ecosystem now reflects more than seven years of historical data encompassing more than 2 billion clinical notes from 300,000+ providers across 200+ specialties – and is growing. For more information, visit www.marketing-dev.omnyhealth.com.
Media Contact:
Chloe Fredericksdorf
omnyhealth@solcomms.co.
OMNY Health, the leading healthcare ecosystem known for facilitating compliant cross-industry data sharing launched its platform designed to power AI-driven health technology companies, further cementing the company’s commitment to democratizing healthcare data. QuantHealth and ArisGlobal are just two of OMNY’s newest partners to leverage this new platform to power their organizational AI-driven needs. OMNY Health’s data network uniquely addresses Generative AI’s need for large de-identified structured and unstructured electronic health record (EHR) data sets across diverse provider and patient populations, further underscoring the platform as delivering the data infrastructure and rails for provider organizations to collaborate and fuel the development and use of effective AI solutions for advancing healthcare.
“Our mission is to free data from silos, allowing it to be shared, analyzed, and morphed into life-saving treatments and better care for patients,” said Mitesh Rao, CEO, OMNY Health. “Life science organizations and providers often struggle with time and budget constraints that hinder their ability to learn from their data. Our work powering AI-driven platforms can unblock this process by partnering with AI developers with data and tools to accelerate breakthrough therapies and monitor new therapies for safety signals to ensure patient populations remain safe.”
Two of OMNY Health’s AI-driven partners being effectively powered by the platform’s data to foster new opportunities for advancing healthcare include QuantHealth, the leading AI-driven clinical trial design company, and ArisGlobal, a technology company at the forefront of life sciences and creator of LifeSphere®.
QuantHealth’s AI technology, trained on a dataset of 350 million patients, enhances clinical trial timelines, mitigates trial risks, and identifies populations likely to respond to treatments. OMNY’s collaboration will help QuantHealth’s pharmaceutical partners expedite drug development through simulated clinical trials, utilizing real-world evidence to predict clinical trial outcomes, drug efficacy, and patient responses.
“Biotech is entering a vibrant part of life sciences history,” said Omri Matalon, VP Clinical Data Science and Head of R&D Operations at QuantHealth. “This partnership furthers our commitment to quality data and access for our life sciences partners. By integrating diverse EHRs into organized, de-identified research data products, we can address disparities in clinical trials and close significant demographic information gaps in drug discovery and development.”
OMNY’s partnership with ArisGlobal, a leader in pharmacovigilance, safety monitoring, and reporting systems, will transform safety signal validation and pave the way for comprehensive, proactive signal detection.
“Up to 95% of adverse event cases go unreported today, while processing ICSRs can be time consuming, and analysis of medical literature and online forums is slow and inefficient,” said Ann-Marie Orange, CIO and Global Head of R&D at ArisGlobal. “Combining LifeSphere products with comprehensive real-time RWD addresses these challenges head-on. By leveraging advanced technology and insights from extensive RWD, we are reshaping drug discovery and development.”
These partnerships demonstrate OMNY Health’s commitment to AI-enabled healthcare improvement through acceleration of diverse participation in clinical trials and the support of research programs that aim to save lives and improve patient outcomes. To learn more about how OMNY Health is transforming lives and driving patient care by connecting providers and life sciences companies through data, visit https://marketing-dev.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, healthcare systems, academic medical centers, and integrated delivery networks span all fifty states and cover over 75 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 ecosystem now reflects more than seven years of historical data encompassing more than 2 billion clinical notes from 300,000+ providers across 200+ specialties – and is growing. For more information, visit www.marketing-dev.omnyhealth.com.
About ArisGlobal
ArisGlobal, an innovative life sciences technology company and creator of LifeSphere®, is transforming the way today’s most successful life sciences companies develop breakthroughs and bring new products to market. Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan, and China. For more updates, follow ArisGlobal on LinkedIn or visit https://www.arisglobal.com/.
About QuantHealth
90% of drugs fail the clinical stage, representing a direct $45B annual waste to pharma companies. To address this challenge at its core, QuantHealth’s Clinical-Simulator predicts how each patient in a clinical trial will respond to treatment, allowing trial design teams to predict how an entire clinical trial will play out and adapt accordingly. Based on its novel AI engine and a vast dataset of 350m patients and over 700K therapeutics, QuantHealth’s simulator can predict clinical trial results with high accuracy, allowing users to answer mission-critical questions such as trial go/no-go, cohort optimization, drug repurposing, and more. QuantHealth was founded by healthcare experts who led commercial, product, and data science at various leading companies in the US and Israel. QuantHealth is backed by expert Life-Science investors in the US, Europe, and Israel and is supported by an advisory board of physicians and scientists from leading academic institutions. To learn more, visit https://quanthealth.ai/.
