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Author: Jona Kerma

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OMNY Health Achieves HITRUST e1 Certification: A Milestone in Healthcare Data Security

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:

  • Enhanced Trust: You can be confident that your data is protected by security measures that meet or exceed industry standards.
  • Simplified Compliance: Our certification helps streamline your compliance efforts, particularly with regulations like HIPAA. 
  • Reduced Risk: With our certified security framework, the risk of data breaches and associated costs is significantly reduced.
  • Improved Interoperability: Our certification enhances our ability to securely share and process data across the healthcare ecosystem.

“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:

  • Continuously improving our security measures 
  • Staying ahead of emerging threats in the digital healthcare landscape
  • Providing our partners with the highest level of data protection 

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.

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Product

Does Implant Design Matter? Studying Total Knee Arthroplasty in Clinical RWD

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.

Comparing Implant Design in Real-World Settings

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.

bar chart showing demographic characteristics among patients with sickle cell

Patient Demographics:

  • Most patients were born between the 1950s and 1960s (SR: 59%, MR: 57%).
  • Women accounted for the majority of cases (SR: 63%, MR: 70%).
  • The SR cohort had a higher proportion of White patients (85%) compared to the MR cohort (75%).
  • More MR patients underwent outpatient procedures (53%) compared to SR patients (43%).

Key Findings: Minimal Differences Between Implant Designs

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.

bar chart showing demographic characteristics among patients with sickle cell

Clinical Outcomes:

  • Mortality rates were low in both cohorts (SR: 1.1%, MR: 0.3%).
  • Postoperative knee pain was reported at comparable rates (SR: 0.6%, MR: 1.2%).
  • Implant removal was rare, with no significant difference observed (SR: 0.4%, MR: 0.0%).

Functional Outcomes:

  • Non-routine discharge disposition (NRDD) rates were identical (SR: 16.4%, MR: 16.4%), suggesting that implant design did not influence post-surgical mobility.

Economic & Utilization Outcomes:

  • Length of stay (LOS) was similar across groups (SR: 0.98 days, MR: 0.96 days).
  • Gross charges were slightly higher for SR patients (Median: $43,879 vs. $39,255 for MR), though differences may be driven by factors beyond implant design.

What This Means for Clinical Decision-Making

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.

The Role of Real-World Data in Orthopedic Research

By integrating structured EHR data with curated clinical measures, OMNY Health provides real-world insights into medical device performance. This data-driven approach enables:

  • Comparisons of implant designs and surgical techniques to refine best practices.
  • Better understanding of patient recovery patterns and healthcare utilization.
  • Support for evidence-based decision-making to optimize orthopedic device selection and patient outcomes.

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.

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Product

Breaking Barriers in Sickle Cell Care: Real-World Insights on Treatment & Healthcare Utilization

Breaking Barriers in Sickle Cell Care: Real-World Insights on Treatment & Healthcare Utilization

Sickle cell disease (SCD) presents unique challenges for patients and healthcare providers alike. To better understand these challenges, OMNY Health analyzed real-world data (2017-2024), leveraging its unique ability to integrate structured EHR data with curated clinical measures to provide a comprehensive view of SCD patients. This study examined the demographics, healthcare utilization, and treatment patterns of 10,958 individuals diagnosed with SCD.

Disproportionate Burden and Frequency of Healthcare Use in Sickle Cell Disease

SCD remains a condition that disproportionately affects minority populations. Among the studied population:

  • 82% identified as Black, with additional representation from Hispanic and Asian/Pacific Islander groups, emphasizing racial disparities in disease burden and healthcare access.
  • The average age of patients was 37 years, showing that SCD continues to impact individuals well into adulthood.

Figure 1. Demographic Characteristics of Patient Population

bar chart showing demographic characteristics among patients with sickle cell

At the same time, these patients experience high levels of healthcare utilization:

  • 66% had an emergency room visit.
  • 65% required outpatient care.
  • 4.3 inpatient admissions per patient on average, though some required over 185 hospital stays.

Comorbidities and Limited Treatment Utilization for Sickle Cell Disease

OMNY Health’s curated datasets capture a wide range of comorbidities, helping to broader clinical patterns that impact SCD progression. Among the most common conditions observed:

  • Anemia, chronic pain, and hypertension, which are linked to SCD progression.
  • Gastroesophageal reflux disease (GERD), urinary tract infections, and vitamin D deficiency, highlighting broader health vulnerabilities.

These figures suggest that many individuals with SCD struggle with disease management, pain crises, and complications that lead to recurring hospital visits. The high frequency of inpatient admissions, even among younger adults, indicates that preventive strategies may not be reaching those who need them most. Many hospital stays are driven by acute complications, highlighting the importance of early intervention and better access to disease-modifying treatments that could reduce the need for emergency care.

Table 1: HCRU Among Individuals with SCD

Figure 2: Top clinical comorbidities among individuals with SCD

Despite available treatments, adoption remains low:

  • 11.3% of eligible patients received hydroxyurea, the most used therapy.
  • Less than 1.1% of patients received newer disease-modifying treatments, such as Crizanlizumab, Voxelotor, L-glutamine, or Stem Cell transplants.

This raises concerns about barriers to access, including cost, provider awareness, and prescribing patterns. Through OMNY Health’s ability to track real-world prescribing trends and treatment adherence, stakeholders can better understand where interventions are needed to improve access.

Moving Forward with Data-Driven Solutions

By leveraging OMNY Health’s robust real-world data, we can provide critical insights into treatment patterns, healthcare utilization, and patient needs. OMNY Health’s curated data and clinical measures enable a more complete understanding of SCD care gaps, supporting efforts to inform policy changes, optimize treatment strategies, and enhance healthcare provider decision-making

For more information about OMNY Health’s product offerings, let’s connect!

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Product

Unlocking Real-World Insights into IBD Treatment: The Power of Clinical EHR and Physician Notes Integration

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.

Key Findings: Uncovering the Real Reasons for Treatment Changes

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:

  • Adverse Drug Events (16-28%)
  • Finance-Related Reasons (4-24%)
  • Patient-Related Factors (2-9%)
  • Lack of Efficacy (1-14%)
  • Symptom Resolution (1-4%)
  • Drug-Disease Interactions (1-3%)
  • Obstetric Concerns (0-2%)

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

Transforming IBD Care: From Data to Insight

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.

The Future of Healthcare Data: A New Era of Personalized Care

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.

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News

GPP Flares Linked to Increased Hospitalizations, Health Care Costs, Study Finds

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News

OMNY Health and Scipher Medicine Partner to Revolutionize Autoimmune Disease Treatment with Clinico-Transcriptomics Data

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News

OMNY Health Launches Dynamic GLP-1 Network of 600,000+ Patients to Fuel Clinical Research on Its Use

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.

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News

OMNY Health Launches Data Platform Designed to Power AI-Driven Health Tech Companies

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/.

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News Product

OMNY Health launches new GI real-world data solutions in partnership with leading US gastroenterology practices

new GI real-world data solutions

OMNY Health’s GI partnerships are a pivotal step in its mission to deliver data and insights to accelerate life-changing innovation. With a focus on catalyzing research and improving outcomes, OMNY aims to make a tangible difference for the millions of individuals in the US impacted by gastroenterology diseases

ATLANTA, GA, April 22, 2024 – OMNY Health is pleased to announce its partnership with the nation’s leading community-based independent gastroenterology (GI) practices and integrated delivery networks (IDNs) to launch a novel set of real-world data and evidence solutions for research. Over 5,000 GI providers serving more than 10 million patients are now part of OMNY’s research network, representing care delivery by over 380,000 providers and 75 million patients across the US. The focus on GI practice data is a notable expansion to OMNY’s real-world data ecosystem, which works with providers to support compliant research partnerships at scale. OMNY works with the health systems to enable insights on patient population characteristics, care delivery patterns, and treatment outcomes based on data extracted from de-identified inpatient and ambulatory care electronic health records (EHRs). OMNY’s solutions deliver valuable information on disease severity, rationale behind treatment decisions, treatment efficacy, and impact of social determinants on treatment selection and disease progression. By integrating disparate EHRs into unified, de-identified research data products, OMNY offers researchers and providers the breadth and depth of information needed to address their biomedical and population health research questions.

“United Digestive remains committed to offering our patients the most suitable and cost- effective healthcare solutions. Our dedication to delivering best-in-class GI care is intricately linked with our data-driven approach,” says United Digestive’s Chief Medical Officer, Dr. John Suh. “We are thrilled to announce our partnership with OMNY Health, which allows us to drive further insights from our data to advance patient care.”

“As Florida’s leading gastroenterology provider, Borland Groover’s mission is to provide exceptional care and improve the lives of our patients. Achieving this objective requires a deep understanding of our patients, patterns of care, outcomes, and opportunities for further improvement through data analysis,” said Borland Groover’s CEO, Dr. Kyle Etzkorn. “Our collaboration with OMNY not only aligns with our mission, but it also presents avenues to identify and pursue future opportunities for elevating GI patient care.”

“Enhancing patient care isn’t just a goal; it’s our responsibility, guided by the personal experiences of every patient we serve. Each piece of patient data is not just a statistic; it is a pathway to better outcomes, a testament to our commitment, and a source of inspiration for ongoing progress” said Christa Newton, MBA, CEO, OneGI. “We are excited to partner with OMNY as a tangible step in realizing these guiding principles for the benefit of our patients.”

“It is important to One GI that our patients are represented when it comes to emerging research, care improvement initiatives, and best in class care. Our partnership with OMNY helps ensure our providers have the data and support they need to deliver easy to access exceptional GI care.” – Dr. Michael Dragutsky, Founder, Chairman, OneGI. Key populations available in the GI specialty offerings are aligned with the significant research and development efforts underway in gastroenterology, including ulcerative colitis, Crohn’s disease, celiac disease, short bowel syndrome, reflux disorders, and many others. Like other OMNY Health specialty-focused solutions, the GI offering includes information covering pharmacy orders, lab and diagnostic test results, comorbidities, symptom checklists, and provider clinical assessment scores. “We are thrilled to welcome our new gastroenterology providers to our network. Over the past two years, we have made great strides connecting researchers and providers participating in our dermatology and ophthalmology research networks. We look forward to building on that impact in the field of gastroenterology,” said Mitesh Rao, MD, CEO, OMNY Health.

About OMNY Health

OMNY Health connects the healthcare ecosystem through data and insights to transform healthcare delivery, improve clinical outcomes, and address patients’ unmet needs.   The OMNY platform serves as a centralized resource for healthcare stakeholders to participate in data sharing and research services at scale, fueling innovation where patients need it the most. For more information, go to https://marketing-dev.omnyhealth.com/

MEDIA INQUIRIES: media@omnyhealth.com 

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Editorial

Linking Real-World Clinical Data with Medical Device Data to Demonstrate Device Value

Clinical Data, Medical Device

Real-World Data in the Medical Device Market

Many life sciences organizations are focused on harnessing real-world data (RWD) capabilities to inform every part of the drug development product life cycle. The same types of RWD can, and should, be applied to innovation around the development and measurement of the effects of medical devices. RWD derived from healthcare sources, such as electronic health records, provides insights into the burden of disease, and after a device market launch, provides insights into competitive stance, safety, efficacy, and outcomes. Traditionally, these types of analyses have been difficult to perform for medical devices because the specific details surrounding the medical device make, model, and manufacturer used in procedures are often buried in the electronic health record or other IT systems, and historically have not been collected uniformly.

Medical Devices in the Real World

Medical Devices have become a critical part of a patient’s daily life, and how patients interact with these devices can tell us a lot about their effectiveness. From joint replacements to life-saving arterial stents and pacemakers, device manufacturers are interested in the benefit-risk profiles to inform future device modifications and technological advancements, Providers can glean important evidence for the clinical effectiveness of these devices, helping to inform what devices to use in their procedures.

Medical device manufacturers are motivated to invest in new strategies to support success. According to McKinsey, despite a period of growth from 2012 through 2019, S&P medical device investments slowed during the pandemic. Recently, however, signs have been promising; in 2023, the U.S. approved more novel medical technologies than in any single year before, and revenue growth rates are starting to stabilize to pre-pandemic levels.

Aggregation of RWD to Inform Device Safety and Evidence for Effectiveness

Using relevant and reliable RWD is important for generating RWE to understand and regulate medical device usage and safety. To get a complete picture of the patient’s use and interaction with a medical device, RWD from clinically relevant sources is required to give a holistic view of the clinical experience both before device implant/initiation and after usage has been initiated. The ability to combine disparate data from multiple sources and care settings is where OMNY Health excels.

The OMNY Health Medical Device Data Advantage

OMNY Health’s Medical Device product offering is a best-in-class view into the healthcare industry’s use of medical devices in patients. Our Medical Device offering is constructed directly from our health provider data sets, with precision down to the patient encounter level. Utilizing the Unique Device Identifier (UDI) and the device version, we have partnered with the FDA’s AccessGUDID database to ensure the highest quality and completeness of data, with unrivaled recency.

OMNY Health’s Medical Device product offering linked with OMNY Health’s EHR data, can help device manufacturers and provider networks better understand and assist the patients they are servicing by examining:

  • Medical Device use and trends
  • Patient journeys and continuity of care
  • Impact of medical devices on clinical, functional, cost, and utilization outcomes
  • Safety/adverse event reporting
  • Providers who are interested in value-based contracting and making procurement decisions

Check out the Total Knee Replacement study utilizing the OMNY Health Medical Device product offering.

Contact OMNY to learn more about how our Medical Device product offering will boost your real-world evidence generation.