In the all-hands-on deck race to conquer the coronavirus pandemic, de-identified patient data from a variety of sources support clinical research, and near real-time data captured through electronic health records (EHR) plays an important role.
EHR data are relatively new in support of clinical research compared to patient data gathered through the administration of health insurance claims used for more than two decades. Particularly in the United States, where the Affordable Care Act (ACA) catalyzed nearly complete EHR adoption, the “data exhaust” generated from these systems informs characteristics of diseases, treatments, and outcomes at a nationwide scale. This data can be enormously valuable for research – augmenting knowledge gained from the execution of rigorous clinical trial protocols with information gathered from patients treated in real-world care delivery settings. The clinical data found within EHR systems contain unique information such as lab results, vital signs and symptoms, demographics, and over-the-counter drug usage vitally important for our understanding of the coronavirus and its effect on patients.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
While health IT systems are ubiquitous, pulling together patient data generated from these systems in a way that enables research is difficult. Data stored within various information systems is not easily curated or harmonized for research purposes. Even among EHR vendors, products from different vendors use different databases, formats and nomenclatures. And connecting different types of data, such as EHR and claims data, often require significant work to create linkages and test the results. Additionally, when accessing patient data for research, it is critical to de-identify the records so they can’t be associated with individual patients, to protect patient privacy and comply with federal privacy regulations.
Government and public health agencies, academic institutions, and commercial organizations, impacted by a deadly global pandemic, turned to real-world patient data to better understand the characteristics and impact of Covid-19 in near real time. To support this need, many data and technology vendors, erstwhile fierce competitors, banded together in cooperative partnerships to enable Covid-19 research.
For example, the Covid-19 Healthcare Coalition is a private sector response that brings together 3 of the top U.S. EHR vendors, among other healthcare organizations, technology firms, nonprofits, academia, and startups to provide data-driven Covid-19 insights to “preserve the healthcare delivery system and help protect U.S. populations.” This Coalition, and other similar cross-industry collaborations, strive to answer diverse and important questions such as:
- Is the supply of drugs used to treat Covid-19 adequate across the country?
- Are patients who were previously diagnosed with Covid-19 becoming reinfected?
- Are any approved pharmaceutical products effective in treating Covid-19?
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Another effort at helping research of this disease is the Covid-19 Research Database, a pro-bono, cross-industry collaborative, composed of organizations donating technology services, health care expertise, and data, enables public health and policy researchers to use real-world data to better understand and combat the pandemic. To date, approximately 400 academic researchers around the U.S. have applied for access to the database for their Covid-19 research, with dozens of publications completed and in-process. [Editor’s Note: The author’s employer — Veradigm, which is a business unit of Allscripts — is one of the many partners that has contributed data to the Covid-19 Research Database. Allscripts is also part of the Covid-19 Healthcare Coalition described above.]
As Covid-19 vaccinations roll out across the globe, EHR patient data also plays a critical role in monitoring patients vaccinated for the virus by early identification of possible side effects. This type of near real-time surveillance is unprecedented. It is crucial as well based on the urgency and speed of the vaccine trials and authorized emergency use of the vaccines, particularly the new mRNA vaccine technology deployed by several manufacturers. Nearly all pharmaceutical companies with approved vaccines monitor their vaccine rollouts with EHR data.
The use of real-world patient data for research in response to the threat of Covid-19 demonstrates a powerful, secondary benefit of widespread EHR adoption. Data captured in EHR systems provide near real-time information about the nationwide vaccine rollout, help monitor potential safety issues, and foster understanding of the Covid-19 virus, treatments and associated outcomes in real-world care settings. These questions are not easily addressed through traditional clinical trials.
Photo: invincible_bulldog, Getty Images
Stephanie leads the Real-World Evidence business unit at Flatiron Health, setting the strategy to drive long term growth and to accelerate Flatiron’s leadership in the way real-world oncology data is collected, combined and analyzed.
Steph joined Flatiron in 2022, with 20 years of experience leading businesses at the intersection of real-world patient data, technology, and analytics within the life sciences industry. Prior to Flatiron, she served as the General Manager of Life Sciences Data and Analytics at Veradigm, an analytics subsidiary of Allscripts.
Steph earned her bachelor’s degree at Widener University and is a candidate for her master’s in business administration at the Smeal College of Business at Penn State University.
