Tag: IQVIA

Empower the Patient: How eCOAs Amplify the Patient Voice

By Melissa Mooney, director, eCOA Solutions Engineering, IQVIA.

Patient centricity has quickly become the biggest buzzword in medicine and clinical research – but it is much more than a trend. Patient centric clinical research allows the healthcare industry to deliver more holistic outcomes for patients, meaning that new treatments not only deliver the desired outcome, but also leave intact or even improve the patient’s quality of life while they are undergoing treatment. As a result of this shift, implementing strategies for capturing the patient’s voice in clinical research has become a top priority for the biopharma industry.

Patients today certainly have more advocacy and are playing a more active role in clinical trial planning and data collection as a condition of their participation, which is a major contributor to this shift. However, regulators and payers are also driving the shift by showing increasing interest in the perspectives of patients as they review submissions for new drug approvals. Electronic clinical outcomes assessments (eCOAs) have emerged as an effective approach to capturing these patient insights that can make or break the trial by giving them a structured platform for reporting their experiences and capturing those reports in measurable and meaningful ways.

What are eCOAs?

An eCOA is a digital approach to capturing patient experience data in traditional clinical trials and real-world studies. During the pandemic, eCOAs shot to prominence in the research space as sponsors sought out more agile tools to capture patient data remotely. At this critical point in time for agile research, eCOAs made it easier for investigators and sponsors to keep track of patient progress outside of the site environment’s confines and collect more patient-specific information to support the safety and efficacy of treatments and their impact on patients’ quality of life.

eCOAs are custom-built interactive assessments that clinical trial participants are prompted to respond to, through provided or personal devices. They allow patients, clinicians, and caregivers to directly report outcomes, supplying real-time insights, and high-quality data collection. These digital assessments have led the way in simplifying patient engagement and amplifying the voice and experience of patience.

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How USCDI Is Reshaping Data Quality and Access In The Healthcare Industry 

Angela Kennedy

By Angela Kennedy, director of strategic operations, medical specialty societies, IQVIA.

In 2016, the 21st Century Cures Act (Cures Act) resulted in new regulations that fundamentally changed the way deidentified patient data is accessed and utilized. However, data quality and interoperability between the various healthcare stakeholders has been a major hurdle.

When it comes to implementing the Cures Act, the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) each must administer the law’s requirements. Therefore, each agency has released a final rule over their respective jurisdiction.

Information blocking is a primary focus of the ONC final rule, which also requires that developers certified by the ONC Health IT Certification Program must have standardized Application Programming Interfaces (APIs) and implement Fast Healthcare Interoperability Resources (FHIR) technology, enabling individuals to access structured electronic health information securely and easily.

These advancements will only make information sharing easier. The CMS Interoperability and Patient Access final rule also focuses on API interoperability, requiring federal payers to make provider directory information publicly available. Specifically, it encourages interoperability and patient access to health information.

In a major step to ensure open sharing of information, the ONC introduced the US Core Data for Interoperability (USCDI). Since ONC is the certifying body for EHRs, providers must be prepared to transition to a new “Cures Edition” version of its software before the end of 2022.

What is USCDI?

USCDI encompasses a standard for data creation, a set of defined data classes and elements that Electronic Health Record (EHR) vendors must be able to provide. This creates an expectation for open and free access to healthcare data by industry stakeholders, including physicians, insurers, labs, registries, and the patients themselves. CMS requires that payers share the USCDI data they maintain with patients via the Patient Access API and with other payers via the Payer-to-Payer Data Exchange.

While some organizations have used APIs to aid the exchange of data, experts in the healthcare industry have been aware that for a truly free and open data exchange to work, modern technology and standards need to be put in place. This is where FHIR comes in.

What is FHIR?

FHIR is based on a new iteration of Representational State Transfer (REST) designs, which uses HTTP to enable the exchange of information between applications. That means if two applications adhere to the standards outlined for REST technologies, it makes it easier for two applications to exchange and manage healthcare data regardless of how it is stored. Not only do these applications now speak the same language, but FHIR has also created categories for certain healthcare interactions to further refine the data exchange by making it easily identifiable within each system.

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