Authored by Manish Sharma, Senior Vice-President Life Sciences, CitiusTech and Parikshit Sheth, Healthcare Consultant, CitiusTech

Life sciences organizations continue to feel the regulatory and legislative pressures associated with the transition from volume to value-based care. To meet the challenges imposed by government regulations and the rising cost of healthcare, these organizations are now going ‘beyond the pill’ with a renewed focus on improving health outcomes and the patient experience.

Through new initiatives such as electronic data capture (EDC), real-world evidence (RWE), cognitive analytics and digital clinical trials, life sciences and pharmaceutical organizations can better engage with patients, improve decision making and deliver better products.

The Need For Interoperability

As life sciences companies begin to incorporate these new strategies, a strong data management and interoperability framework will be required to consolidate data from drug discovery, clinical research, safety and administrative systems, self-monitoring devices and electronic health records (EHRs), to get a comprehensive picture of a patient’s health.

In tandem with FDA and ONC interoperability standards and guidelines, it’s imperative for life sciences organizations to step forward and invest in enterprise interoperability, and adopt emerging standards to support their key business needs.

The answer to life sciences’ interoperability challenges lies in Fast Healthcare Interoperability Resources (FHIR) – a new interoperability standard framework and platform from HL7®. FHIR provides unique support to meet the implementation needs of common healthcare use cases like ambulatory or inpatient encounters, while providing the flexibility and extensibility in fulfilling the needs of advanced cases, such as genetics. 

By leveraging FHIR, life sciences organizations have the opportunity to capitalize on the following strategies.

Electronic Data Capture at Source

With the ability to support EDC at source, FHIR can considerably improve the safety and cost of clinical trials. For example, when data is captured in an EHR system through a clinical trial, it can be converted to FHIR resources, transformed and pre-populated as an electronic case report form (eCRF) within the EDC systems. An electronic case report form is a crucial record in clinical research, which records the project data in a standard format. FHIR profiles also allow for built-in data validations and form-level validations. As a result, FHIR helps increase the use of eCRF for clinical trials by improving the amount of clean data, reducing query, enabling faster access to data, and reducing costs and effort to manually track CRF pages.

Real-World Evidence (RWE)

A RWE study is a scientific examination of real-world data (RWD) using appropriate statistical and/or commercial analytics. Pharma and life sciences organizations are increasingly using RWE to differentiate their products in a saturated and competitive environment.

FHIR provides the transport and data layer to facilitate sharing of clinical and claims data from participating sites. FHIR resources, which are modular components within a FHIR solution, such as “allergy intolerance” or “medication administration,” capture the information related to the allergy issues of patients and medications administered, respectively. This is helpful in evaluating the probability of an adverse event associated with that medicine or device. Similarly, FHIR resources such as “care plan,” “goal” or “observation” encapsulate data to determine the degree to which a patient correctly follows medical advice, helping to determine whether the patient adheres to treatment in real-time.

Personalized Care Treatment

An increasing number of life sciences organizations are developing patient- and provider-centric strategies to optimize and personalize the care delivery function. Some of these initiatives include clinical decision support at point of care, disease exacerbation prediction, drug-drug interaction and others. FHIR resources provide the basic building blocks to develop these smart systems with the ability to support actionable decision-making, embedded within the clinical workflows.

Substitutable Medical Apps & Reusable Technology (SMART) on FHIR is a set of open specifications to integrate these smart systems and applications with EHRs, portals, health information exchanges (HIEs) and other health IT systems. It enables developers to build apps that can connect to health data systems without requiring specialized knowledge about each system. These standards nurture an ecosystem of third party apps that can extend to existing systems with new capabilities, such as integrated personalized care delivery recommendation tools. For example, patient data captured as FHIR resources can be pulled from clinical systems and analyzed by leveraging machine learning algorithms to identify the best medications or therapies for a patient. FHIR also enables bidirectional communication of this data across the clinical and research ecosystems providing better access to patients and providers alike.

Digital Clinical Trials

As contract research organizations (CROs) begin to design new patient-centric trials, it will become crucial to leverage patient data from wearables, sensors, IOT and monitoring devices.  In addition, digital trials help to improve operational efficiency and costs by enabling remote monitoring for medical monitors. Self-monitoring devices that track sleep, movement, blood oxygen saturation, heart rate, perfusion index, etc., can directly send data to clinical monitors in FHIR format. This will significantly improve how digital trials are conducted as they would eliminate the most crucial barrier to carrying out clinical trials – geography.

FHIR Adoption in Life Sciences

Many pharmaceutical and life sciences organizations have started adopting industry standard data models like Observational Medical Outcomes Partnership (OMOP), Federal Health Information Model (FHIM), Operational Data Model (ODM-XML) of CDISC and others. They are able to export their data to external systems in the FHIR format and easily assimilate FHIR resources received from other external systems. Some of the industry standards and models can be integrated with FHIR, including OMOP, ODM-XML of CDISC, Clinical Information Modeling Initiative (CIMI), FHIM, Clinical Document Architecture (CDA) and HL7 V2.X.

The FDA released a list of pharma and life sciences organizations with current pilot programs involving FHIR. Here’s a snapshot of these organizations:

  • Epic, Cerner Corporation, Leidos, Duke University, Bristol-Myers Squibb, HL7: Leveraging FHIR and structured data capture (SDC) to encapsulate and transfer relevant data from the EHR to the EDC system
  • UCB, CDISC and Medidata: Proposing to use the CDISC healthcare link initiative to enable the collection of related healthcare and clinical research information using FHIR
  • Brigham and Women’s Hospital: Leveraging EpicCare EHR system and standards such as HL7 FHIR and substitutable medical apps, reusable technologies (SMART) platform architecture on FHIR
  • Medidata, Genentech, South Texas Accelerated Research Therapeutics (START), Technical Frontiers, Inc.: Demonstrating interoperability between Medidata’s EDC system, Rave, and an EHR system using the Integrating the Healthcare Enterprise (IHE) Retrieve Form for Data Capture (RFD) profile and FHIR

FHIR is an evolving interoperability standard that is progressing at a faster pace than ever before. The resource portfolio to support clinical research and trials is being developed and adopted at a steady rate. While many early adopters have customized FHIR resources for specific use cases in the life sciences industry, in the long run, most will become standard profiles of FHIR. Organizations need to realize that now is the right time to gain momentum and get ahead of the competition with FHIR.

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