FHIR can help tackle daunting digital challenges in research

The emergence and proliferation of advanced technologies like real-world evidence, wearable devices, remote patient monitoring and other trends have created a huge number of opportunities for researchers. Along with those high-tech opportunities, however, come myriad associated challenges.

Along with the obstacles associated with adopting and learning such next-level technology, research and drug development professionals also face difficulties dealing with ever-changing regulations, patents, shrinking drug pipelines, and more.

Outsourcing-Pharma recently spoke with Shreejit Nair, senior vice president and head of life sciences market at CitiusTech, about how the use of fast healthcare interoperability resources (FHIR) could help companies successfully deal with rapid digital evolution and other developments.

OSP: Could you please tell us about CitiusTech—who you are, what you do, key capabilities/services, and how the company stands out from similar organizations?​

SN: CitiusTech is a leading healthcare technology company, providing technology-enabled solutions and services to healthcare and life sciences organizations worldwide over the last 15 years across four business verticals: Life Sciences, Medical Technology, Provider Organizations, and Health Plans. CitiusTech serves customers spanning the digital health ecosystem, including big pharma and biotech, contract clinical research organizations (CROs), medical device companies, providers, and payers, through strategically placed offices, across the United States, Europe, Southeast Asia and the Middle East.

Over the years, CitiusTech has developed and deployed advanced product engineering, data management, and data science offerings to drive artificial intelligence (AI)-enabled innovation for evidence-based solutions in the provider and payer segments. CitiusTech leverages this experience and understanding of clinical data for providers and payers to provide real-world outcomes and digital solutions to life sciences companies.

As India’s first and only healthcare IT unicorn, we are driven by a strong sense of purpose – to help healthcare and life science organizations leverage technology and innovation to enhance healthcare delivery and affordability that in the end meaningfully improves patient’s lives and their well-being.

OSP: Could you please explain FHIR, and why it’s proven helpful/necessary in life sciences?​

SN: First, we need to have a general understanding of what FHIR is. FHIR is an open healthcare data exchange created by Health Level Seven (HL7; it provides data formats and an application programming interface (API) to drive interoperability within our highly fragmented healthcare ecosystem.

Interoperability helps life science organizations promote precision medicine, enable digitalization and drive real-world evidence. As the acceptance of real-world data increases, interoperability enables pharma/ biotech companies to generate crucial intelligence on the actual safety and efficacy of investigational drugs in a real-world environment.

OSP: Can you please share some of the reasons why not having standardization around operability is a risky prospect?​

SN: As the need for data continues to explode in the industry, it’s becoming even more paramount for organizations to capture that data from electronic health records (EHRs), electronic data captures (EDCs), devices and wearables, as it’s locked away in disconnected systems and schemas, driving up cost as well as complexity. The ability to collect, anonymize, transform and apply the power of AI/ ML to current data outputs is the future for better outcomes and health transformation.

Today, the industry continues this push for change, but at a very slow pace, as different systems speak different languages. However, the emergence of FHIR is creating a paradigm shift in the health industry, giving us the ability to transform data quickly and foster collaboration across the healthcare ecosystem, thereby reducing complexity.

Looking at the future, FHIR will provide us the much-needed ability to apply science and rapidly sift through data to increase precision care for all types of patient populations.

OSP: If you could, please share some of the ways in which challenges created or exacerbated by the COVID-19 pandemic could be helped through FHIR?​

SN: The COVID-19 pandemic has taught us many things, including:

• How trials can be run in a decentralized manner
• How trials can be centrally monitored based on risk
• How the industry can work together to reduce the burden on sites during a clinical trial
• How the industry can effectively use real world data to drive drug efficacy

As CROs and pharma/ biotech companies are navigating through 2021, they are continuing to realize the importance of digital technologies. FHIR acts as an interoperability lever to help integrate EHRs to EDCs, thereby reducing some of the burden on clinical trial sites that manually enter data.

FHIR also provides Substitutable Medical Applications, Reusable Technologies (SMART) on FHIR APIs to promote a digital medium that is acutely necessary for decentralized trials. In some ways, it can be said that had FHIR been adopted prior to the COVID-19 outbreak, pharmacos and biotech companies would have been in a better place with regards to the pandemic response.

OSP: What advice would you have for life-sciences professionals unfamiliar with FHIR?​

SN: My advice is two-fold. First, it’s critical to understand the power of FHIR, the use cases it can drive and the potential it holds. Due to the risk-averse nature of life science organizations, current adoption of FHIR is low. But, with the recent CMS Interoperability and Prior Authorization Proposed Rule (IPA) pushing the adoption of FHIR across payers and providers, it is just a matter of time before it becomes the common language across the entire healthcare ecosystem. It is always better to start sooner than later.

My second piece of advice is to start small. For example, conduct a pilot for automating a few clinical trial sites leveraging an electronic case report form (eCFR) that uses FHIR, or launch a SMART on FHIR app to drive clinical decision support for patient populations. The primary objective should be to measure ROI, its benefits to both the site and its patients and then scale it up across studies, sponsors, and other critical party members. 

OSP: Can you recommend any informational resources for professionals looking to get up to speed?​

SN: HL7 publishes and maintains a repository for all FHIR resources and specifications. In addition, I recently spoke during a webinar on the same topic, which specifically discusses the role of FHIR for life sciences customers. Here at CitiusTech, we are stepping up our technological initiatives in the area of FHIR and interoperability as we see the healthcare ecosystem accepting FHIR as the universal standard for data exchange.

OSP: Similarly, can you recommend any technological tools to assist with FHIR?​

SN: CitiusTech has a proprietary and industry-leading tool called FAST+.  It is an end-to-end FHIR implementation suite that offers modular products, accelerators, and services to connect disparate systems and helps standardize data to enable real-time access. Depending on the need, this can be configured and customized to suit a prospect's specific need.

OSP: How can your company help companies unfamiliar with FHIR?​

SN: For those who are unfamiliar with FHIR, we help them to better understand the concept through various use-cases, showcasing the benefits FHIR has to offer. We recently conducted a couple of workshops to help our clients understand the basic concept of FHIR, its regulations and the impact of FHIR across the business continuum.

Once these organizations have a better working knowledge of FHIR, we conduct a more detailed workshop with each of their teams to further help them identify the use-cases that can qualify for FHIR. After these discussions, we help them create and execute a small pilot to establish the benefits and ROI FHIR can offer.

We have seen companies approach us seeking help to train their technical team around detailed FHIR concepts and APIs.

OSP: Do you have anything you’d like to add?​

SN: As the healthcare and life sciences industries continue to transform and move further into the digital space, the adoption of FHIR will scale up considerably. Hence, it becomes important for the industry leaders to evaluate the potential and possibility of FHIR to avoid any re-scaling and re-architecting of solutions in the future.

Furthermore, FHIR enables companies to capture real-world data at a much more granular level, which can help address various outcomes in clinical operations, research and development, patient engagement, and clinical data management.