The shift to structured content and data has been a long-term objective for regulatory agencies and the Biopharma industry. However, progress has been hampered by a lack of open and broadly adopted industry standards and tools. While the Electronic Common Technical Document (eCTD) is a widely adopted standard for regulatory submissions, it only uses XML as the structural backbone for the submissions package and to handle metadata, the content itself is still largely made up of unstructured documents. However, there is a commonly used standard for exchanging health information that is being adopted that could change the landscape over the next several years: FHIR (Fast Healthcare Interoperability Resources) is a widely used application programming interface (API) focused standard used to represent and exchange health information maintained by the standards development organization HL7 (Health Level 7). There are several important Pharma initiatives that are already based on FHIR: the EMA ePI Labeling standard, the FDA PQ/CMC initiative, and the ICH M11 Protocol template initiative, with others to follow.

In this webinar, we will explore

• What is the FHIR standard?
• The transformational potential of FHIR
• How will legacy regulatory systems and processes adopt FHIR?
• What about legacy content formats? The opportunity for coexistence.

The post On Demand Webinar – Data driven content – FHIR and the future of Regulatory Submissions appeared first on Astrix.

What is FHIR?

FHIR stands for Fast Healthcare Interoperability Resources and is a HL7  standard for simplified electronic healthcare information exchange across the industry. The adoption of a FHIR framework is the next step to improve upon data interoperability. FHIR  provides representation and the ability to share information, such as EHRs, across hospitals, organizations or between healthcare providers in a standardized way despite the differences in the way an EHR is housed and stored.¹ HL7 ’s goal is to leverage pre-existing “logical and theoretical models to provide a consistent, easy to implement, and rigorous mechanism for exchanging data between healthcare applications.” ²

What are the basic building blocks?

FHIR is built upon exchangeable information called a “Resource.” It utilizes HTTP-based REST application programming interfaces (APIs) to access, manage and use these specified Resources.³ Resources are comprised of specific data elements, a common set of metadata and a human readable part. For example, a FHIR Resource can represent categories such as patients, specified treatments, laboratory results, imaging, etc. and will be defined by common use data elements that result in exchangeable patient records. Resources take this data information and use the components necessary to connect it to other relevant information related to other Resources. Simplicity, adaptability, and efficiency are what FHIR is accomplishing for the field by making Resources easily understood and implemented for further exchange.

What is philosophy?

The philosophy of FHIR is to build a foundation of Resources, individually or combined, that are adequate for most common use cases, as defined by HL7 . The Resources are used to characterize core information that will be shared amongst the majority of implementations. As for the remaining content, a built-in extension mechanism can be to combine Resources in and Implementation Guide that addresses the specific use case, which leads to expansion of the capabilities set out by FHIR .²

How is it secure?

Protecting health data, such as sensitive patient information, is one of the biggest concerns found within healthcare information technology. It is imperative that stakeholders know that data exchange will be secure. FHIR uses modern security standards, such as authentication, encryption, and labelling sensitive information for authorized users, to protect its data.⁴

How has it evolved?

HL7 FHIR  was initially presented in May 2012, and has since evolved into what it is today through 4 different releases. What started as a true draft standard that included 49 Resources, has now reached 145 Resources, and counting. In 2013, the first release comprised of an emphasis on two use cases – creation of a Personal Health Record on mobile devices and the retrieval of documents to a mobile device – which stimulated the chatter, interest, and thoughts on how this could change the field of healthcare information technology. In 2015 for the second release, additionally non-clinical Resources were implemented, the structure of Resources were adjusted for ease of extensions and the FHIR Maturity Model (FMM) was created that established a 0 – 5 draft to final status set of levels for the Resources to achieve. In the third release in 2017, improvements were made to Resources (Clinical, Administrative, Financial, Clinical Decision Support and Clinical Quality Measure) and a new framework was established to enhance workflow. Currently, we are in release 4 that occurred in 2019. This release included 9 new Resources, Patient and Observation Resources named as normative content, RESTful API, XML and JSON formats, and removed the Trial Use name. Additionally, FHIR release 4 was published as the requirement standard for Health IT Certification in the Final Rule for the 21^st Century Cures Act. From 49 to 145 Resources, the standard has continually upgraded to meet the needs of the community and will continue to do so.⁵

Where are we currently?

In 2023, HL7 published FHIR  Release 5 which offered improvements in interoperability and data management abilities. There were numerous advancements that were made, but here are some of the tops to be explored. To create a more complete FHIR based healthcare data exchange across the field, they focused on the development of more supportive conditions and standardized framework for easier access to the data. Patient data is easier accessed and managed for a focus on care and minimizes the room for error within the data. Users now have the opportunity to use topic-based subscriptions, which enables FHIR notifications when there is a change to data in the system. Medication definition Resources were revised to better align with drug catalogs. Resources can now be managed in large sectors to be more efficient in data exchange, such as Groups and Lists. The number of Resources is now published to be 157. To find a comprehensive list of all that can be found in release 5 and what to know about FHIR , click the link here. FHIR looks to maintain its work and prominence in health IT and continue to integrate itself as the standard.

With healthcare data increasing in complexity, technology advancing and expectations rising amongst users, FHIR will continuously adapt and progress in its capabilities. FHIR is the future of healthcare technology and will continue to promote data interoperability by the use of its central operating system.

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References

1. eCQI Resource Center. FHIR – Fast Healthcare Interoperability Resources | eCQI Resource Center. ecqi.healthit.gov. Published January 31, 2024. https://ecqi.healthit.gov/fhir#:~:text=Fast%20Healthcare%20Interoperability%20Resources%20(FHIR).
2. HL7 FHIR. FHIR Specification (v5.0.0: R5 – STU). www.hl7.org. Published March 26, 2023. https://www.hl7.org/fhir/overview.html.
3. Ayaz M, Pasha MF, Alzahrani MY, Budiarto R, Stiawan D. The Fast Health Interoperability Resources (FHIR) Standard: Systematic Literature Review of Implementations, Applications, Challenges and Opportunities [published correction appears in JMIR Med Inform. 2021 Aug 17;9(8):e32869]. JMIR Med Inform. 2021;9(7):e21929. Published 2021 Jul 30. doi:10.2196/21929.
4. The Office of the National Coordinator for Health Information Technology.What Is HL7  FHIR ? https://www.healthit.gov/sites/default/files/page/2021-04/What%20Is%20FHIR%20Fact%20Sheet.pdf.
5. The Office of the National Coordinator for Health Information Technology.FHIR  Version History and Maturity. https://www.healthit.gov/sites/default/files/page/2021-04/FHIR%20Version%20History%20Fact%20Sheet.pdf.

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