FHIR: Transforming Product Labeling

FHIR also offers the opportunity to move to a more patient-centric approach, because it allows patients and healthcare professionals to access data easily via apps, across different healthcare providers and geographies. As result, patient data is more transparent, more available.

When combined with the platform SMART (Substitutable Medical Applications, Reusable Technologies) – generally called “SMART on FHIR” – developers have been able to create a strong range of healthcare applications that are interoperable across many different health IT systems.

For example, SMART on FHIR opens the way for patients to have a personal health record (PHR) via an app on their smartphone, along with an electronic health record and electronic medical record that contains all information from different health providers (i.e. visits, treatments from different specialists, etc.). Changes to the EHR and EMR might be synchronized with the app, in some cases allowing the patient to view the EHR/EMR. Apple’s Health app is a form of this and uses SMART on FHIR APIs. [8]

This also involves obvious organizational and legal questions of interoperability, especially in regards to data privacy. Policies and processes must therefore ethically keep pace with the technical, syntactic and semantic aspects.

Next level interoperability

FHIR is gaining widespread attention both among regulatory bodies and – as the growth of healthcare apps shows – in the medical and patient community itself. Significantly, it plays a key role in the US 21^st Century Cures Act as FHIR and SMART on FHIR are the minimum conformance standards under the act. Furthermore, as well as stipulating how user authorization is performed and how apps launch, it forbids information blocking by EHR and FHIR providers. [9]

This is causing a shake-up in the healthcare ecosystem. Acceptance of the Act by some EHR vendors and hospital systems has apparently been lukewarm at best. “Intense lobbying against the rule, preceding its release, by EHR vendors and hospital systems signals that control over data and revenue are both at stake. The rule not only enables patient and provider access to medical record data in computable formats but also shifts how they interact with the health care system, which entities control those interactions, and the underlying business models that could either threaten or accelerate interoperability’s potential to improve care delivery.” [10]

Interoperability is therefore raising some very significant commercial questions.

FHIR from a regulatory perspective

Through its CBER-CDER Data Standards Program action plan, the FDA is engaging strongly with FHIR on several levels. [11] The CBER-CDER strategy is all about having comprehensive data standards in place that facilitate the pre- and post-market regulatory review process. Significantly, as part of its project in the area of Identification of Medicinal Product (IDMP) standards – a set of five ISO standards to identify and describe medicinal products [12, 13] – FHIR is foreseen as the standard for global information exchange. It is working together with the European Medicines Agency (EMA) on this project.

Across the Atlantic, EMA also outlines its clear commitment to FHIR when it reiterates that EMA, the FDA and the European medicines regulatory network are “working with Health Level Seven (HL7) to incorporate the ISO IDMP standards into the FHIR specification.” [14]

This is integral to EMA’s Substance and Product Data Management Services (SPOR) programme for managing centralized master data in compliance with ISO IDMP standards. [15, 16, 17] SPOR has four domains. In its Product Management Services (PMS) domain, HL7 FHIR “replaces the current data submission format, the eXtended EudraVigilance Product Report Message (XEVPRM).” [18]

How FHIR is transforming product labeling

Structured Product Labeling (SPL) is one of the most important areas in which FHIR is set to have an impact (see Part II of our series on structured content here]. This XML format (HL7 version 3 SPL) for the exchange of information is the current standard for a range of key FDA drug filings. While FHIR has not yet been introduced, “FDA is working towards replacing Structured Product Labeling (SPL) with HL7 FHIR.  The FDA has created a proof-of-concept system that can receive labeling information using either SPL or FHIR standard (Dual Submission) in addition to a draft Implementation Guide (IG).” [19]

The SPL specification has enormous strengths in terms of semantic and syntactic interoperability, but the strength of FHIR is its technical interoperability across devices and systems. This is crucial when using different devices in the age of electronic labeling (e-labeling), as well as for being able to automate workflows. SPL and its Canadian counterpart, the Structured Product Monograph (SPM), have created windows of opportunity for automation, and FHIR builds on these.

We can see this as the next level in the exchange of information, which began with the nervous exchange of duplicate hardcopy filings and time-consuming manual review by the FDA in a pre-electronic age, then advanced to the age of electronic submission in SPL format, and now has reached the age of FHIR. In brief, the benefits we are already seeing are:

• Cost and time efficiencies through the better exchange of information
• Greater potential for scalability
• Risk mitigation through automation of workflows and processes (information must not be transposed, rewritten or otherwise manually replicated)
• Empowerment and ownership for patients, physicians and other stakeholders through the availability of information
• Information exchange across different devices and media

 In Europe, FHIR in regulatory action can already be seen in EMA’s pilot project on electronic product information (ePI), which began in July 2023. This FHIR-based pilot covers “authorised, statutory product information for medicines (including the summary of product characteristics, package leaflet and labeling) adapted for handling in electronic format and dissemination via the web, e-platforms and in print.” [20] The results of the project can already be accessed on its ePI portal. [21]

FHIR represents a significant step in how we manage, and exchange information and it has rapidly gained acceptance. While regulatory bodies are exercising caution and the required due diligence in implementing FHIR, it features in many different aspects of their planning. HL7 International is working closely on supporting the FDA on future implementation of HL7 Structured Product Labeling (SPL) standard using FHIR. [22] Similarly, in Europe we are seeing its implementation in key regulatory areas of healthcare, including e-labeling. In the commercial arena, it is already changing the face of healthcare.

Read Part I and Part II in our series on structured content.