The New Standard for Global E-Labeling
As the healthcare industry undergoes rapid transformation, it is shifting away from product information (PI) based on physical and unstructured digital formats to electronic data formats offering greater accessibility, interoperability, and potential for global alignment. A key factor in this transformation is the data standard Fast Healthcare Interoperability Resources (FHIR). Experts Mike Baird from Schlafender Hase and Gary Saner from Reed Tech share their thoughts on this industry wide initiative during a RAPS hosted webinar.
“While digital formats for sharing critical information have improved over the years, the commonly used PDF format has the shortcomings of being static, unstructured, and difficult to search for,” explains Mike Baird, Director of Product Management at Schlafender Hase. “We’re also seeing that the structured product labelling (SPL) format lacks the broader interoperability we need today. FHIR is still in the early stages of adoption,” he points out, “but it allows data to be more easily shared, is adaptable, and reusable, making it an ideal tool in a healthcare sector moving towards e-labeling.”
FHIR-ing up healthcare data
FHIR (pronounced “fire”), was developed by Health Level Seven International (HL7), the organization behind Structured Product Labeling (SPL) format used for submissions in the US. It is built in XML and JSON formats and offers excellent flexibility and interoperability across systems and devices.
“FHIR has great potential for sharing electronic product information (ePI) on a customizable basis, Mike Baird explains.
“Here we’re talking about things like patient package inserts (PPIs), electronic health records, electronic patient records, and personal health records on apps and devices, all of which can be readily exchanged across systems and devices. It’s ideal for the e-labeling environment. And e-labeling not only promotes better healthcare decisions, but also allows faster updates, better accessibility especially for multilingual populations, and environmental friendliness because we reduce the reliance on paper. When the FDA made the Health Level 7 SPL format mandatory from 2005 for submissions, it was a major stride ahead,” Mike Baird says, “but FHIR is the next step forward. We’ve now passed through the door of e-labeling, especially in countries like Australia, Brazil, Japan, Singapore, and several other jurisdictions where labelling is accessible online via QR codes or URLs.”
FHIR, he believes, is especially suitable given the huge amount of data now being captured, stored, managed, processed, and distributed.
Key regulators recognize the potential of FHIR
In the US, FHIR will replace the current HL7 version 3 SPL format, which is being phased out by Health Level 7, and regulatory bodies such as the FDA and EMA are moving cautiously but steadily ahead with initiatives and pilots.
“In Europe, we see that the XEVPRM format for submissions is being phased out and replaced by HL7 FHIR3. This is compatible with the EMA’s IDMP, which standardizes definitions for identifying and describing human medicines,” Mike Baird explains. “The EU is taking legislative action to allow for ePI in future based on FHIR, and in 2023-24, 23 European companies piloted ePI successfully.”
“Work is also moving ahead in the US,” explains Gary Saner, Senior Regulatory Principle at Reed Tech, a service and solutions provider for healthcare. “The FDA has worked together with HL7 to create an implementation guide for HL7 Structured Product Labeling (SPL) standard using FHIR. A pilot to evaluate the migration of SPL content to FHIR was highly successful. A raft of other initiatives are also underway. While Health Canada might lag behind the FDA and EMA in terms of FHIR initiatives, perhaps waiting for FHIR to establish itself further, it is also engaging actively with FHIR on development work.”
Transitioning to FHIR
There is strong consensus that FHIR will eventually become the global standard for regulatory submissions and healthcare data exchange. “We have no clear timelines for adoption and implementation,” says Mike Baird, “but having this globally standardized approach is going to be a huge benefit, with the potential to reduce workloads.”
“Nevertheless, there will be pain points”, explains Gary Saner, “especially during the initial phase when some companies may need to submit dual formats to meet new and existing standards”. He points to the fact that many companies will have to invest in migration and other tools to manage legacy data, update their technological infrastructure, and provide training to regulatory staff.
Shifting away from document-centric approaches
“With e-labeling, FHIR and the very many different ways in which information can be shared across platforms and devices, we’re experiencing a shift away from document-centric thinking to a content-based approach,” Mike Baird says. “In our business, that means having workflows and tools in place that are designed for ePI, with capabilities to verify content in all its different formats and possibilities. This includes verifying QR codes, links, ensuring your website is compliant and consistent with your other formats, and much more. We can expect e-labeling to become a primary source for patients and healthcare professionals. Nevertheless, we can already see that the industry will still be required to provide physical product information, not only in transition periods, but also because regulatory authorities often require this on an on-demand basis.”
So how can companies prepare for the challenges of FHIR and e-labeling?
“The learning curve will be huge,” explains Gary Saner. “We saw this with the adoption of SPL in the US, and this will be the case for FHIR, especially in regulatory affairs departments. Based on our experience with the introduction of SPL in 2005, I’m sure we will see companies bringing in additional resources outside to smooth the changeover.”
“It’s important to put processes in place early,” Mike Baird adds. “That means monitoring regulatory developments in this area closely and preparing for the transition by putting in place tools and training. FHIR has the potential to be a transformative force in the sharing and use of healthcare data. A company can’t go wrong if it starts gathering the resources and expertise it needs now.”
This article has been adapted from a RAPS webinar co-hosted by Mike Baird, Director of Product Management at Schlafender Hase, and Gary Saner, Senior Regulatory Principle, Reed Tech, a member of the standards setting board at Health Level Seven International (HL7).
The webinar is now available on-demand: Watch it now
