Discover Fast Healthcare Interoperability Resources, Adopting to EU Common Standards and our end-to-end ePI support

Our experts, Mallikarjun R , VP of Regulatory Services, Murali Prasaanth Babu, Senior Regulatory Associate, Priya Arunachalam, Team Lead, end-to-end regulatory services and Palli Nomuganesh, Senior Manager, Regulatory Operations, recently published an article titled ‘Exploring the potential of FHIRs and e-labelling’ in Pharmaphorum. The article discusses the potential benefits of using Fast Healthcare Interoperability Resources (FHIRs) and electronic labelling (e-labelling) in the healthcare industry.

In our latest blog, our experts provide further details about FHIR and its integration, our end-to-end ePI support and Adopting to EU Common Standards.

What is FHIR and how can it be integrated?

Murali Prasaanth: Fast Healthcare Interoperability Resources (FHIR) is an interoperability standard for electronic exchange of healthcare information. FHIR was developed by Health Level Seven International (HL7) which develops and provides frameworks and standards for the sharing, integration and retrieval of clinical health data and other electronic health information.

It can be integrated using the following method

Column 1: Loose Integration, Focused Scope

If the organization has specific use cases to adopt and has just begun assessing its long-term FHIR strategy, it might look at a solution architected similar to column 1. In this model, team members will learn more about the technology along the way, inform their strategy with experience, and limit the risk and investment until they have defined the strategy and have some expertise.

Column 2: Mild (Hooks) Integration, Broad Scope

If an organization has a strategy, resources (both internal and external), and the desire to use FHIR in the platform-as-a-service (PaaS) model (e.g., Amazon Web Services or Microsoft Azure), it will have greater flexibility to determine which use cases to support. The model in column 2 provides managed FHIR services that allow the organization to focus on the use cases and customers, not the technology.

Column 3: Deep Integration, Broad Scope

Investment in a FHIR-enabled platform modeled in column 3 (e.g., an EMR, EDW, or a cloud-based data platform) will provide additional advantages, particularly in governance and limiting replication of data for FHIR. FHIR would be one of many capabilities of the data platform, deeply integrated with other services such as a master patient index, terminology services, telemetry, and other platform management services.

Three columns of FHIR Integration

Benefits of FHIR for Healthcare:

As healthcare shifts towards value-based standards, data interoperability is becoming increasingly important for providers to interact with patients and improve healthcare outcomes. FHIR implementation can handle data management securely, quickly, and reliably. FHIR has made patient data accessible to patients, care providers, and device manufacturers, improving healthcare IT. For those in the medical field dealing with patient records, FHIR can be highly beneficial as it saves time and streamlines the process of accessing patient data. FHIR is exceptional compared to other techniques for developing information source access normalization, and consistently provides excellent recommendations.

Reference:

https://www.heaptrace.com/what-are-the-benefits-of-fhir-for-healthcare/

What are the directives from European Medicines Regulatory Network towards electronic Product Information (ePI)

Nomu Ganesh Palli: The European Medicines Regulatory Network has adopted a Common Standard for the electronic Product Information (ePI) on medicines in the European Union (EU). This will pave the way for wider dissemination of the unbiased, up-to-date information on all medicines available to patients in the EU through an ever-expanding range of electronic channels.

The adoption of the Common Standard is in line with the ePI key principles which were established following stakeholder consultations and guide the development of the ePI in the EU. The EU ePI Common Standard is based on Fast Healthcare Interoperability Resources (FHIR), an international technical standard describing data formats and elements and an application programming interface for exchanging Electronic Health Records (EHRs). FHIR also supports the exchange of information about medicinal products, substances, and related referential data in the European medicines regulatory network.

Electronic PI already exists in Europe on a regional level. For example, the Spanish Agency for Medicines and Health Products (AEMPS) has already made ePI available for many of its nationally authorized products.

The roll-out of ePI will mean that new safety information, contraindications or side effects are published and available immediately to view/print by prescribers, pharmacies, patients, etc.

A ‘digital first’ approach wherein the ePI is retained in a digital format throughout the submission process rather than Word/PDF could avoid inaccuracies resulting from conversion between document formats.

How can Navitas Life Sciences support clients

Priya Arunachalam: Navitas Life Sciences can provide ePI end to end support:

1) ePI Creation tool for MAH

Navitas Life Sciences can develop a tool which could be used by MAH to create ePI for submission in an application or to create an ePI once the evaluation is complete.

2) Expert Process consulting & Scientific Advice:

Leveraging the vast experience and knowledge of our experts, once the ePI creation is completed, Navitas Life Sciences can support the MAH & clients by providing Submission support. We can also provide Scientific advice for ePI approval by EMA/NCA.

3) Excellent Application support:

• DYNAMIC FILE FORMAT: We need to create a web-based e-Leaflet format which should be optimized for the requirements of healthcare companies, healthcare professionals and general users. Access information from web browsers on any device or use our Navitas Mobile app on smartphones and tablets. Dynamic text reflow, font resize, media and screen size optimization guarantee optimal readability and information access on any platform.
• MULTI-LANGUAGE SUPPORT: Our out-of-the-box multi-language features in Navitas app would provide information in local languages.
• MULTIMEDIA SUPPORT: Forget paper and small text, our Navitas app can provide resizeable text, slideshows, sound and video to help our customers understand and use the products better. Media automatically resize for the target platform so that our customers get the full experience regardless of the device.
• COMPLETE BRANDING: No more black and white paper leaflets, we can add full color, logos and all branding elements to our clients’ digital packaging. We can make sure their customers recognize their brand and keep it on their smartphones wherever they go.
• PATIENT TEMPLATES: Pharmacies map, customer surveys, dosage helpers are some of the digital services that the Navitas app can support.
• MARKETING TEMPLATES: Navitas app can reference all client products to help users navigate all the products. Discounts or special initiatives and promotions can also be listed.
• CONTENT VERIFICATION: Real-time content verification system lets the Navitas app lets patients, doctors and all customers access up-to-date, reliable information wherever they are.

Exploring the potential of FHIRs and e-labelling

Our article ‘Exploring the potential of FHIRs and e-labelling’ by Mallikarjun R , Murali Prasaanth Babu, Priya Arunachalam and Palli Nomuganesh discusses the potential benefits of using Fast Healthcare Interoperability Resources (FHIRs) and electronic labelling (e-labelling) in the healthcare industry. Fast Healthcare Interoperability Resources (FHIRs) allow fast to build REST based APIs, and are revolutionising the way healthcare providers, patients, and vendors share and access sensitive data. As an emerging data exchange standard, FHIRs allow for secure storage and easy-to-understand data communication.

Access the article and get insights on

• How FHIR is different from other interoperability standards
• How healthcare systems benefit from FHIRs
• How an FHIR is linked to electronic Product Information (ePI)
• Why there is a need for end-to-end ePI support

Published by Pharmaphorum

March 2023

Mallikarjun R,

VP of Regulatory Services

Palli Nomuganesh,

Senior Manager, Regulatory Operations

Priya Arunachalam,

Team Lead, end-to-end Regulatory Services

Murali Prasaanth Babu,

Senior Regulatory Associate

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