This is the third post where we will be looking in detail at the EU initiative exploring the introduction on an electronic Product Information (ePI) for human medicines authorized in the EU. We will also be looking at how the eLeaflet solution from myHealthbox performs against the requirements set forth by this EU ePI initiative.

The features expected from an ePI implementation have been divided into 3 main categories:

The features

ePI future functionalities

Regulatory efficiency

ePI could help to increase the efficiency of regulatory processes, for example by simplifying user testing of PLs.

The eLeaflet solution from myHealthbox allows a direct feedback from the user and also implementation of surveys within the eLeaflet whose results and answers can be readily feedback into the editing and content generation process for example addition additional details for areas that prove to be difficult to understand or generate lots of questions. The eLeaflet also suports a FAQ area where the most common Questions and Answers can be easily shared and updated.

Dosing apps and alerts

ePI could be used in apps that help patients manage their own treatment and ensure they follow their dosage regimen correctly.

The eLeaflet solution from myHealthbox supports a dosing application and a pill reminder functionality, these combined can help in one of the most critical parts of treatment: therapeutic adherence.

Reporting of adverse effects and real-world data collection

ePI could facilitate collection of real-world data, including direct reporting of side effects by patients and HCPs.

The eLeaflet solution from myHealthbox natively supports digital Adverse Reaction Forms for both patients and HCPs, these forms can be product- and country-specific. Once filled in these forms are then send to the relevant parties (producer, agency, etc...).

Data collected anonymously in our systems are then fed into a data analytics platform called Medstrends which provides insights into real-world content consumption and trends.

More information about the eLeaflet solution from myHealthbox is available on the eLeaflet website

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