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FAQs.

Frequently Asked Questions and Answers on Gravitate-Health and the G-lens®.

Frequently Asked Questions

These FAQ provide an overview of Gravitate-Health project, now on its final year. Gravitate-Health focused on improving how patients access and understand official information about their medicines. By developing digital tools and a personalized approach —the innovative G-lens® system— the project aims to make medicine information more accessible, relevant, and user-friendly, while supporting patient confidence and safety. The FAQ covers common questions about the project’s goals, technology, data privacy, regulatory considerations, accessibility, and future plans, offering practical guidance for patients, healthcare professionals, and organizations.

1. Understanding the Gravitate-Health Project

Gravitate-Health has been developing and testing an improved method of providing official and approved information about medicines to patients. This information is normally given to patients as paper leaflets when they collect their medicines. However, they could be provided additionally in an electronic form, for example accessed on their mobile phone or home computer.
The project’s goal is to develop digital methods and tools to present this information in a friendly way that is more relevant to each patient, so that they can focus their attention on the information that is most important to their personal needs. Gravitate-Health is medium-agnostic: meaning it does not propose that the existing paper leaflets be discontinued. The project offers a structured electronic format that can be provided as a very usable digital alternative. The ultimate aim is that patients become more confident in taking their medicines, by understanding the information about the medicine, and thus are more likely to take them regularly and safely.

Gravitate-Health does not aim to influence healthcare professional decisions about what medicines should be prescribed to a patient, how it should be taken, how a patient’s use of the medicines should be monitored by the prescribing doctor or what information doctors or pharmacists should provide to their patients at prescription and dispensation respectively. Gravitate-Health aims to support prescribing doctors and dispensing pharmacies by giving a patient a more readable version of the officially approved information, to highlight selected aspects about the medicines they have been prescribed and are taking and to provide links to further guidance such as videos explaining how to take the medicine (such as an inhaler).

  • It is well recognised that some patients may not take their medicines correctly, either on a routine basis or knowing what to do in some situations such as if they accidentally skip a dose or have a gastrointestinal illness such as vomiting. The paper leaflet they receive with their medicines contains such useful information, however quite often, patients do not keep this leaflet. And for those that do consult the leaflet, some can find it hard to navigate an often ‘text dense’ document with small fonts, and cannot always quickly locate and understand the relevant information making the experience less than ideal.
  • Therefore, a project such as Gravitate-Health was needed to provide patients with a more useful and readily available way of obtaining precisely the information they need or want to understand better for any given situation. We also recognise that patient understanding can be further enhanced with use of alternative formats that include pictures and/or other health education materials
  • Gravitate-Health is successfully continuing to demonstrate how medicines information can be adapted to make it easier for a software application such as a smartphone app to locate information that is relevant to any particular patient need. It is also demonstrating how a patient’s medical summary can help to personalise the way that information about their medicines is displayed, so that the patient’s attention is focused on the most relevant facts. It is important to note that all of the prepared patient information for the medicine will always be available to view if the patients choose so. It is not hidden or concealed.
  • These techniques, and the software that has been developed to process the medicines information that has been written for patients to use, will be made available for adoption by health systems and by software development companies.
  • Gravitate-Health has also played a key role in contributing to the development of international standards for medicines information. This will make it easier in the future for this kind of smart support to made available to patients. It is important to note that Gravitate-Health recognises that further development is needed to enrich the solutions it could develop in the project, and to help support medical, regulatory, pharmaceutical, technology and health system organisations to adopt these solutions. It will therefore continue its mission after the project as a not-for-profit permanent organisation.

Gravitate-Health solutions will not be directly available on the market for patients or doctors to use. It will be for national and/or regional healthcare systems to consider and implement these types of solutions.

Although there are many other projects and initiatives helping patients to better understand their health conditions and their medicines, there is no other project that we are aware of, that has been focusing on providing authorised medicines information to patients in a personalised way. This is correct as of September 2025.

2. The European R&D programme that has funded Gravitate-Health

  • The Innovative Health Initiative (IHI) programme is one of many research programmes established by, and governed by, the European Commission (EC). The IHI office is an office of the EC and runs its projects according to the same rules as other EC research programmes.
  • IHI projects are only 50% funded by the EC. The other 50% comes from a collection of private companies who agree to collaborate with each other and with the non-industry partners in each project, to help ensure that the results are useful to serve broader societal purposes and neutral of any competitive or marketing interests by any partners. This societal purpose is decided by an independent IHI board before a call for proposal is launched, and periodically validated during a project lifetime to verify that the project is delivering results of high scientific quality and of wide value.
  • Each specific topic for an IHI project is such that it requires multi-stakeholder and public-private collaboration in a pre-competitive manner for achieving its anticipated outcomes.

3. G-lenses: Concept, Functionality, and Ownership

  • G-lens® is a term created by Gravitate-Health. It defines how different parts of the product information leaflet for a medicine should be combined with information about a patient’s health conditions (which has been consented for use by the patient). It uses this to work out what parts are most relevant to that patient. It is a computer rule that the software uses to decide if
    • a particular sentence or paragraph should be highlighted for a patient matching that rule
    • an information heading is not relevant and may be collapsed (the content is hidden)
    • a link should be provided to a video, diagram or web site
    • a translation or a simplified summary should be added
    • warning, notes and informational pieces should be included.
  • There are different G-lens® rules for different categories of medicines information (e.g. for side effects, for storage instructions) and for different health situations (e.g. for pregnancy). Gravitate-Health has developed a library of G-lens® rules, which will be published so that any software developer can use them.
  • The G-lens® will highlight information relevant to a patient. It will not conceal any of the information in the product information leaflet. The content of headings not relevant to a patient are not displayed, but can easily be made visible through user choice.
  • The not-for-profit organisation we seek to establish at the end of the project will seek funds to help to grow this library of G-lenses and will collaborate with other organisations that could develop such rules.

The G-lenses do not create new medicines information, although they may introduce supplementary non-medication information (e.g. about the pollen count). They help a patient to focus on the information that is most relevant to them, from large documents that can be overwhelming to read.

  • The G-lens® trademark is not intended to restrict access, but to control the quality, reliability and independence of G-lenses so that anyone who uses one can be confident that it is trustworthy.
  • Without a trademark, any organisation could create and publish a rule of a lower quality, or which indirectly markets a product, and call it a G-lens®.

The trademark and copyright of all G-lenses are owned by the Gravitate-Health project and will be transferred from the project to the not-for-profit organisation established at the end of the project.

4. Informed Consent and Data Transparency Privacy

  • Gravitate-Health has developed patient information and consent forms to participate in its pilot testing activities across multiple countries that are part of the project.
  • If the Gravitate-Health solutions are adopted by health systems and technology companies, or by medicines catalogue organisations, they will each develop their own patient information to explain the solution and develop the wording of the consent form.
  • Gravitate-Health will develop suggested wording that these adopting organisations could use, based on our experience from the pilot sites. This will be published and can be used or adapted by others.

It is important that information and consent forms are always worded in a way that can be easily understood by patients, in the commonly used languages in each adopting country. Gravitate-Health will recommend this to adopting organisations.

  • The Gravitate-Health solution is expected, in most or all adopting health systems, to use an “opt in” approach. A patient might “opt in”:
    • To view the information about the medicines they are taking, in a friendly way, but without any personalisation
    • To enter their own health summary information, such as their medical conditions, that will enable some personalisation
    • To authorise the download of their medical summary from their GP or hospital, to enable more rich and perhaps more accurate personalisation
  • European data protection laws (the GDPR) allow people to withdraw their consent and for data that they have entered into the solution to be removed. How this right is provided will depend on how the adopting healthcare system words its consent form and patient information.
  • If a patient has opted in to personalisation features, by entering their own medical summary information such as medical conditions, this information may have to be transferred to a computer programme that will use the G-lens® rules to highlight relevant medicines information. That computer programme will be held by a trusted organisation that is only permitted to use the information to provide this service to patients, and to monitor how well the system is working so that any problems with the software can be detected. This is necessary because many of the G-lenses are too complex to run on a patient’s own smart phone or computer.
  • Anonymised information about the use of Gravitate-Health within a region or country may also help to highlight if improved or new G-lens® rules are required.
  • The location of the computer programmes and any data about individual patients will be determined and must be approved by each healthcare system that adopts Gravitate-Health. This will be clearly communicated in conditions for use / information about the service and use of data.
  • Each patient will always be in control of their personal data, deciding whether to give or withdraw consent. Gravitate-Health has undertaken only to use patient-provided information to monitor and improve the quality of the information and services it provides to patients, and never to allow the system and its data to be used for marketing purposes or to profile people to their disadvantage or harm.

5. Data Privacy and Personalization

  • The Gravitate-Health system can connect the application on the patient’s device to the patient’s nominated healthcare professional electronic health record system in order to access their medical summary, if this is permitted by the healthcare organisation and only if the patient has given consent for this. Gravitate-Health only analyses this information to run the G-lenses, and to display it to the patient. It does not store this patient medical summary separately.
  • Some of the medical facts relevant to a particular medicine are communicated from the patient’s application to the Gravitate-Health system in order to work out which relevant information should be highlighted. The highlighting instructions are sent back to the patient application to use. That medical information is not stored by the Gravitate-Health system.
  • If a patient has chosen to allow their medical summary to be included (imported) from their healthcare organisation into the Gravitate-Health application, they may de-select some imported medicines, perhaps because they have chosen not to use them or use them infrequently or seasonally.
  • If a patient chooses not to permit their medical summary to be imported from a healthcare organisation, or if the healthcare organisation cannot support it, then the patient is free to enter their own medical summary information based on their personal knowledge.
  • Patients may wish to add medicines that have not been imported and/or that they have purchased directly from their pharmacy (and later be able to remove them).
  • Patients can add or update personal administrative information.
  • Patients may wish to de-select some imported conditions or allergies as they are mild, seasonal or which they do not feel accurately reflects their health.
  • Patients may wish to add conditions, allergies or intolerances that they believe are important for Gravitate-Health to take into account, even if these are not in their imported summary. This feature is still under development.
  • Patients may wish to manually de-select G-lenses that are by default activated on some other basis, e.g. to de-activate the pregnancy G-lens® if that is active by default on the basis of gender and date of birth, if the patient is not sexually active and does not plan to be.
  • Patients may wish to manually select a G-lens® to be active, based on lifestyle or for other reasons.

The Gravitate-Health system and the application on the patient’s mobile phone are not accessible to anyone else, therefore their doctor or pharmacist cannot view this information. The patient can add personal notes in the application that they can show to their clinician and discuss at the next visit.

6. Patient Engagement and Information Flow

  • No, Gravitate-Health will not provide patients with two-way communication with their healthcare professionals. Healthcare organisations such as GP practices, hospitals and pharmacies have established ways that patients can make contact or send messages. Gravitate-Health does not wish to complicate the use of these by adding a different communication method.
  • If any issues arise in the use of medicines or if a patient is worried or confused by any information they read about their medicines, they should contact their healthcare professional in their usual way.
  • Gravitate-Health provides patient with information about the medicines they have been prescribed, or purchased from their pharmacy, from:
    • the official product information leaflet created by the manufacturer of the medicine and approved by a medicines regulatory body;
    • Other information sources approved by medicines regulators
    • Explanatory and educational guidance material that has been produced by recognised independent and neutral organisations.
  • Medicines information is available in different languages, but the information is not available in every European language within every European country. Gravitate-Health will provide patients with medicines information in as many languages as it can, so the patient can choose from a wide range of choices.
  • Generally, automatic translation is becoming more accurate but is not yet reliable enough that it can be used to fully translate automatically the content of the medicine’s information leaflet.

7. Regulatory Considerations and Use of Electronic Patient Leaflets (ePI)

In each market or regionally ‘under the umbrella’ of the European Union, a national medicines regulatory body (known as a competent regulatory authority) or the European Medicines Agency (EMA) respectively will approve the content of labelling – whether for use by a healthcare professional, a patient or their caregiver. This happens each time a change needs to be made to the content and for the whole ‘lifetime’ that the medicine is available for use in that given market. Once this approval is given, the leaflet for the patient is made available for public use and if the reproduction is identical to the latest approved patient leaflet, further authorization is not required

No, the ePI is identical to the contents of the latest approved patient leaflet made available publicly.

Generic medicines can have differences in labelling content, as the medicine has been made by a different Marketing Authorization Holder (MAH). The MAH of a Generic Company will be responsible in the same way as an Innovator company for managing the labelling content with the national or regional regulatory authority.

A Marketing Authorization Holder (MAH) is responsible for the management of ePI content. Every time a MAH would like to make an update to the content of the product information, the MAH will submit the proposed changes with supporting documents to the national or regional regulatory authority (RA) as applicable for review and approval. The RA can of course request revised wording and /or reject/accept changes as is. The key point here is that the content is revised as and when relevant in line with the latest scientific knowledge about the product to always ensure safety, efficacy and quality of the product.

There is no mechanism that will alert the patient to new information that has been approved. However, each time the patient uses any of the G-lenses, it will pull information from the latest nationally approved product information leaflet.

The Gravitate-Health solutions are intended to support patients access and understanding to trusted sources of information that can be personalised to suit the patients’ needs. Therefore, any product recall or advisory information will be shared following the existing national process.

8. Accessibility & Usability

Generic medicines can have differences in labelling content, as the medicine has been made by a different Marketing Authorization Holder (MAH). The MAH of a Generic Company will be responsible in the same way as an Innovator company for managing the labelling content with the national or regional regulatory authority.

Gravitate-Health has developed demonstration applications that provide different kinds of accessibility functions, such as adjustable text size and contrast, and the ability to use the application on different kinds of device. Once the project is over different health systems and different technology companies will develop applications that use our functionality and may go further with support for different functional needs. For example, the project has not utilised voice input or voice output, but we expect a lot of products will include this capability.

9. Technical Support & Assistance Questions

The support services to patients will depend on the health systems that adopt the Gravitate-Health solution, and the technology provider who develops the systems for it. They will need to decide how customer support and various kinds of help and reporting are offered to patients. This may be provided per country or per health region, across different European countries.

10. Subscription & Costs

The answer to these questions will depend upon the arrangements made by the patient’s health system and the technology companies they work with. It is not possible for the project to know how these arrangements will be made per European country.