FAQ’s2020-09-29T10:42:31+00:00
Adverse events
How do we deal with adverse event reporting?2020-02-10T17:01:28+00:00

Florio is not a tool for reporting suspected side effects (also known as adverse events) of your medicine and does not store or submit adverse event reports. Please consult your healthcare provider with any questions or concerns you may have regarding your health condition. If there is
any defect as to the content of Florio you should contact the named supplier without delay. Relevant contact details for the manufacturers can be found on the manufacturers’ websites which should be on any medicine packaging. Information about adverse reactions to medicines
and reporting forms can be found at yellowcard.

What happens if I lose my phone or get a new phone?2020-02-10T16:50:06+00:00

You can always install Florio on a new phone and get access to your Florio account using your access data. Access via your lost phone will not be possible as long as your biometric data has not been compromised.

How will Florio track my activity / workouts?2020-02-10T16:49:41+00:00

Florio tracks your daily activities with the help of Apple HealthKit (on iOS) or Google Fit (on Android) to allow your doctor to gain additional information about your activity level. Apple HealthKit and Google Fit store activity and health information (like the number of steps, flights
climbed, activities, calories burned, heart rate, etc.).

Does Florio work on all smartphones?2020-02-10T16:49:19+00:00

Yes, Florio works on all smartphones operating with iOS and Android operating systems.

Is the use of smartwatches a must with Florio? Is it essential?2020-02-10T16:48:59+00:00

Florio offers a great user experience for patients even without a smartwatch. The smartwatch helps capture the patients activity data. It improves the patient experience but is not required to use Florio.

Can I use other wearable devices than an Apple Watch?2020-02-10T16:48:20+00:00

Yes, Florio can use activity data from many wearable devices, including Samsung Galaxy watches, Fitbits and Google Fits on iPhone (not all models supported) and some wearables in connection with android smartphones (excluding Samsung wearables and Fitbits).

Do I need to wear the Apple Watch?2020-02-10T16:47:57+00:00

If you are using Florio on an iPhone, the Apple Watch allows you to capture the most granular level of health and activity data. Florio uses this information to provide a more accurate view of your overall health to your physician. Florio none the less can be used without the Apple Watch.

How do I delete an injection I have already logged?2020-02-10T16:47:26+00:00

From the main navigation button in the top-left of your phone’s screen, select “My Progress” then “All Events”. Find your most recent injection in the list, press it to see more detail then delete it. Please note: your stock level will not be restored to its previous level, before the infusion. Please
manually add the deleted FVIII product to your stock so that the correct number of remaining vials is displayed.

How can I find my current factor level while I am treating a bleed event?2020-02-10T16:46:34+00:00

Factor is consumed differently while you are treating a bleed, so your factor level cannot be accurately estimated until you have finished treating the bleed and returned to your normal prophylaxis.

How can I find my current estimated factor level?2020-02-10T16:45:59+00:00

Based on your most recent prophylactic infusion, your current estimated factor level is shown on the Home screen. The Home screen can be accessed from the main navigation in the top-left of the phone’s screen.

Why should I log bleeds?2020-02-10T16:45:24+00:00

Logging bleeds helps you and your healthcare professional to keep track of instances of bleeding along with their cause and your level of factor when they occurred. This information could potentially enable a more accurate evaluation of your treatment plan at your next consultation
visit.

How do I log bleeds?2020-02-10T16:44:44+00:00

“After selecting the “+” button, hit “Bleed” to log a new bleeding event. Enter the date and time, then tap on the area of the body to confirm where the bleed occurred. You can toggle between the front and back body view.

On the next screen, you have to opportunity to log a photo of your bleed or skip the step. Next, select the level of pain that you felt and the cause of the bleed. You can choose between injury (when you hurt yourself in an accident), spontaneous (when there is no identifiable cause) and physical activity (when the bleed happened during any physical activity).

As a final step you need to select whether you treated the bleed and what dose of factor you used. Don’t forget to add any comments in the provided text field and tap the submit button to save your entry.”

Why should I log infusions?2020-02-10T16:42:56+00:00

“In order to display your estimated factor level, it is necessary to log your latest infusion. It’s very important to log the infusions with the exact date and time to ensure that the displayed factor level is correct.

In addition, logging infusions helps you and your doctor to have easy access to this information, which will make it easier to evaluate your treatment plan at the next consultation visit.”

How do I log infusions?2020-02-10T16:41:38+00:00

“In Florio you can log infusions quickly and easily. By selecting the “+” button on the bottom of the screen, you can either log an infusion or a new event such as a bleed or pain. Simply choose the time/date for the infusion or event, even if it was in the past.

Next, select the dose you injected and tap the submit button to save your entries.”

Can Florio be used without PK?2020-02-10T16:40:38+00:00

A key feature of Florio is the display of estimated factor levels that allows patients to adjust their treatment to their planned activities or their activities to the current and future estimated factor levels. Thus, we do not offer Florio without PK.

Can I use Florio without WAPPS-Hemo?2020-02-10T16:40:02+00:00

Florio installation requires a valid login to the WAPPS-HEMO database. As a patient, please contact your healthcare professional for additional information.

How is the adherence score calculated?2020-02-10T16:39:36+00:00

“Adherence: % of actual infusions “on time” (within 12 hours). For example: if your treatment plan expects 50 infusions in a 6-month period and you miss 10 infusions by more than 12 hours. Your adherence score will be 80%.”

Is Florio available for all products?2020-02-10T16:38:52+00:00

In accordance with the treatment regimen at your haemophilia treatment centre, Florio can be used with all available Factor VIII replacement products.

Is Florio available for other bleeding disorders?2020-02-10T16:38:21+00:00

Florio was developed for patients with congenital haemophilia A. It is currently not available for any other bleeding disorders.

What happens if my treatment is changed?2020-02-10T16:37:56+00:00

Once your physician updates your treatment regimen in WAPPS-Hemo, the treatment regime will automatically update in your Florio account.

Which activities can I perform to stay safe?2020-02-10T16:37:36+00:00

Please refer to your doctor for further information on safe activities.

What is the factor level?2020-02-10T16:37:07+00:00

“The factor level in Florio displays your current estimated clotting factor level based on your last prophylactic infusion. The factor level is provided by WAPPS-Hemo in collaboration with your physician.

Please note that your estimated factor level is an estimate based on the information in WAPPS-Hemo provided by your doctor and your own reporting of infusions in Florio. It is very important to make sure you record your infusions (date, time and dose) as accurately as possible. If you have any doubt about your estimates, please discuss them with your doctor.”

Why was Florio developed?2020-02-10T16:34:16+00:00

Florio was developed to give people with haemophilia individual insights, enabling them to make individual choices and to bring data-driven insights to healthcare professionals supporting them to change lives through personalised care.

What is WAPPS-HEMO?2020-02-10T16:33:41+00:00

WAPPS-HEMO is a platform to perform individual pharmacokinetic assessments, offered by McMaster university. Florio collaborates with WAPPS-Hemo to display estimated factor levels.

How does Florio work?2020-02-10T16:33:15+00:00

Florio uses a combination of your personalised, predicted factor level, provided by WAPPS-Hemo in collaboration with your physician, and data from your Smartphone and (optionally) wearable device to help you better understand your factor levels. Additionally, Florio provides a
core set of features to manage other elements of your condition, acting as your digital diary for logging instances of pain or bleeds, as well as infusions.

What is Florio (intended use)?2020-02-10T16:32:45+00:00

“Florio is a medical device designed to support people with haemophilia by helping you track the events associated with your condition.

Florio displays your estimated factor level (see “What is the factor level?” for details) and allows
you to keep track of your infusions; record bleeding and/or pain, and to track your daily activities.”

How is the data protected?2020-02-10T16:31:19+00:00

Florio uses industry best practices to protect patient data from all forms of attack and loss. Florio encrypts all data in transit and when stored. More information is available via the Privacy Policy and Terms of Use which can be accessed here [insert link].

Can Florio publish my data without my knowledge?2020-02-10T16:30:42+00:00

Florio uses your data to develop new features that will improve the app for patients and physicians around the world. Florio may use aggregated and anonymised data for research purposes. The results might be published in medical journals.

Does WAPPS-Hemo see/store any data reported in Florio?2020-02-10T16:30:15+00:00

In order to display the patient’s individual factor level, Florio sends the following data to WAPPS-Hemo: Infusion date/time, infusion dose, factor level at time of infusion. These data are also visible on the WAPPS-Hemo portal in the patient file.

Does Florio report data to other platforms (for example national registries)?2020-02-10T16:29:13+00:00

In order to display the patient’s individual factor level, Florio sends the following data to WAPPS-Hemo: Infusion date/time, infusion dose, factor level at time of infusion. These data are also visible on the WAPPS-Hemo portal in the patient file. We are working on a solution to link Florio
to national registries in the future.

Is Florio tracking data in the background?2020-02-10T16:27:44+00:00

Florio tracks and displays your daily activity with the help of Apple HealthKit (on iOS) and Google Fit (on Android) to allow your healthcare professional to gain additional information about your activity level. Florio also gives you insights into your estimated factor levels and activity. Apple HealthKit and Google Fit store activity and health information (like the number of steps, flights climbed, activities, calories burned, heart rate, etc.). Florio also tracks usage of the app and features to develop new features and improve the platform.

Does Florio track my location?2020-02-10T16:26:49+00:00

No, Florio does not track your location.

How long will my data be stored?2020-02-10T16:26:34+00:00

Florio will handle your data in accordance with the Terms of Use and Privacy Policies which can be accessed here [insert link]. Data will be stored for up to seven years.

Can other users see my data?2020-02-10T16:26:04+00:00

No, only you and your healthcare professional can see your data.

Can I share my data with my friends or other Florio users?2020-02-10T16:25:42+00:00

Data security and privacy is of highest importance to Florio. Therefore, it is not possible to share data with your friends or third parties.

How does my healthcare professional see my data? / What do they see?2020-02-10T16:25:06+00:00

Your healthcare professional can see all the data that you have entered or captured within the app. These data include infusion data, bleed or pain recordings, activity levels (including type of workouts if specified), factor level over time, responses to micro surveys on bleed or pain impact
or mood. You can see a similar overview of all the data shared with your physician if you go to the “my progress”-section of the Florio app.

What does Florio do with my data?2020-02-10T16:24:16+00:00

Florio uses your data to develop new features that will improve the platform for patients and physicians around the world. Florio may use aggregated and anonymised data for research purposes. The results will be published in medical journals. More information is available via the
Privacy Policy and Terms of Use which can be accessed here [insert link].

Can I download my data?2020-02-10T16:23:23+00:00

If you wish to download your data, please email help@florio.com and the team will be happy to
assist.

Can I delete my data?2020-02-10T17:04:29+00:00

Florio will handle your data in accordance with the terms of use and privacy policy, but you can request that your data will be deleted. If you wish to stop using Florio and have your data deleted, please email help@florio.com and the team will be happy to assist.

Why do I need to consent HealthKit data?2020-02-10T17:03:58+00:00

Florio tracks and displays your daily activities with the help of Apple HealthKit (on iOS) and Google Fit (on Android) to allow your doctor to gain additional information about your daily activities. Apple HealthKit and Google Fit store activity and health information (like the number of
steps, flights climbed, activities, calories burned, heart rate, etc.).

Who has access to my data?2020-02-10T17:03:35+00:00

Your data, which is stored under a pseudonym, will only be shared with third parties in accordance with the Privacy Policy and Terms of Use which can be accessed here [insert link]. Data access is monitored by the independent Florio Data Governance Board.

Who should NOT use Florio (i.e. contraindications)?2020-02-10T17:02:15+00:00

Florio should not be used by Haemophilia A patients who are: 1) on an On-Demand treatment schedule, 2) diagnosed with a current FVIII inhibitor, 3) treated with other drugs than factor VIII replacement products. Florio should also not be used by patients suffering from bleeding
disorders other than Haemophilia A.

I have a question, problem or feedback about Florio, who should I contact?2020-02-10T17:02:51+00:00

Please contact help@florio.com if you have any questions related to the app or Florio platform. With any questions related to your condition, treatment or any other health related matter, always contact your healthcare professional.

Where is my data stored?2020-02-10T17:03:11+00:00

Any data recorded via the app will be securely stored and encrypted. Florio stores and processes data in compliance with GDPR regulations, i.e. within the European Union. More information is available via the Privacy Policy and Terms of Use document which can be accessed here [insert
link].