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    myBETAapp™

    Thank you for registering for myBETAapp™

    Indications

    BETASERON® (interferon beta-1b) is a prescription medicine used to reduce the number of relapses in people with relapsing forms of multiple sclerosis (MS). This includes people who have had their first symptoms of multiple sclerosis and have an MRI consistent with multiple sclerosis. BETASERON will not cure MS but may decrease the number of flare-ups of the disease.

    Important Safety Information

    Do not take BETASERON (interferon beta-1b) if you are allergic to interferon beta-1b, to another interferon beta, to human albumin, or mannitol.

    BETASERON can cause serious side effects, including:

    Liver Problems Including Liver Failure. Symptoms of liver problems may include yellowing of your eyes, itchy skin, feeling very tired, flu-like symptoms, nausea or vomiting, bruising easily or bleeding problems. Your healthcare provider will do blood tests to check for these problems while you take BETASERON.

    Serious Allergic Reactions. Serious allergic reactions can happen quickly and may happen after your first dose of BETASERON or after you have taken BETASERON many times. Symptoms may include difficulty breathing or swallowing, swelling of the mouth or tongue, rash, itching, or skin bumps.

    Depression or Suicidal Thoughts. Call your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse or worry you: thoughts about suicide or dying, new or worse depression (sinking feeling or sadness), new or worse anxiety (feeling uneasy, nervous or fearful for no reason), trouble sleeping (insomnia), acting aggressive, being angry, or violent, acting on dangerous impulses, hallucinations, other unusual changes in behavior or mood.

    Other possible serious side effects with BETASERON include:

    Heart Problems. BETASERON may worsen heart problems including congestive heart failure. Symptoms of heart problems may include swollen ankles, shortness of breath, decreased ability to exercise, fast heartbeat, tightness in chest, increased need to urinate at night, not being able to lay flat in bed.

    Injection Site Problems. Serious skin reactions can happen in some people including areas of severe damage to skin and the tissue below the skin (necrosis). These reactions can happen anywhere you inject BETASERON. Symptoms of injection site problems may include swelling, redness, or pain at the injection site, fluid drainage from the injection site, breaks in your skin or blue-black skin discoloration. Change your injection site each time you inject BETASERON as it will lessen the chance of you having a serious skin reaction. Avoid injecting BETASERON into an area of the skin that is sore, reddened, infected or has other problems.

    Flu-like Symptoms. BETASERON can cause flu-like symptoms including fever, chills, tiredness, sweating, muscle aches when you first start to use it. These symptoms may decrease over time. Taking medicines for fever and pain relief on the days you are using BETASERON may help decrease these symptoms.

    Seizures. Some people have had seizures while taking BETASERON, including people who have never had seizures before. It is not known if the seizures were related to MS, to BETASERON, or to a combination of both. If you have a seizure after taking BETASERON call your healthcare provider right away.

    Blood Problems. You may have a drop in the levels of infection-fighting white blood cells, red blood cells, or cells that help you form blood clots. If drops in levels are severe, they can lessen your ability to fight infections, make you feel tired or sluggish or cause you to bruise or bleed easily.

    Pregnancy:
    Tell your doctor if you are pregnant or plan to become pregnant.

    Most Common Side Effects:
    The most common side effects of BETASERON include low white blood cell count, increases in your liver enzymes, headache, increase in your muscle tension, pain, rash, problems sleeping, stomach pain, weakness. These are not all the possible side effects of BETASERON.

    Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Tell your healthcare provider about all the medicines you take and your medical conditions.

    Please see the full Prescribing Information and Medication Guide for additional information and talk to your healthcare provider.

    You are encouraged to report side effects of prescription drugs to the FDA. Visit definitude or call 1-800-FDA-1088.

    PP-BETA-S-US-0015-1

    Register for myBETAapp™

    myBETAapp™ is intended for patients who have been prescribed BETASERON® (interferon beta-1b) by a healthcare professional. Please select your country and verify that you are a BETASERON user.

  • Please enter the four character lot number (for example: 1234 or A123) located on the Mixject® Transfer Device (also called the “vial adapter”) inside your Betaseron® single dose box.

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    Please Re-verify

    Enter MixJect Code

    Please enter the four character lot number (for example: 1234 or A123) located on the Mixject® Transfer Device (also called the “vial adapter”) inside your Betaseron® single dose box.

  • Verified

    You now have access to myBETAapp™.

    Please note that we will periodically ask you to enter the last 4 digits of your MixJect number for re-verification purposes.

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    To reset your password, enter the email address you provided when you registered for myBETAapp™ and select Submit.

  • Update Account

    myBETAapp was recently updated with new features to enhance your experience using the app.(418) 550-8536

  • Enable sharing with a BETA Nurse
  • Enable sharing

    on/off

    When you enable this functionality, your recorded injection history will be transferred to a web-based dashboard and will be available for review by a BETA Nurse. A BETA Nurse's responsibility is to support BETASERON® (interferon beta-1b) patients. They are directly or indirectly employed by Bayer. BETA Nurses are obligated to keep all provided data/information confidential.

    BETASERON Safety Info

    Indications

    BETASERON® (interferon beta-1b) is a prescription medicine used to reduce the number of relapses in people with relapsing forms of multiple sclerosis (MS). This includes people who have had their first symptoms of multiple sclerosis and have an MRI consistent with multiple sclerosis. BETASERON will not cure MS but may decrease the number of flare-ups of the disease.

    Important Safety Information

    Do not take BETASERON (interferon beta-1b) if you are allergic to interferon beta-1b, to another interferon beta, to human albumin, or mannitol.

    BETASERON can cause serious side effects, including:

    Liver Problems Including Liver Failure. Symptoms of liver problems may include yellowing of your eyes, itchy skin, feeling very tired, flu-like symptoms, nausea or vomiting, bruising easily or bleeding problems. Your healthcare provider will do blood tests to check for these problems while you take BETASERON.

    Serious Allergic Reactions. Serious allergic reactions can happen quickly and may happen after your first dose of BETASERON or after you have taken BETASERON many times. Symptoms may include difficulty breathing or swallowing, swelling of the mouth or tongue, rash, itching, or skin bumps.

    Depression or Suicidal Thoughts. Call your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse or worry you: thoughts about suicide or dying, new or worse depression (sinking feeling or sadness), new or worse anxiety (feeling uneasy, nervous or fearful for no reason), trouble sleeping (insomnia), acting aggressive, being angry, or violent, acting on dangerous impulses, hallucinations, other unusual changes in behavior or mood.

    Other possible serious side effects with BETASERON include:

    Heart Problems. BETASERON may worsen heart problems including congestive heart failure. Symptoms of heart problems may include swollen ankles, shortness of breath, decreased ability to exercise, fast heartbeat, tightness in chest, increased need to urinate at night, not being able to lay flat in bed.

    Injection Site Problems. Serious skin reactions can happen in some people including areas of severe damage to skin and the tissue below the skin (necrosis). These reactions can happen anywhere you inject BETASERON. Symptoms of injection site problems may include swelling, redness, or pain at the injection site, fluid drainage from the injection site, breaks in your skin or blue-black skin discoloration. Change your injection site each time you inject BETASERON as it will lessen the chance of you having a serious skin reaction. Avoid injecting BETASERON into an area of the skin that is sore, reddened, infected or has other problems.

    Flu-like Symptoms. BETASERON can cause flu-like symptoms including fever, chills, tiredness, sweating, muscle aches when you first start to use it. These symptoms may decrease over time. Taking medicines for fever and pain relief on the days you are using BETASERON may help decrease these symptoms.

    Seizures. Some people have had seizures while taking BETASERON, including people who have never had seizures before. It is not known if the seizures were related to MS, to BETASERON, or to a combination of both. If you have a seizure after taking BETASERON call your healthcare provider right away.

    Blood Problems. You may have a drop in the levels of infection-fighting white blood cells, red blood cells, or cells that help you form blood clots. If drops in levels are severe, they can lessen your ability to fight infections, make you feel tired or sluggish or cause you to bruise or bleed easily.

    Pregnancy:
    Tell your doctor if you are pregnant or plan to become pregnant.

    Most Common Side Effects:
    The most common side effects of BETASERON include low white blood cell count, increases in your liver enzymes, headache, increase in your muscle tension, pain, rash, problems sleeping, stomach pain, weakness. These are not all the possible side effects of BETASERON.

    Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Tell your healthcare provider about all the medicines you take and your medical conditions.

    Please see the full Prescribing Information and Medication Guide for additional information and talk to your healthcare provider.

    You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

    PP-BETA-S-US-0015-1

    myBETAapp™

    General Information

    The updated Informed Consent is valid from and has a grace period of 30 days. After this period it is not possible to further use myBETAapp™ without acceptance of the updated Informed Consent.

    Changes to Informed Consent for Sharing of Data

    • Added language to advise patients that their data may be exported out of the Betaconnect Navigator by the BETA Nurse and/or physician for treatment purposes.
    • Added language to advise patients that their healthcare team may not agree to accept the sharing of a patient’s data.
    • Certain formatting and editorial changes to increase clarity and comprehension.

    Changes to Terms and Conditions of Use

    • Revised section on Warranty/Liability to update change of name for one of the vendors covered.

    Terms and Conditions of Use for the myBETAapp™

    These Terms and Conditions were last modified on October 1st, 2018.

    Please read these Terms and Conditions completely. By using or accessing the myBETAapp™ in any way, you are agreeing to be bound by these Terms and Conditions. Please do not use the app unless you agree with these conditions.

    Usage

    The myBETAapp™ is intended to be used only by patients who are 18 years of age or older and who are injecting Betaseron® in the course of the treatment of multiple sclerosis. It supports the responsible use of Betaseron®, tracks the injection history and offers multiple sclerosis related educational information. Please read the drug package insert carefully before starting to take Betaseron® and prior to using the myBETAapp™ or in case you have missed an injection. If you have further questions on myBETAapp™, call a BETA Nurse at 1-800-788-1467, or ask your doctor or nurse.

    Please note that myBETAapp™, BETACONNECT™ Navigator, and/or the BETA Nurse program do not provide data of clinical predictive value and do not provide medical or prescribing advice, and are provided for general informational purposes only. THE MYBETAAPP™, BETACONNECT™ NAVIGATOR, AND BETA NURSE PROGRAM ARE NOT INTENDED TO REPLACE THE ADVICE OF A HEALTHCARE PROFESSIONAL OR PRESCRIBING INFORMATION. PATIENTS SHOULD ALWAYS SEEK MEDICAL ADVICE BEFORE MAKING ANY DECISIONS ON THEIR TREATMENT. Patients should see the full 3183561363, Medication Guide, and BETACONNECT™ Instructions for Use. Healthcare professionals should always refer to the specific labeling information approved for the patient's country or region.

    Patients should always inform their healthcare provider of any bothersome side effect, side effects that do not go away, and about all prescribed medicines and medical conditions. Patients are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA at www.fda.gov/medwatch or by calling 1-800-FDA-1088.

    Furthermore, myBETAapp™ is not intended to be used with other medical products than Betaseron® or other medical devices than BETACONNECT™.

    Access

    We will do our best to ensure that availability of the myBETAapp™ will be uninterrupted and that transmissions will be error-free. However, due to the nature of the Internet, this cannot be guaranteed.

    Your access to the myBETAapp™ may be occasionally limited to allow for maintenance or the introduction of new services. We will limit the frequency and duration of any such suspension or restriction.

    License

    Bayer grants you a limited license to access and make personal use of the myBETAapp™, but not to modify it, except with express written consent of Bayer. The myBETAapp™ may not be reproduced, duplicated, copied, sold, resold, visited, or otherwise exploited for any commercial purpose without Bayer's express written consent.

    You may not frame or use framing techniques to enclose any trademark, logo, or other proprietary information (including images, text, layout, or form) of Bayer and its affiliates without express written consent. Any unauthorized use terminates the permission or license granted by Bayer and may give rise to a claim for damages and/or be a criminal offense.

    You may not use the myBETAapp™ in any way that causes or is likely to cause the app or access to it to be interrupted, damages, or impaired in any way. You may not use the myBETAapp™ for fraudulent purposes or in connection with any unlawful activity. Nor may you send, use, or reuse any material that is illegal, offensive, abusive, indecent, defamatory, obscene or menacing; or in breach of copyright, trademark, confidence, privacy or any other right; or is otherwise injurious to third parties; or objectionable; or which consists of or contains software viruses, commercial solicitation, or any spam.

    Intellectual Property

    The myBETAapp™ and all of its original content, such as text, graphics, logos, button icons, images, and software, are the sole property of or are exclusively licensed to Bayer and are fully protected by the appropriate international copyright and other intellectual property rights laws.

    You may not extract and or re-use parts of the contents of the myBETAapp™ without Bayer's express written consent. In particular, you may not use any data mining, robots, or similar data gathering and extraction tools to extract for re-use of any substantial parts of this app, without Bayer's express written consent. You also may not create and/or publish your own database that features substantial parts of this app without Bayer's express written consent.

    Disclaimers

    The myBETAapp™ is not intended to be used with other medical products than Betaseron® or other medical devices than BETACONNECT™.

    Patients should bring all of the devices they use to access their myBETAapp™ to their doctors' appointments. Patients should not assume that their doctor (or BETA Nurse) is constantly monitoring their data. If they have questions, they should call their doctor and not wait for the doctor or BETA Nurse to call them. Patients should share the information in myBETAapp™ with their doctors at their appointments to ensure their doctor has the information.

    No Warranty, Limitation of Liability

    No representation is made or warranty given, either expressly or inferred, for the completeness, correctness or functional capability of myBETAapp™. Please be aware that the functionality of myBETAapp™ depends on the details supplied by the user. Each change of settings will have impact on the app.

    Bayer HealthCare Pharmaceuticals Inc. and Bayer AG and any and all affiliated companies of Bayer HealthCare Pharmaceuticals Inc. and/or Bayer AG (collectively, "Bayer"), TWT Digital Health GmbH ("TWT Digital Health"), Medicom Innovation Partner a/s ("Medicom") and Syneos Health (“Syneos”) are not responsible and shall have no liability for any adverse effects or consequences resulting from the use of myBETAapp™. Bayer, TWT Digital Health, Medicom and Syneos cannot be held liable for damage or injury resulting from the use or impossibility of use, especially — but not restricted — in the case of external impacts, e.g. damaged hardware, lack of internet connection, or lack of signal, and shall have no liability for any error, omission or outdated material in myBETAapp™. These limitations do not exclude liability for physical injuries stemming from willful misconduct or gross negligence or no-fault liability derived from applicable product liability statutes. Bayer reserves the right to cease marketing the myBETAapp™.

    Information You Provide

    The user of the myBETAapp™ is fully responsible for the content and correctness of information he or she submits to the myBETAapp™.

    How Your Information May Be Used

    Information collected about you through the myBETAapp, including your use of Betaseron, may be shared with Beta Nurses and your healthcare professional (HCP) who may use the data for the purpose of treating you and other myBETAapp users. For more information, please review the Informed Consent of Patient for Database Storage and Use of Personal Data.

    Privacy Policy

    Please review our Privacy Statement, which also governs your use of myBETAapp™, to understand how we collect, use, store, and share your personal information.

    External Links

    The myBETAapp™ may contain links to third-party websites, services, or online resources not owned Bayer. Bayer has no control over, and therefore cannot assume responsibility for, the content or general practices of these third-party sites, services, and resources. Therefore, it is important that you read the entire terms and conditions and privacy policy of any third-party site, service, or resource you visit through a link posted in myBETAapp™.

    Changes to these Terms and Conditions

    Bayer reserves the right to modify these Terms and Conditions at any time. We do so by posting the updated terms in the app, and identifying the changes from the previous version. Your decision to continue using the app after such changes have been made constitutes your acceptance of the new Terms and Conditions. Accordingly, you should check and review these Terms and Conditions regularly. Should you not agree to any provision of these Terms and Conditions or any changes to these Terms and Conditions, you should not use or continue to use this app.

    Electronic Communications

    For contractual purposes, you consent to receive communications from us electronically and you agree that all agreements, notices, disclosures, and other communications that we provide to you electronically satisfy any legal requirement that such communications be in writing.

    Governing Law

    These Terms and Conditions are governed in accordance with the laws of New Jersey, United States.

    Waiver

    If you breach these Terms and Conditions and we take no action, we will still be entitled to use our rights and remedies in any other situation where you breach these conditions.

    Contact Us

    If you have any further questions about the myBETAapp™, call a BETA Nurse at 1-800-788-1467, or ask your doctor or nurse.

    Informed Consent of Patient for Database Storage and Use of Personal data

    a) Information on Database Storage and the use of personal data

    The myBETAapp™ is an application offered by Bayer AG, Leverkusen, Germany ("we" or "us"), providing support to patients of Multiple Sclerosis by supporting the responsible use of Betaseron® (interferon beta-1b), tracking the injection history and offering multiple sclerosis related educational information. With this Privacy Statement, we would like to inform you about how we handle your personal data.

    Which personal data is being handled?
    When you use myBETAapp™ and subject to your prior explicit consent, the following personal data will be collected, processed and used:

    • "Profile Data":
      • Name, place of residence, email address, password, contact data*, date of birth*, gender*, start date of using the app, opt-in date for the [Sharing of Data] functionality, last login timestamp (* if voluntarily provided by you)
    • "Injection Data":
      • Date and time of your injections (manually entered or transmitted from the BETACONNECT™ auto-injector); Injection volume; Setting of the depth adjuster and the speed adjuster, Serial number of the BETACONNECT™ auto-injector
    • "Wellness Tracker Data":
      • Date and time of manually entered wellness questionnaires, manually entered ratings for tracking health and wellness
    • All other data which you enter yourself manually in the myBETAapp™ interface
      • e.g, used injection sites, injection notes

    Please note that the fact that you are using Betaseron® and myBETAapp™ also reveals information about your health status.

    How and where is my personal data stored and transferred to?
    The myBETAapp™ is a cloud-based system. Hence, subject to your prior explicit consent, the above described personal data will be transmitted to and stored on a database located in the United Kingdom.

    In case you make use of our call center services, the information you give to the operator will be transferred to our service provider located in the USA. In case you inquire information about your personal data stored on the database in the United Kingdom, the call center provider will receive respective information from our hosting service provider. However, we have taken appropriate safeguards designed to protect your personal data by having concluded the standard data protection clauses adopted by the EU Commission with our call center provider.

    Who has access to my personal data?
    Neither we as the sponsor of the BETACONNECT™ products, nor Medicom Innovation Partner a/s ("Medicom") - who has developed the BETACONNECT™ auto-injector, the myBETAapp™ and the BETACONNECT™ Navigator for us and who is responsible for these medical devices as legal manufacturer - wish to have access to your personal data.

    Therefore, we have contracted the following service providers who handle your personal data on our behalf and who are either contractually or by law prohibited to provide us or Medicom with any access to your personal data:

    • The database, where your personal data is stored, is operated by TWT Digital Health GmbH ("TWT Digital Health"), a service provider based in Germany who acts on our behalf as our data processor. TWT Digital Health has operational access to all of your personal data for technical support reasons.
    • In case you have activated the [Sharing of Data] functionality and subject to your prior explicit consent, the Beta Nurse and/or a HCP/Physician selected by you will have access to your personal data for the sole purpose of treatment. An appointed Nurse Administrator will connect your account with the Beta Nurse and/or HCP assigned to you. The Nurse Administrator will have access to your Profile Data for the sole purpose of facilitating healthcare operations.
    • In case you have technical problems or data privacy related requests, you have the possibility to contact a call center, which is operated by Convergys Global Services GmbH ("Convergys") that also acts on our behalf as our data processors.

    For which purpose is my personal data handled?
    Our service providers collect, process and use your personal data exclusively in order to be able to provide to you the functionalities of myBETAapp™ or for technical support reasons.

    Furthermore, TWT Digital Health generates and shares with us and other companies of the Bayer Group aggregated data of at least 25 Betaseron® patients for statistical purposes (e.g. usage statistics). However, due to the aggregation process, the data we are using is anonymous and can thus not be used to identify any specific individual.

    Beta Nurses and your HCP may access your personal data for the sole purposes of treatment and healthcare operations. This access may be in the form of exporting the data and printing the data for the Beta Nurse or HCP to use the data for treatment purposes.

    Finally, in case you report any untoward medical occurrence ("adverse event"), we are by law obliged to process and report the respective adverse event information to the competent regulatory authorities. However, these reports only contain your information in a pseudonymized form and thus no information that allows someone to directly identify you.

    How long is my personal data stored and when will it be deleted?
    Injection data older than 7 years will be deleted automatically. All other personal data will not be deleted automatically, but you can irrevocably delete your account including all data at any time by using the "Delete Account" functionality in the Settings.

    What are my rights?
    You have the right to

    • request from us access to and rectification or erasure or restriction of processing of your personal data;
    • object to a processing of your personal data;
    • data portability;
    • at any time withdraw any given consent or
    • lodge a complaint with a supervisory authority

    Who can I contact in case I have a data privacy related question or want to exercise my rights?
    Since we have limited the access to your personal data to our service providers, we are not able to handle your data privacy related requests ourselves. Thus, please address any data privacy related request to our call center, who will process your requests on our behalf, using the following contact information:

    Telephone: 1-844-351-5696 (Toll-free phone number)
    Email: support@mybetaapp.com

    You can reach the data protection officer of Bayer AG using the following address:
    Data Protection Officer
    Bayer AG
    51373 Leverkusen, Germany

    Changes to this Privacy Statement
    We will update this Privacy Statement from time to time to reflect changes to our practices, technology, legal requirements and other factors. Please check the "Last Updated" legend at the bottom of this page to see when this Privacy Statement was last revised.

    b) Information on Sharing of Data

    The myBETAapp™ is intended to assist users of Betaseron® (interferon beta-1b) in keeping track of scheduled injections and, by accepting third party access, allowing the team of BETA Nurses, to review your injection data (e.g. date, time and volume of your injections, and the setting of the depth adjuster and the speed adjuster, serial number of the BETACONNECT™ auto-injector, as well as injection site locations you record) (“Injection Data”). If you agree to this Informed Consent you will enable sharing of your Injection Data (“Sharing of Data”).

    The BETA Nurse Team will get access to the Injection Data and may view it on the BETACONNECT™ Navigator system, which provides a secure web-based dashboard to review your Injection Data. The BETA Nurse Team may access your Injection Data for the purpose of treatment and healthcare operations. This access may be in the form of exporting the Injection Data out of the BETACONNECT Navigator system and/or printing the Injection Data for the BETA Nurse or your physician’s office to use the Injection Data for treatment purposes.

    A BETA Nurse Administrator will then connect your account with the clinical BETA Nurse team assigned to help you. For that purpose the Nurse Administrator is able to get access to your profile (e.g. name, contact Data, date of birth, gender, language, start date of using the app, opt-in date for Sharing of Data), but not to your Injection Data.

    Upon assignment, your clinical BETA Nurse will have the opportunity to review your injection data and your profile. Furthermore the clinical BETA Nurse can provide you with in-app messages to assist you with the injection schedule. Wellness Tracker data that you record in the app will not be included into the Sharing of Data and will not be visible.

    The BETA Nurses are only allowed to have access to your Injection Data after they have declared to keep such information confidential.

    BETA Nurse(s) shall be entitled to further transfer your Injection Data to other BETA Nurses working for the BETA Nurse program. Those individuals will only review your Injection Data for the purpose of supporting you in connection with the appropriate administration of Betaseron® and will only have access to your Injection Data after having declared to keep such information confidential.

    At any time you can disable the Sharing of Data. This will remove the permission to show your Injection Data in the web-based dashboard. All your Injection Data will then be removed from the web-based dashboard and is no longer visible in the dashboard to the BETA Nurse Team or The Healthcare Team. At any time you can also decide to opt-in again into the Sharing of Data.

    After your acceptance or enabling Injection Data sharing, the BETA Nurse Administrator will contact you and confirm with you the contact details of the healthcare team supporting you, such as your physician and/or your specialty pharmacy (“The Healthcare Team”) and will then request the consent of The Healthcare Team to accept the Sharing of Data. THE HEALTHCARE TEAM MAY NOT AGREE TO ACCEPT THE SHARING OF YOUR DATA. IT IS YOUR RESPONSIBILITY TO CHECK WITH THE HEALTHCARE TEAM TO VERIFY IF THEY HAVE AGREED TO ACCEPT THE SHARING OF YOUR DATA.

    If The Healthcare Team agrees to accept the Sharing of Data, The Healthcare Team will have the opportunity to review your Injection Data , as well as your account profile Data (e.g. name, contact Data, date of birth, gender, language, start date of using the app, date for accepting Sharing of Data, serial number of your optional BETACONNECT™ autoinjector). The Wellness Tracker Data in the app will not be included into the Sharing of Data and will not be visible to The Healthcare Team.

    If you do not want to enable access to The Healthcare Team, you understand that after accepting this declaration (Informed Consent), you will need to deactivate the Sharing of Data in the Settings menu in the myBETAapp™, under the setting labeled "Share your recorded injection history with your healthcare team"

    Last Updated: October 1st, 2018

    c) Declaration of Consent for Processing Personal Data and Sharing of Data

    In connection with the installation and the use of the myBETAapp™ on my computing device [e.g. personal computer/tablet PC/smartphone], I make the following declaration regarding my personal data:

    I understand and agree to the collection, storage and processing of my personal data as described above in the 9016188343. I understand that I can withdraw my consent at any time by deleting the account, which will irrevocably delete all my personal data.

    In connection with my request to share my data with the HCPs as described above, I make the following declaration regarding my personal data:

    I understand and agree that upon this consent, any of my personal data that has been transmitted to and stored on the BETACONNECT™ Database will be automatically available for use by (The Team).

    By pressing the button "I Accept" I confirm to accept the above stated Terms and Conditions of Use and Declaration of Consent for Processing Personal Data and Sharing of Data.

    PP-721-US-1243



    Thank You

    Thank you for registering to use myBETAapp™ to help you track your injections. An email message has been sent to the email address you provided.

    You must activate your account using the link in the email to log in and continue using myBETAapp™

    When you have activated your account, follow the instructions on screen to continue to myBETAapp. If you do not already have myBETAapp installed on your computer or mobile device, please follow the link below to download and install:

    Visit www.betaseron.com


    Change Password

    Password must be 8 to 30 characters in length, including at least one number and one uppercase letter.

  • Change Password

    Password must be 8 to 30 characters in length, including at least one number and one uppercase letter.

  • myBETAapp™

    General Information

    The updated Informed Consent for Sharing of Data is valid from and has a grace period of 30 days. After this period it is not possible to share your data further without acceptance of the updated Informed Consent for Sharing of Data.

    Changes to Informed Consent for Sharing of Data

    • Added language to advise patients that their data may be exported out of the Betaconnect Navigator by the BETA Nurse and/or physician for treatment purposes.
    • Added language to advise patients that their healthcare team may not agree to accept the sharing of a patient’s data.
    • Certain formatting and editorial changes to increase clarity and comprehension.

    Informed Consent of Patient for Sharing of Injection Data with BETA Nurses and your Physician, your Specialty Pharmacist/Pharmacy or others supporting your care, (“The Healthcare Team”)

    (A) Information on Sharing of Injection Data

    The myBETAapp™ is intended to assist users of Betaseron® (interferon beta-1b) in keeping track of scheduled injections and, by accepting third party access, allowing the team of BETA Nurses, to review your injection data (e.g. date, time and volume of your injections, and the setting of the depth adjuster and the speed adjuster, serial number of the BETACONNECT™ auto-injector, as well as injection site locations you record) (“Injection Data”). If you agree to this Informed Consent you will enable sharing of your Injection Data (“Sharing of Data”).

    The BETA Nurse Team will get access to the Injection Data and may view it on the BETACONNECT™ Navigator system, which provides a secure web-based dashboard to review your Injection Data. The BETA Nurse Team may access your Injection Data for the purpose of treatment and healthcare operations. This access may be in the form of exporting the Injection Data out of the BETACONNECT Navigator system and/or printing the Injection Data for the BETA Nurse or your physician’s office to use the Injection Data for treatment purposes.

    A BETA Nurse Administrator will then connect your account with the clinical BETA Nurse team assigned to help you. For that purpose the Nurse Administrator is able to get access to your profile (e.g. name, contact Data, date of birth, gender, language, start date of using the app, opt-in date for Sharing of Data), but not to your Injection Data.

    Upon assignment, your clinical BETA Nurse will have the opportunity to review your injection data and your profile. Furthermore the clinical BETA Nurse can provide you with in-app messages to assist you with the injection schedule. Wellness Tracker data that you record in the app will not be included into the Sharing of Data and will not be visible.

    The BETA Nurses are only allowed to have access to your Injection Data after they have declared to keep such information confidential.

    BETA Nurse(s) shall be entitled to further transfer your Injection Data to other BETA Nurses working for the BETA Nurse program. Those individuals will only review your Injection Data for the purpose of supporting you in connection with the appropriate administration of Betaseron® and will only have access to your Injection Data after having declared to keep such information confidential.

    At any time you can disable the Sharing of Data. This will remove the permission to show your Injection Data in the web-based dashboard. All your Injection Data will then be removed from the web-based dashboard and is no longer visible in the dashboard to the BETA Nurse Team or The Healthcare Team. At any time you can also decide to opt-in again into the Sharing of Data.

    After your acceptance or enabling Injection Data sharing, the BETA Nurse Administrator will contact you and confirm with you the contact details of the healthcare team supporting you, such as your physician and/or your specialty pharmacy (“The Healthcare Team”) and will then request the consent of The Healthcare Team to accept the Sharing of Data. THE HEALTHCARE TEAM MAY NOT AGREE TO ACCEPT THE SHARING OF YOUR DATA. IT IS YOUR RESPONSIBILITY TO CHECK WITH THE HEALTHCARE TEAM TO VERIFY IF THEY HAVE AGREED TO ACCEPT THE SHARING OF YOUR DATA.

    If The Healthcare Team agrees to accept the Sharing of Data, The Healthcare Team will have the opportunity to review your Injection Data , as well as your account profile Data (e.g. name, contact Data, date of birth, gender, language, start date of using the app, date for accepting Sharing of Data, serial number of your optional BETACONNECT™ autoinjector). The Wellness Tracker Data in the app will not be included into the Sharing of Data and will not be visible to The Healthcare Team.

    If you do not want to enable access to The Healthcare Team, you understand that after accepting this declaration (Informed Consent), you will need to deactivate the Sharing of Data in the Settings menu in the myBETAapp™, under the setting labeled "Share your recorded injection history with your healthcare team"

    (B) Declaration of Sharing of Data

    In connection with my request to share my Injection Data with The BETA Nurse Team and The Healthcare Team as described above, I make the following declaration regarding my personal Data: "I understand and agree that upon this consent, any of my Injection Data that has been transmitted to and stored on the BETACONNECT™ Database will be automatically available for use by The BETA Nurse Team and The Healthcare Team."

    PP-721-US-1258

    myBETAapp™

    I agree that any of my data that has been transmitted to and stored on the myBETAapp™ Database may be automatically transferred to the contact details of the healthcare professional or physician ("HCP/Physician"). The specific contact details will be requested and confirmed by a Nurse Administrator from my country before any data is automatically transferred to the contact details of HCP/Physician. A BETA Nurse could have the responsibility as a Nurse Administrator. The Nurse Administrator has confidentiality obligations regarding all patient data.

    Such HCP/Physician shall only be entitled to review my data for the purpose of supporting me in connection with the appropriate administration of BETASERON® (interferon beta-1b), provided that the HCP/Physician has declared to keep such information confidential. Such HCP/Physician shall be entitled to further transfer such data to any employee working for the HCP/Physician for the same purpose, provided that they have declared to keep such information confidential.

    I can withdraw my consent at any time by deactivating the account. Deactivation will not prejudice future and continued use of Aggregated Data generated prior to the deactivation.

    myBETAapp™

    I agree that any of my data that has been transmitted to and stored on the myBETAapp™ Database may be automatically transferred to a web-based dashboard to be used by BETA Nurses in my country. A BETA Nurse's responsibility is to support BETASERON® (interferon beta-1b) patients. They are directly or indirectly employed by Bayer.

    Those BETA Nurses shall only be entitled to review my data for the purpose of supporting me in connection with the appropriate administration of BETASERON, provided that they have declared to keep such information confidential. Those BETA Nurses shall be entitled to further transfer such data to other nurses working as BETA Nurses and for the same purpose, provided that they have declared to keep such information confidential.

    I can withdraw my consent at any time by deactivating the account. Deactivation will not prejudice future and continued use of Aggregated Data generated prior to the deactivation.