OPTI-CLOT webportal

User Agreement for OPTI-CLOT Web Portal>

1. Who is bound by this user agreement?

   This user agreement applies between:

   • You, as the user (hereafter: 'user')
   • The public legal entity Academic Medical Center, Chamber of Commerce number 34362777, Meibergdreef 9, 1105AZ Amsterdam, www.amc.nl (hereafter: AMC)

   The user and AMC may also be referred to collectively as 'the parties.'

2. Definitions

   The following terms in this agreement are understood as follows:

   • Portal – The portal named OPTI-CLOT (www.opticlot.nl, www.opticlot.com, and www.opti-clot.com) is an initiative of the SYMPHONY CONSORTIUM, where AMC, together with other healthcare partners, works to improve the treatment of bleeding disorders.
   • User – The user of the portal is a healthcare provider involved in the treatment of a patient with a bleeding disorder.
   • Patient – The patient with whom the user has a treatment relationship and whose data is entered into the portal to receive an advice.
   • Advice – The dosing advice that the user receives based on a scientifically validated model.

3. Purpose and Function of the Portal

   1. The purpose of the portal is:

      • To provide dosing advice to healthcare providers treating patients with bleeding disorders to support their treatment.
      • To collect data, exclusively with patients' consent, for clinical scientific research [for patients with bleeding disorders] [into the causes, effects, and treatments of bleeding disorders].

   2. The advice is based on the individual pharmacokinetic (PK) parameters of the patient. These PK parameters are generated based on values measured in the individual and the population using Bayesian analysis. The advice is sent to the healthcare provider, and contact may be made by phone or email to explain the advice.

4. Conditions of Use

   1. The user:
      • Is a healthcare provider registered in the BIG register or uses the portal under the supervision and instruction of a BIG-registered healthcare provider.
      • Possesses the necessary expertise and education to use the portal.
      • Uses the portal with the permission of their institution, if applicable.
      • Is aware of and agrees with the purpose and operation of the portal and has reviewed the information provided on the portal's website.
   2. Acts in accordance with the applicable healthcare laws and regulations, professional standards, and the conditions specified in this agreement.
   3. Is not allowed to use the portal for any purpose or in any manner other than described in this agreement.

5. Treatment Relationship

   1. The user has a medical treatment agreement with the patient and/or works for an institution that has a medical treatment agreement with the patient.
   2. The user is responsible for fulfilling the medical treatment agreement with the patient. The user informs the patient about the portal and these conditions before using it and obtains the patient's consent.
   3. The user is responsible for maintaining the patient’s medical record.
   4. Using the portal does not establish a medical treatment agreement between AMC and/or the clinical pharmacologists affiliated with the portal and the patient. They act as advisors, not as healthcare providers.
   5. The advice is based on the data provided by the user. The user ensures the accuracy and correct provision of the data. The user determines how and if the advice is used for the patient's treatment.
   6. The treatment following the advice is the sole responsibility of the user. AMC accepts no liability for this.

6. Data Processing

   1. The advice is generated based on data entered by the user in the user interface. For an overview of the required data for generating advice, click [HERE]. An advice request will only be processed if the data is fully completed.
   2. The clinical pharmacologists do not need to know the patient's identity for the advice, but the data processed are considered personal data under the General Data Protection Regulation (GDPR). Both parties agree to process these personal data properly, carefully, and transparently, in accordance with the GDPR, the Medical Treatment Agreement Act, and related privacy laws.
   3. Parties will not process data without the patient’s consent and will only process it for the purpose described in section 3.1.
   4. The user grants the portal permission to process their personal data (name, institution, business email address, and business phone number) to the extent necessary for the purpose described in section 3.1.
   5. Before using the portal, the user has obtained consent from the patient for sharing their personal data (including medical data) for advice purposes and has recorded this consent. The user informs the patient that they may withdraw their consent at any time.
   6. Before using the portal, the user has also obtained the patient’s consent for the processing of their personal data for medical research on bleeding disorders and has recorded this consent. If consent is given, the data is stored in a way that reasonably prevents identification of individual persons.
   7. It is always the user’s responsibility to obtain and record patient consent for using the portal, sharing their personal and medical data, and using that data for research, in accordance with applicable laws. AMC accepts no liability in this regard.
   8. Parties will:
      • Not process more data than necessary to fulfill this agreement.
      • Not store data longer than necessary for fulfilling this agreement.
      Personal data is only accessible to individuals involved in the execution of this agreement, to the extent necessary for fulfilling this agreement.
   9. When either party receives a request from a data subject regarding the exercise of their rights, each party will ensure that the subject can effectively exercise their rights, such as accessing, correcting, or deleting their data, objecting to its processing, or requesting its portability. Parties will properly inform the data subject and provide access to the processed personal data.
   10. If a breach occurs concerning the processing of personal data ('data breach'), the party that detects the breach will promptly inform the other party.
   11. Parties will provide each other with reasonable cooperation to fulfill their legal obligations under the GDPR.

7. Costs

   There are no costs associated with using the portal.

8. Liability

   1. The use of the portal is entirely at the user's own risk. AMC is not liable for any direct or indirect damages resulting from or related to the use of the portal. The user indemnifies AMC from any claims by the patient or third parties in connection with the use of the portal.

9. Effective Date

   These terms of use were established by AMC on October 1, 2021, and take effect between AMC and the user when the user clicks the 'agree' button.

There is already data entered in the field and I cannot change them.

When data has already been entered in the input fields, it means that another user is already logged into SURF (the login system of your institution and the OPTI-CLOT web portal). You cannot access this user's data. Unfortunately, a SURF user can only be logged out by closing the browser. Therefore, to complete your registration, you will need to close your browser window and then navigate back to opticlot.nl/register.