CONSENT FORM - for Child patient (Version of October 2025)
You are either the parent, or the legal guardian, of a child patient. In signing this form, you freely
consent to the inclusion and processing of your child's data in the Growzen® Connect software as per the
information provided in this document.
The Growzen® Connect software (the "Software") is owned and commissioned by Ares Trading SA, Zone
Industrielle de L'Ouriettaz, 1170 Aubonne, Switzerland (hereinafter "ATSA"), an affiliate of Merck KGaA,
Frankfurter Strasse 250, 64293, Darmstadt, Germany ("Merck KGaA (Germany) Group"). It is provided and made
available by Dawn Health A/S, domiciled at Sundkaj 153 1. th., Copenhagen, Denmark, 2150, Denmark ("Dawn
Health"), on behalf of ATSA.
(1)
The Software includes a front-end web application for HCPs to monitor Human Growth Hormone Treatment
(HGHT) adherence and outcomes for patients using the Easypod® injector device or Aluetta® pen transmitter
to administer Saizen® (hereinafter, the "Device" or "Devices"). The Software collects and displays data
uploaded from your child's Device in an online database, to help record, analyse and manage the
administration of Saizen and adherence to the treatment. The software is intended for use by healthcare
professionals (HCPs) in the field of endocrinology as an optional aid to improve care for patients.
Growzen® Connect software includes optional reminders such as email or SMS notifications for injections.
(2)
"Personal Data" is defined in privacy laws as meaning any information relating to, or capable of
identifying, a natural person or "data subject". This can include either direct identification by reference
to a person's legal name, or indirectly through other identifiers (such as referring to the physical,
physiological, genetic, mental, economic, cultural or social identity of an individual).
(3)
The Software has been designed and implemented with due consideration of applicable privacy law, including
the General Data Protection Regulation (EU Reg 2016/679 "GDPR") as a standard reference. Depending on your
location, more specific privacy law may apply in your case. Under applicable privacy law, ATSA acts as a
data controller, and Dawn Health as a data processor in relation to the Software.
(4)
Which data (including Personal Data) is collected by the Software?
- Information transmitted by my child's Device (date, time, dose injected,
injection type, device ID, device settings);
- Personal Data of my child (name, date of birth, gender, email address, phone
number, contact information, insurance number, insurance company, native language, name of my child's
treating HCP, the treatment start date, my child's clinic patient ID);
- Data entered by my child's HCPs into the Software such as notes on treatment
(height/weight measurements), as well as information on related contact persons (name, contact details from
relatives such as parents or other persons close to my child). Also recorded may be sensitive health data of
the child's biological parents (auxological data such as height and weight) for comparative purposes for
HCPs;
- When the Software's mobile application is used, personal and sensitive health
data entered and processed through this will be accessible through the Software interface and accessible by
your HCP(s).
To help ensure compliance with applicable privacy requirements, the Personal Data of your child will not be
visible to ATSA, Merck and their affiliates. Instead, it will be "pseudonymised". The pseudonymization
process of the data consists in assigning, masking or substituting all identifying data with a neutral
identifier (i.e. a random pseudonym, aliases or number). In addition, your child's data will be encrypted on
transfer and stored encrypted in the Growzen® Connect software database, which is located in the European
Economic Area (EEA).
However, some encrypted data may, where needed for operational and maintenance tasks as specified below
(see 3 b) 2), be processed by employees of ATSA, Merck and their affiliates, or contractors working under
ATSA's or Merck's direction (including outside EEA) or by an approved data processor (such as Dawn Health).
ATSA, Merck and their Affiliates will take all reasonable steps to ensure that such Personal Data is
adequately protected and that any such processing complies with applicable privacy law and standards.
Please note that the Software does not include any automated decision making, including profiling.
(5)
Who may access such data (including Personal Data)?
a) Access by HCP. Your child's treating HCPs will have access to all collected
data (name, treatment history, injections, outcomes, etc.) to assist with managing and observing treatment
and adherence over time. For the same purposes your child's treating HCPs may also transfer your child's
data collected through the Software to other systems used by their relevant medical centre or clinic. In
doing so, your HCP would be acting as a separate data controller under applicable privacy law, and would be
responsible for ensuring that any such further use and transfer is compliant with applicable privacy law and
other legal requirements (including medical secrecy) in their location.
b) Access by Patient Support Programs. Where available, medical support and
nursing professionals within the Merck patient support programs and other Merck companies ("Affiliates") may
access Personal Data sets for the purpose of supporting your child's treatment through the Software.
c) Limited access by Merck and/or related Service Providers for operational and
maintenance purposes. Merck, its Affiliates and/or service providers (e.g., Dawn Health) engaged to assist
with the provision of the Software may be required to access some Personal Data for operational and
maintenance purposes. In such cases, the Personal Data will generally be retained in pseudonymised form,
unless otherwise reasonably required for providing the services or when specifically requested by you or
your child's HCP. Further, Merck, its Affiliates and/or service providers may create aggregated statistical
reports and business reviews for operational and development purposes: for example, to understand general
adherence levels in a given country or region. Such data will only be visible in aggregated, anonymous form
(for example, to give the total numbers of patients in a given location, or their broad age range).
d) Access by healthcare and/or insurance providers. Your child's
healthcare/insurance provider ("Payor") may be responsible for paying for your child's growth hormone
treatment. To help measure the impact of Growzen® Connect software, Payors may be provided with aggregated
statistical reports to analyse related trends (including adherence levels). Again, your child's identity
will always be protected in such cases: the statistics in such reports and analysis will always be in
aggregated form based on data from multiple patients (meaning that they never contain data about single
patients or individual data such as the name or date of birth of a given individual). Such statistical usage
can never be used to identify individual patients or to support decisions regarding their specific
treatment.
(6)
Voluntary participation, right to withdraw and other rights. Your decision to consent on behalf of your
child to participate in using Growzen® Connect software is entirely voluntary. You are free to withdraw your
consent at any time by informing your child's HCP, and/or instructing them to delete all related data (for
both you and your child) from the Software. Although you child may continue to receive treatment, they will
no longer be able to benefit from Software and/or any related mobile applications.
Subject to the above, we will retain any Personal Data relating to you or your child to the extent required
by law, or to provide services related to the Software to your child.
Depending on applicable privacy law in your location, you may also have various rights over your or your
child's Personal Data processed through the Software. The following, as an example, includes some of those
applicable under the GDPR (which may be different from those in your own location).
Right of access: The right to obtain further information on the processing of any
Personal Data and to receive a copy of such data.
Right to rectification: The right to request that we correct or complete any
inadequate, incomplete or inaccurate Personal Data.
Right to erasure: As previously mentioned, you may request for such Personal Data
to be deleted (see Section 4 above).
Right to stop processing: Under certain conditions, you may request us to stop or
restrict the processing of such Personal Data, except where we are legally entitled or required to do so.
Right to data portability: You may ask to receive a copy of such Personal Data in
a structured, common and machine-readable format and/or request that such data is transferred to another
data controller (and where reasonably feasible).
Right to lodge a complaint with a supervisory authority: Where you feel that such
Personal Data has been processed in a way that violates applicable privacy law, you may contact the
applicable data privacy regulator for your location.
If you have any questions or concerns you can also contact Merck's data protection officer at
privacy@merckgroup.com. If your query concerns a specific user account, you may be required to provide some
limited Personal Data for authentication purposes. If your query is more general, you may choose to limit
the Personal Data you provide (for example, using a different email address).
(7)
Email notifications, email patient reports and other electronic notifications. The Software can also be
configured to allow sending of reminders (e.g. email notifications/in mobile application push
notifications/SMS) and HCP email reports (such as adherence levels and transmission frequency for their
patients). Merck and its Affiliates have implemented data encryption methods for communication within and
from the Software and related network interfaces (including from and with HCPs). However, please note that
further transmission of such messages over external networks (mobile phone network provider, internet
service providers) is beyond our reasonable control. As such, Merck and its Affiliates cannot be held liable
for any delay, failure, performance, non-performance, interruption or corruption of any data or other
information transmitted through or using such external networks.
To be completed by the parent/legal guardian.
In signing this document, we ask you to confirm that you are eligible to provide consent on behalf of your
child, noting that the age requirements for consent can vary from country to country. For example, if the
age of consent is sixteen in your country, and your child is aged sixteen or over, you should instead ask
for the Adult Patient Version of this consent form and have this individual patient read and sign that form
instead.
NOTE: If your child is participating in a clinical study, the specific consent and related terms may remain
applicable; please contact your child's specific trial doctor for more information.
I hereby consent to the processing of my child's data as per the information provided above.
Name of parent/carer (First and last name)
Completed by the parent/carer: _________________ Signature: ________ Date: ________
To be completed by the responsible HCP or PSP.
I have fully informed the parent/carer of all aspects of Growzen® Connect software:
Name of HCP/nurse using Growzen® Connect software
Signature: _________________ Date: ________
