Privacy Policy

GNE Myopathy – Disease Monitoring Program Online Registry

Last Updated November 16, 2016

The GNE Myopathy – Disease Monitoring Program at https://www.gnem-dmp.com/ or its successor site is the Online Registry (“GNEM-DMP Online Registry”) for a clinical study under the Protocol GNE-Myopathy Disease Monitoring Program (GNEM-DMP): A Registry and Prospective Observational Natural History Study to Assess GNE Myopathy or Hereditary Inclusion Body Myopathy (HIBM) (the “Study”), which is sponsored by Ultragenyx Pharmaceutical Inc. (“Ultragenyx”). Further information about the Study is available at https://clinicaltrials.gov.

The GNE Myopathy – Disease Monitoring Program is supported by an academic and industry partnership between TREAT-NMD and Ultragenyx. TREAT-NMD is located in England, and Ultragenyx has its headquarters in the United States with affiliates, subsidiaries, and partners around the world. TREAT-NMD is responsible for curating the GNEM-DMP Online Registry. The GNEM-DMP Online Registry, a restricted-access website, is operated by Digital Infuzion, Inc. (“DIFZ”). DIFZ is headquartered and has its operations in the United States. The platform and data storage operated by DIFZ are located in the United States.

Each TREAT-NMD, Ultragenyx, and DIFZ is committed to protecting your privacy. This Privacy Policy (together with our Terms of Use) explains our online information practices for the GNEM-DMP Online Registry and the way that we may collect and use information from and concerning you. This Privacy Policy applies only to the GNEM-DMP Online Registry and it does not apply to other online or offline terms and conditions related to Ultragenyx sites, products or services.

Personal Information to be collected at the GNEM-DMP

Online Registry
The GNEM-DMP Online Registry will ask you for registration information (name, email address, phone number, language, country of residence, etc.); and contact information of your doctor and your health information (including biometric or genetic data and images of yourself, which you choose to upload), some of which may be optional; and, if you provide your consent to participate in the Study, your responses to occasional health surveys related to your health, treatment, and experiences with your disease (“Study Data”) (collectively “Personal Information”). Through this GNEM-DMP Online Registry, Ultragenyx will not have access to information to contact you or doctor directly.

If you originally registered at predecessor GNEM-DMP Online Registry, your Personal Information has been transferred to this GNEM-DMP Online Registry.

DIFZ’s Use of Computer Systems-related Information
Besides your Personal Information, DIFZ also automatically receives and records certain information about your computer hardware and software, including your IP address, browser type, operating system, domain name, access times and referring website addresses. DIFZ also collects information about which pages users visit within the website. This site visitation data is identified only by a unique ID number, and it is never linked with Personal Information unless a user consents as described below. This information is used for the operation of the service, to maintain quality of the service, and to provide anonymized statistics regarding use of the GNEM-DMP Online Registry.

DIFZ’s Use of Cookies
When someone visits the site, a cookie is placed on the customer's machine (if the customer accepts cookies) or is read if the customer has visited the site previously. One use of cookies is to assist in the collection of the site visitation statistics described above. We also use cookies to collect information on which newsletter links are clicked by customers. This information is used to ensure we are sending information customers want to read. It is collected in aggregate form and never linked with your personal information.

Web beacons, also known as clear gif technology or action tags, may be used to assist in delivering the cookie on our site. This technology tells us how many visitors clicked on key elements (such as links or graphics) on a web page. We do not use this technology to access your personally identifiable information; it is a tool we use to compile aggregated statistics about the website usage. We may share aggregated site statistics with partner companies but do not allow other companies to place clear gifs on our sites.

If you choose to not have your browser accept cookies from the website, you will be able to view the text on the screens, however you will not experience a personalized visit nor will you be able to subscribe to the service offerings on the site.

Use of your Personal Information
Your Personal Information is used for the following purposes:

  1. DIFZ Website functionality
    1. To allow you secure access to your data or information.
    2. To allow you to manage your own security and account information.
    3. To inform you of technical service or security issues related to the GNEM-DMP Online Registry.
    4. To notify you of changes to our Terms of Use or this Privacy Policy.
    5. For system performance, DIFZ may monitor access to particular data and may perform audits on such access.

  2. TREAT-NMD Responsibilities
    1. To allow the TREAT-NMD Curator to identify and to contact you or your doctor to confirm your eligibility to be included in the Study.
    2. To allow TREAT-NMD researchers to use for research or in publication, but such personal information will not identify you.

  3. Study
    1. To be part of an anonymized and aggregated data set so you and the other Study Subjects can compare your own individual Personal Information against the aggregated Personal Information of the other Study Subjects.
    2. To allow Ultragenyx to analyze your anonymized data to perform scientific research.

  4. Further Research and Disease Awareness/Understanding
    1. To allow other persons or organizations, such as physicians, researchers, or patient advocacy groups among others, to have access to your anonymized Personal Information in order to be better informed about your disease, to use in treatment, to perform research, to publish research, or to raise awareness or understanding about your disease or for other purposes.
    2. To share or exchange your anonymized Personal Information with other online registries around the world for the same purpose as 4.a.
    3. To submit anonymized and aggregated data for post-marketing submissions to Regulatory or other Competent Authorities globally.
    4. To better understand, scope out, and justify proposed clinical study endpoints (targets to show a treatment is effective).
    5. To analyze health economics (for instance, the cost of the treatments versus the benefits of treatments, such as how much money can be saved by a given treatment).

This GNEM-DMP Online Registry is part of a multi-year Study and has many purposes. So, there is no expiration on your consent to this Privacy Policy. If you decide to withdraw consent for this Privacy Policy or the Informed Consent Form and you wish to request that your Personal Information be deleted, please see the heading “Withdrawal of Consent” for making that request. Please note, that because this some of your Personal Information is Study Data, that Study Data cannot be deleted once it has been submitted.

Ultragenyx Sharing of your Personal Information
Ultragenyx may transmit your Personal Information about you to other Ultragenyx affiliates or partners worldwide. These affiliates or partners may in turn transmit your Personal Information to other affiliates or partners. Some Ultragenyx affiliates or partners may be located in countries that do not ensure an adequate level of data protection. Nevertheless, all Ultragenyx affiliates and partners are required to treat your Personal Information in a manner consistent with this Privacy Policy and in accordance with applicable data protection laws.

Also, Ultragenyx may contract with third parties, including TREAT-NMD, to perform activities or functions on our behalf that involve the use of your Personal Information about you. These third parties may be located in countries that do not ensure an adequate level of data protection. Nevertheless, Ultragenyx will require these third parties to protect the confidentiality and security of your Personal Information that is shared with them and to comply with applicable data protection laws. These third parties will be required to agree that they will not use or disclose your Personal Information except as necessary to provide services to us or to perform services on our behalf, or as necessary to comply with applicable laws or regulations.

DIFZ Sharing of your Personal Information
DIFZ may disclose Personal Information from or concerning you, or information from or concerning your computer or device, to third parties in the circumstances described below. By visiting, accessing, or using the GNEM-DMP Online Registry, you consent to the disclosure of your information to certain categories of third parties in the manner described below. This Privacy Policy does not apply to the policies or practices of any of these third parties. DIFZ will only contract services from companies that have Self-Certified under the EU-US Privacy Shield or will ensure that those companies comply with all applicable data use laws, including without limitation the EU Privacy Directive (95/46/EC) and its successor regulation.

DIFZ Service Providers
DIFZ occasionally hires other companies to provide limited services on our behalf, including application components, answering customer questions, providing help desk support, or processing event registration. DIFZ will only provide those companies the information they will use to deliver the service, and they are prohibited from using that information for any other purpose.

Web Hosts
Your Personal Information may be stored and processed in the United States or any other country in which DIFZ or its affiliates, subsidiaries or agents maintain facilities, and by using this site, you consent to any such transfer of information outside of your country where data use protections may not ensure an adequate level of data protection.

Law Enforcement/Legal Process
DIFZ may disclose your Personal Information if required to do so by law or in the good-faith belief that such action is necessary to: (a) conform to the edicts of the law or comply with legal process served on DIFZ or the site; (b) protect and defend the rights or property of DIFZ, or (c) act in urgent circumstances to protect the personal safety of DIFZ employees, users of DIFZ products or services, or members of the public.

Rights and Control of your Personal Information
When you register, or otherwise provide Personal Information in the GNEM-DMP Online Registry, your Personal Information will not be shared with third parties except as explained herein and only for the purposes described herein.

DIFZ will provide you with the means to ensure that your Personal Information is correct and current, and you may contact DIFZ (see bottom of this Privacy Policy) to request corrections to your Personal Information, if you cannot do that yourself, except for Study Data. Because the Study Data needs to be controlled, you will not be able to change your responses after they are submitted.

DIFZ may send out periodic e-mails informing you regarding your registration or technical service or security issues related to the GNEM-DMP Online Registry. Because use of the GNEM-DMP Online Registry is to perform the Study, you must agree to the periodic emails and cannot opt out of them as long as you are in the Study. If you wish to no longer receive the periodic emails, you must withdraw your consent to participate in the Study and must notify DIFZ (see bottom of this Privacy Policy).

Withdrawal of Consent/Deletion of Personal Information
If you do not consent to participate the Study, you may request to have your Personal Information deleted from the GNEM-DMP Online Registry. To do that, please contact DIFZ (see bottom of this Privacy Policy).

If you consent to participate in the Study, but you later decide that you no longer wish to participate in the Study, you may withdraw from the Study in accordance with the Informed Consent Form or by contacting TREAT-NMD (see bottom of this Privacy Policy). If you withdraw from the Study, you may ask DIFZ (see bottom of this Privacy Policy) to delete your Personal Information, except for Study Data.

Security of your Personal Information
DIFZ is committed to protecting the security of your Personal Information. We use a variety of security technologies and procedures to help protect your Personal Information from unauthorized access, use or disclosure. For example, we store the Personal Information you provide in computer servers with limited access that are located in controlled facilities. When we transmit sensitive information (such as health data) over the Internet, we protect it through the use of an appropriate level of encryption. However, no security system is impenetrable. Also, it is important for you to protect against unauthorized access to your password(s) and computer or device, and to log off when using any shared computer. In the event that DIFZ becomes aware of a security breach compromising your Personal Information, DIFZ will make all legally required disclosures, consistent with our ability to determine the scope of the breach, DIFZ’s need to restore the integrity of the system, and the needs of law enforcement.

Changes to this Privacy Policy
DIFZ will occasionally update this Privacy Policy. When we do, we will also revise the "last updated" date at the top of the Privacy Policy. For material changes to this Privacy Policy, DIFZ will notify you and will ask you to agree to the updated Privacy Policy when you next log into the GNEM-DMP Online Registry.

Contact Information
To object to the processing of your Personal Information, to file a concern, complaint, or request for correction of non-Study Data, or to request that your Personal Information, excluding the Study Data, be deleted from the GNEM-DMP Online Registry, please contact:

Digital Infuzion Privacy
Digital Infuzion, Inc.
656 Quince Orchard Road, Suite 300
Gaithersburg, MD 20878
E: nof1support@digitalinfuzion.com

To withdraw your consent from the Study, please contact:
Phillip Cammish
The John Walton Muscular Dystrophy Research Centre, Newcastle University, International Centre for Life, Newcastle upon Tyne
E: phillip.cammish@ncl.ac.uk
T:  0191 241 8905

To contact Data Protection Authorities either for more information about your privacy rights or if you are not able to resolve a problem directly with DIFZ and wish to make a compliant, please review these links for the Data Protection Authority or its equivalent in your country:

EU Member States:

For other countries, please use this as a reference to assist you:

Insert this search into your web browser:

And, select this link or its successor site:
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