[Last Updated: January 1, 2019 ]
The N of 1 Platform is for use by physicians and authorized medical personnel ('the Participating Medical Personnel') and patients ('Patients') who take part in registries, observational studies, or health outcome studies sponsored by Digital Infuzion's customer ('Customer'), as well as members of secondary care teams that provide care for Patients ('Secondary Care Personnel') (collectively, 'Users').
The N of 1 Health Research Platform is restricted-access:
The primary purpose of the N of 1 Health Research Platform is to facilitate, in accordance with the Customer's observational outcomes or other study protocols, Participating Medical Personnel to collect, submit, and view data in connection with these studies. Participating Medical Personnel will have the ability to view pre-defined, real-time reports from this data and to share such individual reports with Secondary Care Personnel and Patients. Each class of User has different rights in relation to the N of 1 Health Research Platform:
Participating Medical Personnel may enter data on the N of 1 Health Research Platform, review and query data stored on the N of 1 Health Research Platform, and generate reports from the N of 1 Health Research Platform;
Secondary Care Personnel may review reports relating to Patients, but only if published and shared by Participating Medical Personnel; and
Patients may review customized reports generated and shared by Participating Medical Personnel and may view a list of Observational outcomes members who are part of the Participating Medical Personnel's team.
Terms Regarding Use of the N of 1 Health Research Platform Applicable to All Users
Digital Infuzion's Use of Information Stored in the N of 1 Health Research Platform. You acknowledge and agree that Digital Infuzion and its Customer may access and use information that is entered into and/or stored in the N of 1 Health Research Platform in accordance with guidelines and restrictions set out in the observational outcomes protocols. Digital Infuzion and its Customer reserve the right to monitor all and any data that are entered into the N of 1 Health Research Platform and to correct data in accordance with study data review standard operating procedures.
Use of the N of 1 Health Research Platform by Participating Medical Personnel and Secondary Care Personnel. You are solely responsible for your use of the information stored in or generated from the N of 1 Health Research Platform, including, but not limited to, any and all course of action, clinical or medical decisions or treatment protocols using any information in or from the N of 1 Health Research Platform. Any record generated from the N of 1 Health Research Platform shall not function as a medical record for any Patient; under no circumstances should such records or reports be considered as replacements of or substitutions for a medical record of any Patient.
Data Privacy and Data Protection. The operation of the N of 1 Health Research Platform is subject to applicable European, United States, and other data privacy laws. Some Patient information that Participating Medical Personnel enter into the N of 1 Health Research Platform may constitute protected personally identifiable information, or personal data, under such laws. In addition to obtaining consents from Patients in accordance with Section 10 here in below (Third Party Consents), before using the N of 1 Health Research Platform and entering any data into the N of 1 Health Research Platform, Participating Medical Personnel must familiarize themselves with any legal obligations and responsibilities applicable to them arising from applicable data privacy or related laws. Digital Infuzion will not be held responsible for any loss, harm or damage arising from or related to the failure of Participating Medical Personnel to abide by any such obligations and responsibilities. Digital Infuzion has taken appropriate measures to ensure that its processing of any personal data complies with applicable data privacy laws, including by adopting appropriate technological and organizational measures to ensure the security and confidentiality of any personal data that are stored on the N of 1 Health Research Platform. Data submitted to the N of 1 Health Research Platform will be encrypted using web security best practices. All Users who have access to Patient clinical data must be approved by the Digital Infuzion Customer and/or the Participating Medical Personnel managing a patient. All data will be stored in a secure third-party hosting facility.
Terms Regarding Registration Applicable to All Users
Registration and Privacy
User Account, Password and Security
In order to become authorized to use the N of 1 Health Research Platform, you may be asked to furnish information that constitutes an electronic signature. You accept that your electronic signature is legally binding and equivalent to your written signature.
Terms Regarding Use Applicable to Participating Medical Personnel
Third Party Consents
Responsibility for Secondary Care Personnel and Patient use of the N of 1 Platform
As a Participating Medical Personnel, you have the ability at your discretion to invite Secondary Care Personnel and your Patients to register in the N of 1 Health Research Platform. Secondary Care Personnel and Patients will only have access to customized reports specifically created and designated by you. You are solely responsible for verifying the identity of such invitees and for the disclosure of the Patient data to Secondary Care Personnel and to the Patients themselves, including any liability related to the disclosure of such data to the extent disclosure is not permissible under local law. For system performance, Digital Infuzion and its Customer may monitor access to particular Patient data stored on the N of 1 Health Research Platform by user ID and may perform audits on such access.
Exclusion of Liability
Any information and material entered by Participating Medical Personnel into the N of 1 Health Research Platform is done at your own discretion and risk and you will be solely responsible for any damage to your computer system or loss, temporary or permanent, of data that results from the input of any such information or material or otherwise from using the N of 1 Health Research Platform.
Disclaimers, Exclusions and Other Important Terms Applicable to All Users
Disclaimer of Warranties
The N of 1 Health Research Platform is provided on an AS IS and AS AVAILABLE basis. You agree that your access to and use of the N of 1 Health Research Platform and the contents available therein is at your own risk.
Although Digital Infuzion will use reasonable efforts to ensure that the N of 1 Health Research Platform remains operational and accessible to Users, by registering for and using the N of 1 Health Research Platform you accept that Digital Infuzion makes no express or implied warranties or representations of any kind as to the accuracy, content, completeness, reliability, operability, or legality of information contained within the N of 1 Health Research Platform; or that the N of 1 Health Research Platform will meet your particular business requirements, needs or expectations; or that the N of 1 Health Research Platform will be uninterrupted, timely, error-free or continuously available; or that the N of 1 Health Research Platform will not cause you any loss, interruption of business, interruption of research or treatment, or any direct, indirect, special, incidental or consequential damages of any kind (including lost profits) regardless of the form of the action whether in contract or in tort (including negligence).
Any use that you make of information stored within the N of 1 Health Research Platform or generated in reports is done at your own discretion and risk. Neither Digital Infuzion, nor any party involved in creating, producing or delivering the N of 1 Health Research Platform, shall be liable for any damages, including without limitation, direct, indirect, special, incidental or consequential damages of any kind (including lost profits) regardless of the form of the action whether in contract or in tort (including negligence), arising out of access to, use of or inability to use the N of 1 Health Research Platform, or regarding any use of information stored within the N of 1 Health Research Platform or generated in reports.
All product names with or without the trademark symbol, are registered trademarks, trademarks or trade names of Digital Infuzion, its Customers, affiliates, related companies, licensors or joint venture partners, unless otherwise noted. The use of these trademarks or any other materials, except as permitted herein, is expressly prohibited and may be in violation of copyright law, trademark law or other proprietary rights of Digital Infuzion.
The contents of the N of 1 Platform are subject to copyright protection and all rights therein are reserved to Digital Infuzion. The contents of the N of 1 Platform may not be copied other than for non-commercial individual reference with all copyright or other proprietary notices retained, and thereafter may not be recopied, reproduced or otherwise redistributed except where necessary in connection with your professional activities and related research endeavors. Except as expressly provided above, you may not otherwise copy, display, download, distribute, modify, reproduce, republish or retransmit any information, text or documents or any portion thereof in any electronic medium or in hard copy, or create any derivative work based on such images, text or documents, without the express written consent of Digital Infuzion. Nothing contained herein shall be construed as conferring by implication, estoppel or otherwise any license or right under any patent or trademark of Digital Infuzion, or any third party.
Void Where Prohibited
The N of 1 Health Research Platform and its contents are intended to comply with the laws and regulations of the State of Maryland, United States. Other countries may have laws, regulatory requirements and medical practices that differ from those in the State of Maryland, United States. Digital Infuzion and its Customer reserve the right to limit use of the N of 1 Health Research Platform to any person, geographic region or jurisdiction.
Third Party Web Sites
Use of the N of 1 Health Research Platform may entail your installing, copying, downloading, accessing or otherwise using software products owned by or proprietary to Digital Infuzion or its licensors (the Software). Users are authorized to install, use, access, display or run the Software only in connection with their use of the N of 1 Health Research Platform, and for no other purpose. You may not reverse engineer, decompile, or disassemble the Software. You may not nor permit others to copy or transfer the Software; distribute, sell, rent, loan, lease, sub-license or otherwise deal in the Software; alter, adapt, merge, modify or translate the Software in any way or for any purpose, including, without limitation, for error correction; remove, change or obscure any product identification or notices of proprietary rights and restrictions on or in the Software. Without prejudice to any other rights it may have, Digital Infuzion and its Customer may revoke your right to use the Software if you do not abide by the terms and conditions contained in this Section 20 (Software Use).
Governing Law and Jurisdiction
The N of 1 Health Research Platform Transferability
Digital Infuzion and its Customer retain various technology partners to operate the N of 1 Health Research Platform system on its behalf. These include Digital Infuzion, Inc. and Medidata Solutions, Inc. who maintain secure hosting services. Digital Infuzion also reserves the right to sell, assign or otherwise transfer operation and control of the N of 1 Health Research Platform or any individual observational outcomes to a third party at some future point in time.
If you are a Participating Medical Personnel or Secondary Care Personnel and have questions about your use of the N of 1 Health Research Platform, please write to us via email. If you are a patient, we recommend that you contact your treating physician who participates in the observational outcomes studies.