V-Wave and its affiliates (“V-Wave“, “we”, “us” or “our”) are focused on developing breakthrough technologies and devices to treat patient diseases, including heart failure (HF) and pulmonary arterial hypertension (PAH).
Clinical Trial Sites (“Trial Sites”), their staff (“Site Staff”), and any of their authorized clinical trial participants (“Trial Participants”) who have engaged with us, including contact and activity data relating to their participation with V-Wave’s device and other features provided by us as part of the clinical trial (the “Trial”); as well as website visitors, prospective Trial Participants or partners (“Visitors”) who visit or interact with our website, http://vwavemedical.com, participate in our events or webinars, online ads and content, emails or communications under our control (collectively, with the administration of the Clinical Trial, the “Products”).
- Data Collection
- Data Uses
- Data Location
- Data Retention
- Data Sharing
- Cookies and Tracking Technologies
- Data Security
- Data Subject Rights
- Roles and Responsibilities
- Additional Information and Contact Details
If you are a Trial Participant who has been already accepted to participate in the Trial, please refer to your Informed Consent Form. If you are a Trial Participant in the USA, note that participating in the Trial includes processing “Protected Health Information” as defined in the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).
You are not legally required to provide us with any personal information, and may do so (or avoid doing so) of your own free will. If you do not wish to provide us with your personal data, or to have it processed by us or any of our Service Providers (defined in Section 5 below), please avoid any interaction with us or any use of our Products (or certain parts of our Products). If you are a Site Staff member, using the Products on behalf of any of our Trial Sites, we suggest that you contact your Trial administrator with any questions.
1. Data Collection
V-Wave collects data regarding our Visitors, Trial Sites and their Site Staff, and Trial Participants (“you” or “your”). Such data is typically collected and generated through your interaction with our Trial or Products, through automatic means, directly from you or from other third-parties.
To the extent the collected data relates to an identified or identifiable individual in the USA, it will be deemed as Personal Information (PI) and Protected Health Information (PHI), according to HIPAA and the US Health Information Technology for Economic and Clinical Health Act (HITECH). According to the EU General Data Protection Regulation (GDPR) it will be deemed as “Personal Data“ and in case of sensitive information (such as health-related information) it will be deemed as a Special Category of Personal Data – “Sensitive Data”. For the remainder of this Policy, Personal Data will also include PI and Sensitive Data will also include PHI (hereinafter; “Personal Data” and “Sensitive Data”, respectively).
Specifically, we collect the following categories of data:
Data received from Site Staff: you may provide us with Personal Data voluntarily, such as your name, workplace and position, contact details (such as business e-mail, phone and address), account login details (such as username and hashed password) mailing address and billing details. To the extent that such data concerns a non-human entity, we do not regard it as “Personal Data” or “Personal Information” and this Policy shall not apply to it.
Data received from Trial Participants: upon registration for Trial participation, you may provide us with Personal Data voluntarily, such as your name, e-mail, phone number, and other data such as your age and gender. In addition to any details you provide us, we will also be accessing certain medical records to ensure you are an appropriate fit for the trial, thereby processing your Sensitive Data.
Data received when you contact us: you may contact us for Trial support, learning more about our Products and offerings (such as medical institutions with which we cooperate, scientific materials concerning the trials etc.), or for any other reason. In doing so, you may provide us Personal Data such as your name, email, workplace and position and any other data you choose to provide or that we may require in order to properly review your inquiry.
Data received from other third-parties: we may receive your Personal Data from other sources. For example, if you participate in an event, conference or webinar that we participate in, we may receive your information from the event organizers. We may also receive your contact and professional details (e.g., your name, position, contact details and professional experience, preferences and interests) from our partners or Service Providers, from Site Trial or Site Staff, and through the use of tools and channels commonly used for connecting between hospitals, Trial sponsors and individuals in order to explore potential collaborations.
2. Data Uses
V-Wave processes your Personal Data and/or Sensitive Data as necessary for the performance of our Products and the Trial study; to comply with our legal and contractual obligations; and to support our legitimate interests in maintaining, and improving our Products, e.g. in understanding how our Products are used, and gaining insights which help us dedicate our resources and efforts more efficiently; in providing technical support; providing education or consulting services, monitoring and testing Trial usage and performance, and protecting and securing our Visitors, Site Staff, Trial Sites, Trial Participants, ourselves and our Products.
Specifically, we use Personal Data and/or Sensitive Data for the following purposes:
- To facilitate, operate, and provide our Trial and Products;
- To test the functionality and improve the performance of the Trial device; To provide our Trial Sites, their Staff and Trial Participants with assistance and support;
- To perform audits, research, measurements and analyses in an effort to maintain, administer, support, analyze, enhance, and protect the Trial and our Products;
- To improve and develop our Trial devices and Products;
- To contact our Trial Sites and/or Site Staff with general or personalized Trial and/or related messages; or with promotional messages (such as newsletters, new features etc.) in accordance with
- To support and enhance our data security measures, including for the purposes of preventing and mitigating the risks of fraud, error or any illegal or prohibited activity;
- To create aggregated statistical data, inferred non-personal data or anonymized or pseudonymized data (rendered non-personal), which we or our business partners and Trial Sites may use to provide and improve our Trials and Products;
- To comply with any applicable laws and regulations.
3. Data Location
We and our authorized Service Providers (as detailed in Section 5 below) maintain, store and process Personal Data and Sensitive Data in the United States, Europe, Australia, Canada and other locations as reasonably necessary for the proper performance of our Trial and delivery of our Products, or as may be required by law.
Notwithstanding the foregoing, Site Staff and Trial Participants’ Personal Data may only be processed in such locations as permitted in our Trial Consent Forms, Data Processing Agreements and other agreements with the respective Trial Sites where the Trial is taking place.
4. Data Retention
We retain Site Staff and Trial Participants’ Personal Data and Trial Participants’ Sensitive Data for the purposes outlined in this Policy; for as long as it is reasonably necessary in order to maintain and expand our relationship and provide you with our Trial and Products; in order to comply with our legal and contractual obligations, for archiving purposes in the public interest and/or for scientific research purposes as part of the clinical Trial, or to protect ourselves from any potential disputes (i.e. as required by laws applicable to log-keeping, records and bookkeeping, and in order to have proof and evidence concerning our relationship, should any legal issues arise following your discontinuance of use), all in accordance with applicable laws and regulations, and as further stipulated in our DPA and other agreements with Trial Sites. Please also note that we may also retain Personal Data and/or Sensitive Data due to the laws and regulations relating to clinical trials, depending on the jurisdiction in which the Trial is conducted.
Please note that except as required by applicable law or our specific agreements with you, we will not be obligated to retain your Personal Data and Sensitive Data for any particular period, and we are free to securely delete it or restrict access to it for any reason and at any time, with or without notice to you. If you have any questions about our data retention policy, please contact us by e-mail at firstname.lastname@example.org.
5. Data Sharing
Legal Compliance: in exceptional circumstances we may disclose or allow government and law enforcement officials access to your Personal Data and Sensitive Data, in response to a subpoena, search warrant or court order (or similar requirement), or in compliance with applicable laws and regulations with or without notice to you. Such disclosure or access may occur if we believe in good faith that: (a) we are legally compelled to do so and solely to the extent that we believe is strictly necessary to comply, (b) disclosure is appropriate in connection with efforts to investigate, prevent, or take action regarding actual or suspected illegal activity, fraud, or other wrongdoing; or (c) such disclosure is required to protect our legitimate business interests, including the security or integrity of our products and Products. Please also note that we may also disclose Personal Data and/or Sensitive Data to the regulatory bodies to which we are subject in relation to the conducting of Clinical Trials such as the FDA and EMA.
Service Providers: we may engage selected third-party companies and individuals to perform services complementary to our own. Such Service Providers include hosting and server co-location services, communications and content delivery networks (CDNs), data analytics services, marketing and advertising services, data and cyber security services, billing and payment processing services, e-mail and SMS distribution and monitoring services, procedure or activity recording services, performance measurement, data optimization and marketing services, social and advertising networks, content providers, support and customer relation management systems, and our business, legal, financial and compliance advisors (collectively, “Service Providers“). These Service Providers may have access to your Personal Data and Sensitive Data, depending on each of their specific roles and purposes in facilitating and enhancing our Products, and may only use it for such purposes.
Sharing Data with our Trial Sites: Site Staff and Trial Participants’ Personal Data and Sensitive Data is typically shared and is available between V-Wave and the respective Trial Site where a part of the Trial takes place. In such cases, sharing such data means that relevant Site Staff may access it on behalf of the Trial Site, and will be able to monitor, process and analyze the Personal Data and Sensitive Data contained therein. This includes instances where we notify your care provider automatically of your potential health problem in real-time.
Please note that V-Wave is not responsible for and does not control any further disclosure, use, or monitoring by, or on behalf of, the Site of which you are a data subject (as an employee or patient for example), that itself acts as the “Covered Entity” or “Data Controller” of such data (as further described in Section 10 below).
Protecting Rights and Safety: we may share Personal Data and/or Sensitive Data with others if we believe in good faith that this will help protect the rights, property or personal safety of V-Wave, any of our Visitors, Trial Sites, Site Staff, Trial Participants or any members of the general public.
For the avoidance of doubt, V-Wave may share your Personal Data and/or Sensitive Data in additional manners, pursuant to your explicit approval, or if we are legally obligated to do so, or if we have successfully rendered such data non-personal, non-identifiable and anonymous. We may transfer, share or otherwise use non-personal and non-identifiable data at our sole discretion and without the need for further approval.
6. Cookies and Tracking Technologies
We and our Service Providers use “cookies” and other technologies for performance, tracking, analytics and personalization purposes and in order to provide you with a better experience. We may share non-identifiable/aggregated extracts of such information with our partners for our legitimate purposes.
Cookies: cookies are packets of information sent to your web browser and then sent back by the browser each time it accesses the server that sent the cookie. Some cookies are removed when you close your browser session – these are the “Session Cookies”. Some last for longer periods and are called “Persistent Cookies”. We may use both types to facilitate the use of the Products’ features and tools. Whilst we do not change our practices in response to a “Do Not Track” signal in the HTTP header from a browser or mobile application, you can manage your cookies preferences, including whether or not to accept them and how to remove them, through your browser settings. Please bear in mind that disabling cookies may complicate or even prevent you from using the Products. The cookies currently present on the Products are:
Please note that if you get a new computer, install a new browser, erase or otherwise alter your browser’s cookie file (including upgrading certain browsers), you may also clear the opt-out cookies installed once you opt-out, so an additional opt-out will be necessary to prevent additional tracking.
Service Communications: we may contact you with important information regarding our Trial and Products. For example, we may send you notifications (through any of the means available to us) of changes or updates to our Products, billing issues regarding Trial Sites, service changes etc. Our Trial Sites and Site Staff may also send notifications, messages and other updates regarding the Trial or Products to Trial Participants on our behalf. Please note that you will not be able to opt-out of receiving certain service communications which are integral to your participation in the Clinical Trial.
Notifications and Promotional Communications: we and our authorized partners (e.g., event or webinar co-sponsors) may also notify you through our newsletter about new features or successful Trial stages, events, webinars, special opportunities or any other information we think you will find valuable, as our Visitor, Trial Site, Site Staff and/or Trial Participant. We may provide such notices through any of the contact means available to us (e.g. mobile or e-mail), through the Products, or through our marketing campaigns on any other sites or platforms.
If you do not wish to receive such promotional communications, you may notify V-Wave at any time by sending an e-mail to: email@example.com, or by following the “unsubscribe”, “stop”, “opt-out” or “change e-mail preferences” instructions contained in the promotional communications you receive.
8. Data Security
We and our hosting services implement systems, applications and procedures to secure your Personal Data or Sensitive Data, to minimize the risks of theft, damage, loss of information, or unauthorized access or use of information. These measures provide sound industry-standard security, taking both the GDPR and HIPAA into consideration. However, although we make efforts to protect your privacy and data, we cannot and do not guarantee the absolute protection and security of any Personal Data or Sensitive Data stored with us or with any third-parties.
9. Data Subject Rights
You have rights concerning your Personal Data and/or Sensitive Data. If you wish to exercise your privacy rights under any applicable law, including the GDPR, HIPAA or HITECH, such as the right to request access to, and rectification or erasure of your Personal Data and/or Sensitive Data held with V-Wave, or to restrict or object to the processing of such Personal Data and/or Sensitive Data, or to port such Personal Data and/or Sensitive Data, or the right to equal Products and prices (each to the extent available to you under the laws which apply to you) – please contact us by e-mail at firstname.lastname@example.org.
Please note that when you ask us to exercise any of your rights under this policy or applicable law, we may need to ask you to provide us certain credentials to make sure that you are who you claim you are, to avoid disclosure to you of personal information related to others and to ask you to provide further information to better understand the nature and scope of data that you request to access. Such additional data will be then retained by us for legal purposes (e.g. as proof of the identity of the person submitting the request), in accordance with Section 4 above. We may redact from the data which we will make available to you any Personal Data and/or Sensitive Data related to others.
10. Roles and Responsibilities
Roles and responsibilities that V-Wave takes as part of your data processing are described here below in accordance with EU and USA perspectives.
In the United States, HIPAA, HITECH, along with the regulations adopted under those statutes, and similar state laws (where those laws are more stringent than HIPAA) govern the handling of Sensitive Data (PHI). In the European Union the General Data Protection Regulation (GDPR) governs the handling of Sensitive Data, including health data.
These data protection laws and regulations, typically distinguish between two main roles for parties processing Personal Data and/or Sensitive Data. usually-Wave is considered as the “Covered Entity” (or under the GDPR “Data Controller”) of its Visitors, Trial Sites, Site Staff and Trial Participants data, since V-Wave determines (alone or with the Trial Site; in which case we will deem them as “co-controllers”) the purposes and means of processing. The Trial Sites and other Service Providers are the “Business Associate” (or under the GDPR “Data Processor”) that process the Trial data or any other data on behalf of V-Wave. Separately, Trial Sites also operate as Trial Participants’ health care providers and take on different roles in that regard that are not connected to the Clinical Trial.
11. Additional Information and Contact Details
Updates and amendments: we may update and amend this Policy from time to time by posting an amended version on our Products. The amended version will be effective as of the date it is published. We will provide prior notice if we believe any substantial changes are involved via any of the communication means available to us or via the Products. After such notice period, all amendments shall be deemed accepted by you. If you are a Trial Participant please refer to your Informed Consent Form.
External Links: we may provide specific external links within this website. All external links will be noted as part of the hyperlink text. Unless noted, V-Wave is not responsible for the content provided; these links are provided for informational purposes only.
If you are a GDPR-protected individual, you also have the right to lodge a complaint with an EU supervisory authority.
Effective Date: April 21, 2021