1.2. CONTACT DETAILS
Trialbee’s contact details for privacy rights questions and requests are:
Full name of legal entity: Trialbee AB, Data Privacy Officer
Email Address: firstname.lastname@example.org
We would appreciate the chance to deal with your concerns before you approach one of the national supervisory authorities, by contacting us in the first instance at email@example.com.
You have the right to make a complaint at any time to the relevant supervisory authority. In the United States, contact the US Federal Trade Commission at: https://www.ftc.gov/faq/consumer-protection/submit-consumer-complaint-ftc.
1.5. THIRD-PARTY LINKS
2. DEFINITIONS AND ACCRONYMS
Anonymized: is a type of information sanitization whose intent is privacy protection. It is the process of removing of personally identifiable information from data sets, so that the person’s identity becomes anonymous.
CCPA: is the United States California Consumer Privacy Act
PII: Personal Identifiable Information
PHI: Protected Health Information
Third Parties means:
- Service providers acting as processors and who provide services to us.
- Professional advisers acting as processors or joint controllers including lawyers, bankers, auditors and insurers who provide consultancy, banking, legal, insurance and accounting services to us.
- Regulators and other state authorities acting as processors or joint controllers in any jurisdiction in which we are operating and who require reporting of processing activities in certain circumstances.
Covered Entity: An institution, organization or other entity that is subject to the rules of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). Covered Entities include: (i) a health plan, (ii) a healthcare clearinghouse and, (iii) a healthcare provider who transmits any personal identifiable health information in electronic form in connection with a transaction covered by HIPAA.
Personal Identifiable Health Information (“PIHI”) means any information including demographic information collected from an individual that:
- relates to (a) the past, present or future physical or mental health or condition of an individual; (b) the provision of healthcare to an individual; or (c) the past, present or future payment for the provision of healthcare to the individual; and
- identifies the individual or there is a reasonable basis to believe it can be used to identify the individual; and
- PIHI does not include education records or medical records covered by the Family Education Rights and Privacy Act or employment records held by Trialbee in its role as an employer.
Personal Information: According to the California Consumer Privacy Act, “personal information” means any information that identifies, relates to, describes, is reasonably capable of being associated with, or could reasonably be linked, directly or indirectly, with a particular consumer or household.
3. DATA WE COLLECT ABOUT YOU
Like many commercial organizations we monitor the use of this website by collecting aggregate information using cookies.
Typically, we collect information about the number of visitors to the website, to each web page and the originating domain name of the visitor’s Internet Service Provider.
This information is used to understand the visitor’s use of the website and may be shared with our affiliates and/or other third parties. We have no means reasonably available to us to ascertain the identity of individual users from aggregate information.
We may collect, use, and share Aggregated Data such as general statistical data for any purpose. Aggregated Data may be derived from your personal data but is not considered personal data in law as this data does not directly or indirectly reveal your identity.
We may also perform or collect categories of personal data about you which are grouped as follows:
- Monitor customer traffic patterns and
- Site usage information to help us to improve the design and layout of our site, to personalize your experience by tailoring the content you see thus optimizing your user experience.
- Perform statistical analysis on our members’ accounts to determine,
- how many are active
- how frequently they are used
- and how many of our other websites you are registered with.
- Identity Data includes first name, maiden name, last name, username, or similar identifier.
- Contact Data includes physical address, delivery address, email address and telephone numbers.
- Transactional Data includes details of products and services you have received or purchased from us and/or affiliates.
- Technical Data includes Internet Protocol (“IP”) address, login data, browser type and version, time zone setting and location, browser plug-in types and versions, operating system and platform, and other technology on the device you use to access this website.
- Usage Data includes information about how you use our website, products, and services.
- Marketing and Communications Data includes your preferences in receiving marketing from us and/or affiliates.
- Health Data includes information in relation to any aspect of your health and/or consequences of taking part in any clinical trials organized by our clients.
We may also obtain information about your opinions if, for example, you send us feedback, or ask us questions.
We may also, occasionally, receive information about you from other sources which we will add to the information that we may already hold about you to help us improve and personalize our service to you.
4. HOW YOUR PERSONAL DATA IS COLLECTED
We use various methods to collect the categories of data described above through but not limited to:
- Data Interactions. You may have given your personal data by filling in forms or by corresponding with us by mail, phone, and email or otherwise. This includes personal data you provide when you:
- Apply online
- Contract to receive services or information
- Request marketing material to be sent to you
- Automated Technologies or Interactions. As you interact with our website, we may automatically collect technical data about your equipment, browsing actions or patterns.
- We collect this personal data by using cookies, log files, and other similar technologies.
- We may also receive technical data about you from other you visit employing our cookies. This aggregate data gives a “macro-view” of the visitor traffic patter and insight to what sections of the website users visit the most. None of this information is linked to any personal information.
- We passively collect and log the following information from visitors to our website such as:
- Browser type
- IP Address
- Domain Name
- Access Time
- Operating System
- We passively collect and log the following information from visitors to our website such as:
- Third-parties or publicly available sources. We may receive personal data about you from various third parties and public sources as set out below.
- Analytics such as Google
- Advertising Networks
- Search Information Providers
- Contact and Transaction Data from providers of technical, payment and delivery services.
- Identity and Contact Data from data brokers or aggregates.
5. HOW WE USE AND DISCLOSE YOUR DATA
We will use your personal data in the following circumstances:
- Where we need to perform the contract, we are about to enter or have entered with you, or to perform other legal obligations.
- Where it is necessary for our legitimate interests or those of a third party.
- Where we need to comply with a legal or regulatory obligation.
We may disclose Personal Data to comply with a legal or regulatory obligation. Unless we have informed you otherwise and have obtained your permission, or the law forces us to, we will only use the collected Personal Data within Trialbee, other entities that you have consented to share the information with, such as the Trialbee or LivaNova representative who may call you to ask health questions or the research center where the clinical trial is being conducted, we may also share the information with business partners that act on our behalf.
5.1. PURPOSES WE USE YOUR DATA
Note, that we may process your personal data for more than one lawful ground depending on the specific purposes, this has been set out in the table below:
|Purpose||Category||Lawful basis for processing, including legitimate interest|
|To register you as a new customer.||
||Performance of a contract with you.|
|To process and deliver services and/or perform contractual obligations for you.||
To manage our relationship with you which could include:
|To enable you to complete a survey/questionnaire.||
|To consider whether you are eligible/suitable for participating in a clinical trial, related to a clinical investigation, or clinical support program sponsored by our clients.||
|To administer and protect our business and this website, including troubleshooting, data analysis, testing, system maintenance, support, reporting, and hosting of data.||
|To deliver relevant website content and advertisements to you and measure or understand that effectiveness of the advertising we serve to you.||
||Necessary for our legitimate interests, to study how customers use our products/services, to develop them, to grow our business and to inform our marketing strategy.|
|To use data analytics to improve our website, products and services, marketing, customer relations, experience and to provide audit record for consent.||
||Necessary for our legitimate interests, to define types of customers for our products and services, to keep our website updated and relevant, to develop our business, and inform our marketing strategy.|
|To make recommendations to you about products or services that may be of interest to you.||
||Necessary for our legitimate interests, to develop our products and services, and grow our business.|
|To comply with legal obligations, including government investigations, subpoenas, or other legal process or as otherwise necessary to prevent physical or financial harm or to prevent crime and fraud.||
5.2. DISCLOSING INFOROMATION TO THIRD PARTIES
Trialbee may share your personal data with trusted clients and service providers where needed for clinical trials, as set out below for the purposes set out in the table in section 5.1 above.
- The study sponsor, LivaNova, who may contact you to discuss the study in more detail.
- Third party sub-contractors who provide services for us and/or help to provide services to you.
- Research centers that are conducting the clinical trial.
- We may disclose personal information to law enforcement, government authorities or otherwise in response to a legal subpoena or process as required by applicable law or in the circumstances involving the possibility of physical or financial harm, fraud, or crime.
We require all third parties to respect the security of your personal data and to treat it in accordance with the law.
We do not allow our third-party service providers to use your personal data for their own purposes and only permit them to process your personal data for the specified purposes and in accordance with our instructions.
We do not sell your personal data to any third party. Our use and disclosure of PHI is limited to the minimum amount needed to accomplish the intended purpose of the specific clinical trial and is used in the relation to pre-screen activities for such clinical research projects. This includes using study questionnaires that only ask questions related/associated to relevant clinical research project as specified in approved protocols, and information will not be disclosed unless we have clear consent from you to do so.
5.3. USE OF HEALTH DATA IN THE UNITED STATES
The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and subsequent regulations published by the Department of Health and Human Services (“DHHS”) impose restrictions on other organizations (Covered Entities) which may be covered under HIPAA with respect to your relationship with Trialbee. Trialbee may, in providing subject recruiting services for one of these organizations, be required to comply with certain aspects of HIPAA in their conduct of human subject research activities.
All PIHI data collected by Trialbee in connection with subject recruiting for a clinical research study is captured electronically and transmitted through a secure network connection to a secure database. Trialbee’s data security policies are consistent with Good Clinical Practices, and HIPAA standards.
5.4. OPTING OUT OF COMMUNICATIONS FROM TRIALBEE
You can opt-out and request us to stop sending you information, and/or reminders, at any time by contacting us at firstname.lastname@example.org.
Where you opt-out of receiving information., and or reminders, will not apply to personal data provided to us because of a product/service such as registration, product/service experience or other transaction.
- to learn how our website is used and how it performs, including cross-site statistics,
- to provide you with additional functionalities and personalization
- to provide you social media interactions and
- for targeting and marketing purposes.
5.5.1. COOKIE PRIVACY PREFERENCES AND CONSENT
5.5.2. USE OF DATA FOR MARKETING
5.5.3. TRIALBEE COOKIE STATEMENT
When you accept cookies, you consent that cookie will be stored on your computer, tablet, or smartphone. If you opt-out of cookies, the website may not work in an optimal fashion.
6. DATA PROCESSING
Consent to processing of personal data is as follows for each clinical trial study.
This policy describes how Trialbee AB, company registration number 556814-3019, address: Södra Tullgatan 3, 211 40 Malmö, Sweden, email@example.com, gathers, processes, stores, and shares personal data.
If you are interested in participating in this study Trialbee will ask you to provide certain information about yourself to process your application for the study. This allows us to evaluate your eligibility for the study and to contact you during the application process. The information we intend to collect are your name, telephone number(s), e-mail address, and answers to questions we ask you for determining eligibility. These answers may include information about your health. Health information is only used for the purposes of determining your eligibility for the clinical study.
Information about you is stored in Trialbee’s system until the clinical study recruitment is completed or until you request that the data is deleted, whichever occurs first.
You can at any time withdraw your consent to the processing of your personal data for the purposes of evaluating your application by contacting Trialbee at firstname.lastname@example.org. If you withdraw your consent, Trialbee will stop processing your personal data for such purposes and your application to participate in the study will be considered withdrawn.
7. TRANSFER OF PERSONAL DATA
7.1. UNITED STATES (US)
8. DATA SECURITY
9. DATA RETENTION
We will only retain your personal data for as long as necessary to fulfil the purpose we collected it for, including for the purpose of satisfying any legal, accounting or reporting requirements.
To determine the appropriate retention period for persona data, we consider the amount, nature and sensitivity of the personal data, the potential risk or harm from unauthorised use or disclosure or your personal data, the purposes for which we process your personal data and whether we can achieve those purposes through other means, and the applicable legal requirements.
We also anonymize your personal data (so that it can no longer be associated with you) and maintain it for research or statistical purposes in which case we may use this information indefinitely without further notice to you.
9.1. NO FEE REQUIRED
10. YOUR DATA PRIVACY RIGHTS UNDER CCPA
If you are a resident of California, you have the following rights under the California Consumer Privacy Act (https://oag.ca.gov/privacy/ccpa), with respect to your Personal Data:
- The right to know what Personal Information we have collected, used, disclosed, and sold about you. To submit a request to know, please contact us by emailing email@example.com. You also may designate an authorized agent to make a request for access on your behalf.
- The right to request that we delete any Personal Information we have collected about you. To submit a request for deletion, please contact us by emailing firstname.lastname@example.org. You also may designate an authorized agent to make a request for deletion on your behalf.
- The right to opt-out of the sale of their personal information.
- The right to non-discrimination for exercising your rights under the CCPA rights.
When you exercise these rights and submit a proper request to us, we will verify your identity by asking you for identifying information such as your email address, telephone number, and/or information about your account with us. We also may use a third-party verification provider to verify your identity. Please note that we are only required to honour such requests twice in a 12-month period.
Your exercise of these rights will have no adverse effect on the price and quality of our goods or services.
11. INTENDED AUDIENCE
12. OTHER INFORMATION
For quality control and training purposes, we may monitor or record your communications with us.