EDETEK, Inc. (“EDETEK”) has adopted this Privacy Shield Policy (“Policy”) to establish and maintain an adequate level of Personal Data privacy protection. This Policy applies to the processing of Personal Data that EDETEK obtains from Customers located in United States, European Union and Switzerland. The common principles of this policy also apply to the processing of Personal Data obtained from other countries and regions.
The Federal Trade Commission (FTC) has jurisdiction over EDETEK’s compliance with the Privacy Shield.
All EDETEK employees who handle Personal Data are required to comply with the Principles stated in this Policy.
EDETEK abides by local data protection and privacy laws in processing Personal Data from all countries and regions.
Capitalized terms are defined in Section 14 of this Policy.
2.1 In Scope
This Policy applies to the processing of Individual Subject Personal Data that EDETEK receives in the United States concerning individual subjects who reside in US, European Union, Switzerland, and other countries and regions. EDETEK provides data standardization, analysis, and reporting services to sponsors or partner organizations who might collect these subjects’ clinical trial data for research purposes.
2.2 Out of Scope
This Policy does not cover data from which individual persons cannot be identified or situations in which pseudonyms are used. (The use of pseudonyms involves the replacement of names or other identifiers with substitutes so that identification of individual persons is not possible.)
3 Responsibilities and Management
EDETEK has designated the Legal Department to oversee its information security program, including its compliance with US, EU and Swiss Privacy Shield program. The Legal Department shall review and approve any material changes to this program as necessary. Any questions, concerns, or comments regarding this Policy also may be directed to email@example.com.
EDETEK will maintain, monitor, test, and upgrade information security policies, practices, and systems to assist in protecting the Personal Data that it collects. EDETEK personnel will receive training, as applicable, to effectively implement this Policy. Please refer to Section 7 for a discussion of the steps that EDETEK has undertaken to protect Personal Data.
EDETEK is aware that on July 16, 2020, the Court of Justice of the European Union issued a judgment declaring as invalid the European Commission’s Decision (EU) 2016/1250 of 12 July 2016 on the adequacy of the protection provided by the EU-U.S. Privacy Shield. EDETEK certifies that it will continue to adhere to General Data Protection Regulation (GDPR) and renew its US-EU Privacy Shield and Swiss-US Privacy Shield certifications annually, unless it subsequently determines that it no longer needs such certification or if it employs a different adequacy mechanism.
Prior to the re-certification, EDETEK will conduct an in-house verification to ensure that its attestations and assertions about its treatment of Individual Subject Personal Data are accurate and that the company has appropriately implemented these practices. Specifically, as part of the verification process, EDETEK will undertake the following:
- Ensure that this Policy continues to comply with the Privacy Shield principles
- Confirm that Individual Subjects are made aware of the process for addressing complaints and any independent dispute resolution process (EDETEK may do so through its publicly posted website, Individual Subject contract, or both)
- Review its processes and procedures for training Employees about EDETEK’s participation in the Privacy Shield programs and the appropriate handling of Individual’s Personal Data
EDETEK will prepare an internal verification statement on an annual basis.
5 Collection and Use of Personal Data
EDETEK provides data standardization, analysis, and reporting to sponsors or partner organizations, who might collect individual subject clinical trial data for clinical research purposes.
The information that we collect from Individual Subjects is used to support sponsors or partner organizations for clinical research purposes. We are acting as a data processor and will process the personal information on behalf of and under the direction of our partners and/or agents.
EDETEK uses Personal Data that it collects directly from its Individual Subjects and for its partners indirectly in its role as a service provider for the following business purposes, without limitation:
- Data Standardization
- Statistical Analysis
EDETEK does not disclose personal information to third parties for purposes that are materially different than what it was originally collected for. Should this change in the future, we will provide individuals with the option to opt-out.
6 Disclosure / Onward Transfers of Personal Data
Except as otherwise provided herein, EDETEK discloses Personal Data only to Third Parties who reasonably need to know such data only for the scope of the initial transaction and not for other purposes. Such recipients must agree to abide by confidentiality obligations.
EDETEK may provide Personal Data to Third Parties that act as agents, consultants, and contractors to perform tasks on behalf of and under our instructions. For example, EDETEK may store such Personal Data in the facilities operated by Third Parties. Such Third Parties must agree to use such Personal Data only for the purposes for which they have been engaged by EDETEK and they must either:
- comply with the Privacy Shield principles or another mechanism permitted by the applicable EU & Swiss data protection law(s) for transfers and processing of Personal Data;
- or agree to provide adequate protections for the Personal Data that are no less protective than those set out in this Policy;
EDETEK also may disclose Personal Data for other purposes or to other Third Parties when a Data Subject has consented to or requested such disclosure. Please be aware that EDETEK may be required to disclose an individual’s personal information in response to a lawful request by public authorities, including to meet national security or law enforcement requirements. EDETEK is liable for appropriate onward transfers of personal data to third parties.
7 Data Integrity and Security
EDETEK uses reasonable efforts to maintain the accuracy and integrity of Personal Data and to update it as appropriate. EDETEK has implemented physical and technical safeguards to protect Personal Data from loss, misuse, and unauthorized access, disclosure, alternation, or destruction. For example, electronically stored Personal Data is stored on a secure network with firewall protection, and access to EDETEK’s electronic information systems requires user authentication via password or similar means. EDETEK also employs access restrictions, limiting the scope of employees who have access to Individual Subject Personal Data.
Further, EDETEK uses secure encryption technology to protect certain categories of personal data. Despite these precautions, no data security safeguards guarantee 100% security all of the time.
9 Accessing Personal Data
EDETEK personnel may access and use Personal Data only if they are authorized to do so and only for the purpose for which they are authorized.
10 Right to Access, Change or Delete Personal Data
From GDPR perspective, EDETEK is a Data Processor. Therefore, EDETEK will work with Data Controller and follow the instructions from Data Controller to ensure the following rights of Individual Subjects.
- Right to Access. Individual Subjects have the right to know what Personal Data about them is included in the databases and to ensure that such Personal Data is accurate and relevant for the purposes for which Data Controller collected it. Individual Subjects may review their own Personal Data stored in the databases and correct, erase, or block any data that is incorrect, as permitted by applicable law and Data Controller policies.
- Requests for Personal Data. Data Controller will track each of the following and will provide notice to the appropriate parties under law and contract when either of the following circumstances arise: (a) legally binding request for disclosure of the Personal Data by a law enforcement authority unless prohibited by law or regulation; or (b) requests received from the Data Subject. If EDETEK receives a request for access to his/her Personal Data from an Individual Subject, then, unless otherwise required under law or by contract with such Individual Subject, EDETEK will contact Data Controller to handle such request.
- Satisfying Requests for Access, Modifications, and Corrections. EDETEK will endeavor to contact Data Controller in a timely manner to all reasonable written requests to view, modify, or inactivate Personal Data.
11 Changes to This Policy
This Policy may be amended from time to time, consistent with the Privacy Shield Principles and applicable data protection and privacy laws and principles. We will make employees available of changes to this policy either by posting to our intranet, through email, or other means. We will notify Customers if we make changes that materially affect the way we handle Personal Data previously collected, and we will allow them to choose whether their Personal Data may be used in any materially different manner.
12 Questions or Complaints
EU and Swiss Individual Subjects may contact EDETEK with questions or complaints concerning this Policy at the following address:
13 Enforcement and Dispute Resolution
In compliance with the US-EU and Swiss-US Privacy Shield Principles, EDETEK commits to resolve complaints about your privacy and our collection or use of your personal information. US, EU and Swiss individuals with questions or concerns about the use of their Personal Data should contact us at: info@EDETEK.com.
If a Customer’s question or concern cannot be satisfied through this process EDETEK has further committed to refer unresolved privacy complaints under US-EU Privacy Shield and Swiss-US Privacy Shield to an independent dispute resolution mechanism operated by the Council of Better Business Bureaus.
If you do not receive timely acknowledgement of your complaint, or if your complaint is not satisfactorily addressed by EDETEK, EU and Swiss individuals may bring a complaint before the American Arbitration Association (AAA). Finally, as a last resort and in limited situations, EU and Swiss individuals may seek redress from the Privacy Shield Panel, a binding arbitration mechanism.
EDETEK commits to cooperate with FTC, EU and Swiss data protection authorities (DPAs) and comply with the advice given by such authorities with regard to human resources data transferred from the US, EU and Switzerland in the context of the employment relationship.
14 Defined Terms
“Individual Subject” means an Individual subject or client of EDETEK from US, EU or Switzerland. The term also shall include any individual agent, representative, of an individual customer of EDETEK and all employee of EDETEK where EDETEK has obtained his or her Personal Data from such Individual Subject as part of its relationship with EDETEK.
“Data Subject” means an identified or identifiable natural living person. An identifiable person is one who can be identified, directly or indirectly, by reference to a name, or to one or more factors unique to his or her personal physical, psychological, mental, economic, cultural or social characteristics. For Subjects residing in Switzerland, a Data Subject also may include a legal entity.
“Employee” means an employee (whether temporary, permanent, part-time, or contract), former employee, independent contractor, or job applicant of EDETEK or any of its affiliates or subsidiaries, who is also a resident of a country within the European Economic Area.
“Europe” or “European” refers to a country in the European Union.
“Personal Data” as defined under the European Union Directive 95/46/EC means data that personally identifies or may be used to personally identify a person, including an individual’s name in combination with country of birth, marital status, emergency contact, salary information, terms of employment, job qualifications (such as educational degrees earned), address, phone number, e-mail address, user ID, password, and identification numbers. Personal Data does not include data that is de-identified, anonymous, or publicly available. For Switzerland, the term “person” includes both a natural person and a legal entity, regardless of the form of the legal entity.
“Sensitive Data” means Personal Data that discloses a Data Subject’s medical or health condition, race or ethnicity, political, religious or philosophical affiliations or opinions, sexual orientation, or trade union membership.
“Third Party” means any individual or entity that is neither EDETEK nor an EDETEK employee, agent, contractor, or representative.