Corporate Clinical: GDPR Statement

Boston Scientific Corporation
GDPR Privacy Notice for Site Personnel



This Privacy Notice explains how Boston Scientific Corporation (“Boston Scientific” - “we”) process the personal data of investigator and site staff (“Site Personnel” or “you”) who are employed by investigative sites where a Boston Scientific study is being performed.

At Boston Scientific, we take great care in processing personal data in compliance with applicable laws. We only collect and use the information necessary to achieve the purposes described below. Boston Scientific Corporation, whose registered address is One Hundred Boston Scientific Way, Marlborough, MA United States of America, is the sponsor of this study.

As such, Boston Scientific, as Data Controller, is the entity responsible for deciding which of your personal data are needed in order to evaluate your suitability to act as study site personnel and manage your participation.

Information that we collect about you and why

Sources

We may collect personal data about you from a variety of sources, including directly from you and your institution and from provided CVs and resumes, from publicly available sources such as the register of licensed medical practitioners in your country, online and other databases and websites, from third party providers, and from other documents or forms that you provide in order to participate in clinical research sponsored by Boston Scientific.

Types of personal data

Boston Scientific may collect and use some or all of the following categories of personal data:

  • personal details, such as your name, age, gender and contact information;
  • professional details, such as your place of practice, job title, the medical field in which you are active, your professional qualifications and scientific activities (such as previous clinical trial experience, and participation in past or pending research studies with Boston Scientific and other companies), research areas of interest, publication of academic or scientific research and articles, and membership in associations and boards;
  • certain financial information, such as the declaration of financial interests, if applicable, and other financial information collected for purpose of payment and reporting of payments in connection with the conduct of clinical trials for Boston Scientific; and
  • details of interactions with us, such as what kind of meetings we have held, topics discussed, your knowledge of and questions you have had on our business, what kind of material we have displayed to you and any feedback that you have provided, as well as your opinions and routines on prescribing, routines regarding your patients and diagnosis, and similar information.

Processing purposes

Your personal data will be processed by Boston Scientific for the following purposes:

  • evaluating your participation in the Study;
  • administration of the Study;
  • managing our relationship with you, including planning, organizing and reviewing any collaboration with you, analysis and/or contacting you;
  • helping ensure that we provide you with information that is relevant given your expertise, interests and preferences;
  • complying with applicable laws and regulations (e.g., in connection with Medical Device Regulations); and/or
  • publicly disclosing certain transfers of value made to you and healthcare organizations under transparency rules applicable for the Medical Device Industry.

The legal bases for this processing are our legitimate interests in maintaining and optimizing a professional relationship or connection with you, performance of a contract with the investigative site at which you are employed, and our compliance with a legal obligation.

Sharing your personal data

Boston Scientific may share your personal data with others, from time to time, in connection with the purposes described in this notice. In particular, we may make your personal data available to:

  • regulatory bodies and authorities, for example in respect of clinical trials and in the context of applying for product registrations;
  • other affiliates or subsidiaries of Boston Scientific (e.g. in the case of shared regional or global databases) and companies with whom we may partner in connection with proposed or actual Boston Scientific projects, such as shared research initiatives;
  • our trusted third-party service providers that supply goods or services to Boston Scientific such as legal counsel, auditors and IT service suppliers;
  • our trusted third-party service providers who supply services on behalf of Boston Scientific (e.g. nurse support services);
  • other trusted third parties pursuant to a court order, to protect the interests of Boston Scientific, or where otherwise required by law or legal process; and
  • actual or prospective purchasers of Boston Scientific businesses in the event of a sale, merger or acquisition; and
  • the public in a limited way through websites such as www.clinicaltrials.gov and other websites and databases that serve a comparable purpose and enhancing clinical trial transparency.

Sharing your personal data as described above may involve transferring it to countries, including countries outside of the EU/EEA. Any transfers of Personal Data to Boston Scientific group affiliates outside the EEA will be done in compliance with the international data transfer restrictions that apply under EU data protection laws, including, where appropriate, through the use of EU model contracts for data transfers or the Privacy Shield.

Boston Scientific complies with the EU-US Privacy Shield Framework and Swiss-U.S. Privacy Shield Framework as set forth by the US Department of Commerce regarding the collection, use, and retention of personal information from the European Union member countries and Switzerland to the United States. Boston Scientific has certified to the Department of Commerce that it adheres to the Privacy Shield Principles of Notice, Choice, Accountability for Onward Transfer, Security, Data Integrity and Purpose Limitation, Access, and Recourse, Enforcement and Liability. A violation of our commitment to Privacy Shield may be investigated by the Federal Trade Commission and/or the United States Department of Commerce. If there is any conflict between the policies in this Privacy Notice and the Privacy Shield Principles, the Privacy Shield Principles shall govern. To learn more about the Privacy Shield program, and to view our certification page, please visit www.privacyshield.gov.

Securing and retaining your personal data

Boston Scientific will take appropriate technical and organizational security measures to protect your personal data consistent with applicable privacy and data security laws. When Boston Scientific retains a third-party service provider, that provider will be carefully selected and required to use appropriate measures in accordance with applicable law to protect the confidentiality and security of personal data. That provider will only be permitted to process your data in accordance with the instruction of Boston Scientific. Boston Scientific stores your personal data for each study in which you participate and for up to 15 years after the completion of your last participation in a Boston Scientific trial.

Your rights

You may contact Boston Scientific to request access to personal data that we process about you and that we correct inaccurate data and complete any incomplete data. In accordance with the conditions and requirements of applicable law, you may object to our processing of your personal data, restrict the processing of such data and request that we erase personal data about you. We may need to discuss the basis of your request as there may be circumstances where we are legally entitled to continue processing your personal data or refuse your request.

To exercise your rights, contact Boston Scientific’s Data Protection Officer by email at EuropePrivacy@bsci.com or via postal letter to Boston Scientific Iberica, S.A. with registered office at Ribera of the Loire Street, No. 38, Building 4, 28042, Madrid (attention: DPO). If Boston Scientific will not be able to provide the requested data or fulfil your request, you will be provided with reasons for such decision. In addition, you are entitled to lodge a complaint with your local data protection authority.

Changes to This Investigators’ Privacy Notice

This Privacy Notice is effective since May 25, 2018. We reserve the right to change this notice at any time (for example, to comply with changes in laws or regulations, our practices, procedures and organizational structures, requirements imposed or recommended by supervisory authorities or otherwise). Changes to this notice shall be applicable on the effective date of implementation. We will communicate any changes to you, where we are required to do so.

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