Effective Revision Date February 28, 2019
Change synopsis: For persons located in the EEA: The EU General Data Protection Regulation (“GDPR”) is in force from 25 May 2018. The GDPR amends and updates the rights you have in relation to your personal data, and what companies that process your personal data are permitted and required to do. It also requires that we provide you with the following information in addition to that which you have already received: This supplemental notice supersedes any information you have already received from us. See section on Updates on EU General Data Protection Regulations.
St. Jude Medical, LLC, an Abbott company, and its affiliates (together referred to in this policy as “St. Jude Medical”, “we” and/or “us”) are committed to protecting and respecting the privacy of individuals.
This policy sets out how and why we collect, use, and disclose personal information of individuals who interact with St. Jude Medical, as well as how we safeguard this information.
This policy also covers information that is collected, used, or disclosed through use of the www.abbott.com family of websites, which are available to visitors located throughout the world and operated for different purposes.
WHAT IS PERSONAL INFORMATION?
Personal information means information that identifies you or could reasonably be used to identify you. Examples of personal information include your name, address, email address, affiliated organization or company name, birth date, age, gender, telephone number, account numbers, profession or specialty, education, or other specific types of personal information. Some kinds of personal information are sensitive personal information. In this policy when we use the term personal information, we include sensitive personal information unless we specifically state otherwise.
Sensitive Personal Information
Sensitive personal information means personal information relating to your racial or ethnic origin, religious or philosophical beliefs, sex life, political affiliation, trade union membership, or information relating to your health such as your diagnosis, treatment or condition information, or medical device model and serial numbers.
How Do We Collect Personal Information?
We collect personal information in a variety of ways, including through personal contact, through our employees and their attendance at industry events via our websites and the internet, over the telephone, through other correspondence where necessary to identify patients, through third parties who have your authority to disclose such personal information to us or where we are required to do so by law. Examples of when personal information may be collected would include when you contact us for more information about our products or services; you fill out or submit a registration form for a St. Jude Medical event or educational session; or we conduct business with our customers, such as providing products and services to customers and their patients.
Generally, where we request personal information from you, we will explain the purpose of its collection and use and to whom it may be disclosed at the time we collect it. The personal information collected by us will be limited to the minimum amount necessary for the purposes identified to you. If you decide to withhold particular information, it may limit our ability to provide you with the services or products you requested.
If you believe that a third party has disclosed your personal information to us without your consent to do so, please contact that third party. If they do not adequately respond to your inquiries, please let us know.
How Do We Use And Disclose Personal Information?
We only use and disclose personal information for the purposes that we have disclosed to you in this policy or at the time of the collection of the personal information, except as otherwise permitted or required by law. If for any reason we would like to use or disclose your personal information for a materially different purpose, we will obtain your consent before we proceed.
We may collect, use, and disclose personal information to meet the needs of our customers and for the following business purposes:
- Recording and reporting on our products and related medical conditions, including reporting to regulatory and medical authorities and recording and responding to product inquiries, feedback, and complaints
- Registering and tracking certain St. Jude Medical implanted devices in compliance with applicable legal obligations and for quality and safety purposes
- Complying with our regulatory, legal, and ethical obligations (such as recording and reporting on adverse events and registering implantable devices)
- Understanding our customers and their needs
- Learning about our markets and improving our products and services
- Shipping product information or providing products and services to our customers
- Performing administrative functions such as accounting, billing, auditing, and collection activities
- Performing services and technical support for our products and services
- Ensuring and protecting health and safety
- Or analytical purposes to evaluate and improve our business (such as analyzing our products and services, researching, improving and developing new products and services, and performing market research)
- Contacting you (including by way of email), including:
- In response to your inquiries, questions, or comments
- To safeguard your interests
- Provide you with information about our products and services, or those of others, that we believe may be of interest to you
- To meet legal requirements
- In the case of health care professionals (HCPs):
- In connection with research and clinical trials that the HCP is involved with or that we believe the HCP may be interested in being involved with
- Provide education, training, evaluation, and/or demonstration of products
- To provide samples
- In connection with conferences, symposia, expert panels, or other events with which we are involved or with which we believe an HCP may wish to be involved
- Or complying with our corporate policies for expense reimbursement that require us to record the names and affiliations or attendees
- In the case of patients
- In connection with our patient programs, research and clinical trials
- In the case of our contractors, distributors, or commissioned agents: – n connection with our Business Purposes, including information to third party suppliers subject to obligations of confidentiality
- Protecting our rights and property against fraud, unauthorized claims or transactions, and other liabilities
- Disclosing information to external service providers that we engage to assist us in the conduct of our business (these service providers will only be permitted to use that information for assisting us)
- In other ways to which you are notified prior to collection or to which you have authorized
In the event we disclose personal information to our service providers, we require our service providers to agree to contractual requirements that are consistent with our privacy and security policies and to comply with applicable legal requirements. We prohibit our service providers from using personal information except for the specific purpose for which we supply it to them or in any way that violates laws and regulations applicable to the personal information in question. We remain responsible and liable under the Privacy Shield Principles if a third-party service provider uses or discloses personal information in a manner inconsistent with the Privacy Shield Principles, unless we prove that we are not responsible for the event giving rise to the damage.
St. Jude Medical and our affiliates may disclose personal information as required by law, regulation, warrant, subpoena, court order, or regulator or law enforcement agency or personnel, as well as in respect to a criminal investigation or to meet government tax reporting requirements. In some instances, such as a legal proceeding or court order, we may also be required to disclose certain information to government authorities. Only the information specifically requested is disclosed and we take precautions to verify that the authorities making the request have legitimate grounds to do so. We also may release certain personal information when we believe that such release is reasonably necessary to protect the rights, property, and safety of others and ourselves.
There are some situations in which we are legally permitted to disclose personal information, such as employing reasonable and legal methods to enforce our rights or to investigate suspicion of illegal activities.
Except as set forth herein, St. Jude Medical does not disclose, sell, and/or trade customer lists to third party companies or organizations.
Through the use of website cookies, we monitor which pages of our website visitors view and how often visitors view them. Through the use of these cookies, we are able to capture standard Web traffic information such as time, date, IP address, and browser, but in most circumstances the information captured cannot identify you as an individual.
The St. Jude Medical websites use session cookies and persistent cookies. Session cookies are temporary bits of information that are erased once you exit your web browser window or turn off your computer. Session cookies are used for purposes such as improving the navigation and usability of our websites, blocking visitors from providing inappropriate information, and collecting aggregated statistical information. Persistent cookies are more permanent bits of information that are placed on the hard drive of your computer or mobile device. Persistent cookies remain on your hard drive until you delete them. Persistent cookies are used for purposes such as retrieving your user preferences and saved login information, customizing the website based on your preferences, and helping us to determine what areas of the website visitors find most valuable. Persistent cookies may contain personal information, but only if you have given your consent to the use of such personal information.
St. Jude Medical may also use web beacons (also known as clear GIFs, invisible GIFs, and internet tags) in combination with cookies to help us understand how visitors use our website. A web beacon is a tiny graphic that is placed on the website, which is used to track which pages are viewed and what information is consulted. We use web beacons to measure traffic and related behavior, and to improve the content available on our websites. A web beacon is a tiny graphic that is placed on the website, which is used to track which pages are viewed and what information is consulted. We use web beacons to measure traffic and related behavior, and to improve the content available on our websites.
How Do We Comply With Information Protection Regulations?
As a global company, in all countries where we do business, St. Jude Medical is committed to complying with applicable laws and regulations when we collect, use, process, transfer, and store information. We value the personal information we are responsible for in our line of work and we protect this information by implementing privacy and security controls throughout our organization. We utilize an Information Security Framework based on ISO/IEC 27001, which integrates with our Privacy Framework based on ISO/IEC 29100. ISO standards are accepted internationally as risk-based auditable principles and allow you to have confidence that your information is being handled securely.
St. Jude Medical complies with all applicable laws and regulations for personal information we collect, use, process, transfer, and store. Additionally, St. Jude Medical complies with the requirements of the EU-U.S. Privacy Shield Framework, and the Swiss-U.S. Privacy Shield Framework. St. Jude Medical’s certification to the Privacy Shield Framework allows for the transfer of personal information from individuals in the EU and Switzerland to the U.S. St. Jude Medical 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. To learn more about the Privacy Shield Framework, and to view St. Jude Medical’s certification, please visit www. privacyshield.gov/. To learn more about how St. Jude Medical complies with the Privacy Shield Principles, please visit the https://www.abbott.com/policies.html
This site is not intended for use by children under the age of 18 and St. Jude Medical does not intentionally collect personal information from such children. If we discover that a child has provided us with personal information online through this website, we will take reasonable steps to delete this information. If you believe we may have received personal information from a child under the age of 18, please immediately contact us at email@example.com.
HOW CAN YOU OPT OUT OF MARKETING MAILINGS?
We may from time to time send you marketing material that we believe may be of interest to you. You have the right to ask us not to process your personal information for marketing purposes. We will inform you if we intend to use it for such purposes or if we intend to disclose your information to any third party for such purposes. If you no longer wish to receive information from us, please use the “opt-out” or “unsubscribe” link on the email to remove yourself from the mailing list. You may also elect not to receive such materials by:
- Checking certain boxes on the forms we use to collect your information
- Contacting us at the following address:
Chief Privacy Officer
St. Jude Medical, LLC
One St. Jude Medical Drive St. Paul, MN 55117 USA
- Please note that we may be required to send certain information to you under a legal, regulatory, or ethical requirement.
Where We Store Your Personal Information
It is important to note that some or all of your personal information provided to third party service providers may be held by them in countries other than your own, including the U.S. You acknowledge and understand that your personal information will be subject to the applicable laws of each such jurisdiction, which may not require the same level of protection as your country of residence. For example, government entities in the U.S., among other countries, may have certain legislative rights to access your personal information. If you would like access to written information about our policies and practices with respect to service providers outside your jurisdiction, you may email firstname.lastname@example.org. Our Chief Privacy Officer or representative will address your questions about the collection, use, disclosure, or storage of personal information by our service providers worldwide.
Security Of Your Personal Information
The security of your information is important to us and we take reasonable steps to secure and protect personal information, as outlined in this policy. Unfortunately, no internet transmission is 100% secure and there will always be risks when using or transmitting information over the internet. Please consider this risk when you visit our sites or send information to us via email or other electronic means.
We take reasonable steps and utilize no less than industry standard security safeguards, including maintaining physical, electronic, and procedural safeguards in compliance with industry standards and applicable laws to protect personal information from loss and unauthorized access, modification, disclosure, inappropriate alteration, or misuse.
Electronic customer files are kept in highly secure environments with restricted access. Paper-based files are stored in locking filing cabinets. Access to electronic and paper-based files is restricted to authorized employees who have a legitimate business purpose and reason for accessing personal information.
We manage our server environment appropriately and strictly adhere to our firewall infrastructure. We have our security practices reviewed on a regular basis and we routinely employ current technologies to ensure that the confidentiality and privacy of your information is not compromised.
For those areas of our website collecting sensitive information, our website uses Secure Socket Layer (SSL) and 128-bit encryption technologies to enhance security when you visit the secured areas of these websites. SSL is the industry standard tool for protecting and maintaining the security of message transmissions over the internet. When you access your accounts or send information from secured sites, encryption will scramble your data into an unreadable format to protect it from interception by others.
To safeguard against unauthorized access to your accounts, you are required to “sign-on” using a user ID and a password to certain secured areas of St. Jude Medical websites. Both user ID and password are encrypted when sent over the internet. If you are unable to provide the correct password, you will not be able to access these sections. You are required to keep your password and user ID secure and not provide that information to third parties. If you suspect that someone is using your user ID or password, please reset your password and immediately report the unauthorized access to our Chief Privacy Officer by sending an email to email@example.com. You have an active role in protecting your own information. Please safeguard your environment and use reasonable steps to ensure that others do not access your information through your computer. Remember to logout to keep your information secure. St. Jude Medical will not be liable for disclosures of your personal information due to errors in transmission or unauthorized acts of third parties.
When you call our customer service centers for patient and product questions, you will be required to verify your identity by providing personal information. We will only use this information in order to identify you.
Access And Accuracy
You may request access to personal information we hold about you by sending written request to firstname.lastname@example.org. We will process that request in line with applicable laws and our policies and procedures in place for dealing with such requests and will respond to you within a reasonable time frame.
There may be circumstances where we are unable to provide access to your personal information. We may deny or restrict access for legally permissible reasons, such as situations where the information contains references to other individuals and is not reasonably severable, or where the information cannot be disclosed for legal, security, or commercial proprietary reasons. We will advise you of any reason for denying or restricting an access request.
We shall make every reasonable effort to ensure your personal information is maintained in an accurate, complete, and up-to- date form. If you believe that we have inaccurate, incomplete, or out-of-date personal information about you, you may ask us at any time to correct or delete that information by sending a written request to email@example.com. When an individual successfully demonstrates the inaccuracy or incompleteness of personal information held by us, we will correct, update, or delete the information as required. Where appropriate, we will communicate these changes to other parties who may have received incorrect information from us.
Please note that before we are able to provide you with any information or correct any inaccuracies, we may ask you to verify your identity and to provide other details to help us to respond to your request. We will only use this information in order to verify your identity.
In the course of daily operations, access to personal information is restricted to authorized employees who have a legitimate business purpose and reason for accessing it. For example, when you contact us, our designated employees will access your information to verify who you are and to assist you in fulfilling your requests.
As a condition of their employment, all employees of St. Jude Medical are required to abide by the privacy standards we have established. Employees are trained about the importance of privacy including prohibiting the disclosure of any personal information to unauthorized individuals or parties.
Unauthorized access and/or disclosure of personal information by an employee of St. Jude Medical is strictly prohibited. All employees are expected to maintain the confidentiality of personal information at all times and failure to do so will result in appropriate disciplinary measures being taken, which may include dismissal.
Subject to applicable business, legal, or regulatory requirements, we securely destroy, erase, or de-identify personal information when it is no longer required to fulfill our services and commitments to you or to enforce our rights or meet our obligations.
Links to third-party sites are provided for information only and do not constitute endorsements of those sites. St. Jude Medical is not responsible for the content of links or third-party sites and does not make any representation regarding their content or accuracy. Your use of third-party websites is at your own risk.
Additionally, we are not responsible for the privacy practices employed by third party websites. Therefore, we suggest that you examine the privacy policies of those websites to learn how your information may be collected, used, shared, and disclosed by the third party in question.
Updates To This Policy
This policy will be published on all of our corporate websites worldwide. St. Jude Medical may amend this policy from time to time. The revisions will take effect on the date of publication of the amended policy, as stated.
Through a notice on our website, we will notify you of any material changes to this policy and draw your attention to the changes made. In the event that the changes we make to the policy are substantial and/or affect the personal information we have already collected in accordance with this policy, you will be entitled to withdraw your consent to such personal information handling practices. Withdrawal of your consent may impact our ability to provide you the services or products you have requested. You may notify us of your desire to withdraw consent by contacting our Chief Privacy Officer at firstname.lastname@example.org.
Complaint About An Interference With Privacy And Contact Information
Chief Privacy Officer
St. Jude Medical, LLC
One St. Jude Medical Drive St. Paul, MN 55117 USA
In compliance with the Privacy Shield Principles, St. Jude Medical commits to resolve complaints about our collection or use of personal information. Individuals in the European Union or Switzerland with inquiries or complaints regarding our Privacy Shield compliance should first contact St. Jude Medical, Inc. by sending the inquiry or complaint to:
Chief Privacy Officer
St. Jude Medical, LLC
One St. Jude Medical Drive St. Paul, MN 55117 USA
We will respond within 45 days of receiving any complaints. Any complaints or concerns that cannot be resolved internally will be referred to JAMS Privacy Shield Program, an alternative dispute resolution provider located in the U.S. in which arbitration is binding. If you do not receive timely acknowledgment of your complaint from us, or if we have not addressed your complaint to your satisfaction, please contact or visit http://www.jamsadr.com/eu-us-privacy-shield for more information or to file a complaint. The services of JAMS Privacy Shield Program are provided at no cost to you.
SJM complies with the Privacy Shield Principles and is subject to the investigatory and enforcement powers of the FTC.
Please address all requests or questions about how we deal with your personal information or this policy to our Chief Privacy Officer at email@example.com.
Updated EU General Data Protection Regulation
For persons located in the EEA: The EU General Data Protection Regulation (“GDPR”) is in force from 25 May 2018. The GDPR amends and updates the rights you have in relation to your personal data, and what companies that process your personal data are permitted and required to do. It also requires that we provide you with the following information in addition to that which you have already received: This supplemental notice supersedes any information you have already received from us.
The GDPR introduces new and extended rights in relation to your personal data beyond those already highlighted to you. These are:
- The right to rectify or erase any wrong or incomplete personal data that Abbott holds about you.
- The right to access the personal data that Abbott holds about you.
- The right, in some cases, to object to the processing of your personal data on legitimate grounds.
- The right not to be subjected to automated decision making intended to evaluate certain personal aspects relating to you, such as analytics based on conduct. Please refer to the cookies section of the privacy notice for more information on how to exercise this right if it is indicated that cookies are being used.
- Where you have provided your personal data to us with your consent or as part of a contract, the right to the portability of that personal data to another person or, if it’s technically feasible for us to do so, to another company.
- The right to lodge a complaint with your national data protection supervisory authority or to receive compensation for any damage you suffer.
- The right to withdraw your consent to Abbott’s processing of your personal data without detriment, where you have provided consent for Abbott to process your personal data.
Further Information You Need To Know
International transfers — We transfer your personal data outside of the European Economic Area (“EEA”) to third countries which do not offer the same level of protection as required by the EEA. In order to safeguard your personal data, we will only make such transfers on the basis of (i) a decision of the European Commission that permits this, or (ii) subject to EU- approved Standard Contractual Clauses. Please note, Abbott has entered into data transfer agreements based on the EU Standard Contractual Clauses to transfer your personal data from the EEA to third countries, which includes the United States. To access or receive a copy of the EU Standard Contractual Clauses which we use to export your personal data from the EEA, please contact our EU DPO (details below).
Storage — Your personal data will be stored for as long as it is needed to provide you with (i) the Abbott service or product that you have requested; and/or (ii) access to our websites and services. Alternatively, your personal data will also be stored for as long as we require it to respond to your queries and concerns or in accordance with any legal requirements, including those in relation to product or medical device safety. For further information please contact your local customer care or the EU-DPO office using the details below.
Why we need your data — The provision of personal data to Abbott is required to fulfil the terms of a contract you have with Abbott, to provide you with a product or service you have requested, to comply with local laws, such as those relating to product or medical device safety. Any failure to provide such personal data will mean that Abbott cannot provide you with the product or service you have requested.
Customer care, queries and issues — Please follow Abbott’s normal recommended channels.
Data Protection Officer — If you have any queries in relation to the processing of your personal data please contact our EU DPO at http://www.eu-dpo.abbott.com/.