myHealthSync App
Privacy Notice and Consent

Version Date: February 2023
 

In the following, please find a summary of the main information on the processing of personal information as part of the HealthSync Applications ("App") for which you currently are registering.

Our comprehensive HEALTHSYNCAPPLICATIONS PRIVACY NOTICE which provides further detailed information is available below.

Controller and how to contact us:

The controller of the processing of your personal data is Abbott Laboratories, 100 Abbott Park Road, Abbott Park, IL 60064 (USA), through its local affiliates listed below (referred to herein as “Abbott”, “we”, “us” or “our”). If you wish to exercise your data subject rights or if you have any other questions concerning our privacy practices, please contact us by clicking on the “Contact Us” link in one of our websites or emailing us at privacy@abbott.com.
 

Processing of personal data:

As part of the Study, Abbott will process the personal data collected through devices provided to the participant, specifically an Apple Watch®, OMRON Weight Scale, OMRON Blood Pressure Monitor, and mobile device (iPhone) with Abbott HealthSync App and Apple HealthKit App.

The HealthSync App accesses data available through Apple HealthKit and transmits the data to an Abbott Cardiac Rhythm Management Azure server for purposes of the Study. The weight and blood pressure data obtained from OMRON devices will be available and collected through the Apple HealthKit app.

Additional details as to the data collected can be found in the full notice at the link below under +Collection of Personal Information
 

Processing purposes and legal basis for personal data:

We process personal data (i) to provide the study participant with our App and the related services, (ii) to conduct product development and scientific research, and (iii) to comply with Abbott’s regulatory obligations, in particular under applicable legal requirements. The processing for the purposes (i) is based on performance of contract and on your consent, (ii) to (iii) is based on your consent, whereas the processing of purpose (iv) takes place for compliance with legal obligations or - as the case may be - our prevailing legitimate interest.
 

App Data transfers and recipients and legal justification for such transfers:

We transfer your personal data (where possible in de-identified, pseudonymized, aggregated, and/or anonymized form information) to dedicated Abbott database location.
 

Retention periods for and deletion of your Personal Data:

Your personal data will be subject to deletion after five (5) years after the study is concluded or later if required by applicable law.
 

Your statutory rights:

You have a number of rights with regard to the processing of your personal data, each as per the conditions defined in applicable law, such as the right to get access to your data, to get the data corrected, erased or provided to you.

For more information and access to the full privacy notice, please see below. The privacy notice will also be available at: https://www.cardiovascular.abbott/int/en/policies/myhealthsync.html.

HealthSyncApplications Privacy Notice
Version Date: August 2022
 

This privacy notice ("Privacy Notice") applies to the HealthSync Application ("App").

Abbott Laboratories, 100 Abbott Park Road, Abbott Park, IL 60064 (USA), through its local affiliates listed below (referred to herein as “Abbott”, “we”, “us” or “our”) is committed to protecting the privacy of our customers and users of Abbott’s applications and products. This Privacy Notice describes how we protect, gather, and use information from the App.

Please read this Privacy Notice carefully before registering to use the App as it applies to the processing, transfer and storage of your personal information, including health-related data by Abbott and certain affiliated companies as described below. It also applies to the processing of your personal information by our affiliated companies and by our processors if required to resolve a service issue related to the App.

This Privacy Notice provides you with detailed information on Abbott's processing activities relating to the App.  Section 1 (General Information) provides information on the processing activities and the rights you have. This information is supplemented by additional information according to the country or region where you reside which is set out in section 2 (Country/Region Specific Information) - please refer to the respective information of your country or region (if applicable) which prevails in case of a conflict with any other information contained in this Privacy Notice.
 

1. General Information

+ About Us

Abbott (as defined above) is the manufacturer of the HealthSync Application (the App) and the controller for the processing of your personal information in the App.
 

+ What HealthSync App?

The HealthSync App accesses data available through Apple HealthKit and transmits the data to an Abbott-controlled server for purposes of the Study.  The weight and blood pressure data obtained from OMRON devices also will be available and collected through the Apple HealthKit App.
 

+ Collection of Personal Information

Personal Information is information that relates to the person using the App.

The following Personal Information are collected and transmitted by the App via the device ID:

  • Height  - entered manually by the user
  • Weight – collected through the OMRON device
  • Blood Pressure - collected through the OMRON device
  • Blood Oxygen (Daily average)
  • Body Mass Index (Latest entry)
  • Body Fat Percentage (Latest entry)
  • Respiratory Rate (Daily average)
  • Active Energy (Daily cumulative sum)
  • Steps (Daily cumulative sum)
  • Sleep (Daily cumulative sum)
  • Sleep Analysis (collected via the mobile device and Apple Watch) (Duration of each sleep stages with timestamps)
  • Walking + Running Distance (Daily cumulative sum)
  • Double Support Time (Daily average)
  • Exercise Minutes (Daily cumulative sum)
  • Heart Rate
  • Resting Heart Rate (Daily average)
  • Heart Rate Variability (Daily average)
  • Flights Climbed (Daily cumulative sum)
  • Resting Energy (Daily cumulative sum)
  • Stand Minutes (Daily cumulative sum)
  • Electrocardiograms (ECG) (Latest entry or N numbers of entries)
  • Wrist temperature

Unless otherwise indicated, the data types listed above are made available and are collected through the Apple HealthKit App.  Information relating to the Apple HealthKit data types can be found at https://developer.apple.com/documentation/healthkit/data_types

Geolocation information for the device may be accessed only for technical support purposes if needed by the sponsor to locate the mobile device given to you as a part of the study.
 

+ Use of Personal Information (Processing Purposes)

Personal Information is processed by Abbott:

  • For purposes of the Study
  • To comply with legal and regulatory requirements as set out further in the section +Other Legal Requirements;
  • To conduct research for limited purposes relating to the implanted medical devices on the basis of de-identified or pseudonymized, aggregated, and/or anonymized data as set out further in the section +Research.
     
+ Other Legal Requirements

Abbott may use personal information where legally required and where possible we will de-identify, pseudonymize, aggregate and/or anonymize information to comply with our legal obligations as a medical device manufacturer. This information is securely held by Abbott and will not be used to identify you individually by your name or email address, except where we are under a legal obligation to include this information.

The legal requirements for which Abbott will use this information are (in any case only to the extent required by applicable law):

  • to ensure the ongoing safety of a device and any future development;
  • to monitor and improve the quality, security and effectiveness of medical devices and systems;
  • to validate upgrades, and to keep related mobile applications safe and secure;
  • to perform broader analysis to detect systemic issues for public interest in the area of public health.
  • to research, develop and test medical devices, including new and existing features and functionality and to test and improve the devices and/or related mobile applications for product development; and
  • where otherwise required by law, including to respond to any competent regulatory, law enforcement body, governmental authorities, to address national security or epidemics, judicial proceeding, court order, government request or legal process served on us, or to protect the safety, rights, or property of our customers, the public, Abbott or others, and to exercise, establish or defend Abbott’s legal rights or where we believe it is necessary to investigate, prevent, or take action regarding illegal activities, suspected fraud, situations involving potential threats to the safety of any person, violations of this Privacy Notice, or as evidence in litigation in which we are involved.

We use the terms ‘de-identify’ and ‘pseudonymize’ interchangeably (i.e., data that can no longer be attributed to a specific individual person without the use of additional information with such additional information being kept separately and subject to technical and organizational measures to ensure that the data are not attributed to an identified or identifiable natural person). Anonymized data is information that does not relate to a person and from which a person cannot be identified.
 

+ Research

Where we use data for research purposes such will not include your name, address, phone number, or email address. We take steps to ensure that there is no reasonable basis from which the de- identified or pseudonymized data can be used to identify you individually. Data used for research may include device model number, intervals between implant date and subsequent visit dates, implant date, and demographics such as age.

We conduct research using this de-identified or pseudonymized data, or aggregated, statistical and/or anonymized data for the following purposes:

  • to improve the quality, security and effectiveness of our devices and systems and to allow for the development of innovative and effective treatment of neuro-related conditions in the interests of public health.
  • to conduct research, for statistical purposes and analysis and to disclose to third party researchers, health care entities or professionals, or public health authorities.
  • to evaluate the effectiveness of the devices and how they are provided and used.
  • to validate the App’ functionality and upgrades, including monitoring and improving the safety and security of such devices and App.
  • to research, develop and test devices, including new and existing features and functionality and to test and improve the App and devices for product development, data analysis, statistical and survey purposes.
  • for public interest in the area of public health, including where the App and devices are eligible for medical reimbursement or are otherwise entitled to social security, insurance or public funding.

If you are asked to participate in a clinical trial, and where required by applicable law, you will be asked to provide a separate informed consent to the research site prior to any such trial and your participation is voluntary. The research in this section does not relate to participation in a clinical trial.
 

+ Data Storage

Data input into the App is transmitted to hosted servers, which are located in the United States. We have implemented appropriate security measures and controls to protect personal information stored in the server location.
 

+ Retention of Personal Information

Personal information collected through the App will be retained in accordance with Abbott’s retention and destruction policies, except as may be required by law. Personal data will be subject to deletion five years after conclusion of the Study. De-identified data relating to the study will be retained.

The section + Deleting Your Information from the App explains how you can arrange to have your personal information deleted from the App.
 

+ Security of Personal Information

Abbott has implemented appropriate security controls within the App to protect personal information from accidental or unlawful destruction or accidental loss, alteration, disclosure, or access.

Personal information collected electronically by the App is encrypted during transmission to ensure that it will remain secure and confidential. We have implemented various security measures to enhance the security of your profile and to prevent unauthorized access to, or disclosure of, personal information. Only Abbott will have access to the data stored in Azure server.

Please be aware that the App may be unavailable during periods of routine maintenance.
 

+ Links to Other Web Sites

Abbott operates multiple Web sites and Web portals for different purposes in countries where laws that differ from those in Australia may apply. This Privacy Notice applies only to the use of the App in Australia.
 

+ How Individual Users Can Access and Correct Personal Information, and Your Rights

Depending on your place of residence, you may have the right to: (a) access the personal information we hold about you; (b) request we correct any inaccurate personal information we hold about you; (c) delete any personal information we hold about you; (d) restrict the processing of personal information we hold about you; (e) object to the processing of personal information we hold about you; and/or (f) receive any personal information you have provided to us in a structured and commonly used machine-readable format or have such personal information transmitted to another party. Please note that Abbott is not required by law to adopt or maintain systems that are technically compatible with other parties’ systems. It may not be possible for Abbott to directly transmit your personal information to another party or system.

To request the exercise of these rights, please contact us using any of the methods set out in the section entitled +Contact Us.
 

+ Deleting Your Personal Information

Study Participants may request from their Clinicians that their personal information be removed. Participants may choose to delete collected data, at any time.

If you would like to delete your personal information, you may do so by contacting Abbott or the study investigator. Please be aware that if you delete your data, we will retain aggregated and de-identified information and may need to retain certain personal information as permitted or required by law.
 

+ Contact Us

If you have questions, concerns or complaints about personal information in the App, or wish to exercise your data protection rights, please contact us by clicking on the “Contact Us” link in one of our websites or emailing us at privacy@abbott.com. Alternatively, you may write to us at:

Abbott Medical Devices
Global Clinical Affairs
15900 Valley View Ct
Sylmar, CA 91342
merlinconsent@abbott.com
 

+ Changes to this Privacy Notice

This Privacy Notice is kept under regular review. If we make changes to our privacy practices, an updated version of this Privacy Notice will reflect those changes. You will be alerted to updates to this Privacy Notice via the study.

Without prejudice to your rights under applicable law, we reserve the right to update and amend this Privacy Notice without prior notice to reflect technological advancements, legal and regulatory changes and good business practices to the extent that it does not change the privacy practices as set out in this Privacy Notice.
 

2. Country-/Region-specific Information

+ Australia

Legal basis for the processing of your personal information: Abbott's collection and processing of your Personal Information is done on the basis of your consent or as otherwise permitted under the Australian Privacy Act 1988 (Cth) (Privacy Act).

Consequences if information not provided: If you do not provide us with any of the information requested, we may not be able to provide you with the full set of services available through the App.

Data Subject Rights: You have all such data subject rights as granted under the Australian Privacy Act including rights to access and correct the Personal Information Abbott may hold about you as well as the right to withdraw your consent at any time with future effect. Such a withdrawal will not affect the lawfulness of the processing prior to the consent withdrawal.

Please note that if you withdraw your consent relating to the provision of the App and related maintenance, support and troubleshooting activities, we will be unable to further provide the App to you and consequently you will not be able to further use the App upon the withdrawal.

Overseas Disclosures of Your Personal Information: Your Personal Information may be disclosed to overseas recipients outside Australia including to Abbott in the USA as well as to third party service providers. Notwithstanding any provisions of this Notice, the disclosure of your Personal Information to overseas recipients is not intended to and will not remove our responsibility for any breach of the Australian Privacy Principles under the Australian Privacy Act.

Changes: To the extent any changes are made to this Notice materially affect the protection given to your Personal Information or your rights under this Notice, we will provide you with written notice and an option to withdraw your consent to us processing your information in accordance with this Notice.

Complaints: If you have any complaints about our handling of your Personal Information, you should contact us in accordance with this Notice and we will respond to you as soon as reasonably possible. You also have the right to lodge a complaint with the Office of the Australian Information Commissioner if you have any concerns about our handling of your personal information.

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