Author: Beatriz Neira

This notice provides you with information on how your personal data is used for the Maela patient engagement and remote monitoring solution, offered by a company called Medtronic (hereafter, the “Services”). The Services are available to patients whose physicians are proposing the Services to. It is meant to help patients engage in their care and, when needed by their physician, share information about their health status with their physician for remote monitoring by the hospital care team.

Your healthcare provider is required to obtain your explicit consent to process your personal data (including health data) for the provision of the Services.

If you have any questions or concerns about this notice or the Services, please ask your physician for more information.

Description of the Services

The Services are designed to support patients through their care pathway. Through a protocol validated by your care team, the Services are adapted to your specific intervention and pathway, and allow you to share relevant information with your care team.

The Services consist of the following elements:

• Patient registration: your healthcare provider will register you into the Maela solution, creating your account.
• Remote tasks and information sharing: depending on the settings configured by your physician and depending also on your choice, you may access your account on the solution via the internet browser of your computer, or via a mobile application on your smartphone (Maela Patient application for iOS or Android only). Additionally or alternatively, on your smartphone, you may receive SMS with secure links. When clicking on such a link, a secure temporary form opens on your smartphone browser, which you can fill and submit. Instructions might be provided to you by the hospital care team through these forms. On the web or mobile app, you may also access educational content, tasks, reminders, instructions, messages and other functionalities that can help you engage in your care and help you communicate with your care team. The information that you share is stored in a cloud-based information system.
• Hospital care team monitoring of your status: your Hospital care team will monitor the information that you provide via the Maela solution and contact you if necessary. Access will be possible only for authorised users who have a secure (password-protected) log-in.
• Technical support: the Services include all the technical support necessary to enable the proper functioning of the Maela solution, and all the work required to enable the continuous improvement of the Maela solution, including but not limited to the review of your satisfaction with the programme, the analysis of your experience with the platform based on your de-identified data and the ensuing modification of the Maela solution.
• [Add if relevant other services e.g. nurse support centre etc.]

Utilization of the Maela platform and Emergency Situations

The Services are intended to better support you through your care pathway. You should always contact your doctor in case of a medical emergency.

Your personal data

Personal data means all information relating to an identified or identifiable natural person, i.e. all information which can either directly or indirectly lead to knowing who you are. Your healthcare provider processes such personal data, including health data. Health data is classified as a ‘special category of personal data’ for which stricter rules apply.

By using the Services, the following categories of your Personal Data may be utilized:

• Full name;
• Hospital, Department name;
• Your email and phone number;
• Optional data (gender, date of birth, etc.) as determined by your physician;
• List of devices (smartphone, computer) used to access the Services;
• Medical data provided by you, or by your healthcare provider in accordance with your hospital’s digital care protocol (e.g. intervention type and underlying condition, postoperative symptom diary, etc.).

Use of the personal data

Your personal data are collected as part of the use of the Services for the following purposes:

• To make personal data available to your healthcare provider and other persons authorized by the hospital through the Maela solution;
• To enable the functioning of the Maela solution; this includes cookies if using the browser-based application;
• To evaluate and improve functioning of the Services. For more details, please refer to the Technical support in the section on the Description of the Services;
• To aggregate data to a level where you are no longer identifiable. This aggregated data may be used to improve the content of the solution, to create statistics, and obtain scientific analysis to identify health trends and patterns, through the general use of the Services;
• For any other purposes required to comply with applicable laws, court orders or regulations.

The processing of your Personal Data can only be done based on your explicit consent and for the purposes as mentioned above.

In order to provide the Services, your healthcare provider directs third-party service providers, listed in the paragraph below, to access your personal data in order to carry out the Services. Such third-parties will not use your personal data other than for the stated purposes within this form and under the instructions of your healthcare provider. The following describes in detail the way such third-parties will access and manage your personal data to carry out the Services.

Medtronic and Maela, for the purposes of

• Providing the Maela solution and technical support;
• Helping with the resolution of problems or incidents;
• Analysing the functioning and provisioning of the Maela solution and the provision of the Services in order to improve them;
• Providing the Maela application development and maintenance, data hosting support and data hosting maintenance.

All third-party service providers are established within the European Economic Area (EEA) and provide an adequate level of protection of your Personal Data. No Personal Data is transferred outside the EEA. We ensure that all third-party service providers adhere to high privacy and security standards and requirements.

Data security

Your personal data will be processed in a manner that ensures appropriate security, including protection against unauthorised or unlawful processing and against accidental loss, destruction or damage, using appropriate technical or organisational measures.

The Maela solution utilizes encryption to secure your data when it is in transit and when stored at rest to prevent unauthorized access.

You remain responsible for securing the access to your phone.

Data transfer

Beyond the usage of the data by your hospital, for the provision of the Services, your personal data will remain in Switzerland or in the European Economic Area (EEA), which are by the European Commission as providing an adequate level of data protection. Additionally, such entities have committed to adhere to standard contractual model clauses offering sufficient safeguards on data protection for exchange of personal data within Medtronic entities as provided by the European Commission.

Retention of your data

We do not store personal data longer than is necessary for the purposes mentioned above, unless otherwise legally required. Your personal data is stored and maintained in two (2) places:

• The Maela solution, for the purpose of delivering the Services and allowing the hospital to have access to a copy of the data for their archiving obligation and research purposes should you have consented to such purposes. Personal health data stored in the Maela solution will be maintained until the hospital no longer uses the Services. After that, your data will be deleted from the Maela solution. Please note your healthcare provider may download an export of your data, in alignment with the purposes listed in this privacy notice or other purposes you may have consented to separately.
• The Maela analytics database: your de-identified personal data from the Services may be used in the Maela analytics database and retained on behalf of the hospital to provide it the possibility to analyse its care activity in relation to your care and progress stemming from activity involved via the Services. Medtronic cannot in any way (re-)identify you and shall use the de-identified Personal Data solely for the purposes set out in this notice.

Please note that your Personal Data, through the Services, is made available to your healthcare provider who may need to keep this data due to healthcare legal data retention requirements even after the service is stopped.

Cookie usage

A cookie is a numeric code that a website transfers to PC or mobile device for easier recordkeeping purposes. When a user connects for the first time to the Maela web application from a given browser on a given hardware device (or after the user password has expired, or after all cookies have been deleted by the user for that given browser in that given device or after the user deleted that cookie via the Maela menu “My verified devices”), the user goes through a two factor authentication process, where an SMS code is sent to the user’s phone via SMS. During that connection, a token is created and is stored for a month. That token can be deleted in the menu “My verified devices”. It can also be deleted from your browser tools directly along with all other cookies from your browsing history.

Your rights

You may be entitled to request to access, rectify, erase, and restrict your personal data, and/or obtain more information about the processing of your personal data and the applicable safeguards. You can contact your healthcare provider to withdraw your consent. You may also revoke your consent through the mobile application or the web application if you have been provided access to it by your physician. Please be aware that the withdrawal of your consent shall not affect the lawfulness of processing of your personal data based on the consent before your withdrawal. You have the right to lodge a complaint with the competent supervisory authority.

You can exercise your rights by sending a signed letter or an email to the hospital Data Privacy Officer at this address [insert address]. We will assist you in any privacy requests or concerns that you may have.

 

This is the privacy notice version 1.0, dated July the 27^th, 2020.

PLEASE READ THESE TERMS OF USE CAREFULLY.

These Terms of use describe the rules applicable to users of the Maela website, mobile application and associated services (thereafter “the Solution”). They apply only to the Solution. If you move on to other applications or websites, please familiarise yourself with their respective terms of use.

The Solution is owned and operated by the supplier MEDTRONIC and its third-parties, in particular the Maela company who developed and owns the Solution. MEDTRONIC is the name we use to refer to our whole business, including Medtronic plc and any of the companies that it controls, including subsidiaries and affiliates, such as Covidien and Medtronic Inc. Below, when we use the words “we” or “our”, we mean MEDTRONIC and its third-parties owning and operating the Solution. When we use the words “you” or “your”, we mean you as a user of the solution.

A User means any natural person who accesses and uses the Solution. Each User has a User Account, which is a virtual personal area belonging exclusively to the user registered in the Solution. This secure area is accessible only by the User who created it, by means of his username and the personal password he has chosen at the time of registration and allowing him to access the Solution.

These Terms of Use were updated on July 27^th, 2020. We reserve the right to modify them at any time and it is your responsibility to check whether any changes have been made. By using the Solution, you accept the most recent version of the Terms of Use.

THE SOLUTION DOES NOT OFFER ANY MEDICAL ADVICE. IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY, CALL YOUR DOCTOR IMMEDIATELY.

We do not act as healthcare professionals and therefore do not provide medical diagnoses. The use of the Solution can in no way substitute for a medical examination. MEDTRONIC therefore invites users to consult a doctor regularly, especially if they are unsure of their state of health.

ABOUT THE SOLUTION

The Solution allows you and the healthcare practitioners of a healthcare institution having contracted for the Solution to be in permanent contact before and / or after an intervention, a hospital visit and / or a hospitalisation.

In order to benefit from these services, you have been provided with identifiers and you have already given your express consent to the healthcare institution so that your personal data can be accessible via the Solution for the healthcare practitioners. You also have declared having been informed about the Terms of use of the Solution for the purposes of remote monitoring of your health status.

Consequently, after having downloaded a mobile application published by the Maela company, or by connecting directly to the Solution accessible via [insert url for your country], you want to benefit from the various services offered and to exchange data.

The Solution allows the exchange of educational content and Data but in no way relieves the healthcare professional of his obligations and in particular those of informing you, of filling in your medical record, and of ensuring that you are in a position to leave the healthcare institution.

You accept that in using the Solution, we do not cover any cost linked to accessing or using the Solution. In particular, the costs related to your access to the internet necessary for the use of the Solution are yours to bear.

ABOUT THE INFORMATION ON THIS PLATFORM

The information available in the Solution relates to your condition and treatment, proposed actions with checklists and reminders, and certain collected pieces of data, some of which you record directly. Information you read on the Solution is provided for information purposes and cannot replace the relationship that you have with your healthcare team. You should always talk to them for diagnosis and treatment.

The Solution is not designed to support clinical values measurement. You understand that we cannot be held responsible for the information and /or data that you are reporting by using the Solution. In particular, you are responsible for the exactitude of the information and/or data you are reporting, and we cannot be held responsible if you share erroneous information and/or data in the Solution.

AVAILABILITY, TECHNICAL REQUIRMENTS AND TECHNICAL SUPPORT

[Update if required] Accessing the Solution can be done 24 hours a day, 7 days a week. We cannot warrant that the Solution shall be available without interruption. Interruptions shall not give rise to any claim from the User.

We do not guarantee the compatibility of the Solution to all computer equipment, smartphone, software configuration and operating system. For the web application, we recommend the use of the two most recent major versions of the browsers incorporated with Windows, the MacOS, and iOS, as well as the Chrome and Firefox browsers. For the native application, we recommend the use of the two most recent major versions of iOS and Android.

The User is aware of the nature of the internet, including its technical performance and response times for consulting, querying or transferring information. It is your responsibility to take all appropriate measures to protect your data and software from contamination by possible viruses circulating on the internet and from the other software and hardware systems you use.

The Solution includes a technical support service. We cannot be held responsible in the event of the service being unavailable. We do not cover any costs linked to the consultation of technical support service. These costs are set by your telecommunications operator.

THIS IS A TECHNICAL SUPPORT SERVICE ONLY AND DOES NOT PROVIDE ANY MEDICAL ADVICE. UNDER NO CIRCUMSTANCES CAN IT BE USED AS AN EMERGENCY SERVICE.

Health information changes quickly. Therefore, it is always best to confirm information with your healthcare team.

COPYRIGHTS AND TRADEMARKS

The materials available on this Solution belong to or are licensed to us or your healthcare institution. The materials are protected by copyright laws. The materials available on this platform remain our property or that of their authors. All rights that are not expressly granted are reserved.

There are some rules about copying these materials. You may e-mail, download or print copies of the materials on this solution, but only for your own personal, non-commercial use. When you e-mail, download or print a copy of the materials on this solution, you must also include all copyright and other notices that are in the materials, including on the bottom of the page.

There may be special rules for the use of materials provided on certain parts of this Solution. These special rules will be posted near the materials.

If you use the materials or trademarks on this solution in a way that is not clearly allowed by these Terms of use, you are violating your agreement with us and may be violating copyright, trademark and other laws. In that case, we automatically revoke your permission to use this Solution.

ACCEPTABLE USE OF THE SOLUTION

MEDTRONIC grants you, the non-exclusive and non-transferable right to use the Solution, provided that you are prohibited – directly or indirectly – from copying, modifying, creating a derivative work, inverting the design or assembly or otherwise attempt to obtain the source code (except as provided by law), sell, assign, sublicense or otherwise transfer any right in the Solution.

You must behave in a legal and honest manner at all times when you access the Solution. You agree not to use the Solution for fraudulent or criminal purposes or as part of any other illicit activities.

You agree not to attempt to publish on the Solution, nor to use our contact addresses to publish, any material that is defamatory, obscene, in violation of copyrights, vulgar or offensive or inciting harassment, threats, violence or hatred, or that is otherwise degrading or intimidating towards any individual or group of individuals in any way on the basis of religion, gender, sexual orientation, race, ethnic origin, age or disability.

Under no circumstances will you carry out any advertising or promotion of your products or services or of those of third parties. You shall under no circumstances attempt to send spam e-mails by using the Solution.

You shall under no circumstances attempt to introduce any viruses, Trojan horses or similar into the Solution.

LINKS TO THE SOLUTION AND USE OF OUR TRADEMARKS

You are hereby granted a non-exclusive, limited, and revocable license to link to the Solution. We reserve the right to revoke this license generally, or your right to use specific links, at any time. If we revoke this license, you agree to remove and disable any and all of your links to the Solution immediately.

You agree not to present any link to the Solution in such a way that it is associated with advertising or appears to be an endorsement of any organisation, product or service. You agree not to place any link to our solution on a platform that a reasonable person may consider obscene, defamatory, harassing, grossly offensive, or malicious. You must never place our solution or materials in a cache, or copy all or part of our solution to another website. You agree not to display or use the trademark in any manner without our prior written permission.

LINKS TO OTHER WEBSITES

This platform may contain links to applications and/or websites not operated by MEDTRONIC or its third-parties. We provide those links for your information, but we do not control the materials they contain nor are we responsible for them. We are not responsible for the performance of such applications and/or websites or for your business dealings with them. Your use of these applications and/or websites is subject to their terms of use, including with regard to privacy.

YOUR FEEDBACK, COMMENTS AND IDEAS

While we are pleased to receive your feedback, comments and ideas, we want you to understand that any information that you submit through the Solution will be considered non-personal, non-confidential, and non-proprietary (other than personal information as defined in the privacy notice). If you transmit any ideas, information, concepts, know-how or techniques or materials to us through the Solution, you hereby grant us an unrestricted, royalty-free, irrevocable licence to use, reproduce, display, perform, modify, transmit and distribute them in any medium, and agree that we are free to use them for any purpose.

NO WARRANTIES

All materials on the Solution are provided to you on an “as is” and “as available” basis. The information contained in these pages may be updated from time to time and may sometimes be out of date. We make no warranty as to the accuracy, completeness or reliability of any materials available through the Solution nor do we warrant that they are up to date. We hereby disclaim all warranties of any kind, either express or implied, statutory or otherwise including but not limited to the implied warranties of merchantability, fitness for a particular purpose and non-infringement. You agree to use the Solution at your own risk.

MEDTRONIC makes no representations or warranties that use of the Solution will be uninterrupted, secure or error-free. From time to time, we must undertake maintenance work. Although we try to avoid any service interruptions as far as possible, we cannot guarantee the continual availability of the Solution. We will not accept any liability in the event that the Solution cannot be accessed (whether due to a hardware failure, unavailability of communication services, incorrect configuration or for any other reason whatsoever). You are responsible for taking all precautions necessary to ensure that any materials you may obtain from the Solution are free of viruses and any other potentially destructive computer code.

LIMITATION OF LIABILITY

You recognise that we are not liable for any loss or damage resulting from your use of or inability to use the Solution. This exclusion of liability covers claims based on the rules governing warranties, contracts, strict liability and any other legal rules. It covers MEDTRONIC, its officers, directors, employees, agents and suppliers as mentioned in the Solution. This protection covers all loss or damage including, without limitation, direct or indirect, special, incidental or consequential loss or damage, personal injury/wrongful death, lost profits, or damage or loss resulting from lost data or business interruption.

The total liability of MEDTRONIC, its officers, directors, employees, agents and suppliers, if any, for loss or damage shall be limited to the amount of your actual loss or damage. In no event shall MEDTRONIC, its officers, directors, employees, agents, or suppliers be liable to you for any loss or damage other than the amount described above. All other loss or damage, whether direct or indirect, special, incidental or consequential, resulting from any use of the Solution or its materials are excluded even if MEDTRONIC has been advised of the possibility of such loss or damage.

PROTECTION OF PERSONAL DATA

In accordance with the European Regulation n ° 2016/679 of April 27, 2016 relative of data privacy, the Users are informed that MEDTRONIC performs an automated processing of their personal data for the purpose of using the Solution.

Each User has the rights of access, communication and correction of data concerning him, as well as a right of opposition. For this purpose, it is advisable to contact your healthcare provider. It is reminded that with regard to the rectifications and updates of the data relating to their Account, Users proceed directly to the necessary modifications and deletions on the latter.

For more details on how we protect and use the information we collect through our Solution, Users are encouraged to review the privacy notice.

OTHER RULES CONCERNING OUR SOLUTION

In addition to the rules in these Terms of use and the privacy notice, you may be subject to additional terms that may apply when you access particular services or materials on certain areas of our solution, such as when you purchase enhanced services, or by following a link from our solution.

Your obligations under the paragraphs “Other rules concerning the Solution”, “Your observations, comments and ideas”, “No warranties” and “Limitation of liability” will remain in force after the termination of these Terms of use.

If any provision of these Terms of use is found to be invalid by any court having competent jurisdiction, the invalidity of such provision shall not affect the validity of the remaining provisions of these Terms of use, which shall remain in full force and effect. No waiver of any of these Terms of use shall be deemed a further or continuing waiver of such term or condition or any other term or condition.

If you violate these Terms of use or the privacy notice in a way that causes harm to others, you agree to hold MEDTRONIC harmless against any liability for that harm.

[Modify if necessary] By using the Solution, you agree that the only proper jurisdiction and venue for any dispute with MEDTRONIC, or in any way relating to your use of this solution, is the Court of the city your healthcare institution who contracted for the Solution depends on. You further agree and consent to the exercise of jurisdiction in these courts in connection with any dispute involving MEDTRONIC.

These Terms of use are governed by the law of the country where the healthcare institution (that contracted for this Solution) of the User is located.

QUESTIONS, COMMENTS, AND NOTICES

You may contact us through our contact e-mail address dl.getreadysolution-privacyandsecurity@medtronic.com.

We may also contact you by e-mail, telephone or post.

This Terms of Use version 1.1 is published on the 27th of July 2020. We work continuously to complete and improve it.