Terms of Use

BreatheSmart Terms of Use for Patients

Last modified: November 2025

1. Introduction

Aptar Digital Health, LLC and its affiliates Voluntis SAS (“ADH,” “we” or “us”) own or control a mobile application (the “App” or “BreatheSmart”) that provide healthcare professional and their patients with access to and use of BreatheSmart, which can be used through tablets, smartphones, connected televisions, and other devices. The App operates in conjunction with paired Bluetooth-enabled HeroTracker® Sense medicine inhaler sensors (the “Devices”), as well as the BreatheSmart Connect web portal (‘the Portal’). The App, the Devices and the Portal are collectively referred to as the “Platform” or “Services”. Services are designed for patients with Chronic Respiratory disease and their healthcare team professional (“Professional”) as a medication reminder and as a technique of monitoring device. Services are intended for users in the United States.

These Terms of Use (“Terms”) govern your use of the Services. Please read these Terms in full before accessing or using the Platform because they constitute a legal agreement between you and ADH.

By clicking "I AGREE", you agree to and accept:

PLEASE READ THIS TERMS OF USE AGREEMENT CAREFULLY. THIS AGREEMENT IS A LEGAL CONTRACT BETWEEN YOU AND ADH.

DO NOT SEND URGENT OR EMERGENCY MESSAGES USING OUR SITE OR APPLICATION. IN CASE OF AN EMERGENCY, YOU SHOULD CALL A PROFESSIONAL.

2. About these Terms

We Respect Your Privacy. Information that you provide to us or that we collect about you is governed by our Privacy Policy. Please review our Privacy Policy carefully before registering your account, using BreatheSmart, or otherwise providing us with your information. By accessing this link, you can learn more about the types of personal information we collect, how we use it, whether collection and processing is optional, sources of the personal information we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for ADH’s data protection officer.

ADH and its Suppliers receive and process personal information about you such as your first and last name, date of birth, mobile number, email address, and account ID to register you for BreatheSmart.

ADH also processes your sensitive personal information, your health information, including medication usage (called “Patient Data”). ADH and Professional will receive and have access to this health information. Any vendors ADH hires to process your personal information will be contractually-bound to protect it. The technology behind BreatheSmart will use machine learning to continuously learn how to improve the way it helps you track your condition. Unless you request we delete your registration information sooner, ADH will retain your registration information for kept two (2) years following the end of the study, or as necessary to fulfill legal or regulatory obligations.

If BreatheSmart is modified in a manner that may affect your decision to allow us to use your personal information (including sensitive personal information), we will re-issue this notice and obtain your re-consent.

You may have the right to access, edit, restrict, move, delete or object to the use of your personal information. You also may have a right to report concerns to the authority responsible for data privacy where you live or work, depending on your location.

Please contact us at informationgovernance@aptardigitalhealth.com if you have any questions or concerns or would like to exercise your rights.

Note about electronic communications: When you use BreatheSmart, you are communicating with us electronically, and you consent to receive communications from us electronically, including emails, notifications, in-app messages, and messages posted to your account. You acknowledge and agree that all agreements, notices, disclosures, and other communications that we provide to you electronically satisfy any legal requirement that the same be in writing.


3. BreatheSmart’s use

The Services are designed to allow you to receive medication and other reminders, track inhaler use, record symptoms and triggers, and provide related data and reports to a professional, to allow Professionals to track and monitor your symptoms and progress, and to communicate with each other.

A. Access to BreatheSmart

BreatheSmart is not available to you unless Professional has given you an activation code to create a BreatheSmart account and you have subsequently registered for that account. If the foregoing does not apply to you, you are not authorized to access or use BreatheSmart, and you must discontinue your use and notify us immediately.

If you are authorized as described in the preceding paragraph, you may access BreatheSmart by downloading the App from third parties like the Apple App Store or Google Play.

B. User’s information

Regarding your account, you agree to:

  1. provide true, accurate, current, and complete information when registering to use BreatheSmart and establishing your account (“Registration Information”) and,
  2. maintain and promptly update the Registration Information to keep it true, accurate, current, and complete.
  3. If you provide any information that is untrue, inaccurate, not current, or incomplete, or ADH has reasonable grounds to suspect that such information is untrue, inaccurate, not current, or incomplete, ADH may suspend or terminate your account.

    Additionally, you agree:

  4. to maintain the strict confidentiality of your account and any passwords issued to you for your use of or access to BreatheSmart or any portion thereof and,
  5. not to allow any other entity or person to use any username(s) or password(s) that are issued to you.

You are responsible for all activity that occurs under your account or password. If you create a personal PDF report of your data and download it onto a personal computer/mobile device or other any support external to the Services, you assume full responsibility for the confidentiality of these data. If you wish to cancel a username or password, or if you become aware of any loss, theft or unauthorized use of a username or password, please notify us immediately.

C. User’s treatment

As a user of BreatheSmart, you acknowledge and agree that:

  1. Your use of BreatheSmart has been authorized by Professionals;
  2. You will input accurate information about yourself, and, if you discover any inaccurate information in BreatheSmart regarding you or your condition, you agree to take all reasonable steps necessary to correct such inaccurate information;
  3. Clinical treatment and medications prescribed by Professional and the service coverage under your health plan are determined independent of, and without input from, ADH. The content provided by BreatheSmart is based on the personalized medication schedule entered by you, and does not constitute independent medical advice;
  4. You will use BreatheSmart to benefit from features such as medication reminders to ensure timely doses, tracking inhalation techniques for optimized treatment (MDIs), recording symptoms for better self-awareness;
  5. BreatheSmart is designed to help you manage your medical condition, but you are ultimately responsible for your own treatment and care;
  6. The contents of the Services, such as graphics, images, information, and other materials are for informational purposes only. The provision of such content does not create a doctor-patient relationship, and does not constitute a medical opinion, medical advice, or diagnosis or treatment of any particular condition.
  7. Personal data PDF reports available from the App are no longer ADH responsibility once they are downloaded outside of the Services.
  8. The Devices user guides (the “User Guides”) include the indications and contraindications for use of HeroTracker® Sense medicine inhaler sensors, and you acknowledge the importance of reading the User Guide;

If you experience any serious problem or need immediate medical assistance, you should immediately call a professional or call 911 for emergency help.

D. License Grant

BreatheSmart is licensed to you, not sold. Except for the limited license granted in this Agreement, ADH retains all right, title and interest in BreatheSmart and all proprietary rights in BreatheSmart, including copyrights, patents, trademarks and trade secret rights.

ADH grants you a limited, personal, revocable, nontransferable, non-assignable, non-sub licensable, nonexclusive license to access and use the Services solely as described in these Terms of Use. You may download BreatheSmart on your phone or computer. You may not install or use BreatheSmart on a device that you do not own or control.

E. Limitations

The license granted to you in this Agreement is restricted as follows:

  • Limitations on Copying and Distribution. You may not copy or distribute BreatheSmart.
  • Limitations on Reverse Engineering and Modification; APIs. You may not (i) access or use BreatheSmart application programming interfaces (“APIs”) for any purpose other than your licensed use of BreatheSmart or (ii) reverse engineer, decompile, disassemble, modify or create works derivative of BreatheSmart, or otherwise attempt to gain access to any source code or trade secret within BreatheSmart.
  • Sublicense, Rental and Third Party Use. You may not assign, sublicense, rent, timeshare, loan, lease or otherwise transfer BreatheSmart or your BreatheSmart account, or directly or indirectly permit any third party to copy and install BreatheSmart on a device not owned and/or controlled by you.
  • Proprietary Notices. You may not remove any proprietary notices (e.g., copyright and trademark notices) from BreatheSmart or its documentation.
  • Use in Accordance with Documentation. All use of BreatheSmart must be in accordance with its then-current User Guide or other documentation made available to you relating to BreatheSmart.
  • Device. You may not use BreatheSmart on or in connection with rooted or jail broken devices or use on any mobile device that is not in conformance with the manufacturer’s original specifications, including use of modified versions of the operating system (collectively, “Modified Devices”). ADH is not responsible for any loss of the data entered into BreatheSmart if you lose your mobile device or if it is stolen or if you delete the mobile application without previous synchronization (manual or automatic) of data to the site.
  • Compliance with Applicable Law. You are solely responsible for ensuring that your use of BreatheSmart is in compliance with all applicable foreign, federal, state and local laws, and rules and regulations.

F. Data Access and Use

You hereby grant to ADH a nonexclusive, nontransferable right and license to access and use your Patient Data (a) for purposes of providing BreatheSmart to you, (b) as permitted under the HIPAA Regulation and any applicable national implementing laws or regulations; in each case as amended from time to time, and (c) to create aggregate, de-identified data from your Patient Data, which Data will be owned by ADH and may be used by ADH for any and all lawful purposes.

You should refer to Professional’s notice of privacy practices with respect to Professional’s use of information that they collect from you.


4. Ownership of Materials

  1. ADH is, unless otherwise stated, the owner of all copyright, trademark, patent, trade secret, database and other proprietary rights to information on the App. Except for the limited right to access and use BreatheSmart in accordance with these Terms, ADH grants no other rights to you, no other use of BreatheSmart or any intellectual property or other rights owned or controlled by ADH is permitted, and all other rights are expressly reserved.
  2. Any feedback, suggestions, or ideas you submit regarding the App—including potential improvements—will be considered non-confidential and non-proprietary. By submitting such feedback, you agree that ADH is free to use, disclose, reproduce, or otherwise exploit it without restriction or compensation to you.
  3. This application uses fonts distributed under the SIL Open Font License (OFL) 1.1.To comply with the OFL requirements, all fonts used under this license must include the appropriate author credits. These credits are clearly stated as followed: Key conditions:
    • Fonts may be used, modified, and redistributed, but cannot be sold by themselves.
    • Any original or modified version must remain under the OFL 1.1 license.
    • “Reserved Font Names” cannot be used in modified versions.
    • No warranty: fonts are provided “as is”.

5. Site Availability

We use commercially reasonable efforts to make BreatheSmart available 24 hours every day, 365 days per year, subject to reasonable downtime for scheduled and emergency maintenance. However, websites and mobile applications do sometimes encounter downtime due to server and other technical issues as well as issues beyond our reasonable control. Therefore, you agree that ADH is not responsible or liable in the event that BreatheSmart is unavailable at any time for any reasons.

You agree that BreatheSmart may be temporarily unavailable due to issues such as system failure, maintenance or repair. Where possible, we will try to give our users advance warning of maintenance issues but will not be obliged to do so.

Any data fees on your mobile device or charges incurred related to your transfer of data via the internet are at your expense.

We use industry standard methods designed to maintain BreatheSmart free from computer viruses, Trojan horses, worms, and other harmful and malicious code (collectively, “Harmful Materials”), however, we are not responsible for the presence of any Harmful Materials. You agree to take reasonable and appropriate precautions to scan for computer viruses or otherwise protect your computer or mobile device, and you should ensure that you have a complete and current backup of the applicable items on your computer or mobile device. While we use commercially reasonable efforts to provide smooth and continuous operation of BreatheSmart, we make no guarantees, and particularly, do not warrant BreatheSmart will operate error free.


6. Disclaimers

IF YOU ARE EXPERIENCING A MEDICAL EMERGENCY, CALL A PROFESSIONAL OR CALL 911.

Consult your doctor if you have concerns regarding BreatheSmart. THE INFORMATION PROVIDED BY BreatheSmart IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE BUT TO ASSIST YOU TO FOLLOW THE PERSONALIZED TREATMENT PROGRAM RECOMMENDATIONS OF YOUR HEALTHCARE PROFESSIONALS. IF YOU EXPERIENCE A MEDICAL EMERGENCY, STOP USING BreatheSmart AND CONSULT A MEDICAL PROFESSIONAL.

YOU ACKNOWLEDGE THAT THE INFORMATION PROVIDED THROUGH BreatheSmart IS PROVIDED “AS IS” AND “AS AVAILABLE” AND IS NOT INTENDED, OR TO BE CONSTRUED, AS INDEPENDENT MEDICAL ADVICE, DIAGNOSIS OR TREATMENT, AND IS NOT A SUBSTITUTE FOR CONSULTATIONS WITH QUALIFIED HEALTHCARE PROFESSIONALS WHO ARE FAMILIAR WITH YOUR INDIVIDUAL MEDICAL NEEDS. ADH ACCEPTS NO RESPONSIBILITY FOR YOUR RELIANCE ON INFORMATION RESULTING FROM USE OF BreatheSmart.

TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ADH, ITS LICENSORS AND SUPPLIERS HEREBY EXPRESSLY DISCLAIM ANY REPRESENTATIONS OR WARRANTIES OF ANY KIND RELATING TO BreatheSmart OR YOUR ACCESS AND USE THEREOF, WHETHER ORAL OR WRITTEN, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, INCLUDING, WITHOUT LIMITATION, ALL IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR ANY PARTICULAR PURPOSE.

In addition, without limiting the general disclaimers provided above in this section, and to the extent not attributable to an act of negligence or wrongful intentional acts or omissions of ADH, you acknowledge and agree that ADH is not responsible for: (a) any errors in data or data entry, whether caused by you, a professional, hardware, software or otherwise; (b) errors in therapeutic conclusions or interventional instructions provided by professional, including as a result of erroneous data or data entry; (c) malfunction or loss of use of any hardware or software; (d) loss or degradation of communications between you, your healthcare professional, BreatheSmart and/or ADH for any reason not within control of ADH; (e) personal injury; (f) your failure to correct erroneous data or to comply with proper instructions; and (g) errors resulting from unauthorized access to BreatheSmart.


7. Limitation of Liability

IN NO EVENT WILL ADH, ITS AFFILIATES OR THEIR LICENSORS, SERVICE PROVIDERS, EMPLOYEES, AGENTS, OFFICERS, MANAGERS OR DIRECTORS BE LIABLE FOR DAMAGES OF ANY KIND, UNDER ANY LEGAL THEORY, ARISING OUT OF OR IN CONNECTION WITH YOUR USE, OR INABILITY TO USE, BreatheSmart OR ANY CONTENT ON BreatheSmart, INCLUDING ANY DIRECT, INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES, INCLUDING, BUT NOT LIMITED TO, PERSONAL INJURY, PAIN AND SUFFERING, EMOTIONAL DISTRESS, LOSS OF REVENUE, LOSS OF PROFITS, LOSS OF BUSINESS OR ANTICIPATED SAVINGS, LOSS OF USE, LOSS OF GOODWILL, LOSS OF DATA, AND WHETHER CAUSED BY TORT (INCLUDING NEGLIGENCE), BREACH OF CONTRACT OR OTHERWISE, EVEN IF FORESEEABLE.


8. Indemnification

You agree to defend, indemnify and hold harmless ADH, its affiliates, licensors, and service providers, and its and their respective officers, directors, managers, employees, contractors, agents, licensors, suppliers, successors, and assigns from and against any claims, liabilities, damages, judgments, awards, losses, costs, expenses, or fees (including reasonable attorneys’ fees) arising out of or relating to your violation of these Terms of Use, your use of BreatheSmart, including, but not limited to, any use of BreatheSmart’s content, services, and products other than as expressly authorized in these Terms of Use or your use of any information obtained from BreatheSmart, your violation of any rights of ADH or any other party, including any intellectual property or privacy right, or any violation of any laws, rules, or regulations. ADH reserves the right, at its own cost, to assume the exclusive defense and control of any matter otherwise subject to indemnification by you, in which event you will fully cooperate with ADH in asserting any available defenses. You agree that the provisions in this Section will survive any termination of this Agreement or your access to BreatheSmart.


9. Third Party Content/Liability

These Terms are only applicable to the use of BreatheSmart. We do not have any control over third-party websites or applications, and as such, ADH, its suppliers and licensors disclaim all liability from your use of those third-party websites and applications. Any link on or within BreatheSmart to another site is not an endorsement of such other site. No judgment or warranty is made with respect to the accuracy, timeliness, or suitability of the content of any site to which we may link, and we take no responsibility for it. You should be sure to review any third-party website’s terms of use and conditions and privacy policies when you choose to download BreatheSmart through such third-party website.


10. Apple Device Additional Terms

If you access the App via a mobile device or tablet branded by Apple, Inc. (“Apple”) and running Apple’s iOS (an “Apple Device”), the following terms (“Apple Device Additional Terms”) are hereby made part of these Terms:

  • Conflicting Terms. If these Apple Device Additional Terms conflict with any other provision of these Terms, then the Apple Device Additional Terms shall control with respect to access and use of BreatheSmart via an Apple Device.
  • Agreement with ADH, Not Apple. You acknowledge that these Terms are an agreement between ADH and you, and not with Apple. ADH, not Apple, is solely responsible for any App you access via your Apple Device (“iOS App”) and the content thereof. If these Terms are less restrictive with respect to an iOS App or otherwise conflict with, the Apple App Store Terms of Service (the “App Store Terms of Service”), the App Store Terms of Service shall apply to the extent of any conflict.
  • Scope of License. The license granted to use an iOS App is limited to a non-transferable license to use the App on an Apple Device that you own or control and as permitted by the usage rules set forth in the App Store Terms of Service.
  • Maintenance and Support. You acknowledge that Apple has no obligation whatsoever to furnish any maintenance and support services with respect to any iOS App. If ADH decides (in its sole discretion) to provide support and maintenance services for an iOS App, ADH is solely responsible for providing such services.
  • Warranty. In the event of any failure of an iOS App to conform to any applicable warranty provided by ADH in these Terms, you may notify Apple and Apple will refund the purchase price for the iOS App (if any) and, to the maximum extent permitted by applicable law, Apple will have no other warranty obligation whatsoever with respect to the iOS App. Any other claims, losses, liabilities, damages, costs or expenses attributable to any failure to conform to any warranty is ADH’ sole responsibility. Notwithstanding the foregoing, ADH is not obligated to provide any warranty with respect to an iOS App and you acknowledge and agree that this paragraph will not have any effect on the warranty disclaimers provided in these Terms.
  • Intellectual Property Rights. You acknowledge that, in the event of any third party claim that an iOS or your possession and use (in accordance with these Terms) of an iOS App infringes that Product Claims. You hereby acknowledge that ADH, not Apple, is responsible for addressing your or any third-party claims relating to an iOS App and/or use of an iOS App, including, but not limited to: (i) product liability claims; (ii) any claim that an iOS App fails to conform to any applicable legal or regulatory requirement; and (iii) claims arising under consumer protection or similar legislation. Note that pursuant to the limitation of liability provision set forth in these Terms, these Terms will not limit ADH’ liability beyond what is permitted by applicable law.
  • third party’s intellectual property rights, ADH (if and to the extent set forth in these Terms), not Apple, is solely responsible for the investigation, defense, settlement and discharge of any such intellectual property infringement claim.
  • Legal Compliance. You represent and warrant that (i) you are not located in a country that is subject to a U.S. Government embargo, or that has been designated by the U.S. Government as a “terrorist supporting” country; and (ii) you are not listed on any U.S. Government list of prohibited or restricted parties.
  • Third Party Beneficiary. You hereby acknowledge and agree that Apple, and Apple’s subsidiaries, are third-party beneficiaries of these Terms with respect to any iOS App, and that, upon your acceptance of these Terms, Apple has the right (and deemed to have accepted the right) to enforce the Terms against you with respect to the iOS App as a third party beneficiary thereof.
  • Questions or Complaints. Please address your questions, complaints or claims with respect to an iOS App to ADH to informationgovernance@aptardigitalhealth.com.ADH' principal offices are located at 125 Cambridgepark Drive Cambridge MA 02140.

11. Termination

ADH may terminate your access to all or any part of BreatheSmart in its sole discretion and without notice to you and without liability to you or any third party and/or in the event of any breach of these Terms.

You may reactivate your access to BreatheSmart by contacting Professional. If you wish to terminate your account, you may do so by contacting ADH informationgovernance@aptardigitalhealth.com. All provisions of the Terms which by their nature should survive termination will survive termination, including, without limitation, ownership provisions, warranty disclaimers, and indemnity.


12. Assignment

These Terms, and any rights and licenses granted hereunder, may not be transferred or assigned by you.


13. Exclusive Venue

To the extent the parties are permitted under this Agreement to initiate litigation in a court, both you and ADH agree that all claims and disputes arising out of or relating to these Terms of Use or BreatheSmart will be litigated exclusively in the state courts located in New York County, New York or federal courts located in the Southern District of New York.


14. Governing Law

This Agreement and any action related thereto will be governed and interpreted by and under the laws of the state of New York, consistent with the Federal Arbitration Act, without giving effect to any principles that provide for the application of the law of another jurisdiction. The United Nations Convention on Contracts for the International Sale of Goods does not apply to this Agreement.

We make no representations that the content or BreatheSmart are appropriate or may be used or downloaded outside the United States. Access to BreatheSmart and/or the content may not be legal in certain countries outside the United States. If you access BreatheSmart from outside the United States, you do so at your own risk and are responsible for compliance with the laws of the jurisdiction from which you access the website.

We may seek injunctive or other equitable relief in any jurisdiction in order to protect our intellectual property rights. Either you or we may seek an injunction at any time from any court of competent jurisdiction as necessary to protect the rights or property of you or us pending the completion of arbitration.


15. General

You and we agree to be bound by the following terms:

  • These Terms of Use, which include our Privacy Policy, constitute the entire agreement between us and you concerning use of the Services.
  • If any provision of these Terms is deemed invalid by a court of competent jurisdiction, the invalidity of such provision will not affect the validity of the remaining provisions of these Terms, which will remain in full force and effect.
  • No waiver of any term will be deemed a further or continuing waiver of such term or any other term, and our failure to assert any right or provision under these Terms will not constitute a waiver of such right or provision.
  • A printed version of these Terms and of any related notice given in electronic form shall be admissible in arbitral, judicial or administrative proceedings based upon or relating to these Terms to the same extent and subject to the same conditions as other business documents and records originally generated and maintained in printed form.
  • You agree that we may send you notice via email to the email address you have provided, and we are not responsible for your failure to receive notice if email is quarantined by your email security system (e.g., “junk” or “spam” folder) or if you fail to update your email address. You also agree that we may send you notice through BreatheSmart.
  • ADH reserves the right to modify these Terms of Use or its policies relating to the BreatheSmart at any time (in a manner that does not affect your decision to allow us to use your personal information), effective upon posting of an updated version of these Terms of Use. You should regularly review these Terms of Use, as your continued use of BreatheSmart after any such changes constitutes your agreement to such changes.
  • Headings and captions are for convenience only.
  • These Terms inure to the benefit of and will be binding upon our and your permitted successors and assigns.
  • You must not transfer any of your rights or obligations under these Terms to anyone else without our prior written consent. All of our rights and obligations under these Terms may be assigned or transferred by us without your consent.

16. Contact Us

If you have any questions, concerns, complaints or suggestions regarding these Terms or otherwise need to contact us, please email us at informationgovernance@aptardigitalhealth.com.




BreatheSmart’s Privacy Policy

Last modified: November 2025

1. Introduction

Aptar Digital Health, LLC and its affiliates Voluntis SAS (hereinafter “ADH,” “our” “we” or “us”) own or control BreatheSmart, a mobile application (the “App”) and a Connect web portal (“the Portal”) that provides healthcare professional (‘Professional’) and their patients ('you') with Chronic Respiratory disease an aid in recording and monitoring the actuations and related technique of use of prescribed inhaler usage.

Please read this privacy policy carefully as it explains how your personal data is used and how to exercise your rights. This privacy policy supplements any documents or notices that may refer to this privacy policy (i.e Terms of Use which users are required to accept at the time of their first login to the App or Dashboards).

Using BreatheSmart means you have already been selected by a Professional to take part in a Demonstration Project and that you have given your consent.

A Special Note about Minors: If you are UNDER SIXTEEN (16) YEARS OLD, you are not allowed to use the App.

Should you have any questions, you may contact your Professional or directly contact ADH by sending an email to informationgovernance@aptardigitalhealth.com.

2. Who is the Data Controller of your personal data?

ADH is the data controller of your personal data to the extent that:

  • it determines the purposes of the processing related to the App,
  • providing you with access to the App,

Professional is the data processor of your personal data to the extent that it is responsible for:

  • selecting you according to the Project’s inclusion and exclusion criteria,
  • providing you with Notice of Privacy Practices information,
  • obtaining your consent (or any other permission) to share your Personal Information,
  • ensuring that you complete all electronic patient reported outcomes (ePROS),

ADH also acts as the data controller of your personal data:

  • when it operates personal data processing in order to comply with its legal and regulatory obligations, in particular regarding the vigilance obligations; and
  • when it operates personal data processing in order to improve the App, the Site and/or its services.

3. What does our Privacy Policy include?

This Policy describes how ADH collects, uses and shares information about you through BreatheSmart. Please read this Policy carefully to understand what we do. If you do not understand any aspects of our Privacy Policy, please feel free to contact us as described at the top of this Policy. This Privacy Policy applies only to information we collect through the App and the Site. BreatheSmart also contains links to third party sites that are not owned or controlled by ADH. We are not responsible for the privacy practices of such other sites. ADH does not share Personal Information (defined below) with those sites. We encourage you to be aware when you leave BreatheSmart and to read the privacy statements of each and every website that collects personal information.


4. What information does ADH collect?

ADH collects two types of information: (1) information received from you, and (2) information received from others.

Find below the detailed list of all personal data provided by you via BreatheSmart or generated by BreatheSmart (also BreatheSmart automatically collects data via cookies(2) and other trackers):

Type of Data

Examples of Data

Identification data

First name, Last name

Contact details

Email address, phone number,

Health data

Symptoms

Medication (type, dates, times, inhalation technique when you use your inhaler with an add-on sensor)

Exchanges with ADH

Date, hour, and subject of your exchanges with ADH

Electronic network activity information (2)(Traffic data)

Date and time of the visit, viewed pages and files, amount of time spent on particular pages, IP address, device type, browser type and language, operating system, system configuration data, referring URLs, carrier and country location, hardware and processor information.

Information from cookies and trackers

Use of the Platform, compile reports on activity, demographic data, analyze performance metrics, Services usage

Other personal information

Environmental conditions, triggers, geolocational information, tagging data, favorites, preferences, session lengths

(1) Cookies are small packets of data that a website stores on your computer’s or mobile device’s hard drive so that your computer will “remember” information about your visit.

(2) These data are necessary for the proper functioning of BreatheSmart, as well as internal analytics purposes.


5. For what purposes does ADH use your personal data?

ADH processes your personal data for the following purposes only:

Purposes

Examples of use of your Personal Data

Legal Bases

Creating and managing your BreatheSmart’s account

  • to create your patient account
  • to enable you to sign in on BreatheSmart
  • to provide you with the BreatheSmart’s services
  • to enable you to update your patient account

Performance of the contract

Providing BreatheSmart’s services

  • to provide symptom management
  • to facilitate Professional use of BreatheSmart in connection with your treatment and care.
  • to receive medication reminders

Performance of the contract

Managing after-sales service (call support)

  • to contact you
  • to answer your questions
  • to solve your technical issues

Performance of the contract

Compliance with legal and regulatory obligations 

  • to comply with legal and regulatory obligations (i.e for materiovigilance obligations)
  • to process your requests to exercise your rights

Legal and regulatory obligations to which ADH is subject as data controller

Sending monthly newsletters 

  • Provide regular and updated information on events and/or conferences related to a medical theme, or specific information on new medical advancements.

Legitimate interest of ADH in engaging and maintaining contact with users.

ADH may also process your personal data for the following purposes only:

Purposes

Examples of use of your Personal Data

Legal Bases

Improving the BreatheSmart’s services

  • to evaluate and improve BreatheSmart
  • to facilitate your use of BreatheSmart
  • to take steps designed to protect the security of the BreatheSmart

Legitimate interest of ADH to improve BreatheSmart and the patient experience

Pre-litigation or litigation management

  • to take action against any identified breach
  • to manage any dispute or litigation

Legitimate interest of ADH in defending its rights and interests

Compliance with legal and regulatory obligations 

  • to comply with legal and regulatory obligations, in particular regarding the materiovigilance obligations
  • to process your requests to exercise your rights

Legal and regulatory obligations to which ADH is subject as legal manufacturer

Sending monthly newsletters 

  • provide regular and updated information on events and/or conferences related to a medical theme, or specific information on new medical advancements.

Legitimate interest of ADH in engaging and maintaining contact with users.


6. Who can access your Personal Data ?

ADH will not sell or rent your Personal Data. Your personal data may be transmitted to the following recipients when you use BreatheSmart and the services it provides:

Recipients

Purposes

ADH and its duly authorized employees Exclusively for the purposes detailed in the Section 5 of this privacy policy
Your healthcare provider and its duly authorized employees Exclusively for the purposes detailed in the Section 5 of this privacy policy
Companies of the ADH Group and their duly authorized employees Exclusively for administrative, operational and technical purposes related to the management of BreatheSmart and its services
ADH' service providers(hosting provider, IT service providers, etc.) Exclusively for operational and technical purposes related to the management of BreatheSmart and its services
Administrative or judiciary authorities Exclusively in the case of an express and justified request or in case of an alleged violation of legal or regulatory provisions
Lawyers and all interested parties Exclusively in the case of the management of possible disputes and other legal matters where appropriate
Other third parties Following or during a restructuring, reconstitution, acquisition, debt financing, merger, sale of assets of ADH or a similar transaction, as well as in case of insolvency, bankruptcy or receivership where personal data are transferred to one or more third parties as assets of ADH


7. What are your rights regarding your Personal Data ?

If you have any questions or wish to exercise your rights, you may contact your Professional or directly contact ADH by sending an email to informationgovernance@aptardigitalhealth.com.

  • you can request the access to your personal data in order to obtain clear, transparent and understandable information on how ADH processes your personal data and on your rights (as provided in this policy), as well as a copy of your personal data (you can access certain information relating to your account (name, contact information and preferences) by signing into your account and going to the “ACCOUNT” section of our mobile application).
  • you can request the rectification of your personal data in order to obtain the modification of your personal data if they are obsolete, inaccurate or incomplete.
  • you can request the closure of your online account. If you close your account, we will no longer use your online Personal Information or share it with third parties. ADH may, however, retain a copy of the information for legal purposes and to avoid identity theft or fraud.
  • you have a right to ask to get an Accounting of Disclosures of when and why your health information was shared.
  • you may decide if you want to give your authorization before your health information may be used or shared for certain purposes, such as for marketing.
  • you have the right to receive your information in a confidential manner.
  • you have a right to restrict who receives your information.

Under certain circumstances, ADH may ask you for specific information in order to confirm your identity and ensure the exercise of your rights. This is another appropriate security measure to ensure that personal data is not disclosed to an individual who does not have the right to receive it.

If you suspect improper use of your health information or a violation of your privacy rights, you may file a complaint with your national data protection authority or with the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) under HIPAA.

To do so, you may:

  • Submit a HIPAA complaint online via the OCR Complaint Portal at https://ocrportal.hhs.gov
  • Or mail a completed HIPAA complaint form to:
    Office for Civil Rights
    U.S. Department of Health and Human Services
    200 Independence Avenue, S.W., Room 509F, HHH Building
    Washington, D.C. 20201

8. How is your Personal Data protected?

ADH has implemented technical and organizational measures in order to protect your personal data, in particular against potential data breaches likely to cause, either by accident or unlawfully, the destruction, loss, modification, unauthorized access or divulgation of your personal data. These measures will guarantee a level of security adapted to the data and will take into account the state of the art and the cost of implementation in relation to the risks and nature of the data to be protected.

ADH also guarantees that all members of its personnel and any other person processing your personal data will respect the internal rules and procedures related to the processing of personal data, including the technical and organizational security measures put in place to protect your personal data. In this context, ADH reviews and updates its practices regularly to enhance your privacy and ensure that its internal policies are followed.

However, even with these safeguards, ADH cannot guarantee, ensure, or warrant the security of any information you transmit to us. There is no guarantee that information may not be accessed, disclosed, altered, or destroyed by breach of any of our physical, technical, or managerial safeguards. It is your responsibility to protect the security of your login information. Please note that e-mails and other communications you send to informationgovernance@aptardigitalhealth.com are not encrypted, and we strongly advise you not to communicate any confidential information through these means.

If you have found a vulnerability or would like to report a security incident, you may send an email to informationgovernance@aptardigitalhealth.com or contact your national data protection agency FTC (as described in section 7).


9. Where and how long will your Personal Data be maintained?

BreatheSmart mobile and Dashboards are hosted and managed on servers located within the United States. By using and accessing BreatheSmart, you agree and consent to the transfer to and processing of Personal Information on servers located in the United States, even when you travel outside the United States, and you recognize that the protection of such information may be different than required under the laws of any location that you visit.

As a general rule, your personal data will only be retained for two (2) years following the end of the Demonstration Project, or as necessary to fulfill legal or regulatory obligations.

In the absence of applicable exceptions:

  • your traffic data will be kept for a period of thirteen (13) months from the connection date.

10. How will you know if this Policy changes?

This Privacy Policy may be amended from time to time, in particular to reflect the changes in the services provided by BreatheSmart or the applicable regulations. Any revised version of the Privacy Policy will be posted on this page and at other places deemed appropriate.


11. How can you contact ADH if you have questions?

If you have any questions, concerns, complaints or suggestions regarding our Privacy Policy or otherwise need to contact us, please email our Data Protection Officer at informationgovernance@aptardigitalhealth.com.

In the event of any fraud or scams, you may report a complaint to your national data protection agency (HHS agency) as described in section 7.