Privacy Policy PARI Study Connect App
June 2025
PLEASE READ THIS PRIVACY POLICY CAREFULLY BEFORE USING THE APP.
With the following information, we would like to inform you about data processing in connection with the use of the PARI Study Connect App.
PARI Pharma GmbH is based in the EU and therefore the data transfer is covered by the European regulations on data privacy.
The PARI Study Connect App is used in different countries. In some countries, regulations may differ from those within the scope of the regulations of the European Union on data privacy.
It is also possible that country-specific data protection regulations that deviate from or supplement the regulations of the European Union may apply. Only in case country-specific data protection regulations that deviate from or supplement the regulations of the European Union apply to your location, you will find additional information at the end of this Privacy Policy. In case no additional regulations apply to your location, we have refrained from adding information that is not relevant for you.
Depending on the country you are located, the legal basis for the processing is either your consent or scientific research in public interest, as set forth in the participation documents you signed to participate in the clinical study.
If you have any queries or complaints about our Privacy Policy please contact your study center with any questions or concerns you may have.
The study sponsor who is organizing the study you are participating acts as the data controller. PARI acts as commissioned data processor. Please contact your study center with any questions or concerns you may have.
You will usually find the contact details of the data protection officer/s responsible for the study in the study participation documents or you will receive them from your study center.
The purpose of the processing is to document and transfer data on inhalations using the eTrack Controller during the course of the clinical study. The purpose of the clinical study is explained in the study participation documents you signed.
Via the app we currently collect and process the following information:
the study code;
the serial number of the inhalation device (eTrack Controller);
the date and time of the start of nebulization and the duration of nebulization;
the number and total duration of pauses;
additional technical data of your inhalation device (e.g. shut-off criteria, ID for counting nebulizations, error codes).
This personal information is transferred to the PARI cloud and is available to the study personnel via a web portal.
The pseudonymous data collected during the use of the PARI Study Connect App is used for the purposes of the clinical study and may be used for the purpose of monitoring and analyzing the technical performance of the nebulizer system as well as for aggregated statistical presentation on the efficacy and usefulness of the PARI Study Connect App.
If you have given your consent within the scope of the participation documents in the study to process your personal data, processing will only take place in accordance with the purposes and to the extent agreed in the declaration of consent.
PARI Pharma GmbH is based in the EU and therefore the data transfer is covered by the European regulations on data privacy. Depending on the country you are located, the legal basis for the processing is either your consent or scientific research in public interest, as set forth in the participation documents you signed to participate in the clinical study.
Within the study, access to your study data is granted to those persons that need it to fulfill their study-related tasks and are authorized to process this data.
Your personal data is processed in IT systems. Suitable technical and organizational measures protect the data against unauthorized access and data loss. Furthermore, a technical transfer of data to (sub-)processors may be possible in individual cases on the basis of contractual agreements. Those sub-processors are listed under Section 6 below.
For the technical implementation and management of the PARI Study Connect App and access to the PARItrack Dashboard as well as for support, the data processor is PARI Pharma GmbH, Moosstraße 3,82319 Starnberg, Germany, who processes the data within the EEA.
The study sponsor and PARI Pharma GmbH have concluded a Data Processing Agreement in accordance with Art. 28 GDPR.
In the course of our relationship, your personal data may be transferred or disclosed to third party companies. These may also be located outside the European Economic Area (EEA), i.e. in third countries. Such processing takes place exclusively for the fulfillment of contractual and business obligations and to maintain your relationship with us.
Some third countries are certified by the European Commission as having a level of data protection comparable to the EEA standard through so-called adequacy decisions. However, in other third countries to which personal data may be transferred, there may not be a consistently high level of data protection due to a lack of legal provisions. If this is the case, we ensure that data protection is adequately guaranteed. This is possible via binding company regulations, standard contractual clauses of the European Commission for the protection of personal data pursuant to Art. 46 (1), (2) lit. c GDPR, certificates or recognized codes of conduct.
PARI Pharma GmbH uses additional sub-processors for the provision of the app services. These are:
affiliated companies of the PARI group of companies (PARI GmbH, PARI Medical Holding GmbH);
Amazon Web Services EMEA SARL, 38 Avenue John F. Kennedy, L-1855 Luxembourg ("AWS") and
only for the Android version of the app: Google Ireland Limited ("Google"), Gordon House, Barrow Street, Dublin 4, Ireland - "Google Analytics Firebase" for app crash reports.
Only for iOS version of the app: if you have activated the sharing of iPhone analysis data with Apple Inc. and its subsidiaries in your iPhone settings, we may also be given the opportunity to access anonymized crash reports from Apple Inc., but no personal data.
In case you are located in a country where the legal basis for the processing is scientific research in public interest, we process and store your personal data until it is no longer necessary for the fulfillment of the purposes mentioned in Section 3.
In case you are located in a country where the legal basis for the processing is your consent, we process and store your personal data until you have withdrawn your consent to the processing or until it is no longer necessary for the fulfillment of the purposes mentioned in Section 3, depending on what occurs first.
You may withdraw your consent to participate in the clinical study at any time, and no new personal data about you will be collected.
In each of these cases, PARI will continue to process your personal data collected up to the date of your withdrawal, in accordance with your study participation documents.
Depending on your jurisdiction, you may have the following rights as a "data subject" whose data we process:
Right of access;
Right to rectification;
Right to erasure ("right to be forgotten");
Right to restriction of processing;
Right to data portability;
Right to object in special cases.
In case of scientific research in public interest, your rights as a data subject may be limited if these are likely to render impossible or seriously impair the realization of the research and the restriction is necessary for the fulfilment of the research. This applies to your right to information, your right to rectification, your right to restriction of processing and your right to object.
If you believe that the processing violates data protection rules, you also have the right to complain to a data protection supervisory authority.
Country Specific Additional Information
– for users in UK, Australia, Canada and Quebec (Canada) only –
General
For users in UK:
The legal basis of the processing is scientific research in public interest.
For users in Australia:
We have, among others, adopted the Australian Privacy Principles (APPs) contained in the Privacy Act 1988 (Cth) (the Privacy Act). The APPs govern the way in which we collect, use, disclose, store, secure and dispose of your Personal Information.
A copy of the Australian Privacy Principles may be obtained from the website of The Office of the Australian Information Commissioner at https://www.oaic.gov.au/.
For users in Canada:
The legal basis to process personal information is consent. By using the PARI Study Connect App, or otherwise providing PARI with your personal information through the PARI Study Connect App, you are hereby consenting to PARI’s collection, use, disclosure, communication and other handling of your personal information in accordance with this Privacy Policy. If you do not consent to the practices described in this Privacy Policy, you may not use the PARI Study Connect App. If you have any queries or complaints about our Privacy Policy, please contact your study center or our support team at PARItrack-support@pari.com with any questions or concerns you may have.
referring to 1 Controller
For users in Canada:
Canadian privacy laws generally do not distinguish between the terms “data controller” and “data processor”. In connection with the study you are participating, PARI act as a service provider to the study sponsor, we only process personal information as authorized by our contracts with the study sponsor, or as otherwise required or permitted by applicable laws.
referring to 4 Legal Basis of the Processing
For users in UK:
The legal basis of the processing is scientific research in public interest.
For users in Canada:
We will process your personal information where we have consent to do so and as required or permitted by applicable laws.
referring to 5 Recipients of the Data
For users in UK:
The study sponsor and PARI Pharma GmbH have concluded a Data Processing Agreement in accordance with Article 28 UK-GDPR.
For users in Québec, Canada:
Within PARI, your personal information may be accessible to personnel with a need to know the information in order to perform their duties. Depending on the type of personal information processed, this may include personnel in customer support and service, IT and security, management and quality.
referring to 6 Transfer to Third-Countries or international organization
For users in UK:
In the course of our relationship, your personal data may be transferred or disclosed to third party companies. These may also be located outside the European Economic Area (EEA) or the UK, i.e. in third countries. Such processing takes place exclusively for the fulfillment of contractual and business obligations and to maintain your relationship with us.
Some third countries are certified by the European Commission and UK as having a level of data protection comparable to the EEA and UK standard through so-called adequacy decisions. However, in other third countries to which personal data may be transferred, there may not be a consistently high level of data protection due to a lack of legal provisions. If this is the case, we ensure that data protection is adequately guaranteed. This is possible via binding company regulations, standard contractual clauses of the European Commission for the protection of personal data pursuant to Art. 46 (1), (2) lit. c GDPR as well as the ICO, certificates or recognized codes of conduct.
For users in Canada:
In the course of our relationship, your personal information may be transferred to, and processed in, countries outside of Canada. If you live in Québec, your personal information may be communicated to entities outside of Québec. Our group companies and third-party service providers and partners may operate around the world. This means that when we collect your personal information, such information may be processed in any of these countries, and accordingly, may be accessible to courts, law enforcement and national security authorities of those countries. If you have any questions or wish to obtain further written information about our policies and practices with respect to the processing of your personal information by service providers, affiliates or other third parties outside of Canada, you may contact our support team at PARItrack-support@pari.com.
referring to 7 Duration of Storage
For users in Canada:
We will retain your personal information only as long as necessary to fulfil the purposes mentioned in Section 3 (subject to legally required retention periods), after which time we will either destroy the personal information or anonymize it (where permitted by applicable laws).
referring to 8 Your Rights
For users in Canada:
In order to exercise your data protection rights or should you have any questions, concerns or complaint regarding our Privacy Policy or the processing of your personal information, you may contact the study center or our support team at PARItrack-support@pari.com.
For users in Québec, Canada:
We will make and post specific information about our policies and practices relating to:
retention and destruction of your personal information;
the roles and responsibilities of members of our personnel throughout the life cycle of your personal information; and
the process for dealing with complaints regarding the protection of your personal information.