EMA Wellness, a Massachusetts Company having its primary address at 500 Boylston St, Boston MA (“Address”) is committed to protecting and preserving your privacy. This Privacy Notice provides information about how we process any personal data we collect from you, that you provide to us, or that we obtain about you in connection with your use of our mobile application (“Application”) in a clinical trial. As used herein the term “Services” means the functionalities of our Application. If you are not a resident of an EU Member State, you consent to the use of information that you provide us in accordance with this Privacy Policy.
Certain features of the Application have been developed for clinical trial sponsors, and for clinical trial patients who are using the Application under the direction of licensed health care professionals, in order to facilitate and coordinate patient medication adherence in connection with those clinical trials. We have agreed to provide our clinical trial services to sponsors of a clinical trials and to provide you a statement concerning your privacy rights on behalf of such sponsors, who retain at all times control over the use of your data in the course of such clinical trials (“Covered Clinical Trials”).
1. Data Processing On Behalf Of Sponsors Of Clinical Trials
In context of providing our Services, we are collecting and processing personal data on behalf of individual clinical trial sponsors. In case such processing activities are subject to the EU General Data Protection Regulation (“GDPR”) we will be acting as data processors (as such term is defined in the GDPR) pursuant to a data processing agreement meeting the requirements of the GDPR from the following categories of data subjects (collectively, “Affected Data Subjects”):
a) Individuals enrolled in a Covered Clinical Trial,b) persons working with a clinical trial site and need access to our system.
In all those instances, the clinical trial sponsors determine the means and purposes of such processing activities, including, which patients will use an Application, the principal Application functions, the personal data it will collect, how that data will be used and by whom such data is accessed, and how long the data will be retained. The sponsor acts as controller (as such term is used under the GDPR) of the personal data and of the Affected Data Subjects and is responsible for giving them information about how the Application processes their personal data; we provide you the Application only in accordance with instructions from the sponsor.
The Privacy Notices applicable to the processing of your data in connection with such Covered Clinical Trials can be found in the clinical trial material provided to you, including the Informed Consent Form reviewed in accordance with your entry into the clinical trial. In the event of any inconsistencies between the Informed Consent Form (ICF) included in materials provided in accordance with the Covered Clinical Trial and any of the terms within this Privacy Policy, the terms of the Covered Clinical Trial Informed Consent Form will apply.
2. Processing Of Personal Data Resulting In Improvement Of Our Application And Meeting Our Compliance Obligations.
In context of your enrollment with a Covered Clinical Trial, our processing of your data will also result in improvement of our systems and therefore indirectly support other our commercial products, or our regulatory filings for future applications of our product. Collected non-identifiable and anonymized data may also be retained after the Covered Clinical Trial. If you are a resident of an EU Member State this type of processing activity will be subject to certain special conditions and rights that you have as a data subject more particularly described in the below Additional Privacy Notice for Users in Jurisdictions Subject to GDPR Regulation.
3. Contacting Us
We welcome any queries, comments, complaints or requests you may have regarding this Privacy Policy. Please do not hesitate to contact us at:
EMA WellnessAttn: Gordon Kessler
Data Privacy Officer
Phone: 1-800-304-6152
Email: gkessler@emawellness.com
Changes to this Notice
If we alter our Privacy Notice, you can review any changes at this web location. Updated 16Apr2025
Additional Privacy Notice For Clinical Trial Subjects In Jurisdictions Subject To GDPR Regulation
In context of your enrollment with a Covered Clinical Trial, we collect personal data about you when the Sponsor subscribes to the Services and designates you as a Clinical Trial Subject, and when you register to use and thereafter use the Services. We do not collect personal data about you from any third party but the Sponsor.
1. Personal Data We May Collect And Be Processing
Such data are: audio/video images of you performing one or more sequences of steps, such as answering questions in response to prompts presented to you. This data is initially collected in a non-anonymized, non-pseudonymized format. The data is stored in an encrypted format, both when in motion and at rest.
2. Use Of Your Personal Data
To provide our Covered Clinical Trial Services, we may process your personal data for the following purposes:
- to process stored audio/video recordings;
- to answer questions in response to prompts presented to you
- to irrevocably anonymize your personal data, after which we may disclose it to third parties for research or similar purposes.
