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. 

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. 

We welcome any queries, comments, complaints or requests you may have regarding this Privacy Policy. Please do not hesitate to contact us at: 

 If we alter our Privacy Notice, you can review any changes at this web location. Updated 16Apr2025

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. 

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. 

In context of your enrollment with a Covered Clinical Trial, the lawful ground for processing your collected Personal data is your explicit consent. To the extent not provided in your explicit consent, the lawful ground for processing your other personal data is the Sponsor’s desire to accomplish a legitimate objective without prejudice to your overriding privacy and other important interests in ensuring that you respond to any provided questions or evaluations so that your treatment is optimized and the clinical trial results are as reliable as possible. 

You may revoke this consent at any time free of charge in the same manner as such consent was given or in any other form of communication that makes sure we receive your communication. If you withdraw your consent we will no longer process your data unless we are relying on grounds different from your consent for processing the data in question. Also, the withdrawal of your consent does not affect the lawfulness of any processing based on your consent that occurred prior to your withdrawal. 

Any collected audio/video recordings and identifiable data will be deleted at the end of the Covered Clinical Trial. Regulatory agency regulations may require us to retain clinical trial related data after the completion of a study as defined by the entity conducting the Covered Clinical Trial). If the collected recordings and/or data is required to be stored for regulatory purposes, this regulatory requirement will comprise the legal grounds for processing this data. Such data will be securely stored for 25 years.

We will not share your data with third parties unless we have obtained your consent or there is another legal basis recognized by the applicable data protection laws of the European Union or its Member States, such as the fulfillment of a contract you may have entered into with us. Moreover, as we are regulated by the U.S. agency overseeing the medical device industry, the FDA, we may be compelled to disclose such data to the FDA in the context of regulatory investigations. 

In addition we may be granting third parties access to your data as we reasonably believe to be necessary (a) to comply with applicable law, including laws outside your state or country of residence; (b) to comply with legal process; (c) to respond to requests from public and government authorities including public and government authorities outside your state or country of residence; provided that in all instances mentioned in (a) – (c) the subject request is based upon an international agreement, such as a mutual legal assistance treaty, in force between a requesting third country and the European Union, or a Member State, or is lawful based on other grounds recognized by the GDPR or applicable laws of EU Member States. We may also share your data with third parties to the extent that is reasonably required for us (a) to enforce our terms and conditions; or (b) taking into account your fundamental rights and freedoms, (i) to protect our operations or those of any of our affiliates; (ii) to protect your rights, privacy, safety or property, and/or ours or that of our affiliates or others; and (iii) to allow us to pursue available remedies or limit the damages that we may sustain. We may also be required to disclose personal information in response to lawful requests by public authorities, including to meet national security or law enforcement requirements. 

We are located in the United States and enter into the EU approved Standard Contractual Clauses as a data processor in order to transfer your data to the United States. We also implement additional safeguards to mitigate any additional risk posed by transferring your data to the United States. By submitting your personal data via the Application, your personal data will be transferred to us pursuant to these Standard Contractual Clauses and Additional Safeguards. 

You may exercise your rights as a data subject listed in this Section 7 by contacting us at privacy@emawellness.com or by writing to us at the address listed in Section 8 of this Privacy Statement. We will respond to any such inquiries within one month from the date we receive your inquiry either by fulfilling request or informing you about any obstacles or questions in relation to your request. Depending on the circumstances, we may need up to two additional months to complete our response to your request.

Pursuant to Article 27 of the General Data Protection Regulation (GDPR), EMA Wellness has appointed European Data Protection Office (EDPO) as its GDPR representative in the EU. You can contact EDPO regarding matters pertaining to the GDPR: 

– by using EDPO’s online request form: https://edpo.com/gdpr-data-request/ 

– by writing to EDPO at Avenue Huart Hamoir 71, 1030 Brussels, Belgium. 

Pursuant to the UK GDPR, EMA Wellness has appointed EDPO UK Ltd as its UK GDPR representative in the UK. You can contact EDPO UK regarding matters pertaining to the UK GDPR: 

– by using EDPO’s online request form: https://edpo.com/gdpr-data-request/ 

– by writing to EDPO UK at 8 Northumberland Avenue, London WC2N 5BY, United Kingdom.

You have the right to lodge a complaint with the supervisory authority of your habitual residence, place of work or place of alleged infringement, if you consider that the processing of your personal data by us or the way we respond to your inquiries infringes applicable data protection laws. A list of data protection supervisory authorities is available here. http://ec.europa.eu/justice/article-29/structure/data-protection-authorities/index_en.htm 

You have the right to request access to your personal data (including receiving a copy thereof) as well as additional information about the processing. 

In case you discover factual inaccuracies with the respect to the personal data we hold with respect to you, you may request a correction to make such data factually accurate. 

You are entitled to have your personal data erased under specific circumstances, such as where you have withdrawn your consent, where you object to processing based on legitimate interests and we do not have overriding legitimate grounds (see below) or where personal data is unlawfully processed, provided that applicable law does not provide otherwise. Please be advised that it may not be technologically possible to remove from our systems immediately every record of your personal data. The need to back up our systems to protect information from inadvertent loss means that a copy of your personal data may exist in a non-erasable form that may make it difficult or impossible for us to locate or remove immediately but will be stored encrypted in a data-at-rest state and will be deleted over time in accordance with our backup deletion policy. 

You have the right to restrict the processing of your personal data (that is, allow only its storage) where:

– you contest the accuracy of the personal data, until the Sponsor or we have taken sufficient steps to correct or verify its accuracy;

– where the processing is unlawful but you do not want the Sponsor or us to erase the personal data;

– where the Sponsor no longer needs your personal data for the purposes of the processing, but you require such personal data for the establishment, exercise or defense of legal claims; or

– where you have objected to processing justified on legitimate interest lawful grounds (see below), pending verification as to whether the Sponsor has compelling legitimate grounds to continue processing.

Where your personal data is subject to such a restriction of processing, we will only process it with your consent or for the establishment, exercise or defense of legal claims.

Where we rely upon legitimate interests to process personal data (which includes processing of all data for which we have not obtained your explicit consent), you have the right to object to that processing. If you object, we must stop that processing unless we can demonstrate compelling legitimate grounds for the processing that override your interests, rights and freedoms, or we needs to process the personal data in question for the establishment, exercise or defense of legal claims, or applicable law requires otherwise. 

While we do not use your personal data for direct marketing, you have the right to object to our use of your personal data (including profiling) for direct marketing purposes. 

You have the right to receive all such personal data which you have provided to us in a structured, commonly used and machine-readable format, and may also require us to transmit such data to another controller where this is technically feasible. 

We welcome any queries, comments, complaints or requests you may have regarding this Privacy Policy. Please do not hesitate to contact us at: 

EMA Wellness has appointed 2B Advice GmbH as its European GDPR Data Protection Officer. You can reach them by sending an email to ________@2b-advice.com. 

 If we alter our Privacy Notice, you can review any changes at this web location. Updated 16Apr2025