Privacy Policy

PRIVACY POLICY

Please read the Privacy Policy carefully for information relating to our collection, use, storage, disclosure of your personal information. The Privacy Policy is incorporated by this reference into, and made a part of, these Terms.

This Privacy Policy describes personal data Motif obtains about you, how we use that information, with whom we share it, what rights you have regarding your personal data, and how to contact us to exercise these rights.

This Privacy Policy does not apply where Motif processes your personal data on behalf of your medical institution or healthcare professional in connection with your medical treatment. Your medical institution and/or healthcare professional is solely responsible for the processing of your personal data for the provision of your medical treatment and care.

Personal Data We Collect

Unless required to comply with laws and regulations, Motif does not require you to provide personal data to us. If you voluntarily chose to provide Motif with your personal data, Motif may use your personal data to provide you with information and related services.

Motif’s Website

When you visit Motif’s website (https://motifneuro.tech) including subdomains of that URL (collectively, the “Site”), we may collect and or process your personal data derived from you interaction with the Site.

Personal data collected by the Site includes:

• Electronic device information, such as device identifiers, operating system type, and device characteristics.
• Geolocation data, including approximate location information while using the Site.
• Internet or network activity information, such as internet protocol address (IP address), web browser characteristics, domain name, language preferences, and navigation or interaction information as you navigate or interact with the Site.

Contacting Us

You may make an inquiry to Motif by submitting personal data to our Patient Registry (https://www.motifneuro.tech/patient-registry) form. You may also choose to provide Motif your personal data to sign up for a newsletter distributed by Motif, or when you participate in a Motif event. If you contact us by submitting personal data to our Patient Registry form, or to request Motif’s newsletter, or by providing your personal data at an event, we may collect and or process the following personal data about you:

• Contact information you directly submit to us, including name; postal code; state of residence; email address; whether you are a patient, caregiver, or provider; or relevant professional information.
• We may also collect session information and device and network identifiers including IP address.

Social Media

We may collect personal data if you interact with Motif, or communicate about Motif on social media. For such activities, Motif may collect or process personal data about you such as: social media information, social media username, profile picture, information about you that is contained in your comments or your posts, your country, or other content that you share on social media services that relates to Motif.

Regulatory Compliance

As part of our commitment to comply with U.S. Food and Drug Administration (FDA) regulations governing medical devices, including clinical trials and post-market surveillance, we collect and process certain personal data to fulfill our legal obligations for complaint handling, adverse event monitoring, and Medical Device Reporting (MDR). This data is necessary to ensure the safety and efficacy of our medical devices and to meet regulatory requirements under 21 CFR Parts 803, 820, and 812.

We may collect the following types of personal data from clinical trial participants, healthcare providers, investigators, or other individuals involved in the use or evaluation of our medical devices:

• Contact Information: names, addresses, phone numbers, or email addresses of individuals reporting complaints, adverse events, or participating in clinical trials.
• Health Information: medical history, treatment details, or other health-related information relevant to reported adverse events, device performance, or clinical trial outcomes.
• Device Usage Information: details about the use of our medical device, including any malfunctions, user errors, or incidents, which may include identifiable information about the individual using or affected by the device.
• Clinical Trial Data: information collected during clinical trials, such as participant identifiers, demographic information (e.g., age, gender), and health outcomes, as required by the trial protocol or FDA regulations.
• Other Identifying Information: any additional details provided in complaints, adverse event reports, or communications with trial staff that may identify an individual (e.g., patient or provider identifiers).

Clinical and Research Activities

Motif may collect personal data when it performs clinical studies, clinical investigations, clinical surveys and other research activities. For these clinical and research activities, Motif processes personal data of the activity’s participants, as well as personal data of the healthcare personnel involved in such activities. The types of personal data Motif obtains, and or processes, is dependent on the particular clinical or research activity, but generally includes:

• Data concerning participants’ health, such as vital status, and any other sensitive data relevant to the subject of the clinical or research activity.
• Information indirectly identifying participants in those clinical or research activities including age, date of birth, place of birth, gender, country of residence, and an identifier used in place of a participant’s first and last name.
• Details of participants’ personal and professional life, such as family situation, current profession, business travel, tobacco use, alcohol use, drug use, lifestyle, and any other relevant information.
• Dates relating to the conduct of the clinical or research activity, including the date of inclusion.
• Insurance information or participant reimbursement information, including health insurer or payer information, personal data for reimbursement of costs incurred by the participant, or personal data regarding the annual amount of compensation received.
• Personal data regarding a participant’s participation in other clinical or research activities.

Motif typically has no access to directly identifiable information about patients or participants in clinical or research activities, as that information is kept confidential by the relevant healthcare professional, except if required for the purposes of the study or regulatory reporting.

Motif may also collect and process personal data regarding the healthcare professionals involved in our clinical or research activities, including:

• Personal data used for professional identification, such as name, gender, professional contact details, bank details.
• Personal data regarding the skillset, training, and qualifications of the healthcare professionals.
• Personal data regarding the professional life of the healthcare professionals, such as publications, or involvement in other research or clinical activities.
• Identification numbers found in the directory of health professionals.
• Personal data regarding compensation and remuneration.
• History of access, and connection to the medical data of participants in the clinical or research activities.

Cookies or Other Tracking Technologies

When you visit the Site, Motif may collect certain information by automated means, including cookies and similar technologies, such as Flash cookies, local storage, web beacons and pixels, JavaScript, software development kits (SDKs) and device identifiers. While personal data collected through these technologies is not shared for money or other similar compensation, the use of these technologies may be considered personal data sharing under applicable law. Motif’s cookie policy describes the types of technologies Motif uses, the purposes of use, parties involved, and controls available to you.

Personal Data of Children

Motif does not intentionally collect personal data from children (as defined by applicable law) unless we have received verifiable consent from the parent of the child (depending on the requirements of applicable law) and unless a legal requirement or vital interest applies. If you believe Motif has collected personal data from a child, contact us using the contact information provided below.

How We Use Your Data

Website

The personal data collected by the Site may be used to: ensure the Site operates correctly; improve the Site in terms of visitation experience, feature use, and clickthrough; or to provide additional content such as targeted ads on other sites or social media channels.

Contacting Us

We may use personal data submitted by you to our Patient Registry form, newsletter request, or submitted to attend an event, in order to: respond to you, provide you with required support, and follow up on your request; to perform analytics and research; or to improve our products, content, and services. We may also keep a record of the communications we have with you.

Social Media

Motif may use your social media personal data to review or respond to your message or comments. Motif may also use your social media personal data to improve Motif’s products and services.

Regulatory Compliance

We collect and process this personal data to: investigate and document complaints or issues related to our medical devices; monitor, evaluate, and report adverse events or unanticipated adverse device effects to the FDA, Institutional Review Boards, or other regulatory authorities, as required; ensure compliance with FDA regulations for clinical trials, including investigational device exemption requirements; and maintain records for regulatory audits and to support future FDA submissions.

Clinical and Research Activities

Motif may use personal data collected in clinical or research activities to carry out such clinical and research activities, including to: generate evidence to submit to health regulatory authorities in order to comply with our medical device manufacturer’s obligations; to assess the safety, performance and quality of Motif’s medical devices; and to develop and improve the safety and performance of these medical devices. Such uses are based on consent or as required by applicable law in conducting the clinical or research activities.

Some of the personal data we collect and use in the context of clinical and research activities is considered sensitive under applicable laws, such as, health and financial related personal data. Motif’s collection and use of such sensitive personal data is limited to that which is necessary to effectuate the purposes of the clinical or research activity, and for additional purposes for which you have provided your consent. If such sensitive personal data is necessary to effectuate the purposes of the clinical or research activities, and you withdraw or withhold your consent, you may not be able to participate in the clinical or research activities.

How Your Data May Be Shared

Motif may share your personal data with certain categories of third parties. First, Motif may share your data with Motif affiliated companies, service providers, or Motif’s advisors. Such affiliated companies include subsidiaries of Motif. Such service providers include third parties who act on Motif’s behalf to fulfill the activities described in this privacy policy, such as IT providers, contract research organizations, customer relationship management providers, survey providers, event providers, accounts payable providers, cloud hosting service providers, and contract management providers. Motif’s advisors may include Motif’s attorneys, consultants, auditors, tax advisors, banks, and payment service providers.

Second, Motif may share your personal data in the context of a corporate transaction. In such a context, your personal data may be shared with the parties to a potential, pending, or in process corporate transaction, which may include a merger, acquisition, joint venture, reorganization, divestiture, dissolution, or liquidation.

Third, Motif may disclose personal data to your physician to coordinate or manage your healthcare, or to health oversight agencies such as government regulators to support with audits, investigations, and inspections.

Finally, Motif may share your personal data to respond or comply with a legal request. Such legal requests include situations where Motif is required by law to share your personal data; required to disclose and/or share your personal data with regulatory, public, or governmental authorities to comply with any law, regulation, court order, legal, or government request; allowed or required by law for public health purposes, including reporting complaints and quality issues to medical device regulators; needed to protect its own or others vital interests, including the safety of life and property, or for investigating illegal or malicious activities, where allowed by law; needed to exercise or defend legal claims; or needed with its corporate affiliates, who have the same privacy requirements

How Your Data Is Retained

Motif will only keep your personal data for so long as necessary to fulfill the purposes for which we are allowed to use it, as set forth in this privacy policy. Your personal data may be archived for longer in order to take into account applicable statute of limitation periods, or as otherwise required by law.

You Rights With Respect To Your Personal Data

You may have some of the rights below relating to your personal data, depending on applicable laws:

• The right to access your personal data and confirm how your personal data is being processed.
• The right to transfer or obtain a copy in a structured, machine-readable, or portable format.
• The right to correct or amend your personal data if it is incomplete, inaccurate, or outdated.
• The right to request deletion of your personal data.
• The right to restrict or limit excessive or unlawful processing, where the accuracy of the data is contested.
• The right to object to or opt-out of processing in circumstances where your rights outweigh Motif’s legitimate interests in processing such data, such as where personal data is used for direct marketing.
• The right to withdraw or alter your consent where it is the basis for processing.

How to Exercise Your Rights

You or your authorized agent may exercise these rights at any time or contact us with any inquiries by email via: privacy@motifneuro.tech.

In response to an inquiry, Motif will first confirm that we have received your inquiry. To appropriately respond to rights inquiries, Motif must verify your identity, your right to access the information requested, and, if using an agent, your agent’s authority to act on your behalf. Motif may need additional information from you or your agent that will help us do so, including government-issued IDs containing your name and address, utility bills containing that same information, or similar materials that demonstrate identity. We will only use that additional information in the verification process, and not for any other purpose.

After Motif verifies your identity, and if necessary, your agent’s authority, Motif will process your inquiry and then contact you with our response to your inquiry, including any data and reasons for rejection as applicable, within the time required by applicable law. If we need more time, we will notify you in accordance with applicable law.

Motif may charge a reasonable fee in some geographies to process or respond to your inquiry only if allowed by applicable law, for instance if it is excessive, repetitive, or manifestly unfounded. If a fee is warranted, Motif will tell you why we made that decision and provide a cost estimate before completing your inquiry.

Miscellaneous

Motif does not sell your personal data for money or other consideration, nor share it for direct or behavioral marketing purposes with unrelated third parties, except as described in relation to Motif’s use of cookies and tracking technologies.

This Privacy Policy does not apply to personal data processing activities and practices for Protected Health Information (PHI), which is regulated under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Personal data that is PHI and regulated by HIPAA may be deidentified through either or both the Safe Harbor and Expert Determination methods. Motif does not, and will not permit others to, reidentify deidentified PHI except as required by applicable law or as directly consented to by the owner of that PHI.

This Privacy Policy may be updated periodically by Motif should Motif make changes in its personal data practices. The date on which this current Privacy Policy is updated can be found at the top of this page.

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