Diality develops care solutions for patients and their healthcare providers, including the Moda-flx Hemodialysis System and associated mobile or desktop application and services (“Moda-flx”). Depending on our relationship with a patient’s healthcare provider, data collected through Moda-flx may be governed by a business associate agreement that we have in place with a healthcare provider that is a “covered entity” for purposes of the Health Insurance Portability and Accountability Act (“HIPAA”). Such data is considered “protected health information” (“PHI”) and is not addressed by this privacy policy. Please refer to your healthcare provider’s HIPAA Notice of Privacy Practices for more information about how your healthcare provider may collect, use, and disclose your PHI.

This privacy policy describes our use and disclosure of personal data (i.e., information that identifies, relates to, or could reasonably be linked with you or your household) collected through Moda-flx when we are not operating as a business associate of HIPAA covered entities. This privacy policy also describes how we collect, use, and disclose personal data through our website and associated operations (the “Site”), and other platforms or offerings (collectively with the Site and Moda-flx, the “Services”).

Depending on your relationship with us, we may collect some or all of the following categories of personal data when you access the Services:

• Contact and Account Information: Name, email address, postal address, and phone number. We also collect information required to manage and process invoices for our Services, such as payment information.
• Website Activity: We collect information related to your access to and use of our Services, including the type of browser you use, access times, pages viewed, your IP address, and the page you viewed before and after visiting our Services.
• Device Information: We collect information about the computer or mobile device you use to access our Services, including the hardware model, operating system and version, unique device identifiers, and mobile network information.
• Geolocation Information: We may collect the approximate location of your computer or mobile device from your IP address. Additionally, we may collect your geolocation and other details from your mobile device in accordance with your device settings.
• Commercial Information: We collect information about your product and service preferences and interests.
• Social Media Information: Account names, handles, biographies, and other details that you make available on social media networks.
• Business and Professional Information: If you are a healthcare provider or similar industry professional, we may collect details such as your title, business contact information, and professional affiliations and specialties.
• Other information that you may provide to us, such as if you contact us by phone or other online mechanism, or other information that we may infer based on the above.
• Additional Information Collected in Connection with Moda-flx: Moda-flx account username and password; demographic information, including your age, date of birth, and gender; Moda-flx identifier and device serial number; treatment information and system logs; related treatment or health information; information that you authorize us to receive.
• Mobile App Access: Our mobile application asks for permission to use the camera on your mobile device to allow you use Moda-flx with ease. If you chose to not allow access to the camera, you will still be able to use the application by using the virtual keypad to enter the required information. Our mobile application does not request access to any other privacy services on your mobile device.

We collect personal data directly from you in the below contexts. We also collect personal data about you through sources like your healthcare team (although, as noted above, information from healthcare providers is typically HIPAA PHI, and thus governed by the Notice of Privacy Practices posted by the healthcare provider), service providers, data analytics providers, advertising or marketing networks, social media networks, and other third parties.

• When you use Moda-flx, create a Moda-flx account, or otherwise access the Services;
• In connection with your interactions, inquiries, or other requests;
• When you upload or share a photo or other digital content through the Services, or share content linking to any of our profiles on social media networks or otherwise interact with us on social media networks;
• When you participate in a clinical trial or other survey or promotion;
• When you interact with us through educational events, speaker series, or other industry events and conferences;
• When you contact us through our customer service, including through the use of online chat tools or webforms that we may make available; and
• When we and our third-party vendors use tracking tools, such as browser cookies, flash cookies, pixels, and web beacons to collect information about you. Please see “How do we use cookies and other tracking technologies?” for more information.

We may use your personal data in the following ways:

• To provide, operate, maintain, protect, and improve our Services and to develop new modalities, functionalities, devices, or other products and services;
• To communicate with you, advertise to you, respond to your inquiries, participate in educational events and conferences, and to send you information by email, mail, telephone, text message, notifications, or other means about our products and services;
• To enhance and help us better understand your browsing experience, needs, and preferences and provide consistent, personalized services and experiences across our Services;
• To protect the security or integrity of the Services, including to perform security analyses to verify that the Services are functioning properly;
• To monitor the quality and safety of Moda-flx and comply with applicable institutional and legal reporting requirements;
• To provide maintenance, support, or recovery services for Moda-flx;
• To conduct clinical trials and other research activities;
• To protect us, our users, and the public, and comply with applicable law, regulation, or legal process, including to validate user information for fraud and risk detection purposes, resolve disputes and protect the rights of users and third parties, respond to claims and legal process (such as subpoenas and court orders), fulfill our reporting obligations, monitor and enforce compliance with our contracts, and otherwise detect, prevent, or stop any activity that may be illegal, unethical, or legally actionable; and
• To evaluate or conduct a merger, divestiture, restructuring, reorganization, dissolution, or other sale or transfer of some or all of our assets, whether as a going concern or as part of bankruptcy, liquidation, or similar proceeding, in which personal data held by us about our customers is among the assets transferred.

We disclose your personal data to the following categories of third parties:

• Vendors that support the Services: We engage vendors to perform certain functions on our behalf such as: mailing and marketing services, professional services consultants, payment processors, providers of data hosting, storage, and analytics services, and IT and security vendors. We also work with vendors and third parties to identify opportunities for and operate clinical trials and other research efforts.
• Social media networks: Where you choose to interact with us through social media, your interaction with these programs typically allows the social media network to collect some information about you through cookies and other digital tracking mechanisms that they place on your device. Please visit the social media networks’ respective privacy policies to better understand their data collection practices and the controls they make available to you.
• Companies involved in advertising: We work with companies that assist us in advertising our Services to you and others who may be interested in the Services. We do not currently work with advertising companies that use tracking technologies on our Site to collect or receive information over time and across different websites or platforms, however we may do this in the future.
• Corporate affiliates: We may share personal data with our subsidiary or affiliate companies in the future.
• Business partners: We may work with other companies to provide you with certain product or service offerings or conduct clinical trials and similar research.
• Law enforcement, government agencies, or parties in a legal proceeding: We may share personal data with these entities to comply with the law or assist law enforcement. We may also provide your personal data to third parties in the context of a subpoena or similar legal process.
• Third parties in the context of a merger or similar business transaction.

We and our third-party vendors may use cookies, pixel tags, and other tracking technologies on the Site in a variety of ways to enhance or personalize your online browsing experience. These tracking technologies help us better understand your needs and preferences and tell us which parts of our website you have visited, facilitate and measure the effectiveness of our advertisements, and provide consistent and personalized services and experiences.

You can set your browser not to accept cookies or to notify you when you are sent a cookie, giving you the opportunity to decide whether or not to accept it. If you do not accept cookies, however, you may not be able to access your account information or utilize certain functionalities on our Site. Please note that our Site does not currently recognize “Do Not Track” signals.

Third-party links on the Services may direct you to third-party websites that are not affiliated with us, including social media networks. We are not responsible for the content or accuracy of third-party websites, or for any other materials, products, or services of third parties.

We are not liable for any harm or damages related to the purchase or use of goods, services, resources, content, or any other transactions made in connection with any third-party websites. Please review carefully the third party’s policies and practices and make sure you understand them before you access their website.

We take reasonable precautions, including implementing physical and electronic safeguards, to help protect the security and privacy of your personal data. However, please be aware that no means of transmitting data over the internet is 100% secure. Please take steps to protect your own personal data, such as by selecting a unique and complex password for your account.

We will never knowingly request personal data from anyone under the age of 18. Our Site is not targeted to or intended for use by children. Accordingly, we do not have actual knowledge that we sell or share the personal data of consumers under the age of 16 years old. However, if we learn that we have received personal data from a child under the age of 18 without appropriate parental consent, we will delete that information from our database.

We retain personal data for as long as needed or permitted based on the purpose for which it was obtained and consistent with applicable law. The criteria used to determine our retention periods include:

• The length of time we have an ongoing relationship with you and provide the Services to you (for example, for as long as you have an account with us);
• Whether there is a legal obligation to which we are subject (for example, we are required to keep records of your transactions for a certain period of time); or
• Whether retention is advisable in light of our legal position (such as in regard to applicable statutes of limitations, litigation, or regulatory investigations).

You can review and change certain personal data related to your use of the Services (such as your name and contact information) by signing into your account or by contacting us as described in “Contact Us” below.

If you prefer not to receive promotional or marketing communications from us, you can let us know by contacting our customer service as described in “Contact Us” below. You may also follow the instructions included with the message, such as by following unsubscribe or opt out links. Please note that we may still send you messages in response to your inquiries or about other non-promotional items, such as managing your account or relationship with us.

You may have the rights listed below (“Data Subject Rights”) with respect to the personal data that we collect or process about you, but these rights differ depending on your country or state of residency.

Under the California “Shine the Light” law, California residents may request information about businesses’ information sharing practices with third parties for their direct marketing purposes. We do not currently share personal data with third parties for their direct marketing purposes.

Under Nevada law, residents of Nevada may request that we not sell their personal data. We do not sell personal data as defined by the Nevada law.

We may update this Privacy Policy from time to time and notify you in accordance with law, which may include email or other notice posted to the Services. Any changes to this Privacy Policy will become effective when we notify you of the changes. Your use of the Services following any such updates will constitute your acceptance of such updates.

For questions about our privacy policy, to make choices about receiving promotional communications, to request to exercise a Data Subject Right, or to update your personal data, you can contact us by email, at support@diality.com, or by writing us at 181 Technology Drive Suite 150, Irvine, California 92618.

Diality is dedicated to the advancement of medical science, the improvement of patient care, and, in particular, the contributions that high quality, innovative Medical Technologies make toward achieving these goals. Our mission is to develop solutions that improve the care and lives of patients with kidney disease. Our vision is a future where our technology enables all patients to control their kidney disease.

Diality recognizes the obligation to facilitate ethical interactions between our company and those individuals or entities involved in the provision of health care services and/or items to patients, which purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe Companies’ Medical Technologies in the United States (“Health Care Professionals”).

The scope of Diality’s policy will include appropriate interactions with healthcare professionals, guidelines for interactions with such HCPs as well as prohibited activities not allowed by Diality. The scope of beneficial interactions with Health Care Professionals and Companies is broad and includes interactions intended to:

Promote the Advancement of Medical Technologies. Developing and improving cutting edge Medical Technologies are a collaborative process between Diality and Healthcare Professionals. Innovation and creativity are essential to the development and evolution of Medical Technologies, which often occur outside a Company’s laboratory. 

Enhance the Safe and Effective Use of Medical Technologies. The safe and effective use of sophisticated electronic, diagnostic, clinical, or other Medical Technologies often requires Companies to provide Health Care Professionals appropriate instruction, education, training, service and technical support. Regulators often require this type of training as a condition of product approval.

Encourage Research and Education. Diality may support of bona fide medical research, education, and enhancement of professional skills improves patient safety and increases access to the use of its products.

Foster Charitable Donations and Giving. Companies make monetary and Medical Technology donations for charitable purposes, such as supporting indigent care, as well as patient and public education. This increases access to—as well as the quality of—care and treatment in patient populations that may not otherwise be reached. 

Diality has a responsibility to make training and education on its products available to Health Care Professionals. Companies may also provide education to Health Care Professionals. “Training” means training on the safe and effective use of Medical Technologies. “Education” means communicating information directly concerning or associated with the use of Companies’ Medical Technologies, e.g., information about disease states and the benefits of Medical Technologies to certain patient populations. Training and Education programs include, but are not limited to, “hands on” training sessions, lectures and presentations, and grand rounds. In fact, the U.S. Food and Drug Administration mandates training and education to facilitate the safe and effective use of certain Medical Technologies. Companies should adhere to the following principles when conducting training and education programs concerning Medical Technologies for Health Care Professionals:

Programs and events should be conducted in settings that are conducive to the effective transmission of information. These may include clinical, educational, conference, or other settings, such as hotels or other commercially available meeting facilities. In some cases, it may be appropriate for a Company representative to provide training and education at the Health Care Professional’s location.

Programs providing “hands on” training on Medical Technologies should be held at training facilities, medical institutions, laboratories, or other appropriate facilities. The training staff used by the Company should have the proper qualifications and expertise to conduct such training. Training staff may include qualified field sales employees who have the technical expertise necessary to perform the training.

Diality may provide Health Care Professional attendees with modest meals and refreshments in connection with these programs. Any such meals and refreshments should be modest in value and subordinate in time and focus to the training and/or educational purpose of the meeting. 

Where there are objective reasons to support the need for out-of-town travel to efficiently deliver Training and Education on Medical Technologies, Diality may pay for reasonable travel and modest lodging costs of the attending Health Care Professionals. It is not appropriate for Diality to pay for the meals, refreshments, travel, or other expenses for guests of Health Care Professionals or for any other person who does not have a bona fide professional interest in the information being shared at the meeting.

Bona fide independent, educational, scientific, and policymaking conferences promote scientific knowledge, medical advancement and the delivery of effective health care. These typically include conferences sponsored by national, regional, or specialty medical associations and conferences sponsored by accredited continuing medical education providers. Companies may support these conferences in various ways:

Conference Grants. Diality may provide a grant to the conference sponsor to reduce conference costs. The company may also provide grants to a training institution or the conference sponsor to allow attendance by medical students, residents, fellows, and others who are Health Care Professionals in training. Diality may provide grants when: (1) the gathering is primarily dedicated to promoting objective scientific and educational activities and discourse; and (2) the training institution or the conference sponsor selects the attending Health Care Professionals who are in training. Such grants should be paid only to organizations with a genuine educational function and may be used to reimburse only the legitimate expenses for bona fide educational activities. Such grants also should be consistent with applicable standards established by the conference sponsor and any body accrediting the educational activity. The conference sponsor should independently control and be responsible for the selection of program content, faculty, educational methods, and materials.

Conference Meals and Refreshments. Diality may provide funding to the conference sponsor to support the provision of meals and refreshments to conference attendees. Also, Diality itself may provide meals and refreshments for Health Care Professional attendees if such meals and refreshments are provided: (1) to all Health Care Professional attendees (with the limited exception noted by specific state guidelines), and (2) in a manner that is consistent with applicable standards established by the conference sponsor and the body accrediting the educational activity. Meals and refreshments may be provided to fewer than all Health Care Professional attendees if the Company providing such meals and refreshments satisfies all other principles related to meals set forth later in this SOP. Any meals and refreshments should be modest in value, subordinate in time and focus to the purpose of the conference, and clearly separate from the continuing medical education portion of the conference. 

Faculty Expenses. Diality may make grants to conference sponsors for reasonable honoraria, travel, lodging, and modest meals for Health Care Professionals who are bona fide conference faculty members. 

Advertisements and Demonstration. Diality may purchase advertisements and lease booth space for Company displays at conferences. 

Diality may conduct sales, promotional, and other business meetings with Health Care Professionals to discuss, for example, Medical Technology features, sales terms, or contracts. Often, these meetings occur close to the Health Care Professional’s place of business. It is appropriate to pay for reasonable travel costs of attendees when necessary (e.g., for laboratory or plant tours or demonstrations of non-portable equipment) and/or to provide occasional modest meals and refreshments in connection with such meetings. However, it is not appropriate to pay for meals, refreshments, travel, or lodging of guests of Health Care Professionals or any other person who does not have a bona fide professional interest in the information being shared at the meeting. See later reference for additional principles related to the provision of meals associated with Health Care Professional business interactions.

Diality may engage Health Care Professionals to provide a wide-range of valuable, bona fide consulting services through various types of arrangements, such as contracts for research, product development, development and/or transfer of intellectual property, marketing, participation on advisory boards, presentations at Company-sponsored training and other services. Diality may pay consultants fair market value compensation for performing these types of services, provided that they are intended to fulfill a legitimate business need and do not constitute an unlawful inducement. These should comply with the following standards in connection with consulting arrangements with Health Care Professionals:

Consulting agreements should be written and describe all services to be provided. As one example, when Diality contracts with a consultant to conduct clinical research services, there should also be a written research protocol.

Consulting arrangements should be entered into only where a legitimate need for the services is identified in advance and documented.

Selection of a consultant should be made on the basis of the consultant’s qualifications and expertise to meet the defined need.

Compensation paid to a consultant should be consistent with fair market value in an arm’s length transaction for the services provided and should not be based on the volume or value of the consultant’s past, present or anticipated business. 

Diality may pay for documented, reasonable and actual expenses incurred by a consultant that are necessary to carry out the consulting arrangement, such as costs for travel, modest meals, and lodging.

The venue and circumstances for Company meetings with consultants should be appropriate to the subject matter of the consultation. These meetings should be conducted in clinical, educational, conference, or other settings, including hotel or other commercially available meeting facilities, conducive to the effective exchange of information.

Company-sponsored meals and refreshments provided in conjunction with a consultant meeting should be modest in value and should be subordinate in time and focus to the primary purpose of the meeting. Companies should not provide recreation or entertainment in conjunction with these meetings.

Diality’s sales personnel may provide input about the suitability of a proposed consultant, but sales personnel should not control or unduly influence the decision to engage a particular Health Care Professional as a consultant.

Diality interactions with Health Care Professionals should be professional in nature and should facilitate the exchange of medical or scientific information that will benefit patient care and the safe and effective use of our products. To ensure the appropriate focus on educational and/or informational exchange and to avoid the appearance of impropriety, Diality employees should not provide or pay for any entertainment or recreational event or activity for any non-employee Health Care Professional. Such activities include, for example, theater, sporting events, golf, skiing, hunting, sporting equipment, and leisure or vacation trips. Such entertainment or recreational events, activities, or items should not be provided, regardless of: (1) their value; (2) whether the Company engages the Health Care Professional as a speaker or consultant; or (3) whether the entertainment or recreation is secondary to an educational purpose.

Diality’s business interactions with Health Care Professionals may involve the presentation of scientific, educational, or business information and include, but are not limited to, the different types of interactions described in earlier sections of this standard operating procedure. Such exchanges may be productive and efficient when conducted in conjunction with meals. Accordingly, modest meals may be provided as an occasional business courtesy consistent with the limitations in this section.

The meal should be incidental to the bona fide presentation of scientific, educational, or business information and provided in a manner conducive to the presentation of such information. The meal should not be part of an entertainment or recreational event. When engaging Healthcare Professionals, the budget per person for each meal should not exceed $125. In circumstances that demand a higher per person meal cost such as when a location for medical conference is held in a high-cost geography (e.g., New York City, Zurich Switzerland), approval from a company officer will be required.

Meals should be in a setting that is conducive to bona fide scientific, educational, or business discussions. Meals may occur at the Health Care Professional’s place of business. However, in some cases the place of business may be a patient care setting that is not available for, or conducive to, such scientific, educational, or business discussions. In other cases, it may be impractical or inappropriate to provide meals at the Health Care Professional’s place of business, for example, (1) where the Medical Technology cannot easily be transported to the Health Care Professional’s location, (2) when it is necessary to discuss confidential product development or improvement information, or (3) where a private space cannot be obtained onsite. 

Diality may provide a meal only to Health Care Professionals who actually attend the meeting. Diality may not provide a meal for an entire office staff where everyone does not attend the meeting. Diality also may not provide a meal where its representative is not present (such as a “dine & dash” program). Diality may not pay for meals for guests of Health Care Professionals or for any other person who does not have a bona fide professional interest in the information being shared at the meeting.

Diality may occasionally may provide items to Health Care Professionals that benefit patients or serve a genuine educational function for Health Care Professionals. Other than medical textbooks or anatomical models used for educational purposes, any such item should have a fair market value of less than $100. Diality may not provide items that are capable of use by the Health Care Professional (or his or her family members, office staff or friends) for non-educational or non-patient-related purposes, for example, an iPhone or iPad. Diality should not give Health Care Professionals any type of non-educational branded promotional items, even if the item is of minimal value and related to the Health Care Professional’s work or for the benefit of patients. Examples of non-educational branded promotional items include pens, notepads, mugs, and other items that have a Company’s name, logo, or the name or logo of one of its Medical Technologies. Companies also may not provide Health Care Professionals with gifts such as cookies, wine, flowers, chocolates, gift baskets, holiday gifts or cash or cash equivalents.

Providing products to Health Care Professionals at no charge for evaluation or demonstration purposes can benefit patients in many ways. These benefits include improving patient care, facilitating the safe and effective use of products, improving patient awareness, and educating Health Care Professional regarding the use of products. Under certain circumstances described below, Diality may provide reasonable quantities of products to Health Care Professionals at no charge for evaluation and demonstration purposes. This section is limited to providing evaluation and demonstration products only and is not intended to address any other arrangement. Company products that may be provided to Health Care Professionals for evaluation include single use (i.e., Diality single use cartridges) and multiple use products (referred to as “capital equipment”). These products may be provided at no charge to allow Health Care Professionals to assess the appropriate use and functionality of the product and determine whether and when to use, order, purchase, or recommend the product in the future. Company products provided for evaluation are typically expected to be used in patient care. 

Single Use/Consumables/Disposables. The number of single use products provided at no charge should not exceed the amount reasonably necessary for the adequate evaluation of the products under the circumstances. 

Multiple Use/Capital. Multiple use products provided without transfer of title for evaluation purposes should be furnished only for a period of time that is reasonable under the circumstances to allow an adequate evaluation. The terms of an evaluation of such multiple use products should be set in advance in writing. Diality will retain title to such multiple use products during the evaluation period and should have a process in place for promptly removing such multiple use products from the Health Care Professional’s location at the conclusion of the evaluation period unless the Health Care Professional purchases or leases the products.

Demonstration. Company demonstration products are typically unsterilized single use products or mock-ups of such products that are used for Health Care Professional and patient awareness, education, and training. For example, a Health Care Professional may use a demonstration product to show a patient the type of device that will be implanted in the patient. Demonstration products also are typically identified as not intended for patient use by use of such designations as “Sample,” “Not for Human Use,” or other suitable designation on the product, the product packaging, and/or documentation that accompanies the product. A Company should provide Health Care Professionals with documentation and disclosure regarding the no-charge status of evaluation and demonstration products.