Revisions and Updates
Your Personal Information is Important to Us
Collecting Information About You
We collect Personal Data from you when you voluntarily choose to provide such information such as when you enter your Personal Data on our Websites or when you download and register or otherwise access or use an Application. If you contact us, we may also keep a record of that contact.
Non-Identifiable Data: When you interact with Renovia through the use of the Services, we may receive and store certain personally non-identifiable information. We may store such information ourselves, or it may be included in databases owned and maintained by affiliates, agents or service providers of Renovia. We may use such information and pool it with other information to track, for example, the total number of visitors to our Websites, the number of visitors to each page of our Websites, the domain names of our visitors’ Internet Service Providers (ISPs), technical mobile device data such as device model and name, device operating system and version. It is important to note that no Personal Data is available or used in this process.
In operating the Services, we may use various technologies, including “cookies” and other tools. A cookie is a piece of information given to your web browser or device when you access the Services. Our cookies help provide additional functionality to the Services and help us analyze usage of the Services more accurately. For instance, our Websites may set a cookie on your browser that keeps you from needing to remember and then enter a password more than once during a visit to the Websites. On most web browsers, you will find a “help” section on the toolbar. You can refer to this section for information on how to receive notification when you are receiving a new cookie and how to turn cookies off. We recommend that you leave cookies turned on because they allow you to take advantage of some of the Services’ features.
Using and Disclosing Your Personal Information
Our purpose in collecting Personal Data about you is to:
• provide you with information which we believe may interest you;
• effectively communicate with you;
• respond to your requests and inquiries;
• provide you with products and services;
• provide your healthcare provider with information related to your use of the Services;
• provide you with updates and options about our products and services;
• analyze our customers’ experiences with our products and services, including the Services described above; and
• improve our products and services.
Renovia may also use or disclose your Personal Data to third parties if we believe that such disclosure is:
• required by law;
• necessary to fulfill the above purposes;
• necessary to protect the rights, property or personal safety of another Renovia user, Website visitor, other users of the Services, or any member of the public; or
• In order to operate the Services, fulfill the purposes set out above or otherwise deliver a product or service, we may sometimes share your Personal Data with an affiliate, agent, service provider, distributor, pharmacy, healthcare provider or other company in a business relationship with Renovia. When we use another company to perform a function of this nature, we endeavor to provide them only with the information that they need to perform their specific function and we instruct them to limit their use of the Personal Data accordingly.
Additional Uses and Disclosures of Your Personal Information
We may also use or disclose your Personal Data in the following circumstances:
• Required by Law: We may use or disclose your Personal Data to the extent that applicable law requires the use or disclosure of such Personal Data. Where the use and/or disclosure of Personal Data is by law, the use or disclosure will be made in compliance with the law and will be limited to the relevant requirements of the law. You will be notified, as required by law, of any such uses or disclosures.
• Public Health: We may disclose your Personal Data for public health activities and purposes to a public health authority that is permitted by law to collect or receive the information. The disclosure will be made for the purpose of preventing or controlling disease, injury or disability. We may also disclose your Personal Data, if directed by the public health authority, to a foreign government agency that is collaborating with the public health authority.
• Communicable Diseases: We may disclose your Personal Data, if authorized by law, to a person who may have been exposed to a communicable disease or may otherwise be at risk of contracting or spreading the disease or condition.
• Health Oversight: We may disclose Personal Data to a health oversight agency for activities authorized by law, such as audits, investigations, and inspections. Oversight agencies seeking this information include government agencies that oversee the healthcare system, government benefit programs, other government regulatory programs and civil rights laws.
• Food and Drug Administration: We may disclose your Personal Data to a person or company as directed or required by the Food and Drug Administration: (i) to collect or report adverse events (or similar activities with respect to food or dietary supplements), product defects or problems (including problems with the use or labeling of a product), or biological product deviations, (ii) to track FDA-regulated products, (iii) to enable product recalls, repairs or replacement, or look back (including locating and notifying individuals who have received products that have been recalled, withdrawn, or are the subject of look back), or (iv) to conduct post-marketing surveillance.
• Legal Proceedings: We may disclose your Personal Data in the course of any judicial or administrative proceeding (i) in response to an order of a court or administrative tribunal (to the extent such disclosure is expressly authorized), and (ii) in certain conditions in response to a subpoena, discovery request or other lawful process, after we receive satisfactory assurance that the party seeking the information has reasonably attempted to notify you of the request or has reasonably attempted to secure a qualified protective order (in a court or administrative tribunal, or by stipulation) to limit disclosure of your Personal Data.
• Law Enforcement: We may disclose Personal Data, as long as applicable legal requirements are met, for law enforcement purposes. These law enforcement purposes include: (i) legal processes otherwise required by law, (ii) limited information requests for identification and location purposes, (iii) pertaining to victims of a crime, (iv) suspicion that death has occurred as a result of criminal conduct, (v) in the event that a crime occurs on the premises of the practice, and (vi) medical emergency in which it is likely that a crime has occurred.
• Research: We may disclose your Personal Data to researchers when their research has been approved by an institutional review board that has reviewed the research proposal and established protocols to ensure the privacy of your Personal Data.
• Criminal Activity: Consistent with applicable federal and state laws, we may disclose your Personal Data, if we believe the use or disclosure is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public. We may also disclose Personal Data if it is necessary for law enforcement authorities to identify or apprehend an individual.
• Military Activity and National Security: When the appropriate conditions apply, we may use or disclose Personal Data of individuals who are Armed Forces personnel (i) for activities deemed necessary by appropriate military command authorities; , or (ii) to foreign military authority if you are a member of that foreign military service. We may also disclose your Personal Data to authorized federal officials for conducting national security and intelligence activities.
• Workers’ Compensation: We may disclose your Personal Data as authorized to comply with workers’ compensation laws and other similar legally-established programs.
• Inmates: We may use or disclose your Personal Data to a correctional institution or law enforcement official if you are an inmate of a correctional facility and your physician created or received your Personal Data in the course of providing care to you, and disclosure is necessary for (i) providing you with health care; (ii) the health and safety of you, other inmates, or others at the correctional institution; or (iii) the administration and maintenance of the safety, security, and good order of the correctional institution.
• Required Uses and Disclosures: Under the law, we must make disclosures to you when required by the Secretary of the Department of Health and Human Services to investigate or determine our compliance with the requirements of the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations (“HIPAA”).
• Non-identifiable Information: We may use or disclose your Personal Data if we have removed from it any information that is personally identifiable to you.
When We Will Contact You
• We may contact you at the email address, mail address, telephone number, usernames or other contact information which you supply us in order to provide you with:
• Updated information about the Services;
• Updated information about Renovia;
• Updated options and information about our products and services;
• Other information that you have chosen to receive; and
• A response to your request(s).
What Are Your Choices?
You can use certain of the Services without providing any Personal Data. However, you may not be able to obtain certain products or services from Renovia including, without limitation, the leva and your leva mobile applications that are required in order to use the leva Pelvic Digital Health System and leva Pelvic Digital Therapeutic, respectively.
Storage and Security of Your Personal Data
At Renovia, we endeavor to take reasonable steps to keep secure any Personal Data that we hold about you, and to keep such Personal Data accurate and up to date. Access to your Personal Data is restricted within Renovia to employees, agents, affiliates or service providers, who have specific authorization. Since no data transmission over the Internet can be guaranteed to be totally secure, we do not promise that the information you provide to us will always be totally secure. Renovia disclaims any responsibility for events arising from unauthorized access to your Personal Data.
Children’s Online Privacy Protection Act
California “Do Not Track” Disclosure
In accordance with the California Online Privacy Protection Act (“CalOPPA”) Amendment of 2013, we inform you that Renovia does not respond to Do Not Track requests or signals at this time.
What to Do If You Have a Problem or Question
Attn: Privacy Officer
263 Summer Street
Boston, Massachusetts 02210