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    CYNOGEN Inc. is required by law to maintain the privacy of Protected Health Information (“PHI”) and to provide you with notice of our legal duties and privacy practices with respect to PHI. PHI is information that may identify you and that relates to your past, present, or future physical or mental health or condition and related health care services. This Notice of Privacy Practices (“Notice”) describes how we may use and disclose health information about you, as well as how you may obtain access to such information. The Notice also describes your rights with respect to your PHI. We are required to provide this Notice to you by the Health Insurance Portability and Accountability Act (“HIPAA”).

    CYNOGEN is required to follow the terms of this Notice. We will not use or disclose your PHI without your written authorization, except as described in this Notice. We reserve the right to change our practices and this Notice and to make the new Notice effective for all PHI we maintain. Upon request, we will provide any revised Notice to you.

    How We May Use and Disclose Protected Health Information About You

    The following categories describe different ways that we use and disclose your protected health information. We have provided you with examples in certain categories; however, not every permissible use or disclosure in a category will be listed in this Notice. Some information, such as HIV-related information, genetic information, alcohol and/or substance abuse records, and mental health records may be subject to special confidentiality protections under applicable state or federal law. CYNOGEN will abide by these special protections as they pertain to sensitive information in your health records.

    Treatment. We may use your health information to provide and coordinate the treatment and laboratory services you receive. For example, we may disclose information about you to doctors, nurses, technicians, or other personnel involved in your health care. We may also share this information about you with other agencies or facilities to facilitate the provision of services or products you may need, such as medications, equipment, supplies, or other product or services recommendations.

    Payment. We may use your health information for various payment-related functions. For example, we may contact your insurer, health plan, or other health care payor to determine whether it will pay for laboratory services and supplies and the amount of your co-payment. We will bill you or a third-party payor for the cost of laboratory services rendered to you. The information on or accompanying the bill may include certain health information that identifies you. If applicable state or federal law requires us to obtain a written authorization from you prior to disclosing health information for payment purposes, we will ask you to sign an authorization form.

    Health Care Operations. We may use and disclose your health information for our health care operations. For example, we may use information in your health record to monitor the performance of the staff providing laboratory services to you. This information will be used in an effort to continually improve the quality and effectiveness of the health care and service we provide.

    We may also use and disclose your PHI without your prior authorization for other purposes:

    To Communicate with Individuals Involved in Your Care or Payment for Your Care. If authorized by applicable law, we may disclose to a family member, other relative, close personal friend or any other person you identify, PHI directly relevant to that person’s involvement in your care or payment related to your care. Additionally, we may disclose information about you to your “personal representative.” If a person has the authority by law to make health care decisions for you, we will generally regard that person as your “personal representative” and treat him or her the same way we would treat you with respect to your health information.

    Food and Drug Administration (“FDA”). If authorized by applicable law, we may disclose to the FDA, or persons under the jurisdiction of the FDA, PHI relative to adverse events with respect to devices, products and product defects, or post-marketing surveillance information to enable product recalls, repairs, or replacement.

    Worker’s Compensation. We may disclose your PHI to the extent authorized by and to the extent necessary to comply with laws relating to worker’s compensation or other similar programs established by law.

    Public Health. As required by applicable law, we may disclose your PHI to public health or legal authorities charged with preventing or controlling disease, injury, or disability.

    Law Enforcement. We may disclose your PHI for law enforcement purposes or in response to a subpoena or court order, if such disclosure is required and authorized by applicable law.

    As Required by Law. We will disclose your PHI when required to do so by applicable federal, state, or local law.

    Health Oversight Activities. We may disclose your PHI to an oversight agency for activities authorized by law, and if such disclosure is authorized by applicable law. These oversight activities include audits, investigations, inspections, and credentialing, as necessary for licensure and for the government to monitor the health care system, government programs, and compliance with civil rights laws.

    Judicial and Administrative Proceedings. If you are involved in a lawsuit or a dispute, we may disclose your PHI in response to a court or administrative order if authorized by applicable law. We may also disclose health information about you in response to a subpoena, discovery request, or other lawful process instituted by someone else involved in the dispute, but only if efforts have been made, either by the requesting party or us, to first tell you about the request or to obtain an order protecting the information requested, and only if authorized by applicable law.

    Research. We may disclose your PHI to researchers when their research has been approved by an institutional review board or privacy board that has reviewed the research proposal and established protocols to ensure the privacy of your information, and when authorized by applicable law. When required, we will obtain authorization from you prior to disclosing your PHI for research.

    Coroners, Medical Examiners, and Funeral Directors. If authorized by applicable law, we may release your PHI to a coroner or medical examiner. This may be necessary, for example, to identify a deceased person or determine the cause of death. We may also disclose PHI to funeral directors consistent with applicable law to enable them to carry out their duties.

    Organ or Tissue Procurement Organizations. Consistent with applicable law, we may disclose your PHI to organ procurement organizations or other entities engaged in the procurement, banking, or transplantation of organs for the purpose of tissue donation and transplant.

    Notification. If authorized by applicable law, we may use or disclose your PHI to notify or assist in notifying a family member, personal representative, or another person responsible for your care, regarding your location and general condition.

    Correctional Institution. If you are or become an inmate of a correctional institution, we may disclose to the institution or its agents PHI necessary for your health and the health and safety of other individuals in accordance with applicable law.

    To Avert a Serious Threat to Health or Safety. We may use and disclose your PHI when necessary to prevent a serious threat to your health and safety or the health and safety of the public or another person in accordance with applicable law.

    Military and Veterans. If you are a member of the armed forces, we may release PHI about you as required by military command authorities, if we are authorized to do so by applicable law. We may also release PHI about foreign military personnel to the appropriate foreign military authority consistent with applicable law.

    National Security, Intelligence Activities, and Protective Services for the President and Others. We may release PHI about you to federal officials for intelligence, counterintelligence, protection to the President, and other national security activities authorized by law, if such release of PHI is in accordance with applicable law.

    Victims of Abuse or Neglect. If authorized by applicable law, we may disclose PHI about you to a government authority if we reasonably believe you are a victim of abuse or neglect. We will only disclose this type of information to the extent required by law, if you agree to the disclosure, or if the disclosure is allowed by law and we believe it is necessary to prevent serious harm to you or someone else.

    Other Uses and Disclosures of PHI. We will obtain your written authorization for disclosure of psychotherapy notes, use or disclosure of PHI for marketing, and for the sale of PHI, except in limited circumstances where applicable law allows such disclosure without your authorization. We will also obtain your written authorization before using or disclosing your PHI for purposes other than those described in this Notice. You may revoke an authorization in writing at any time. Upon receipt of the written revocation, we will stop using or disclosing your PHI, except to the extent that we have already taken action in reliance on the authorization. 

    Your Health Information Rights

    Obtain a paper copy of the Notice upon request. You may request a copy of our current Notice at any time. Even if you have agreed to receive the Notice electronically, you are still entitled to a paper copy. You may obtain a paper copy by submitting a request in writing to the CYNOGEN Privacy Officer.

    Request a restriction on certain uses and disclosures of PHI. You have the right to request additional restrictions on our use or disclosure of your PHI by sending a written request to the CYNOGEN Privacy Officer. We are not required to agree to the restrictions, except in the case where the intended disclosure is to a health plan for purposes of carrying out payment or health care operations, is not otherwise required by law, and the information pertains solely to a health care item or service for which you, or a person on your behalf, has paid out-of-pocket in full.

    Inspect and obtain a copy of PHI. You have the right to access and obtain a copy of the PHI that we maintain about you in accordance with applicable state and federal law. To inspect or obtain a copy of your PHI, you must send a written request to the Privacy Officer. You may request that we transmit a copy of your health information to other individuals or entities that you have designated. However, this right is subject to a few exceptions. The exceptions include disclosures of psychotherapy notes, information collected for certain legal proceedings, and any health information restricted by law.

    We may deny your request to inspect and copy in certain limited circumstances. If you are denied access to your health information, you may request that the denial be reviewed.

    Request an amendment of PHI. If you feel that PHI we maintain about you is incomplete or incorrect, you may request that we amend it. To request an amendment, you must send a written request to the CYNOGEN Privacy Officer. You must include a reason that supports your request. If we deny your request for an amendment, we will provide you with a written explanation of why we denied it in accordance with applicable law, and you will have the opportunity to submit a written statement disagreeing with the denial.

    Receive an accounting of disclosures of PHI. With the exception of certain disclosures, you have a right to receive a list of the disclosures we have made of your health information to individuals or entities other than you, in accordance with applicable law. To request an accounting, you must submit a request in writing to the CYNOGEN Privacy Officer. Your request must specify a time period. The list will not include disclosures before April 14, 2003, disclosures made more than six years prior to your request, or disclosures made pursuant to your authorization.

    Request communications of PHI by alternative means or at alternative locations. You have the right to request that we communicate with you about medical matters in a certain way or at a certain location. For instance, you may request that we contact you at a different residence or post office box. To request confidential communication of your PHI, you must submit a request in writing to the CYNOGEN Privacy Officer. Your request must tell us how or where you would like to be contacted. We will accommodate all reasonable requests. However, if we are unable to contact you using the ways or locations you have requested we may contact you using the information we have.

    Notification of a Breach. You have a right to be notified following a breach of your unsecured PHI, and CNYOGEN will so notify you in accordance with applicable law.

    Where to obtain forms for submitting written requests. You may obtain forms for submitting written requests by contacting the Privacy Officer at: 949-225-7257 or toll-free by telephone at 877-429-6643.

    For More Information or to Report a Problem

    If you have questions or would like additional information about CYNOGEN’s privacy practices, you may contact our Privacy Officer at: or toll-free by telephone at 877-429-6643. If you believe your privacy rights have been violated, you can file a complaint with CYNOGEN’s Privacy Officer or with the Secretary of Health and Human Services. There will be no retaliation for filing a complaint.

    Effective Date

    This Notice is effective as of September 19, 2013.