Effective Date: August 28, 2019
Orgenesis is committed to protecting the confidentiality of your medical and health information (protected health information), as described in this notice, and maintains the privacy of your protected health information as required by law. We have provided this notice to describe our privacy practices relating to protected health information, including how we may use your protected health information within Orgenesis and how, under certain circumstances, we may disclose it to others outside Orgenesis. This notice also describes the rights you have concerning your protected health information. Please review carefully, and if you have questions about any part of this privacy notice, or if you want more information about Orgenesis’ privacy practices, please contact the privacy officer listed at the end of this notice.
The law permits Orgenesis to use your protected health information for treatment, billing of services, and healthcare operations, as explained below. Certain types of protected health information have additional protection under state or federal law.
Your protected health information may be used and disclosed only for the following purposes:
For treatment: We may use your protected health information to provide you with medical treatment and other services. We may also disclose your protected health information to others who need information to treat you, such as doctors, physician assistants, nurses, medical and nursing students, technicians, therapists, emergency service and medical transportation providers, medical equipment providers, and others involved in your care. For example, we will allow your physician to have access to laboratory results to assist in your treatment and for follow-up care.
For payment: We may use and disclose your protected health information to get paid for the medical services and supplies we provide to you. For example, your health plan or health insurance company may ask to see parts of your medical record before they will pay us for your treatment.
To business associates: We may provide your protected health information to other companies or individuals that need the information to provide services for us. These other entities, known as business associates, are required to maintain the privacy and security of protected health information. For example, we may provide information to companies that assist us with billing of our services.
To family members and others involved in your care: We may disclose your protected health information, unless prohibited by applicable federal or state law, to a family member, another relative, a close personal friend, a person identified by you who is involved in your medical care, or someone who helps pay for your care. If you do not want us to disclose your protected health information to family members or others, please Contact Koligo’s privacy officer, as provided below.
For research: We may use or disclose your protected health information without your consent or authorization for research projects, such as studying the effectiveness of a treatment you received, if an institutional review board approves a waiver of authorization for disclosure. These research projects must go through a special process that protects the confidentiality of your protected health information.
As required by law: Federal, state, or local laws sometimes require us to disclose protected health information. For instance, we are required to report child abuse or neglect and must provide certain information to law enforcement officials in domestic violence cases. We also are required to give information to the State Workers’ Compensation Program for work related injuries.
For public health activities: We may use and disclose certain protected health information for public health purposes, such as preventing or lessening a serious and/or imminent threat to an individual’s or the public’s health or safety. We may also report information to your employer as required under laws addressing work-related illness and injuries or workplace medical surveillance. For instance, a positive communicable disease test result may be reported to the state health department. We also may need to report patient problems with medications or medical products to the Food and Drug Administration (FDA).
For public health or safety: In limited circumstances, we may disclose protected health information to prevent or lessen a serious and/or imminent threat to an individual’s or the public’s health or safety.
To law enforcement officials: We may disclose protected health information to law enforcement officials as required by law or in compliance with a search warrant, subpoena, or court order. We also may disclose protected health information to assist law enforcement officials in identifying or locating a person, to prosecute a crime of violence, to report deaths that may have resulted from criminal conduct, and to report criminal conduct at Orgenesis.
For military, veterans, national security, and other government purposes: If you are a member of the armed forces, we may release your protected health information to the Department of Veterans Affairs or as required by military command authorities. We may also disclose protected health information to federal officials for intelligence and national security purposes, or for presidential protective services.
For judicial proceedings: We may disclose your protected health information if we are ordered to do so by a court or if we receive a subpoena or a search warrant.
For health oversight activities: We may disclose protected health information to a government agency that oversees Orgenesis or its personnel, such as the College of American Pathologists (CAP), the federal agency that oversees Medicaid and Medicare (CMS), and the FDA, to ensure compliance with state and federal laws.
To coroners, medical examiners, and funeral directors: We may disclose protected health information concerning deceased patients to coroners, medical examiners, and funeral directors to assist them in carrying out their duties.
For organ and tissue donation: We may disclose protected health information to organizations that facilitate organ, eye, or tissue donation or transplantation.
Orgenesis cannot use your protected health information for anything other than the reasons mentioned above without your signed authorization: a written document signed by you giving us permission to use or disclose your protected health information for the purposes you specifically set forth. You may revoke your authorization at any time by delivering a written statement to Koligo’s privacy officer (identified below). If you revoke your authorization, Orgenesis will no longer use or disclose your protected health information as previously permitted in your written authorization document. However, your revocation of authorization will not reverse the use or disclosure of your protected health information made while your authorization was in effect.
Right to request your protected health information: You have the right to access your protected health information. You must make the request for such protected health information in writing Koligo’s privacy officer (identified below). Within 30 days after we receive your request, you will receive a copy of protected health information in Orgenesis’ possession, unless an exception applies. Exceptions include if the access is reasonably likely to endanger the life or physical safety of you or another person as determined by a licensed health care professional. If the results cannot be produced within the 30 days, you will be notified by mail.
To request the forwarding of your protected health information to your healthcare provider, write to Koligo’s privacy officer, as set forth below. We may charge a fee for the costs of copying, mailing, or other supplies associated with your request, but we will let you know about the fee in advance.
Right to request amendment of protected health information you believe is erroneous or incomplete: If you examine your protected health information and believe that some of the information is wrong or incomplete, you may ask us to amend your record. We will comply with your request, unless we are not the originator of the information, believe that the information you request to be amended is accurate and complete, or special circumstances apply. To ask us to amend your protected health information, write to Koligo’s privacy officer.
Right to receive an accounting of disclosures of your protected health information: You have the right to request a list of certain disclosures we make of your protected health information. Under the law, this does not include disclosures made for purposes of treatment, payment, or healthcare operations or certain other purposes. If you would like to receive such a list, write to Koligo’s privacy officer. Your request must state a time period desired for the accounting, which must be within the past six years. We will provide the first list to you free of charge, but we may charge you for any additional lists you request during the same 12-month period. We will tell you in advance of any associated fees, at which time you may withdraw or modify your request.
Right to request restrictions on how Orgenesis will use or disclose your protected health information for treatment, payment, or healthcare operations: You have the right to request us not to make uses or disclosures of your protected health information to treat you, to seek payment for care, or to operate our laboratories. We will consider your requests carefully, but we are not required to agree to your requested restriction. If you want to request a restriction, submit your request in writing to Koligo’s privacy officer and describe your request in detail. Koligo’s privacy officer will reply within 30 days of receiving your request.
Right to request special communications: You have the right to ask us to communicate your protected health information by alternative means of communication or at alternative locations. For example, you can ask us not to call your home, but to communicate with you only by mail. To make such a request, write to Koligo’s privacy officer.
Right to receive a paper copy of this notice: You have the right to a paper copy of this Notice at any time. You may download or print a paper copy of the notice or request one by writing to Koligo’s privacy officer.
From time to time, we may change our practices concerning how we use or disclose protected health information or how we will implement patient rights concerning such information. We reserve the right to change this notice and to make the provisions in our new notice effective for all protected health information we maintain. If we change these practices, we will publish a revised notice. You can receive a copy of our current notice at any time by downloading or printing a paper copy of the notice or you may request one by writing to Koligo’s privacy officer.
If you have any questions about this notice or have further questions about how Orgenesis may use and disclose your protected health information, please contact the privacy officer. We welcome your feedback regarding any problems or concerns you have with your privacy rights or how Orgenesis uses or discloses your protected health information.
Koligo’s Privacy Officer:
2401 Terra Crossing Blvd.
Louisville, KY 40245
If Orgenesis cannot resolve your concern or complaint, you may also file a complaint with the federal government. We will not penalize you or retaliate against you in any way for filing a complaint.