Notice of privacy practices




Biofidelity, Inc. (“Biofidelity”) is committed to protecting the privacy of your health information. This Notice of Privacy Practices describes our privacy practices.  Biofidelity is required by law to maintain the privacy of health information about you (known as “Protected Health Information” or “PHI”) and to provide you with this Notice of our legal duties and privacy practices with respect to PHI.  Examples of documents that may contain your PHI include laboratory test orders, test results, and invoices for the health care services we provide. When Biofidelity uses or discloses PHI, we are required to abide by the terms of this Notice currently in effect.


How Biofidelity May Use and Disclose Your PHI

The following categories describe ways Biofidelity may use and disclose your PHI (however, not every use or disclosure falls into one of the categories listed).  Biofidelity does not need your written authorization to use or disclose your PHI for the purposes listed below, unless otherwise noted.


Treatment – Biofidelity provides laboratory testing for patients as requested by physicians and other health care professionals and we use PHI as part of our testing processes.  We disclose PHI to physicians and other authorized health care professionals who need access to the laboratory results to treat you and coordinate your care. In addition to the treating physician, we may provide your test results to pathologists or other consulting physicians to help interpret your test results before they are released to the ordering physician. 


Payment – Biofidelity may use and disclose your PHI for purposes of billing and receiving payment for our services.  For example, Biofidelity may disclose your PHI to submit claims and obtain payment from your health plan. We may use and disclose you PHI with our third-party billing partners to assist us in preparing bills and receiving payment.


Health Care Operations – Biofidelity may use and disclose your PHI as necessary to support our health care operations and management.  For example, Biofidelity may use and disclose your PHI for purposes of performing quality checks on our testing, conducting internal audits, developing reference ranges for tests, and arranging for legal services.


Information Related to Your Care – Biofidelity may use your PHI to communicate with you about testing services or other health-related benefits we offer relating to your treatment or care.  Biofidelity will not use or disclose your PHI for other marketing purposes without first obtaining your written authorization. 


Individuals Involved in Your Care or Payment for Your Care – Biofidelity may disclose your PHI to a person identified by you who is involved in your care, such as a family member, friend, or caregiver, when the information is relevant to that person’s involvement in your care or payment related to your care.  Biofidelity will attempt to obtain your agreement to such use or disclosure, if possible. If agreement is not possible due to incapacity or an emergency circumstance, Biofidelity will exercise its professional judgment in disclosing health information that is directly relevant to the person’s involvement with your health care.


Business Associates – Biofidelity may disclose PHI to business associates to perform certain services for Biofidelity or on our behalf related to your healthcare. For example, our business associates may use your PHI to conduct billing, collections, or record storage services on our behalf. Our business associates are required to maintain the privacy and security of your PHI.


Public Health – Your PHI may be disclosed for public health activities such as to assist public health authorities to prevent or control disease, injury or disability.  In other instances, Biofidelity may be required to: (1) report cases of child abuse and neglect, elder abuse, disabled persons abuse, rape, and sexual assault; (2) disclose information about products and services under the jurisdiction of the U.S. Food and Drug Administration for purposes related to the quality, safety or effectiveness of an FDA-regulated product or activity, including reporting reaction to medications or problems with products or notifying people of recall of products; (3) disclosures to an employer about an employee to conduct medical surveillance in certain limited circumstances concerning work-place illness or injury report information to your insurer and/or a state industrial accident board (and any party involved in a workers’ compensation matter) as required under laws addressing work-related illnesses and injuries or workplace medical surveillance; or (4) disclosures to notify a person who may have been exposed to a disease or may be at risk for contracting or spreading a disease or condition. 


Health Oversight Activities – Your PHI may be disclosed to health oversight agencies as authorized by law.  Health oversight activities include audit, investigation, inspection, licensure or disciplinary actions, and civil, criminal or administrative proceedings or actions. Biofidelity also is required to disclose your PHI to the Secretary of Health and Human Services, upon request, to determine our compliance with the Health Insurance Portability and Accountability Act. 


Serious Threat to Health or Safety – Biofidelity may use or disclose PHI to prevent or lessen a serious and imminent danger to you or to others if the disclosure is to a person who is reasonably able to lessen or prevent the threat, including the target of the threat.  Biofidelity may disclose PHI about an individual to a government authority, including social services, if we reasonably believe that an individual is a victim of abuse, neglect, or domestic violence.


Judicial and Administrative Proceedings – Biofidelity may disclose PHI in the course of a judicial or administrative proceeding in response to a legal order or other lawful process. 


Law Enforcement Officials – Your PHI may be disclosed to the police or other law enforcement officials as required or permitted by law or in compliance with a court order or a grand jury or administrative subpoena accompanied by a court order.  


Specialized Government Functions – Biofidelity may use and disclose your PHI to units of the government with special functions, such as the U.S. military or the U.S. Department of State under certain circumstances as required by law.


Ordered Examinations – Biofidelity may release your PHI when required to report findings from an examination ordered by a court or detention facility. 


Decedents – Biofidelity may disclose your PHI to a coroner or medical examiner as authorized by law. 


Organ and Tissue Procurement – If you are an organ donor, Biofidelity may disclose your PHI to organizations that facilitate organ, eye or tissue procurement, banking or transplantation.


Research – Biofidelity may use or disclose PHI for research purposes. Limited data or records may be viewed by researchers to identify patients who may qualify for a research project or for other similar purposes, so long as the researchers do not remove or copy any of the PHI. Before Biofidelity uses or discloses PHI for any other research activity, one of the following will happen: 1) an institutional review board or privacy board has reviewed a research proposal and determined that the research activity poses minimal risk to privacy, has established plans to ensure the privacy of your PHI, and determined that your authorization is not required; and 2) the researcher will be provided only with limited information that does not identify you directly.  We may also use or disclose PHI about deceased individuals when the researchers give Biofidelity assurances that the PHI is necessary for the research and will be used only as part of the research.  


De-identified Information and Limited Data Sets — Biofidelity may use or disclose, for our own purposes, health information and/or biospecimens that have been “de-identified” by removing certain identifiers making it unlikely that you could be identified. Your HIPAA Authorization is not required for the sale, license or any other use or disclosure of such de-identified information or biospecimens. We also may disclose limited health information, contained in a “limited data set”. The limited data set does not contain any information that can directly identify you. For example, a limited data set may include your city, county and zip code, but not your name or street address.  


Required by Law – Biofidelity may use and disclose your PHI when required to do so by federal, state or local law.


Highly Confidential Information – Federal and state law require special privacy protections for certain highly confidential information about you (“Highly Confidential Information”), including: (1) your HIV/AIDS status; (2) genetic testing information; (3) substance use disorder information protected under 42 CFR Part 2; and (4) confidential communications with a psychotherapist, psychologist, social worker, sexual assault counselor, domestic violence counselor, or other allied mental health professional, or human services professional.  In order for us to disclose your Highly Confidential Information, we must obtain your separate, specific written consent and/or authorization unless we are otherwise permitted by law to make such disclosure.  Most uses and disclosures involving Psychotherapy Notes (as defined in the Federal privacy regulations) require your authorization. Further rights may apply if you are an emancipated minor.


Other Uses and Disclosures That Require Your Authorization – Uses and Disclosures other than those listed above will only be made with your written authorization, unless otherwise permitted or required by law.  We will not sell your PHI or otherwise use or disclose it for purposes of marketing (as defined by federal privacy laws) without obtaining your prior written authorization.  


Note Regarding State Law – For all of the above purposes, when state law is more restrictive than federal law, we will follow the more restrictive state law.


Your Rights Regarding Your PHI

Subject to certain exceptions, you have certain rights with regard to your PHI:

Right to Access and Receive Copies of Your PHI - Subject to certain exceptions, you have the right to request and receive a copy of your lab tests or reports ordered by your physician or other PHI we maintain. You have the right to receive a copy of your PHI in electronic format if we maintain your PHI in an electronic format and we can readily produce a readable electronic copy. We may ask you to make your request for a copy of your records in writing and to provide us with the specific information we need to fulfill your request. We reserve the right to charge a reasonable fee for the cost of producing and mailing the copies of such information.


Right to Amend Your PHI - If you believe that your PHI contains a mistake, you may request us to amend your PHI. All requests for amendment must be in writing. In certain cases, we may deny your request. For example, we may deny a request if we did not create the information, or if we believe the current information is correct. If your request is denied, we will provide a written explanation of the reason for the denial. If you wish to request an amendment to your records, please submit a written request to our Privacy Officer.  


Right to Request Confidential Communications — You have the right to request that Biofidelity communicate with you about your PHI at an alternative address or by an alternative means. We will accommodate reasonable requests. All requests for confidential communications must be in writing.


Right to an Accounting of Disclosures - You have the right to receive a list of certain disclosures of your PHI made by Biofidelity in the past six years from the date of your written request. Under the law, this does not include disclosures made for treatment, payment, or healthcare operations or certain other purposes.


Right to Request Restrictions – You have the right to request a restriction on the way we use or disclose your PHI for treatment, payment or health care operations. In many cases, we are not required to agree to a requested restriction. If we do agree to a restriction, we may not use or disclose your PHI in violation of the restriction, unless otherwise required by law or an emergency when the information is necessary to treat you. If you request that we not provide PHI to your health insurer for purposes of carrying out payment or health care operations, we are required to agree to that restriction if you have paid in full for the service provided. All requests for reasonable restrictions must be in writing and directed to Biofidelity’s Privacy Officer.


Right to Revoke Your Authorization – At any time you may revoke in writing your authorization (or consent) to our future uses/disclosures of your PHI. If you revoke your authorization, we will no longer use or disclose your PHI except to the extent we have already taken action based on your authorization.


Right to Receive Notice of Privacy Practices - You have a right to receive a paper copy of this Notice of Privacy Practices upon request at any time by contacting our Privacy Officer.


Right to Notice of a Breach –You have the right to receive notice of a breach of your unsecured PHI that complies with applicable Federal and State laws and regulations. 


Changes to this Notice

Biofidelity reserves the right to revise and change this Notice and to our privacy practices from time to time. Changes adopted will apply to any PHI we maintain about you.  We are required to abide by the terms of the Notice then in effect.  When changes are made, we will post a copy of the revise Notice on our website and will update the effective date accordingly.


Complaints/Questions/Contact Information

If you have questions or comments regarding this Notice of Privacy Practices, or have a complaint about our use or disclosure of your PHI or our privacy practices, please contact our Privacy Officer at:

Phone Number: 919-659-3285

Email Address:

Mailing Address:   Biofidelity Clinical Laboratory, 5151 McCrimmon Parkway, Suite 230, Morrisville, NC 27560


You also may file a complaint with the Secretary of the Department of Health and Human Services.  Biofidelity will not retaliate against any individual for filing a complaint against our privacy practices.

Office for Civil Rights

Department of Health and Human Services

200 Independence Ave., SW

Rm. 509F, HHH Building

Washington, D.C.  20201




Effective Date of Notice: June 1, 2023.

Last revised: June 1, 2023.