THIS NOTICE DESCRIBES HOW HEALTH INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN GET ACCESS TO THIS INFORMATION. PLEASE REVIEW IT CAREFULLY.
NeoGenomics Laboratories, Inc. and its subsidiaries and affiliates, is required by the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”), to maintain the privacy and security of your protected health information (PHI) and to provide you with a notice of NeoGenomics’ legal duties and privacy practices with respect to protected health information (PHI) that NeoGenomics may collect and maintain about you. This protection extends to any PHI whether in oral, written, or electronic format. This Notice of Health Information Privacy Practices (“Notice”) describes how we may use and disclose your protected health information (PHI) to carry out treatment, payment or health care operations and for other specified purposes that are permitted or required by law. The Notice also describes your rights with respect to your protected health information (“PHI”) when in the hands of NeoGenomics and its business associates, which are vendors that may assist us in providing services to you. PHI is any information that identifies you or may be used to identify you (e.g., basic demographic information); that is created or received by a health care provider, health plan, employer or health care clearinghouse; and that relates to your past, present or future physical or mental health or condition and related health care services, or provision of or payment for health care. In certain places, this Notice also describes how we use leftover biological samples that remain after our testing has been completed.
We are required by law to abide by the terms of this Notice. We will not use or disclose your PHI without your prior written authorization, except as permitted or required by law and described in this Notice. Please note that if other federal, state, or local laws, rules or regulations restrict or limit the use and disclosure of your PHI in ways that are permitted under this Notice, NeoGenomics will only use or disclose your PHI in compliance with the stricter law, rule or regulation. We strongly urge you to read this Notice carefully and thoroughly so that you will understand both our commitment to protecting the privacy of you PHI and how you can participate in the protection of this information.
What PHI We Collect
We attempt to collect the minimal amount of information necessary for NeoGenomics to provide our services to you and to obtain payment for those services. This may include your name, address, telephone number, social security number, date of birth, medical history, diagnosis, treatment, provider identification, financial responsibility, health insurance coverage (including group numbers and member identification numbers), and payment information.
How We May Use and Disclose Protected Health Information About You WITHOUT YOUR CONSENT
With the exception of information that may qualify for special protection under state and/or federal law, the following categories describe different ways that we use and disclose your PHI. Not every possible use or disclosure in a category is listed below. However, all of the ways in which we are permitted to use and disclose PHI will fall within one of the categories below. Also, NeoGenomics must limit its uses, disclosures, or requests for your PHI to the “minimum necessary” to accomplish the intended purpose of such use, disclosure, or request, except as permitted by law. Please note that, for purposes of this Notice, any references to “we” or “NeoGenomics” include all business associates we may engage.
Treatment: We may use or disclose your PHI to provide and coordinate the treatment and services you receive. For example, we may use your PHI to perform diagnostic tests, or provide your test results to your physician or other authorized health care provider. We may also disclose your PHI to another testing laboratory if we are unable to perform the testing ourselves and as such need to refer your specimen to that laboratory to perform the requested testing. We may also disclose your PHI to another entity in order to schedule phlebotomy services on your behalf.
Payment: We may use and disclose your PHI to others for purposes of receiving payment for treatment and services that you receive. For example, we will submit a claim to you, your health care provider, or your health plan/insurer that includes information that identifies you and the type of services we performed for you.
Health Care Operations: NeoGenomics may use or disclose your PHI in order to support the health care operations of its business and monitor the quality of the care we provide. For example, we may use information in your health record to evaluate the services we provide or to train NeoGenomics’ staff. In addition, “health care operations” include conducting quality assessment and improvement activities, including outcomes evaluation and development of clinical guidelines; patient safety activities; training healthcare and non-healthcare professionals; population-based activities relating to protocol development, case management and care coordination, contacting of health care providers and patients with information about treatment alternatives, and related functions that do not include treatment; submitting claims for stop-loss coverage; conducting or arranging for medical review, legal services, and audit services; wellness and disease management programs; and business planning, development, management and general administration of the clinical lab. We may also disclose your PHI to your healthcare provider for a quality-related health care operation activity or for the purpose of health care fraud and abuse detection or compliance. We may also use your biological samples that remain after we perform testing for quality assurance, test validation, training and similar purposes.
To Communicate with Individuals Involved in Your Care or Payment for Your Care: We may disclose to a family member, other relative, close personal friend or any other person you identify, PHI that is directly relevant to that person's involvement in your care or payment related to your care. We may disclose the relevant PHI to these persons if you do not object or we can reasonably infer from the circumstances that you do not object to the disclosure. If you are incapacitated, we can make the disclosure if, in the exercise of professional judgment, we believe the disclosure is in your best interests. To the extent permitted under federal and state law, we may disclose PHI of minors to their parents or legal guardians.
Business Associates: There are some services provided by NeoGenomics through contracts with business associates (e.g., billing services), and we may disclose your PHI to NeoGenomics’ business associate so that they can perform the job we have asked them to do. To protect your information, however, we require the business associate to enter into a Business Associate Agreement, which specifies the ways in which the business associate may use and disclose your PHI and must appropriately safeguard your information.
Government Agencies: We may disclose to certain government agencies (e.g., FDA, CMS, OIG, CLIA accreditation organizations, etc.), or persons under the jurisdiction of the of such agencies, PHI relative to adverse events with respect to products and/or services we provide, or information to enable product recalls, repairs, or replacements. 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. These programs provide benefits for work-related injuries or illness without regard to fault.
Public Health: As permitted by law, we may disclose your PHI to public health or legal authorities charged with preventing or controlling disease, injury, or disability; to report the abuse or neglect of children, elders, dependent adults, or others; or to a person who may have been exposed to a communicable disease or otherwise be at risk of contracting of spreading the disease or condition.
Law Enforcement or As Otherwise Required by Law: We may disclose your PHI when required to do so by federal, state, or local law or for law enforcement purposes as permitted by law, such as in response to a valid subpoena or court order and to assist in locating suspects, fugitives or witnesses, or victims of crime.
Health Oversight Activities: We may disclose your PHI to an oversight agency for activities authorized by law. These oversight activities may include audits, investigations, and inspections necessary for licensure and for the government to monitor the health care system, government programs, and compliance with laws.
Judicial and Administrative Proceedings: We may disclose your PHI in response to a court or administrative order. We may also disclose PHI in response to a subpoena, discovery request, or other lawful process, but only if efforts have been made, either by the requesting party, or us to tell you about the request or to obtain an order protecting the information requested.
Research: Under certain circumstances, we may use and disclose your PHI for research purposes. In many cases, we will ask for your written authorization before using or sharing your PHI with others in order to conduct research. However, under some circumstances, we may use and disclose your PHI without your written authorization if an institutional review board or privacy board, applying specific criteria, determines that the particular research poses no more than minimal risk to your privacy. We may also use or disclose your PHI without your written authorization to determine whether you might qualify to participate in a research project or to prepare a future research project as long as your PHI is not removed from NeoGenomics premises. We may also use or disclose a copy of your PHI that has had your name and other information that can readily identify you removed, if the recipient of the information enters into a legal contract agreeing to protect the information from unauthorized access. Under certain circumstances, we may use and disclose your PHI for research purposes, as well as PHI of deceased persons if the research satisfies certain criteria. Biological samples that remain after we perform testing may be used for research purposes, both internally and through sharing with third parties. If the samples contain PHI, we may use and disclose them in the same manner as we use and disclose PHI for research, as described in this Notice.
Coroners and Medical Examiners: We may disclose 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 your PHI to funeral directors consistent with applicable law to enable them to carry out their duties.
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.
To Avert a Serious Threat to Health or Safety: We may use and disclose your PHI, if in good faith, we believe the use or disclosure: (i) is necessary to prevent or lessen a serious and imminent threat to your health and safety or the health and safety of the public or another person, and is to a person or persons reasonably able to prevent or lessen the threat, including the target of the threat; or (ii) is necessary for law enforcement authorities to identify or apprehend an individual based on statements made by the individual admitting to participation in a violent crime, or where the individual has escaped from a correctional institution or from lawful custody, or (iii)is necessary for national security, intelligence, or protective services activities.
Military and Veterans: If you are a member of the armed forces, we may use and disclose PHI about you for activities deemed necessary by appropriate military command authorities to assure the proper execution of a military mission. For the same reason, we may also release PHI about foreign military personnel to the appropriate foreign military authority. Disaster Relief: In the event of a disaster, we may provide your PHI to disaster relief organizations.
National Security, Intelligence Activities, and Protective Services for the President and Others: We may disclose PHI about you to authorized federal officials for the conduct of lawful intelligence, counterintelligence, protective services to the President, and other national security activities authorized by law.
Treatment Alternatives and Health-Related Benefits and Services: We may use and disclose your PHI to tell you about possible treatment options or alternatives and health-related benefits and services that may be of interest to you. Sale or Merger: In the event of a sale or merger with another organization, your PHI will become the property of the new owner.
De-Identified Information and Samples: We may use your PHI to create “de-identified” information, which means that information that can be used to identify you will be removed. There are specific rules under the law about what type of information needs to be removed before information is considered de-identified. Once information has been de-identified as required by law, it is no longer subject to this Notice, and we may use it or share it with third parties for any purpose without any further notice or compensation to you unless prohibited from doing so by other federal, state, or local laws, rules or regulations. We may also de-identify leftover biological samples that remain after our testing is completed and use them or share them for any purpose without any further notice or compensation to you unless prohibited from doing so by other federal, state, or local laws, rules or regulations.
Use and Disclosure of PHI (WITH YOUR CONSENT)
NeoGenomics will obtain your written authorization before using or disclosing your PHI for purposes other than those provided for in this Notice (or as otherwise permitted or required by law). Examples include any uses and disclosures of your PHI for marketing purposes, and disclosures that constitute a sale of PHI require your written authorization. You may revoke this 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.
Fundraising: NeoGenomics does not currently use protected health information (PHI) for fundraising purposes. If NeoGenomics performs fundraising activities at some future time, you may be contacted, but you would have the option to tell us not to contact you again.
Your Rights Regarding Your Health Information/PHI
Obtain a Paper Copy of the Notice upon request. You may request a paper copy of NeoGenomics’ current Notice at any time from the NeoGenomics’ Compliance & Ethics department. Even if you have agreed to receive the Notice electronically, you are still entitled to a paper copy. All requests for a paper copy of the Notice must be submitted in writing or electronically to NeoGenomics at the contact information listed below.
Right To Access And Obtain A Copy Of PHI. You (or your designated representative) have the right to access and receive a copy of your PHI that may be used to make decisions about your care or payment for your care. If we maintain the information you have requested in an electronic format you may ask for it to be provided to you electronically, and also ask us to electronically send copies to another person. To exercise this right, you must contact NeoGenomics. You may use NeoGenomics “Patient Authorization for Access to Medical Information” form in English or Spanish, to make your request.
We may deny your request to inspect and copy if (a) the PHI being requested was compiled in reasonable anticipation of a civil, criminal or administrative action (e.g., lawsuits and similar proceedings); (b) the information was collected during the course of research, and to which you previously consented to non-access during the term of the research; (c) the information is contained in records that are subject to the provisions of the federal Privacy Act; or (d) the information was obtained from another person or entity (not a health care provider) under the promise of confidentiality, and allowing access would be reasonably likely to reveal the source of the information. If you are denied access to your PHI, you will receive a written denial and information regarding how your denial may be reviewed.
Request A Restriction On Certain Uses And Disclosures Of PHI. You have the right to request additional restrictions on how we use or disclose your PHI for treatment, payment, health care operations, and communications to those involved in your care. Unless otherwise instructed by federal or state law, we are not obligated to agree to any restriction you may request, except if (a) the use of disclosure is for the purpose of carrying out payment or health care operations and is not otherwise required by law and (b) the PHI pertains solely to health care item or service for which you (or person other than the health plan on your behalf) has paid NeoGenomics in full. If we agree to a restriction, we will abide by them, except in emergency situations when the disclosure is for purposes of treatment. All requests for restrictions on the use or disclosure of your PHI must be submitted in writing to NeoGenomics at the contact information listed below. We retain the right to terminate an agreed-to restriction if we believe such termination is appropriate. In the event we have terminated an agreed-to restriction, we will notify you of such termination.
Request An Amendment Of PHI. You have a right to request that PHI that we maintain about you be amended or corrected. To request an amendment, you must send a written request to NeoGenomics at the contact information listed below. You must include a reason that supports your request. We may process your request in accordance with our policy, but original information will not be removed. In certain cases, we may deny your request for an amendment for various reasons, including if we did not create the information or if we believe the current information is accurate and complete. You will be notified in writing if your request is denied. If you request is denied, you have the right to submit a written statement disagreeing with the denial, which, at your request, may be appended or linked to the PHI in question. All requests for an amendment of your PHI must be submitted in writing to NeoGenomics.
Receive An Accounting Of Disclosures Of PHI. You have the right to receive an accounting of the disclosures NeoGenomics or its business associates have made of your PHI for most purposes other than treatment, payment, health care operations, and certain other limited purposes. The right to receive an accounting of disclosures is subject to certain exceptions, restrictions, and limitations. To request an accounting, you must submit your request in writing to NeoGenomics’ Compliance & Ethics department. Your request must specify the time period for which you would like an accounting, but this time period may not be longer than six years prior to your request. We will provide an annual accounting without charge, but may charge a reasonable, cost-based fee for any subsequent accounting within the same twelve (12) month period.
Request Confidential Communications Of PHI By Alternative Means Or At Alternative Locations. You have a right to request to receive communications of PHI by alternate means or at alternate locations. For instance, you may request that we contact you about medical matters only in writing or at a different residence or post office box. To request confidential communication of your PHI, you must submit a request in writing to NeoGenomics’ Compliance & Ethics department, by using our Request for Confidential Communication form. Your request must state how or where you would like to be contacted.
Right to Receive Notification in the Event of a Breach. You have a right to receive notification if there is a breach of your unsecured PHI, except in those instances where we determine that there is a low probability that the PHI has been compromised. After learning of such a breach, we must provide notice to you without unreasonable delay and in no event later than sixty (60) calendar days after NeoGenomics’ discovery of the breach, unless a law enforcement official requires us to delay the breach notification.
Security of Your PHI Access to PHI is restricted to only those employees, agents or contractors of NeoGenomics who require it to provide services to you or your healthcare provider(s) or obtain payment from those financially responsible for payment. NeoGenomics maintains physical, technical, and procedural safeguards protecting PHI against unauthorized use and disclosure. NeoGenomics’ Compliance & Ethics department is responsible for overseeing the proper and effective implementation of all required rules and regulations, as well as policies and procedures concerning the use and disclosure or PHI, including ensuring proper educating/training, investigating all issues, complaints and concerns, audit and monitoring compliance by NeoGenomics and its employees, agents and contractors. Please note that any e-mail communication you initiate with NeoGenomics regarding your PHI is not secured in accordance with the HIPAA security standards. As a general rule, NeoGenomics will not communicate with you through e-mail unless the e-mail can be properly encrypted or with your permission/consent.
To file a complaint with NeoGenomics, you must submit a written complaint to NeoGenomics’ Compliance & Ethics department at the address listed below. Any submission must be marked “Confidential,” and should include your name, address, and telephone number where we can contact you (unless you chose to remain anonymous) and a brief description of your concern, issue, or complaint. Filing a complaint will not affect your rights to your personal data or services provided by NeoGenomics.
How to Contact Us
If you would like to exercise your rights or would like additional information about NeoGenomics' privacy practices, you may contact:
NeoGenomics Laboratories, Inc. Attn: Compliance & Ethics 9490 NeoGenomics Way Fort Myers, Florida 33912
If you believe your privacy rights have been violated, you may also file a complaint with NeoGenomics’ Compliance & Ethics department or with the applicable agency listed below:
U.S. Based Individuals
Office for Civil Rights The U.S. Department of Health and Human Services 200 Independence Avenue, S.W. Washington, D.C. 20201
1-202-619-0257 or toll free at: 1-877-696-6775
EU/European Economic Area/United Kingdom
For individuals residing in the EU, EEA, or UK, you may have additional rights detailed in the Additional Information for EEA and UK Residents notice.
Changes to this Notice
NeoGenomics reserves the right to change its practices and the terms of this Notice as, and to the extent permitted by law, to make the new Notice effective for all PHI and personal data we maintain without prior notice to you. The new Notice will be available upon request and on our web site.
Obtaining a Copy of this Notice.
You are permitted to print or make a copy of this Notice for your records. If you do not have the ability to print or make a copy, you may request one by contacting NeoGenomics’ Compliance & Ethics department; contact information listed above.
This Notice was revised and became effective as of July 31, 2023.