GENETIC DATA AND USAGE

Notice of Privacy Practices

THIS NOTICE DESCRIBES HOW HEALTH INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN GET ACCESS TO THIS INFORMATION. PLEASE REVIEW THIS NOTICE CAREFULLY.

Avellino Lab USA, Inc. and its wholly owned subsidiaries (collectively “Avellino”) are committed to protect the privacy of your identifiable health information (“protected health information” or “PHI”). PHI is your demographic information, medical history, laboratory results, and other health information that may be collected, generated, used, and communicated by Avellino to produce genetic testing results and bill for Avellino’s testing services. Examples of PHI include your name, date of birth, medical record number, social security number, and genetic information.

Avellino is required by the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) to maintain the privacy of your PHI. Avellino must provide you with this notice, which describes Avellino’s legal duties, privacy practices, as well as your patient rights under the HIPAA. Avellino is required to notify affected individuals in the event of a breach involving unsecured protected health information. This notice does not apply to non-diagnostic services that PHI may perform -eg, clinical trials testing services.

How Avellino May Use or Disclose Your Health Information

Your PHI may be used for treatment, payment, healthcare operations, or for other purposes permitted or required by law. Avellino may use and disclose your health information for the following purposes:

Treatment

Avellino provides laboratory testing for physicians and other healthcare professionals, and Avellino uses your information in its testing process. Avellino discloses your health information to authorized healthcare professionals who order tests or are otherwise involved in your care and need access to your test results for treatment purposes. Examples of other treatment-related purposes include disclosure to a genetic counselor to help interpret your test results. To the extent disclosure is made to a genetic counselor for treatment purposes, Avellino does not anticipate having access to the genetic counselor’s notes. Notwithstanding, Avellino may use or disclose your genetic counseling notes to the extent required by law; for treatment, payment, or healthcare operations; to defend itself in a legal action or other proceeding brought by you; or to avert a serious threat to health or safety. Any other use or disclosure of your genetic counseling notes requires your written consent.

Payment

Avellino will use and disclose your PHI for purposes of billing and payment. For example, Avellino may disclose your PHI to health plans or other payers to determine whether you are enrolled with the payer or eligible for health benefits or to obtain payment for Avellino’s services. If you are a minor or otherwise insured under another person’s health insurance policy (for example, parent, spouse, domestic partner, or a former spouse), Avellino may also send invoices to the subscriber whose policy covers your health services.

Healthcare Operations

Avellino may use and disclose your PHI for activities necessary to support its healthcare operations, such as performing quality checks on testing, internal audits, arranging for legal services, or developing reference ranges for tests.

Business Associates

Avellino may provide your PHI to third-party companies or individuals that need the information to provide services. For example, Avellino may provide information to companies that assist with billing. Avellino may use an outside collection agency to obtain payment to the extent necessary. These third-party entities are known as “business associates” under the law and, as a result, are also required to maintain the privacy and security of PHI.

Law Enforcement Activities and Legal Proceedings

Avellino may use and disclose your PHI, if necessary, to prevent or lessen a serious threat to your health and safety or that of the general public. To the extent so required, Avellino may also provide PHI to law enforcement officials, for example, in response to a warrant, investigative demand or similar legal process, or for officials to identify or locate a suspect, fugitive, material witness, or missing person.

Avellino may also disclose PHI to appropriate agencies, as required under the law, if it reasonably believes an individual to be a victim of abuse, neglect, or domestic violence. Avellino may also disclose your PHI as required to comply with a subpoena, court or administrative order, or other legal process.

Research

Avellino may disclose PHI for research purposes when an Institutional Review Board or privacy board has reviewed the research proposal and established protocols to ensure the privacy of your PHI and determined that the researcher does not need to obtain your authorization prior to using your PHI for research purposes. Avellino may also disclose information about decedents to researchers under certain circumstances.

Sale

Avellino will never sell your PHI to any third party without your express written consent.

As Required by Law

Avellino may use and disclose your PHI as required by law. For all of the purposes articulated herein, when state or municipal law is more restrictive than federal law, Avellino is required to and will follow the more restrictive law.

Other Uses and Disclosures

Avellino may disclose your PHI for public health-related activities -eg, reporting diseases to authorized public health authorities; public health investigations; or notifying a manufacturer of a product regulated by the U.S. Food and Drug Administration of a possible problem encountered when using the product in Avellino’s testing process.

Avellino may disclose your PHI to a healthcare oversight agency for activities that are authorized by law, such as audits, investigations, inspections, and licensure activities. For example, Avellino may disclose your PHI to agencies responsible for ensuring compliance with the rules of government health programs such as Medicare or Medicaid.

Your Rights Regarding Your Medical Information

Right to Receive Test Information

You, or your authorized or designated personal representative, have the right to inspect and copy the PHI maintained by Avellino. Avellino may deny access to certain information for specific reasons, for example, if the access requested is reasonably likely to endanger the life or safety of you or another person. If your request for information is denied, you may request that the denial be reviewed.

Right to Amend Health Information

You may request amendments to your PHI by making a written request. However, Avellino may deny the request in some cases (such as if Avellino determines that the PHI is accurate), in which case Avellino will provide you with a written explanation of the reason for the denial and additional information regarding further actions that you may take.

Right to an Accounting of Disclosures

You have the right to receive a list of certain disclosures of your PHI made by Avellino in the past 6 years from the date of your written request. Under the law, this does not include disclosures made for purposes of treatment, payment, or healthcare operations or certain other purposes.

Right to Request Restrictions

You have the right to request restrictions on Avellino’s use and disclosure of your PHI. While Avellino will consider all requests for additional restrictions carefully, it is not required to agree to a requested restriction except for payment or operations restrictions where payment has been made “out-of-pocket” and paid-in-full. If Avellino agrees to a requested restriction, you will be notified in writing.

Right to Request Confidential Communications

You have the right to request that Avellino send your health information by alternative means or to an alternative address, and Avellino will accommodate reasonable requests.

Right to a Copy of this Notice

You have the right to obtain a paper copy of this notice upon request.

How to Exercise Your Rights

You may write or send an email to Avellino with your specific request, including requesting a form to complete to obtain a copy of your test results. Avellino will consider your request and provide you a response.

Information Breach Notification

Avellino is required to notify you following the discovery of a breach of unsecured PHI, unless there is a demonstration, based on a risk assessment, that there is a “low probability” that the PHI has been compromised. You will be notified in a timely fashion, no later than 60 days after discovery of the breach.

Complaints/Questions

Note

Avellino reserves the right to change its privacy practices and the terms of this notice at any time, provided such changes are permitted by applicable law. Avellino will promptly post any changes to this notice on its website at www.avellino.com. Please review this website periodically to ensure that you are aware of any updates.

Genetic Data Usage Notice

https://avellino.com/en/privacy/genetic-data-usage

At Avellino Lab USA Inc., we and our affiliates and subsidiaries, (collectively referred to throughout this Notice as “Avellino”) are committed to responsible and respectful stewardship of the data in our custody, including your genetic data. This Genetic Information Usage Notice (the “Notice”) relates only to genetic testing performed by Avellino Lab USA, Inc. and its affiliates and subsidiaries (“Avellino”) that is not clinical diagnostic testing performed by request of a physician. If your physician has ordered a clinical diagnostic test to be performed by Avellino, please refer to our HIPAA Notice of Privacy Practices for information regarding how we use and disclose your protected health information (PHI) related to clinical tests, and your rights with respect to your PHI. This Notice applies only to genetic testing that is not directly related to clinical diagnostic testing, such as general research studies for which an individual has volunteered and provided explicit consent.   Avellino is committed to the protection of individual personal information, including genetic testing information. We believe a better understanding of the links between genes and wellness allows individuals to make educated and proactive choices about their health, and that individuals should have the right to determine how their genetic information is used. This Notice governs the manner in which Avellino collects, uses, maintains, and discloses Genetic Information, as defined below, collected through our testing. By taking one of Avellino’s tests, you signify your acceptance of this Notice. If you do not agree to this Notice, please do not test. At Avellino, we believe that individuals are the sole owners of their Genetic Information and should have the right to determine how the information is used, and that a better understanding of the links between genes, health, and wellness allow individuals to make informed choices about their health. More information regarding your privacy rights can be found in Avellino’s website Privacy Notice.

Definitions

For purposes of this Notice, “Genetic Information” is defined as any data, regardless of format, that results from the analysis of a biological sample from an identifiable individual, or from another element enabling equivalent information to be obtained and concerns genetic material (such as DNA and RNA), including any information extrapolated, derived, or inferred therefrom. Data that is irreversibly deidentified or anonymized, or data that cannot be used to infer specific information about, or otherwise be linked to, a particular individual is not considered Genetic Information within the scope of this Notice.

Information that We Collect and How We Use the Information

Genetic Information is the knowledge that can be derived from the biological sample that you provide us for analysis. You are the sole owner of your personal Genetic Information and have the right to determine how that information is used. We will not use your Genetic Information for any purpose other than to provide diagnostic testing without your prior consent unless it is expressly required or permitted by law. You may also independently share your Genetic Information at your discretion. Please note: At the time of testing, you may have been provided with an Informed Consent agreement. If you have any questions regarding the details of the consent you provided at that time, please refer to the copy of that Informed Consent agreement that was presented to you at that time. Please contact your healthcare provider if you have any questions regarding the documents provided to you at the time of your testing. We do not share your Genetic Information with employers or health insurance providers. US residents are protected under the federal law known as the Genetic Information Nondiscrimination Act (GINA) of 2008, and you may be further protected under laws of various states.  

Information of Minor Children

A parent, guardian or other authorized representative may collect a sample from, create an account for, and provide information related to, a child who is a minor. The parent, guardian or representative is certifying that they have the legal right to collect and provide this Genetic Information to Avellino, and they assume full responsibility for ensuring that the information provided to Avellino or its affiliates about the minor child is accurate. The testing services are not directed to or structured to attract users under 13 years of age. If you are under 13 years of age, do not use the testing services without an adult, and do not send information to Avellino.  

How we Protect Genetic Information

We adopt data collection, storage and processing practices and security measures to protect against unauthorized access, alteration, disclosure, or destruction of Genetic Information.  

Use and Retention of Samples and DNA

Our testing involves extracting DNA from samples to perform diagnostic testing. Your samples and DNA will be retained in accordance with the Informed Consent to which you agreed at the time of testing, unless applicable law requires that the samples be destroyed sooner. Information derived from those samples, such as test results, genetic sequencing data, or other related information may be retained for as long as permitted by law.

Transfer of Genetic Information in the Event of Acquisition

Your agreement to this Notice includes your consent to the transfer of your Genetic Information to any entity that may acquire Avellino or its assets, either directly or indirectly, and to any parent, affiliate, or subsidiary of Avellino. Depending on the terms of the Informed Consent to which you agreed, your data – in either anonymized or deidentified form – may be transferred to third parties for use in research and development of new technologies and diagnostic procedures. Please refer to the Informed Consent agreement for more details regarding how we anonymize or deidentify your data and how you may rescind any previously granted consent.  

Governing Law; Dispute Resolution

This Notice will be governed by and construed in accordance with the laws of the State of California, USA, without regarding to conflicts of law principles. Any matters that arise that cannot be resolved will be resolved by final and binding arbitration with the American Arbitration Association, through a single arbitrator in Menlo Park, California. YOU ACKNOWLEDGE AND AGREE THAT YOU ARE HEREBY WAIVING YOUR RIGHTS TO HAVE YOUR CASE DECIDED BY A JURY AND TO PARTICIPATE IN A CLASS, MASS, REPRESENTATIVE, PRIVATE ATTORNEY GENERAL, OR CONSOLIDATED ACTION AGAINST US.  

Changes to this Notice

We may, in our sole discretion, revise this Notice at any time and from time to time. Your continued use of the testing services following the posting of revisions to this Notice will be deemed your acceptance of such revisions. You acknowledge and agree that it is your responsibility to review this Notice periodically. The date at the bottom of this Notice will be updated for each revision.  

Contacting Us

If you have any questions about this Notice or our testing services, please contact us at: Avellino Lab USA, Inc. 1505 Adams Drive, Suite B2 Menlo Park, CA 94025 privacy@avellino.com Last Updated: [________]