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Counsyl Notice of Privacy Practices for Protected Health Information

THIS NOTICE APPLIES TO OUR U.S. CUSTOMERS ONLY AND DESCRIBES HOW MEDICAL INFORMATION ABOUT OUR U.S. CUSTOMERS MAY BE USED AND DISCLOSED AND HOW U.S. CUSTOMERS CAN GET ACCESS TO THIS INFORMATION. PLEASE REVIEW IT CAREFULLY.

The purpose of this notice is to assist you in understanding our practices, specifically regarding your protected health information ("PHI"), so that you can make an informed choice about using Counsyl's products, websites or services (hereafter, the "Site" "Service" or "Services"). We are required by law to abide by the terms of the Notice of Privacy Practices ("Notice") currently in effect.

To understand our comprehensive privacy practices as they apply to you, please also read our Privacy and Security Policy. By accessing the Sites, transmitting information to us electronically or in hard copy, or by otherwise using our Services, you accept and agree to be bound and abide by the terms of this Notice and our other policies, found at this link, and incorporated herein by reference. We take your privacy very seriously -- if you have any questions, please contact us at privacy@counsyl.com or refer to other methods of contact described further below.

What is "PHI"?

PHI is any information that may identify you and:

  • Is created or received by a healthcare provider, health plan, employer, or healthcare clearinghouse; and
  • Relates to your past, present, or future physical or mental health or condition; or
  • Relates to the provision of healthcare products and services to you; or
  • Relates to your past, present, or future payment for the provision of healthcare to you.

Who must follow this Notice?

Counsyl provides you healthcare services by processing your samples to provide a result in the form of a laboratory report ("Report") and by helping you understand the content of the Report through Counsyl's genetic counseling ("GC") services. This is a joint notice of our information privacy practices ("Notice"). The following people or groups will follow this Notice:

  • any health care provider who provides services to you at or from Counsyl's locations (these professionals include genetic counselors and others);
  • all departments and units of our organization; and
  • our employees, contractors, and volunteers, including regional support offices and affiliates. These entities, sites, and locations may share medical information with each other for treatment, payment, or health care operations purposes described in this Notice.

In addition, we also use and share your information for other reasons as allowed and required by law. If you have any questions about this Notice, please see our contact information on the last page of this Notice.

How does Counsyl use or share my PHI?

You agree that we may use your PHI for the purposes detailed below and any other permissible use or disclosure not listed. When required by law to seek your prior authorization to use or disclose your PHI, we will ask for your written or electronic authorization. You may later revoke that authorization by notifying us in writing of your decision.

We will abide by any federal or state laws that require us to afford certain types of PHI, such as genetic information, with special confidentiality protections. Please note, however, that we may disclose your information as required by law. We encourage you to read your doctor and other health care providers' Notice of Privacy Practices, as they may have different practices or notices about their use and sharing of medical information than Counsyl.

  • To provide our Services. We will use and share your PHI to provide you with our Services, including price estimates and customer support, to perform our genetic tests ("Tests"), to provide Reports and the underlying results to you, your doctor, or your authorized representatives, and to coordinate other services you receive through us, including GC services.

Example: Our lab technicians use your PHI to create your Counsyl Report and notify you and your doctor when it is available to view.

  • To perform and improve our Services. We will use and share your PHI to, among other things, assist with your healthcare provider's operations to facilitate the provision of healthcare services, improve and develop new screenings and other services, provide customer service when you have questions about your billing, results, or otherwise, and to run and improve our organization. We may share your PHI with your healthcare provider by discussing your Report with them or by processing claims for payment.

Example: We use your PHI for internal controls to improve our genetic tests.

  • For billing. We use and share your PHI to bill and receive payment from health plans or other entities that pay for all or part of our Services. Please note, if you pay for our Services outside of your health insurance plan, we will not share any PHI with your insurer, except as required by law.

Example: When your health insurance plan pays for Services, we give them PHI about you so it knows the tests for which it is required to pay Counsyl.

  • For research. We may also choose to use your PHI internally and share your PHI with organizations that support medical research or that find, investigate, or cure diseases. To do this, we will either ask your permission to use your PHI or we will use standard de-identification practices to de-identify your PHI before it is disclosed.

Example: We participate, when appropriate, in providing genetic data to the National Center for Biotechnology Information ("NCBI") ClinVar database, which improves the quality of information available to interpret genetic screens.

  • To share with a designated recipient. We may disclose PHI about you to a friend, relative, or family member whom you designate. Additionally, we may use or disclose your PHI to such an individual when we can reasonably infer that you do not object to the disclosure – such as when this individual is present when we are discussing your PHI with you.

Example: If you and your partner consent to perform a joint genetic test or later decide to merge your results, we will share the test results with both of you (as well your respective healthcare providers). Depending on when either you or your partner take your Test, the Report may be available to one or both of you and your healthcare providers.

  • To Business Associates. We may contact third parties to perform certain services for us, such as billing or consulting services. Some of these third parties are considered "Business Associates" and may require access to your PHI to perform services for us. Business Associates are required by law and by contract to provide adequate safeguards for your PHI, and only use and disclose it as necessary to perform their services to us.

  • For a business transaction. We may share your PHI as a part of a business transaction, such as a merger or acquisition of all or part of our business. In the event this happens, your PHI will still be afforded the same or similar protections contained in this Notice.

  • To avert a serious threat to health or safety. In our discretion we may share your PHI if we deem it is necessary to use and disclose your PHI to prevent a serious threat to your health and safety or the health and safety of the public or another person.

  • For public health activities. Counsyl may disclose your PHI for the following public health activities to: (1) prevent or control disease, injury or disability; (2) report births and deaths; (3) report regarding the abuse or neglect of children, elders and dependent adults; (4) report reactions to medications or problems with products; (5) notify people of recalls of products they may be using; (6) notify a person who may have been exposed to a disease or may be at risk for contracting or spreading a disease or condition; and (7) notify emergency response employees regarding possible exposure to HIV/AIDS, to the extent necessary to comply with state and federal laws.

  • For health oversight activities. We may disclose your PHI to a health oversight agency for activities authorized by law. These oversight activities include, for example, audits, investigations, inspections, and licensure. These activities are necessary for the government to monitor the health care system, government programs, and compliance with civil rights laws.

Example: The Department of Health and Human Services or similar state-level public agency may require use to share your PHI for purposes such as an audit, inspection or investigation.

  • For lawsuits and other legal disputes. We may use and disclose PHI in responding to a court or administrative order, a subpoena, or a discovery request. We may also use and disclose your PHI to the extent permitted by law without your authorization, for example, to defend against an allegation, lawsuit, or arbitration if we believe, after due consideration, that doing so is reasonably necessary to comply with a law, regulation, subpoena, discovery request or other valid legal process, whether instituted by you or someone else.
  • To law enforcement officials. We may disclose your PHI to the police or other law enforcement officials as required or permitted by law, including, but not limited to: (1) in response to a court order, subpoena, warrant, summons or similar process; (2) to identify or locate a suspect, fugitive, material witness, or missing person; (3) about the victim of a crime if, under certain limited circumstances, we are unable to obtain the person's agreement; (4) about a death we believe may be the result of a criminal conduct; (5) about criminal conduct at Counsyl; or (6) in emergency circumstances to report a crime; the location of the crime or victims; or the identity, description or location of the person who committed the crime.
  • Decedents. We may disclose your PHI to medical examiners, funeral directors or coroners so that they may carry out their duties, as authorized by law.
  • Example: We may share your PHI with a medical examiner so that they can identify a deceased person or determine the cause of death.

What rights apply to PHI?

You have the following rights relating to your PHI:

Right to receive an electronic or paper copy of your PHI. A copy of your test results may be downloaded from your account. If you prefer that we send you a paper copy, or would like to receive any other PHI from us, please contact Privacy at privacy@counsyl.com.

Right to access and modify your health record. You may modify, update or correct PHI pertaining to you from your account on counsyl.com. If you believe that we have collected any PHI about you that is incorrect or incomplete, or that you cannot modify in your account, please contact Client Services at support@counsyl.com for assistance.

Right to request confidential communications. You may ask us to contact you at a specific phone number or to send mail to a specific address. We will agree to all reasonable requests.

Right to ask us to limit what we use or share. You may ask us not to use or to share certain PHI for treatment, payment, or other operations by sending a written request to the Privacy Officer. The Privacy Officer's contact information can be found at the bottom of this Notice.

Please note, we are not required to agree to your request and we may refuse if it would affect your care or our ability to be paid for the services we provide you.

Billing: If you pay for your Services outside of your healthcare policy, we will not share the test results with your health insurer unless we have a legal obligation to do so.

Research: If you prefer not to have any PHI about you used in research, you may request this by contacting Client Services at support@counsyl.com. Please note, in some cases where your PHI was already used in a completed study it may not be possible to withdraw your information from the completed study, though we will be able to remove your information from future research use.

Right to an accounting. You can ask for a list of identifying when we have shared your PHI, for six years prior to the date of your request, with whom we shared it, and for which purposes. We will include all the disclosures except for those about treatment, payment, and health care operations, and certain other disclosures (such as any you asked us to make). We will provide one accounting a year for free but will charge a reasonable, cost-based fee if you ask for another one within 12 months.

Right to a copy of this privacy notice. You can ask for a paper copy of this notice at any time, even if you have agreed to receive the notice electronically. Please request a copy from our Client Services at support@counsyl.com and we will promptly provide you with a paper copy.

Right to choose someone to act for you. If you have given someone medical power of attorney or if someone is your legal guardian, that person can exercise your rights and make choices about your PHI. We will take reasonable steps to confirm that the person has this authority and can act for you before we take any action.

What are Counsyl's duties with regard to my PHI?

The Health Insurance Portability and Accountability Act ("HIPAA") requires Counsyl to:

  • Make reasonable efforts not to use, disclose, or request more than the minimum amount of PHI necessary to accomplish the intended purpose of the use, disclosure, or request, taking into consideration practical and technological limitations;
  • Maintain the privacy of your PHI;
  • Provide you with notice of our legal duties and privacy practices with respect to your PHI; and
  • Notify you following a breach of your unsecured PHI.

How do I make a complaint?

If you are concerned that we have violated your privacy rights, you may contact us by email at privacy@counsyl.com,by written letter or by telephone: Privacy Officer, Counsyl, Inc., 180 Kimball Way, South San Francisco, CA 94080; 1-888-COUNSYL (1-888-268-6795).

If you are not satisfied with your response, you may file a written complaint with the U.S. Department of Health and Human Services Office for Civil Rights by sending a letter to 200 Independence Avenue, S.W., Washington, D.C. 20201, calling 1-877-696-6775, or visiting www.hhs.gov/ocr/privacy/hipaa/complaints/.

We will not retaliate against you for making a complaint with us or the Office of Civil Rights.

Will this Notice ever change?

We may change our policies at any time and the changes will apply to PHI we already hold, as well as new information we receive about you after the change occurs. Before we make a significant change, we will post the new notice on our website at counsyl.com/policies.

How do I contact Counsyl?

If you have any questions or comments, please do not hesitate to contact us in writing, via e-mail or phone call at:

Privacy Officer Counsyl, Inc. 180 Kimball Way South San Francisco, CA 94080

1-888-COUNSYL (1-888-268-6795)

privacy@counsyl.com

This notice is effective: August 24, 2017.

Counsyl has renamed its products effective July 19, 2017. The Family Prep Screen is now the Foresight Carrier Screen. The Informed Pregnancy Screen is now the Prelude Prenatal Screen. The Inherited Cancer Screen is now the Reliant Cancer Screen.

The new names now appear on all communications from Counsyl. If you have any questions, please contact Counsyl directly.

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