For patients based in the outside of the US, including the EU, please visit our Ariosa Privacy Notice for additional information about how your personal information will be used and processed for the Harmony Prenatal Test.

Ariosa Diagnostics Privacy Notice - Updated May 2018

Notice of Patient Privacy Practices

This Notice of Privacy Practices (“Notice”) is effective October 15, 2014.
We are required by the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) to maintain the privacy of health information about you and to provide you with this Notice of our legal duties and Privacy Practices.
We understand the importance of privacy and are committed to maintaining the confidentiality of your health information. We make a record of your health information, such as the clinical laboratory test results we produce, and we may obtain records related to your medical care from others. We use these records to provide or enable other health care providers to provide quality medical care, to obtain payment for services provided, and for administrative and operational purposes. When we use or disclose your health information, we are required to abide by the terms of this Notice (or other notice in effect at the time of the use or disclosure) and to comply with HIPAA.


Ariosa Diagnostics’ (“Ariosa”) Privacy Officer is the contact person for all issues and complaints regarding your health information and privacy rights. If you have any questions or concerns about this Notice, please contact the Corporate Privacy Officer at:

U.S. Mail and Overnight Delivery: Ariosa Diagnostics
ATTN: Privacy Officer
5945 Optical Court
San Jose, CA 95138
Phone 1-855-9-ARIOSA (855-927-4672)
International Phone: +1 925-854-6246


This Notice describes health information Privacy Practices followed by the members of Ariosa’s workforce.


This Notice applies to the information and records and other health information about you maintained by Ariosa, as required by laws governing clinical laboratories, related to laboratory results performed and reported on your behalf by Ariosa. Your health information may include information received or created by Ariosa, may be in the form of written or electronic records or spoken words, and may include information about your health history, test results, related billing activity, and any similar types of health-related information about you.

We are required by law to give you this Notice. This Notice provides a summary of the ways we may use and disclose health information about you, and describes your rights and our obligations regarding the use and disclosure of that information. As used in this Notice, “you” and “your” refer to you as the individual receiving services provided by Ariosa.
For simplicity, we will refer to all of this information throughout this Notice as “Your Health Information.”


The following is a summary of the purposes for which Ariosa may use and disclose Your Health Information. Not every type of use or disclosure is listed, but the general ways in which Ariosa uses and discloses Your Health Information will fall under these purposes.
Uses and Disclosure for Treatment, Payment, and Health Care Operation. We may use and disclose Your Health Information for the following purposes:
Treatment: We may use and disclose Your Health Information to provide you with care and with others involved in your care, including doctors, therapists, and other health care professionals.
For example: We are required by law to provide your Ariosa laboratory results to the healthcare practitioner who ordered the testing for you. We may also need to give your other treating healthcare professionals your Ariosa lab results so they can interpret and properly diagnosis and treat your medical condition.
Payment: We may use and disclose Your Health Information to bill and collect payment from you, your insurance company, or other responsible third party for the lab testing services you receive from Ariosa.
For example: We may need to provide your health plan with Your Health Information about laboratory testing services you received from Ariosa so your health plan will pay us or reimburse you for those services. We may also inform your health plan about specific lab testing that your treating healthcare practitioner has ordered for you to obtain approval, or to determine whether your plan will pay for the testing.
Health Care Operations: We may use and disclose Your Health Information for our own operations and quality assurance processes.
For example: We may use Your Health Information to evaluate internally the performance of our laboratory services. We may use Your Health Information to improve our efficiency and quality of care.

Uses and Disclosures of Your Health Information Without Your Authorization. We may use and disclose Your Health Information without an authorization as may be required or permitted by law. We have to meet many conditions in the law before we may use or disclose health information for these following purposes, however:

  • To Avert a Serious Threat to Health or Safety: We may use and disclose health information about you when we believe disclosure is necessary to prevent or lessen a serious and imminent threat to someone’s health and safety.
  • Required by Law: We will disclose health information about you when required to do so by federal, state, or local law.
  • Research: Under very limited circumstances and with your specific consent as required by law, we may use and disclose health information about you for medical research.
  • Special Government Functions: We may be required to use or disclose Your Health Information for special government functions, such as military and veterans, national security, protective services for the President, and law enforcement.
  • Worker’s Compensation: We may disclose Your Health Information for worker’s compensation or similar programs. These programs provide benefits for work-related injuries or illness.
  • Public Health Activities: We may be required to use and disclose Your Health Information for certain public health activities, such as to prevent or control disease, injury, or disability; report disease, injury, and vital events (such as birth or death); assist with the public health surveillance, investigations, and interventions; report adverse events and product defects; help with product recalls; and notify a person who may be at risk of getting or spreading a disease.
  • Health Oversight Activities: We may disclose Your Health Information to a health oversight agency for activities authorized or required by law, such as audits, investigations, or licensure or disciplinary actions.
  • Lawsuits and Disputes: We may disclose Your Health Information for lawsuits and legal actions, such as in response to court or administrative orders, subpoenas, discovery requests, and other lawful processes.
  • Law Enforcement: We may disclose Your Health Information to a law enforcement official for certain law enforcement purposes including: as required by law; for reporting of certain types of injuries; as required by a court order, subpoena, warrant, summons, or similar process; and, in limited situations, about a person who is a victim of a crime.
  • Coroners, Medical Examiners, and Funeral Directors: We may disclose Your Health Information to coroners or medical examiners for purposes of identifying a deceased person, determining cause of death, or their other duties. We may disclose Your Health Information about you to funeral directors, as permitted by law, as necessary for them to carry out their duties.
  • Information Not Personally Identifiable and Limited Data Sets: We may use and disclose Your Health Information about you in a way that does not personally identify you by removing certain identifiers (such as name and address) making it unlikely that you could be identified. We also may disclose limited health information, contained in a “limited data set,” as allowed by law.
  • To Report Abuse, Neglect, or Domestic Violence: We may notify government authorities if we believe someone is the victim of abuse, neglect, or domestic violence. We will make this disclosure only when specifically required or authorized by law or when the individual agrees to the disclosure.
  • To Business Associates: We may disclose Your Health Information with our contractors who create, receive, maintain, or transmit health information for certain activities on behalf of Ariosa. All these business associates must agree to safeguard Your Health Information.
  • Incidental Disclosures: Incidental disclosures of Your Health Information may occur as a by-product of permitted uses and disclosures.
  • Determination of Compliance: We may disclose Your Health Information with the Secretary of the Department of Health and Human Services for purpose of determining Ariosa’s compliance with any of the HIPAA rules.
  • Personal Representatives: Minors and incapacitated adults may have “personal representatives.” These personal representatives may be able to act on the individual’s behalf and exercise the individual’s privacy rights

Uses and Disclosures of Health Information If You Do Not Object. Unless you object in writing, Ariosa may use and disclose health information about you in the following situations:

  • Individuals Involved in Your Care: We may disclose, to a family member, friend, or other person you designate, who is involved in your health care or the payment for your health care, Your Health Information that is directly relevant to that person’s involvement.
  • Notification Purposes: We may use and disclose Your Health Information directly, or to an entity assisting in a disaster relief effort, so that your family, your personal representative, or another person responsible for your care can be notified about your condition.

We will not disclose Your Health Information for any purpose other than those identified in the previous sections without your specific written authorization. We generally will not sell Your Health Information about you or use or disclose health information for marketing. If you give us authorization to use or disclose Your Health Information, you generally may revoke that authorization, in writing, at any time. If you revoke the authorization, we will no longer use or disclose Your Health Information for the reasons covered by your written authorization, but we cannot take back any uses or disclosures already made with your permission. We are required to retain our records of the care that we provided to you.
Of note, we will need specific written authorization from you in order to disclose certain types of certain types of protected information about you, such as information related to genetic testing, mental health, AIDS/HIV, and substance abuse. Further, raw sequence data will not be included in your request for Your Health Information. We will produce a copy of the raw sequence data upon separate request and require an appropriate fee.

You have the following rights regarding Your Health Information maintained by Ariosa. To exercise any of these rights, please contact our Chief Compliance Officer:

1. Right to Inspect and Copy: You have the right to inspect and get a paper or electronic copy of certain of Your Health Information that we keep and use to make decisions about your care. You must submit your request in writing. We may charge a reasonable cost-based fee for copying, mailing, or associated supplies. We may deny your request to inspect or obtain copies of Your Health Information in certain limited circumstances, however. If you are denied copies of or access to health information that we keep about you, you may ask that our denial be reviewed. If the law gives you a right to have our denial reviewed, we will select a licensed health care professional to review your request and our denial. The person conducting the review will not be the person who denied your request, and we will comply with the outcome of the review.

2. Right to Amend: If you believe Your Health Information maintained by Ariosa is incorrect or incomplete, you may ask us to amend that information. You have the right to request an amendment as long as the health information is kept by us. You must submit your request in writing and provide a reason to support the request.

We may deny your request, however, if you ask us to amend information that:

  • We did not create, unless the person or entity that created the information is no longer available to make the amendment.
  • Is not part of the health information that we keep.
  • You would not be permitted to inspect and copy.
  • Is accurate and complete.


3. Right to an Accounting of Disclosures: You have the right to request an accounting of disclosures Your Health Information. This is a list of the disclosures that we make of Your Health Information for purposes other than treatment, payment, health care operations, and a limited number of special circumstances involving national security, correctional institutions, and law enforcement. The list also will exclude any disclosures we have made based on your written authorization.

Your request should state a time period, not longer than six (6) years. Your request should indicate in what form you want the list (for example, on paper, electronically, etc.). The first list you request within a 12-month period will be free. For additional lists, we may charge you a reasonable cost-based fee for preparing and providing that list. We will notify you of the cost involved and you may choose to withdraw or modify your request at that time before any costs are incurred.

4. Right to Request Restrictions: You have the right to request a restriction or limitation on any of Your Health Information that we use or disclose about your treatment, payment, or health care operations. You have the right to request a limit on Your Health Information that we disclose about you to someone who is involved in your care or the payment for your health care, such as a family member or friend.
Except as required by law, we are not required to agree to your request. If we do agree, we will comply with your request unless the information is needed to provide you emergency treatment or we are required by law to disclose the information. Upon receipt of your written request, we will agree not to disclose to a health plan information about services for which you pay out-of-pocket in full, subject to certain exceptions.

5. Right to Confidential Communication: You have the right to request that we communicate with you about medical matters a certain way or at a certain location. For example, you may ask that we only contact you at work or by mail. We will not ask you the reason for your request. We will try to accommodate all reasonable requests. Your request must be in writing and specify how or where you wish to be contacted.

6. Right to a Paper Copy of this Notice: You have the right to a paper copy of this Notice. You may ask us to give you a copy of this Notice at any time. Even if you have agreed to receive it electronically, you are still entitled to a paper copy.


We reserve the right to change this Notice and to make the revised Notice effective for health information we have about you as well as any health information we create or receive in the future. We will post the current Notice on our website and at our laboratory offices with its effective date in the top right hand corner.


If you believe your privacy rights have been violated, you may file a complaint with our Chief Compliance Officer or with the Secretary of the Department of Health and Human Services. You will not be penalized or retaliated against by Ariosa for filing a complaint.


We are required by law to: maintain the privacy of health information, provide to you this Notice of our duties and privacy practices with respect to Your Health Information, follow this Notice as may be amended from time to time, and notify affected individuals following a breach of unsecured health information.


The Harmony prenatal test was developed by Ariosa Diagnostics, a CLIA-certified laboratory. As with other laboratory-developed tests, it has not been cleared or approved by the FDA and is not available for sales as an IVD in the U.S. Non-invasive prenatal testing (NIPT) based on cell-free DNA analysis is not diagnostic; results should be confirmed by diagnostic testing.

ARIOSA, the Ariosa Logo, ARIOSA DIAGNOSTICS, the Ariosa Diagnostics Logo, HARMONY PRENATAL TEST and HARMONY are trademarks of Roche.

All other trademarks are the property of their respective owners.