THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN ACCESS THIS INFORMATION. PLEASE READ CAREFULLY.
Monogram Biosciences, Inc. ("Monogram"), a world leader in individualized medicine for people with HIV and cancer, is committed to protecting the privacy of the personal and health information of its customers. Monogram is committed to protecting the confidentiality of our laboratory test results and other patient-protected health information (PHI) that we collect or create as part of our diagnostic testing activities.
Please read this Notice of Privacy Practices carefully so that you will understand both our commitment to the privacy of your PHI, and how you can participate in that commitment. Should you have any questions about this Notice or our privacy practices, please call us at (650) 635-1100, via e-mail to HERmarkfirstname.lastname@example.org, or write to us at the following address:
Monogram Biosciences, Inc.
Attention: Privacy Compliance Officer
345 Oyster Point Blvd.
South San Francisco, CA 94080
Monogram is required by law to provide you with this Notice of Privacy Practices with respect to PHI, to maintain the privacy of PHI, to state the uses and disclosures of PHI that Monogram may make, and to list the rights of individuals and our legal duties with respect to their PHI. Your PHI at Monogram includes personal and medical information (such as your name, address, social security number, date of birth, etc.) that we obtain from you, your physician, health plan, or other sources related to the test services requested. Your PHI also includes any laboratory testing results that we create.
Monogram will abide by the terms of this Notice of Privacy Practices currently in effect. We reserve the right to change the terms of this Notice of Privacy Practices and to make the provisions of the new Notice of Privacy Practices effective for all PHI that we maintain. We will maintain this Notice on our Web site and a hard copy is available upon request.
How We Use and Disclose Protected Health InformationYour PHI will be used or disclosed for treatment, payment, or healthcare operations purposes and for other purposes permitted or required by law. Not every use or disclosure is listed; however, all of the ways we use or disclose your PHI fall into one of the broader categories listed below.
If we intended to use or disclose your PHI for other purposes, we would need your written authorization. For example, patient authorization is often required by state law for each release of HIV drug resistance test results, except if the results are being released to public health officials as required by law. You have the right to revoke your authorization at any time, except if we have already made a disclosure based on that authorization. We do not need authorization or permission to use or disclose your PHI for the following purposes:
For TreatmentAs a healthcare provider that provides laboratory testing for ordering physicians, Monogram uses PHI as part of our testing process and discloses your PHI to physicians and other authorized healthcare professionals who need access to your laboratory results in order to treat you. In addition to your treating physician, we may provide a specialist or consulting physician with information about your results. Occasionally, we may also contact you or your physician to arrange to redraw a specimen.
For PaymentWe will use your PHI in our billing and accounts receivable departments and disclose your PHI to insurance companies, hospitals, physicians, other referring laboratories and health plans for payment purposes, or to third parties to assist us in creating bills, claim forms, cashing checks or getting paid for our services. For example, we may send claim information including name, test performed, diagnosis code, ordering physician and other information as requested to a health plan so that the plan will reimburse us for the services provided. We may have to contact you and/or your physician in order to obtain information for billing and collection purposes. We may use an outside collection agency to obtain payment.
For Internal UsesWe may use or disclose your PHI in the course of activities necessary to support our laboratory operations, such as development and validation of our assays, performing quality checks on our testing, for teaching purposes, or for developing normal reference ranges for tests that we perform. We may also use PHI for purposes of research and development as approved by our Privacy Board.
Disclosures to Business AssociatesMonogram may disclose your PHI to other companies or individuals who need your PHI in order to provide specific services to us. These other entities, known as "business associates," must comply with the terms of a contract designed to ensure that they will maintain the privacy and security of the PHI we provide to them or which they create on our behalf. Our business associates must only use your PHI for designated treatment, payment, or healthcare operations purposes that they perform on our behalf. For example, we may disclose your PHI to temporary employees or to the College of American Pathologists (CAP) or other private accrediting organizations that inspect and certify the quality of our laboratories.
As Permitted or Required by LawWe may use or disclose your PHI for various public policy purposes that are authorized or required by federal or state law. For example, we are required to disclose your PHI to the Secretary of the US Department of Health and Human Services ("HHS") upon request. We must provide you with copies of your PHI at your request, except where restricted or prohibited by state law. We will provide the information regarding your specific state to you upon request.
Public HealthPHI may be disclosed in reporting communicable disease results to public health departments as required by law. We may disclose your PHI for FDA reporting purposes.
Public SafetyIn certain circumstances, we may also use or disclose PHI to prevent or lessen a serious and imminent threat to the health or safety of a person or the public.
To Avert a Serious Threat to Health or SafetyWe may use or disclose your PHI if necessary to prevent a serious threat to your health and safety or that of another person or the general public.
Health OversightWe may disclose your PHI in connection with governmental oversight, licensure, auditing, and other purposes. For example, governmental agencies periodically review our records to ensure that Monogram is complying with the rules of various regulatory and licensing agencies, including HHS and various state Health Departments. Other agencies may audit our billing and laboratory records to verify that the healthcare was provided as claimed or that we were paid correctly.
Judicial and Administrative ProceedingsWe may disclose your PHI as required to comply with court orders, discovery requests or other legal process in the course of a judicial or administrative proceeding.
Law Enforcement/Governmental AgenciesWe may also disclose PHI for law enforcement purposes. For example, we may be required to release PHI as required by law or in compliance with a court order, judicial subpoena, court-ordered warrant, grand jury subpoena, administrative request, investigative demand or similar legal process, but only if efforts have been made to tell you about the request or to obtain an order of protection for the requested information. We may release PHI for other law enforcement purposes, such as to identify or locate a suspect, fugitive, material witness, or missing person. We may disclose your PHI for military and veterans activities, national security or intelligence purposes, or to correctional institutions, or to law enforcement officials having custody of an inmate.
Workers CompensationWe may disclose your PHI as necessary to comply with requirements of workers' compensation or similar programs that provide benefits for work-related injuries or illness without regard to fault. For example, workers compensation programs may require that we provide the results of laboratory testing as part of the case file.
State LawFor all of the above purposes, in situations where the laws of any state in which we provide services are more restrictive than applicable federal law, we are required to follow the more restrictive state law. For example, some states require physician authorization to release laboratory test results to patients, and other states prohibit a laboratory from releasing test results directly to a patient.
We may contact you for specific reasonsAlthough we do not do so today, we may want to contact you in the future regarding health-related products or services that may be of interest to you.
Your rights concerning privacy and confidentiality
AccessYou and/or your authorized or designated personal representative have the right to inspect and copy your PHI. Monogram will deny access to certain information for specific reasons, such as cases where state law and/or CLIA regulations prohibit such patient access.
AmendmentsYou have the right to request amendments to your PHI (but we are not required to make the requested amendments).
AccountingYou have the right to receive an accounting of disclosures, if any, of your PHI that were made by Monogram for a period of up to six years prior to the date of your written request, but not including any disclosures of your PHI made prior to April 14, 2003, when the Privacy Rule went into effect. Under the law, this accounting does not include disclosures made for purposes of treatment, payment, healthcare operations, or certain other excluded purposes, but includes other types of disclosures of your PHI, including disclosures for public health reporting or in response to a court order.
RestrictionsYou have the right to ask us if we will agree to restrictions on certain uses and disclosures of your PHI, but we are not required to agree to your request.
Confidential CommunicationsYou have the right to request that we send your PHI to an alternate address, but we are not required to agree to your request.
Notice of Privacy PracticesYou have the right to request a paper copy of this Notice.
ComplaintsIf you believe your privacy rights have been violated, please contact us at the address located at the beginning of this Notice. You also have the right to register a complaint with Monogram or the Secretary of the US Department of Health and Human Services. We will not retaliate against any individual for filing a complaint.
Exercising Your RightsWrite to us with your specific written request and be sure to include sufficient information for us to identify all of your records. We will consider your request and provide a response within a reasonable timeframe. Should we deny your request, you have the right to ask for the denial to be reviewed by another healthcare professional designated by Monogram.
How To Contact UsIf you have questions or concerns regarding the privacy or confidentiality of your PHI, or you wish to register a complaint, please write us at the address located at the beginning of this Notice.
Monogram reserves the right to amend this Notice of Privacy Practices at any time, to reflect changes in our privacy practices. These changes will apply retroactively. Any such changes will be applicable to and effective for all Protected Health Information (PHI) that we maintain including PHI we created or received prior to the effective date of the Notice revision.