NOTICE OF PRIVACY PRACTICES
THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN GET ACCESS TO THIS INFORMATION. PLEASE REVIEW IT CAREFULLY.
CLARIENT, Inc. ("CLARIENT") is required by law to maintain the privacy of your protected health information and to provide you with a notice of our legal duties and privacy practices with respect to protected health information. This Notice of Privacy Practices ("Notice") describes how we may use and disclose your protected health information 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. "Protected health information" or "PHI" is information about you, including basic demographic information, that may identify you and that relates to your past, present or future physical or mental health or condition and related health care services.
We are required to follow the terms of this Notice of Privacy Practices. We will not use or disclose your protected health information without your written permission, except as described in this Notice. We reserve the right to change our practices and this Notice as and to the extent permitted by law and to make the new Notice effective for all protected health information we maintain. Upon your request, we will provide you with a revised Notice.
Examples of How We Use and Disclose Protected Health Information About You
Subject to applicable state law, a summary of which is appended to this Notice, the following categories describe different ways that we use and disclose your PHI.
Treatment: We may use your health information to provide and coordinate the treatment and services you receive. For example, we may use your information to perform diagnostic tests, or provide your test results to your physician.
Payment: We may use and disclose your health information to others for purposes of receiving payment for treatment and services that you receive. For example, we will submit a claim to you or your health plan/insurer that includes information that identifies you and the type of services we performed for you.
Health Care Operations: We may use or disclose your PHI in order to support the operations of our laboratories and monitor the quality of the care we provide. For example, we may use information in your health record to evaluate the services our laboratories provide or to train our staff. In addition, we may contact you as part of a fundraising effort.
Subject to applicable state law, in some limited situations we may be permitted or required to use or disclose your health information for purposes beyond treatment, payment, and operations, including as set forth below.
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 directly relevant to that person's involvement in your care or payment related to your care.
Business Associates: There are some services provided by CLARIENT through contracts with business associates (e.g., billing services), and we may disclose your PHI to our 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 appropriately safeguard your information.
Food and Drug Administration (FDA): We may disclose to the FDA, or persons under the jurisdiction of the FDA, PHI relative to adverse events with respect to drugs, foods, supplements, products and product defects, or post marketing surveillance information to enable product recalls, repairs, or replacement.
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.
Public Health: As required by law, we may disclose your PHI to public health or legal authorities charged with preventing or controlling disease, injury, or disability.
Law Enforcement: We may disclose your PHI for law enforcement purposes as permitted by law or in response to a valid subpoena or court order.
As Required by Law: We will disclose your PHI when required to do so by federal, state, or local law.
Health Oversight Activities: We may disclose your PHI to an oversight agency for activities authorized by law. These oversight activities include audits, investigations, and inspections necessary for licensure and for the government to monitor the health care system, government programs, and compliance with civil rights laws.
Judicial and Administrative Proceedings: If you are involved in a lawsuit or a dispute, 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 by someone else involved in the dispute, 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: We may disclose your PHI to researchers when their research has been approved by an institutional review board or privacy board that has reviewed the research proposal and established protocols to ensure the privacy of your information.
Coroners, Medical Examiners, and Funeral Directors: We may release 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 PHI to funeral directors consistent with applicable law to enable them to carry out their duties.
Organ or Tissue Procurement Organizations: Consistent with applicable law, we may disclose your PHI to organ procurement organizations or other entities engaged in the procurement, banking, or transplantation of organs for the purpose of tissue donation and transplant.
Notification: We may use or disclose your PHI to notify or assist in notifying a family member, personal representative, or another person responsible for your care, regarding your location and general condition.
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 when necessary to prevent a serious threat to your health and safety or the health and safety of the public or another person.
Military and Veterans: If you are a member of the armed forces, we may release PHI about you as required by military command authorities. We may also release PHI about foreign military personnel to the appropriate foreign military authority.
National Security, Intelligence Activities, and Protective Services for the President and Others: We may release PHI about you to authorized federal officials for intelligence, counterintelligence, protection to the President, and other national security activities authorized by law.
Victims of Abuse or Neglect: We may disclose PHI about you to a government authority if we reasonably believe you are a victim of abuse or neglect. We will only disclose this type of information to the extent required by law, if you agree to the disclosure, or if the disclosure is allowed by law and we believe it is necessary to prevent serious harm to you or someone else.
Other Uses and Disclosures of PHI
We will obtain your written authorization before using or disclosing your PHI for purposes other than those provided for above (or as otherwise permitted or required by law). 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.
Your Health Information Rights
Obtain a paper copy of the Notice upon request. You may request a copy of our current Notice at any time from the Privacy Officer. Even if you have agreed to receive the Notice electronically, you are still entitled to a paper copy.
Request a restriction on certain uses and disclosures of PHI. You have the right to request additional restrictions on our use or disclosure of your PHI by sending a written request to Clarient's Privacy Officer. We are not required to agree to those restrictions.
Inspect and obtain a copy of PHI. By law, a patient generally has the right to access and copy his/her PHI. However, PHI that is maintained by entities that are subject to the Clinical Laboratory Improvement Amendments of 1988 ("CLIA") is specifically exempted from the right to access, to the extent the provision of access to the patient would be prohibited by law. Since CLARIENT is subject to CLIA, the applicable state law provisions, a summary of which are appended to this Notice, may restrict your right to access and copy your PHI. If state law permits access, to inspect and copy your PHI, you must send a written request to the Privacy Officer. We may charge you a fee for the costs of copying, mailing and supplies that are necessary to fulfill your request. We may deny your request to inspect and copy in certain limited circumstances.
Request an amendment of PHI. If you feel that PHI we maintain about you is incomplete or incorrect, you may request that we amend it. To request an amendment, you must send a written request to the Privacy Officer. You must include a reason that supports your request. In certain cases, we may deny your request for amendment. For example, in circumstances under which the patient would be denied access to his/her PHI, we may deny a request for amendment.
Receive an accounting of disclosures of PHI. You have the right to receive an accounting of the disclosures we have made of your PHI after April 14, 2003 for most purposes other than treatment, payment, or operations. The right to receive an accounting is subject to certain exceptions, restrictions, and limitations. To request an accounting, you must submit a request in writing to the Privacy Officer. 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.
Request 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 the Privacy Officer. Your request must state how or where you would like to be contacted. We will accommodate all reasonable requests.
For More Information or to Report a Problem
If you have questions or would like additional information about our privacy practices, you may contact:
Clarient, Inc.
Privacy Officer
31 Columbia
Aliso Viejo, CA 92656
If you believe your privacy rights have been violated, you can file a complaint with the Privacy Officer or with the United States Secretary of Health and Human Services. There will be no retaliation for filing a complaint.
Effective Date
This Notice is effective as of April 14, 2003.
STATE LAW ADDENDUM
CALIFORNIA
Disclosure
California law limits disclosure of your medical information in ways that would otherwise be permitted under federal law. In the situations described below, the laboratory will disclose your medical information as follows:
(a) the information may be disclosed to providers of health care, health care service plans, contractors or other health care professionals or facilities for purposes of diagnosis or treatment of the patient. This includes, in an emergency situation, the communication of patient information by radio transmission or other means between licensed emergency medical personnel at the scene of an emergency, or in an emergency medical transport vehicle, and licensed emergency medical personnel at a health facility;
(b) the information may be disclosed to an insurer, employer, health care service plan, hospital service plan, employee benefit plan, governmental authority, contractor or any other person or entity responsible for paying for health care services rendered to the patient to the extent necessary to allow responsibility for payment to be determined and payment to be made. If the patient is, by reason of a comatose or other disabling medical condition, unable to consent to the disclosure or medical information and no other arrangements have been made to pay for the health care services being rendered to the patient, the information may also be disclosed to a governmental authority to the extent necessary to determine the patient's eligibility for, and to obtain, payment under a governmental program for health care services provided to the patient. The information may also be disclosed to another provider of health care or health care service plan as necessary to assist the other provider or health care service plan in obtaining payment for health care services rendered by that provider of health care or health care service plan to the patient;
(c) the information may be disclosed to any person or entity that provides billing, claims management, medical data processing, or other administrative services for providers of health care or health care service plans or for any of the persons or entities specified above in paragraph (b). However, no information so disclosed may be further disclosed by the recipient in any way that would be violative of California laws governing the use and disclosure of medical information without authorization from the patient;
(d) the information may be disclosed to organized committees and agents of professional societies or of medical staffs of licensed hospitals, licensed health care service plans, professional standards review organizations, independent medical review organizations and their selected reviewers, utilization and quality control peer review organizations, contractor's or persons or organizations insuring, responsible for, or defending professional liability that a provider may incur, if the committees, agents, health care service plans, organizations, reviewers, contractors or persons are engaged in reviewing the competence or qualifications of health care professionals or in reviewing health care services with respect to medical necessity, level of care, quality of care, or justification of charges;
(e) a provider of health care or health care service plan that has created medical information as a result of employment-related health care services to an employee conducted at the specific prior written request and expense of the employer may disclose information to the employee's employer that:
(1) is relevant in a law suit, arbitration, grievance, or other claim or challenge to which the employer and the employee are parties and in which the patient has placed in issue his or her medical history, mental or physical condition, or treatment, provided that information may only be used or disclosed in connection with that proceeding;
(2) describes functional limitations of the patient that may entitle the patient to leave from work for medical reasons or limit the patient's fitness to perform his or her present employment, provided that no statement of medical cause is included in the information disclosed;
(f) unless the provider of health care or health care service plan is notified in writing of an agreement by the sponsor, insurer, or administrator to the contrary, the information may be disclosed to a sponsor, insurer, or administrator of a group or individual insured or uninsured plan or policy that the patient seeks coverage by or benefits from, if the information was created by the provider of health care or health care service plan as the result of services conducted at the specific prior written request and expense of the sponsor, insurer, or administrator for the purpose of evaluating the application for coverage or benefits;
(g) the information may be disclosed to a health care service plan by providers of health care that contract with the health care service plan and may be transferred among providers of health care that contract with the health care service plan, for the purpose of administering the health care service plan. Medical information may not otherwise be disclosed by a health care service plan except in accordance with the provisions of this part;
(h) the information may be disclosed to an insurance institution, agent or support organization of medical information if the insurance institution, agent, or support organization has complied with all requirements for obtaining the information pursuant to the requirements of the California Insurance Code provisions.
(i) the information may be disclosed to an organ procurement organization or a tissue bank processing the tissue of a decedent for transplantation into the body of another person, but only with respect to the donating decedent for the purpose of aiding the transplant;
(j) the information may be disclosed to a third party for purposes of encoding, encrypting, or otherwise anonymizing data. However, no information may be further disclosed by the recipient in any way that would be unauthorized manipulation of coded or encrypted medical information that reveals individually identifiable medical information;
(k) for purposes of disease management programs and services, information may be disclosed to any entity contracting with a health care service plan or the health care service plan's contractors to monitor or administer care of enrollees for a covered benefit, provided that the disease management services and care are authorized by a treating physician or to any disease management organization that complies fully with the physician authorization requirements, provided that the health care service plan or its contractor provides or has provided a description of the disease management services to a treating physician or to the health care service plan's or contractor's network of physicians.
HIV/AIDS
We will not disclose an individual's HIV/AIDS test results, except in situations where the subject of the information has provided us with a written authorization allowing the release or where we are authorized or required by state or federal law to make the disclosure.
Medicaid
For Medicaid recipients: We will not disclose your medical records without your written consent, except:
(a) to individuals or institutions providing care to you;
(b) to fiscal intermediaries;
(c) to state or local official agencies; or
(d) for the purpose of effecting recovery where you have or are owed other means of payment for services (e.g., private insurance, injury for which another person is found liable, etc.).