Your Personal Health Information

A federal government rule has been issued to protect the privacy rights of patients. This rule was issued under a law called the Health Insurance Portability and Accountability Act of 1996 (HIPAA). This rule is designed to protect the confidentiality of your personal health information. Your personal health information is information about you that could be used to find out who you are. For a research study, this includes information in your existing medical records (such as symptoms, test results, diagnoses, treatment, and health information from other providers) needed for the study and new information created or collected during the study.

This Privacy Practices Notice explains how your personal health information will be used and disclosed, and who it will be given to for a specific research study. It also describes your privacy rights, including your right to get access to your personal health information.

We will not use or disclose your health information to others without your authorization, except as described in this Notice, or as required by law.

Using Your Personal Health Information

If you agree to participate in the research study, your personal health information will be used and disclosed in the following ways:‍

‍‍The study doctor and staff will use your medical records and information created or collected during the study to conduct the study.
The study doctor and staff will send your study-related health information (“study data”) to the sponsor of the study and its representatives (“sponsor”). Because the sponsor conducts business related to clinical research in many countries around the world, this may involve sending your study data outside of the United States. Other countries may have privacy laws that do not provide the same protections as the laws in this country. However, the sponsor will respect the terms of this Privacy Practices Notice in all countries.
The study data sent by the study doctor to the sponsor does not include your name, address, social security number, or other information that directly identifies you. Instead, the study doctor assigns a code number to the study data and may use your initials. Some study data sent to the sponsor may contain information that could be used (perhaps in combination with other information) to identify you (e.g. Date of birth). If you have questions about the specific health information that will be sent to the sponsor, you should ask the study coordinator.
The sponsor will use the study data for research purposes to support the scientific objectives described in the consent document and the process of getting regulatory approvals for its drugs.
The sponsor may add your study data to data from other studies in research databases so that they can study better measures of safety and effectiveness, study other therapies for patients, develop a better understanding of diseases, or improve the design of future clinical trials.
Your study data, either alone or combined with data from other studies, may be shared with regulatory authorities in the United States and other countries, doctors at other institutions participating in the study, and the ethical review board overseeing the study.
Study data that does not directly identify you may be published in medical journals or shared with others as part of scientific discussions.
Your original medical records, which may contain information that directly identifies you, may be reviewed by the sponsor, the ethical review board overseeing this study, and regulatory authorities in the United States and other countries. The purpose of these revisions is to assure the quality of the study conduct and the study data, or for other uses authorized by law.
We contract with individuals and entities to perform jobs for us or to provide certain types of services that may require them to create, maintain, use and/or disclose your health information. We may disclose your health information to a business associate, but only after they agree in writing to safeguard your health information. Examples include records storage facilities and records destruction services.
The sponsor works with business partners in drug development. The sponsor may share your study data with these business partners, but only if the business partners need the information as part of this work with the sponsor, and only if the business partners sign a contract that requires it to protect your study data in the same way as the sponsor.
We and/or the sponsor may request payment from your health insurance plan specifically in the case of study-related injury or illness. Health plans may need information from us about your participation in the research study. Information provided to health plans may include your diagnoses, procedures performed, or information created or collected during the study to conduct the study. You or the person you tell us is responsible for your care may have to pay for your care if it is not covered by the sponsor or your health insurance. Rainier Clinical Research Center, LLC and/or the sponsor will not disclose personal health information to insurance companies unless required to do so by law, or unless you provide separate written consent to do so.
We may also use your health information when we call you for appointments or to advise you about future research study opportunities.
Your medical records and study data may be held and processed on computers.
We may use certain demographic information and other health care service and health insurance status information about you to contact you to raise funds. If we contact you for fund-raising, we will also provide you with a way to opt out of receiving fund-raising requests in the future.

The fund-raising communication above is a HIPAA required statement, but is not applicable to Rainier Clinical Research Center, LLC as we do not practice fund-raising activities.

Using Your Personal Health Information Without Your Consent

We are legally required to use or disclose identifiable health information about you without your consent to meet special reporting requirements, to facilitate continuity of care, or for public health and other purposes. For example, we provide:

Reports to the Food and Drug Administration
Data for health oversight activities such as auditing or licensure
Reports to Public Health on communicable diseases
Reports to employers for work-related illnesses or injuries such as in Workers’ Compensation
Reports to law enforcement on abuse, neglect, domestic violence, or judicial activities (specific circumstances at your request or by subpoena or court order)
Reports to avert a serious threat to health or safety or to prevent serious harm to an individual
To federal officials for national security for purposes authorized by law
Communication with designated family members or other individuals who you select as your personal representative about your care.

Special Authorization

Certain federal and state laws that provide special protections for certain kinds of personal health information call for specific authorizations from you to use or disclose information. When and if your personal health information falls under these special protections, we will contact you to secure the required authorizations to comply with federal and state laws such as:

Psychotherapy Notes: if we record or maintain psychotherapy notes, we must obtain your authorization for most uses and disclosures of psychotherapy notes.
Marketing Communications: we must obtain your authorization to use or disclose your health information for marketing purposes other than for face to face communications with you, promotional gifts of nominal value, and communications with you related to currently prescribed drugs, such as refill reminders.
Sale of Health Information: disclosures that constitute a sale of your health information require your authorization.

If we need your health information for any other reason that has not been described in this Notice, we will ask you for your written authorization before using or disclosing any identifiable health information about you. Most important, if you choose to sign an authorization to disclose information, you can revoke that authorization at a later time to stop any future use and disclosure. Your revocation does not affect information that has already been released. It also does not affect any action taken before we have it. Sometimes, you cannot cancel an authorization if its purpose was to obtain insurance.

Your Individual Rights

The health and research records we create and store are the property of Rainier Clinical Research Center, LLC. The protected health information in it, however, generally belongs to you. You have a right to:‍

Limit use: You may ask us to restrict certain uses and disclosures. You must deliver this request in writing to us. We are not required to grant the request unless the request is to restrict disclosure of your protected health information to a health plan for payment or health care operations and the protected health information is about an item or service for which you paid in full directly. You will have the opportunity to do this when you sign the Authorization to Use and Disclose Personal Health Information.

Receive confidential communications: We may call you to confirm an appointment and leave a message on your voice mail or with another person. Any information deemed sensitive or private by you or the staff at Rainier Clinical Research Center, LLC will be communicated by phone or in person only. You have the right to receive confidential communication by alternative means or locations. This includes an alternative mailing address or an email address. If this is necessary, please let us know.

Transmittal of emails may not be private. Whenever you voluntarily disclose personal information online (e.g. via email), we cannot and do not provide any assurances that your information will not become known or accessible to third parties. If you provide any confidential information about you or your health to us via electronic communication, it is at your own risk. Rainier Clinical Research Center, LLC employs strict security measures to safeguard information, but no site has been proven to be impenetrable. Any communication by email will become a part of your source documents at Rainier Clinical Research Center, LLC.

Inspect and copy: You have the right to look at your health information and review your record of healthcare. Please submit your request to view your record to us in writing. You may request a copy of your health information. Standard copy fees will be assessed.

‍Request amendments: If you believe that information in your record is incorrect or if important information is missing, you have the right to request in writing that the existing information be amended. You may write a statement of disagreement if your request is denied. It will be stored in your source document and included in any release of your records.

Know about disclosures: You have the right to receive a list of instances where we have disclosed information for reasons other than treatment, payment or health care operations. You may receive this information without charge once every 12 months. We will notify you of the cost involved if you request this information more than once every 12 months.

Receipt of this notice: You have the right to receive, read and ask questions about this Notice. You have the right to receive this Notice either on paper or electronically. Please let us know if you would like a copy of this notice in another format.

Request cancellation: You have the right to cancel prior authorizations to use or disclose health information by giving us a written revocation. Your revocation does not affect information that has already been released. It also does not affect any action taken before we receive the revocation. Sometimes, you cannot cancel an authorization if its purpose was to obtain insurance.

Complaints: If you are concerned that we have violated your privacy, or you disagree with a decision we made about access to your records, you may discuss this with your study coordinator or the Privacy Compliance Officer either in person or by calling our office at 425-251-1720. You may also deliver a written complaint to the Privacy Compliance Officer at Rainier Clinical Research Center, LLC.

If you are not satisfied with the protection of your personal health information, you may also file a complaint with the Department of Health and Human Services Office of Civil Rights (OCR) if you feel your privacy rights have been violated. Rainier Clinical Research Center, LLC will not retaliate against a patient for filing a complaint.

Our Legal Duty

We are required by law to protect the privacy of your information, provide this Notice about our information practices, to follow the information practices that are described in this Notice, and to notify you if we become aware of a breach of your unsecured protected health information.

When New Uses Are Required

Rainier Clinical Research Center, LLC reserves the right to change the terms of this Notice and to make the new notice provisions effective for all the personal health information that it maintains. We may change our policies at any time but with any significant policy change the new notice will be changed, posted, and distributed to our patients. Also, this notice will be promptly revised and distributed whenever there is a material change to the uses or disclosures, your rights, our legal duties or other privacy practices changes. Any such changes will become effective on the date the revised notice is issued. You may request a copy of this Notice from Rainier Clinical Research Center, LLC at any time.

This Notice is effective as of: April 14, 2003, revised September 9, 2012, revised September 23, 2013, revised September 15, 2020, revised November 30, 2020, revised January 12, 2021.

NOTICE OF PRIVACY PRACTICES ACKNOWLEDGEMENT

Rainier Clinical Research Center, LLC has a responsibility to protect the privacy of your health care information and to provide a Notice of Privacy Practices that describes in detail how your health information may be used and disclosed, how you can access your information, and whom to contact if you have questions, concerns, or complaints.