THIS HIPAA NOTICE OF PRIVACY PRACTICES (THIS “NOTICE”) DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED BY PROFIL INSTITUTE FOR CLINICAL RESEARCH, INC. (“US,” “WE” or “PROFIL”), AND HOW YOU MAY GAIN ACCESS TO THIS INFORMATION. PLEASE REVIEW THIS NOTICE CAREFULLY.
A. Your Protected Health Information.
This Notice applies to your protected health information (“PHI”) in Profil’s possession, such as your name, address, telephone number, social security number, health information, health status, and the health care and clinical trial services that you have received or may receive from Profil.
We are required by law to give you this Notice. It explains how we may use and disclose information about you. It also describes your rights and our obligations regarding the use and disclosure of your PHI and other personal information by Profil, as applicable.
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B. Uses and Disclosures of PHI Requiring Your Written Authorization.
Profil must have your written, signed authorization (“Your Authorization”) to use and disclose your PHI and certain other information about you. You may revoke Your Authorization at any time, in writing. If you revoke Your Authorization, then we will no longer use or disclose your PHI or other personal information; however, we will not be able to withdraw any uses or disclosures that were made during the time that we had Your Authorization for disclosure.
Additionally, federal and state laws require special privacy considerations for a certain subset of your PHI (“Highly Confidential Information”). Your Highly Confidential Information includes information that is: (I) maintained in psychotherapy notes or pertaining to mental health and developmental disabilities services; (II) about alcohol and drug abuse prevention, treatment or referral; (III) about HIV/AIDS testing, diagnosis or treatment; (IV) regarding venereal disease testing, diagnosis or treatment; (V) regarding genetic testing; (VI) about sexual assault; or (VII) pertaining to abortion. We must obtain a separate written authorization from you specifically permitting us to disclose any or all of your records that contain your Highly Confidential Information.
We may request Your Authorization to use or disclose your PHI, or we may request your separate written authorization to use and disclose your Highly Confidential Information, for any of the following reasons:
1. Participation in Research Studies. We may use your PHI and other personal information to provide you with medical treatment or services as part of the research studies that Profil conducts. We may disclose information about you to doctors, nurses, technicians, coordinators, office staff or other personnel who help us conduct our studies. Our staff may need to know if you have health problems that could complicate your participation in or include/exclude you from participation in a research study. In addition, our staff may use your medical history to decide which research study is best for you. The study doctor may tell another doctor about your condition to help determine the most appropriate care for you and to make recommendations regarding your research study participation;
2. Treatment. We may use your PHI and other information about you to provide you with medical treatment or services that are not part of a research study. For example, personnel in our office may use your PHI when submitting prescriptions to your pharmacy, scheduling lab work, etc.;
3. Stipend Payment. Profil may use and disclose information about you so that you may receive a stipend for your research study participation; and
4. Other Business Purposes. Profil may use your PHI to evaluate the performance of our staff in caring for you, to help us decide what additional research studies we should offer to you, to learn how we can become more efficient, and to determine whether certain new treatments are effective.
Profil may contact you to (I) remind you about appointments at Profil, (II) inform you about test results, or (III) tell you about research studies, products or services that might interest you. Please notify us if you do not wish to receive communications about research studies or health-related products or services. If you advise us in writing that you do not wish to receive such communications, then we will not use or disclose your information for these purposes.
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C. Permissible Uses and Disclosures Without Your Authorization.
Profil may use or disclose PHI and other information about you without Your Authorization for the following purposes, subject to applicable legal requirements and limitations:
1. Research. We may use or disclose your PHI without your consent or authorization if an Institutional Review Board or Privacy Board approves a waiver of authorization for such disclosure;
2. Disclosures to Relatives, Close Friends and Caregivers. We may use or disclose your PHI to a family member, other relative, a close personal friend or any other person identified by you at the time of, or prior to, such disclosure if we: (I) obtain your agreement; (II) provide you with the opportunity to object to the disclosure and you do not object; or (III) reasonably infer that you do not object to the disclosure. If you are not present, or the opportunity to agree or object to the disclosure cannot practicably be obtained because of your incapacity or an emergency circumstance, then we may exercise our professional judgment to determine whether a disclosure is in your best interests. If we disclose information to a family member, other relative or a close personal friend, then we would disclose only information that we believe is directly relevant to the person’s involvement with your healthcare. We also may disclose your PHI in order to notify, or assist in notifying, such persons of your location, general condition or death;
3. Victims of Abuse, Neglect or Domestic Violence. If we reasonably believe that you are a victim of abuse, neglect or domestic violence, then we may disclose your PHI to a governmental authority, including a social services or protective services agency authorized by law to receive such reports of abuse, neglect or domestic violence;
4. Public Health Activities. Profil may disclose your PHI for the following public health activities: (I) to report health information to public health authorities for the purpose of preventing or controlling disease, injury or disability; (II) to report child abuse and neglect to public health authorities or other government authorities authorized by law to receive such reports; (III) to report information about products or services under the jurisdiction of the U.S. Food and Drug Administration; (IV) to alert a person who may have been exposed to a communicable disease or may otherwise be at risk of contracting or spreading a disease or condition; and (V) to report information to your employer as required under laws regarding work-related illnesses and injuries or workplace medical surveillance;
5. Health or Safety. We may use or disclose your PHI to prevent or lessen a serious or imminent threat to the safety of a person or to the public health;
6. Health Oversight Activities. We may disclose your PHI to a health oversight agency that oversees the healthcare system and is charged with the responsibility for ensuring compliance with the rules of government health programs such as Medicare or Medicaid;
7. Judicial and Administrative Proceedings. We may disclose your PHI in the course of a judicial or administrative proceeding in response to a legal order or other lawful process;
8. Law Enforcement Officials. We may disclose your PHI to the police or other law enforcement officials as required or permitted by law or in compliance with a court order or a grand jury or an administrative subpoena;
9. Decedents. We may disclose your PHI to a coroner or medical examiner as authorized or required by law;
10. Organ and Tissue Procurement. We may disclose your PHI to organizations that facilitate organ, eye or tissue procurement, banking or transplantation;
11. Specialized Government Functions. Under certain circumstances, we may use or disclose your PHI to units of the government with special functions, such as the U.S. Military or the U.S. Department of State;
12. Workers’ Compensation. We may disclose your PHI as authorized by and to the extent necessary to comply with state law relating to Workers’ Compensation or other similar programs;
13. As Required by Law. We may use and disclose your PHI as when required to do so by any other law not already referred to in this Notice; and
14. Information Not Personally Identifiable. Profil may use or disclose your PHI in ways that do not personally reveal your identity.
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D. Your Rights Regarding Your PHI.
1. Right to Revoke Your Authorization. You may revoke Your Authorization at any time by providing a written request to Profil. Your revocation will be effective when received by Profil; except, that, the revocation will not apply to any uses or disclosures that occurred before Profil received your written revocation. If you revoke your Authorization, then Profil may elect to discontinue your participation in our research studies and any related health care treatments or programs;
2. Right to Request Restrictions. You may request restrictions or limitations on our use and disclosure of your PHI. Your request must be in writing. While we will carefully consider all requests for restrictions and limitations, we are not required to agree to a requested restriction or limitation;
3. Right to Confidential Communications. You may request, and we will accommodate, any reasonable request from you to receive communications from Profil by alternative means of communication or at alternative locations;
4. Right to Inspect and Copy Your Medical Records. You may request access to your medical record file that is maintained by Profil in order to inspect and request copies of your records. Under certain circumstances, we may deny you access to a portion of your records. If you desire to access your records, please submit a written request to Profil. Please note that we may charge you a fee to cover the costs of retrieving, copying and/or delivering to you the requested records;
5. Right to Amend Your Records. You have the right to request that we amend your PHI in your medical record file that is maintained by Profil. If you desire to amend your records, please send a written request for the amendment, including a reason for the amendment, to Profil. We will comply with your request unless we believe that the information that would be amended is accurate and complete or other special circumstances apply;
6. Right to Receive an Accounting of Disclosures. Upon written request, you may obtain an accounting of certain disclosures of your PHI made by Profil during any period of time prior to the date of your request; provided, that, such period does not exceed six (6) years and does not apply to disclosures that occurred prior to April 14, 2003; and
7. Right to Receive a Paper Copy of this Notice. Upon request, you may obtain a paper copy of this Notice, even if you have agreed to receive this Notice electronically.
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E. Modifications to this Notice.
1. Our Right to Change Terms of this Notice. We reserve the right to change the terms of this Notice at any time, and to make the revised or changed notice effective for PHI that we already have. Changes to this Notice will be posted on our Website. You also may obtain any new notice by contacting Profil.
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If you believe that Profil has violated your privacy rights, you may file a complaint with our Corporate Secretary at:
Profil Institute for Clinical Research, Inc.
Centre Medical Plaza II
855 3rd Avenue, Suite 4400
Chula Vista, CA 91911
Attention: Corporate Secretary
You may also file a complaint with the Secretary of the Department of Health and Human Services at OCRComplaint@hhs.gov.