LINK --->>> https://bytlly.com/2tkm5c
We know how important security is, so you can place your order with confidence. All of the information you share with us online is encrypted by what is called a Secured Socket Layer, or SSL. You can see this for yourself! You know that a web site has SSL when the URL begins with https:// rather than just Also you will find an icon of a locked padlock. It is usually found near the URL bar, but may be in a different location depending upon your browser.
With state of the art 256-bit SSL technology, your important data is encrypted before it even leaves your computer. Your credit card transaction is handled directly with our processing service; no employee of Phi Kappa Psi Official Store ever has access to credit card numbers entered online.
If your item(s) come damaged or incorrect, we want to make it right. Please email us with your name, order number, and a picture to verify, and we'll issue you a return label. We want you to love what you ordered!
Key Points:De-identified health information, as described in the Privacy Rule, is not PHI, and thus is not protected by the Privacy Rule. PHI may be used and disclosed for research with an individual's written permission in the form of an Authorization. PHI may be used and disclosed for research without an Authorization in limited circumstances: Under a waiver of the Authorization requirement, as a limited data set with a data use agreement, preparatory to research, and for research on decedents' information.
The Privacy Rule describes the ways in which covered entities can use or disclose PHI, including for research purposes. In general, the Rule allows covered entities to use and disclose PHI for research if authorized to do so by the subject in accordance with the Privacy Rule. In addition, in certain circumstances, the Rule permits covered entities to use and disclose PHI without Authorization for certain types of research activities. For example, PHI can be used or disclosed for research if a covered entity obtains documentation that an Institutional Review Board (IRB) or Privacy Board has waived the requirement for Authorization or allowed an alteration. The Rule also allows a covered entity to enter into a data use agreement for sharing a limited data set. There are also separate provisions for how PHI can be used or disclosed for activities preparatory to research and for research on decedents' information.
It is important to note that there are circumstances in which health information maintained by a covered entity is not protected by the Privacy Rule. PHI excludes health information that is de-identified according to specific standards. Health information that is de-identified can be used and disclosed by a covered entity, including a researcher who is a covered entity, without Authorization or any other permission specified in the Privacy Rule. Under the Privacy Rule, covered entities may determine that health information is not individually identifiable in either of two ways. These are described below.
Covered entities may use or disclose health information that is de-identified without restriction under the Privacy Rule. Covered entities seeking to release this health information must determine that the information has been de-identified using either statistical verification of de-identification or by removing certain pieces of information from each record as specified in the Rule.
The Privacy Rule allows a covered entity to de-identify data by removing all 18 elements that could be used to identify the individual or the individual's relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity also must have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following:
Covered entities may also use statistical methods to establish de-identification instead of removing all 18 identifiers. The covered entity may obtain certification by \"a person with appropriate knowledge of and experience with generally accepted statistical and scientific principles and methods for rendering information not individually identifiable\" that there is a \"very small\" risk that the information could be used by the recipient to identify the individual who is the subject of the information, alone or in combination with other reasonably available information. The person certifying statistical de-identification must document the methods used as well as the result of the analysis that justifies the determination. A covered entity is required to keep such certification, in written or electronic format, for at least 6 years from the date of its creation or the date when it was last in effect, whichever is later.
Under the first method, unique identifying numbers, characteristics, or codes must be removed if the health information is to be considered de-identified. However, the Privacy Rule permits a covered entity to assign to, and retain with, the health information a code or other means of record identification if that code is not derived from or related to the information about the individual and could not be translated to identify the individual. The covered entity may not use or disclose the code or other means of record identification for any other purpose and may not disclose its method of re-identifying the information. For example, a randomly assigned code that permits re-identification through a secured key to that code would not make the information to which it is assigned PHI, because a random code would not be derived from or related to information about the individual and because the key to that code is secure.
A covered entity is permitted to de-identify PHI or engage a business associate to de-identify PHI. For example, a researcher may be a covered entity him/herself performing, or may be hired as a business associate to perform, the de-identification. In most cases, the covered entity must have a written contract with the business associate containing the provisions required by the Privacy Rule before it provides PHI to the business associate. In addition, a covered entity, if a hybrid entity, could designate in its health care component(s) portions of the entity that conduct business associate-like functions, such as de-identification.
De-identifying PHI according to Privacy Rule standards may enable many research activities; however, the Privacy Rule recognizes that researchers may need access to and generate identifiable health information during the course of research. Where PHI is needed for research activities, the Privacy Rule permits its use and disclosure if certain standards are met. These standards are discussed in the following sections.
One way the Privacy Rule protects the privacy of PHI is by generally giving individuals the opportunity to agree to the uses and disclosures of their PHI by signing an Authorization form for uses and disclosures not otherwise permitted by the Rule. The Privacy Rule establishes the right of an individual, such as a research subject, to authorize a covered entity to use and disclose his/her PHI for research purposes. This requirement is in addition to the informed consent to participate in research required under the HHS Protection of Human Subjects Regulations and other applicable Federal and State law.
A valid Privacy Rule Authorization is an individual's signed permission that allows a covered entity to use or disclose the individual's PHI for the purposes, and to the recipient or recipients, as stated in the Authorization. When an Authorization is obtained for research purposes, the Privacy Rule requires that it pertain only to a specific research study, not to nonspecific research or to future, unspecified projects. The Privacy Rule considers the creation and maintenance of a research repository or database as a specific research activity, but the subsequent use or disclosure by a covered entity of information from the database for a specific research study will require separate Authorization unless the PHI use or disclosure is permitted without Authorization (discussed later in this section). If an Authorization for research is obtained, the actual uses and disclosures made must be consistent with what is stated in the Authorization. The signed Authorization must be retained by the covered entity for 6 years from the date of creation or the date it was last in effect, whichever is later.
An Authorization differs from an informed consent in that an Authorization focuses on privacy risks and states how, why, and to whom the PHI will be used and/or disclosed for research. An informed consent, on the other hand, provides research subjects with a description of the study and of its anticipated risks and/or benefits, and a description of how the confidentiality of records will be protected, among other things. An Authorization can be combined with an informed consent document or other permission to participate in research. Whether combined with an informed consent or separate, an Authorization must contain the following specific core elements and required statements stipulated in the Rule:
The Privacy Rule does not specify who may draft the Authorization, so a researcher could draft it regardless of whether the researcher is a covered entity. However, in order to have a Privacy Rule-compliant Authorization, it must be written in plain language and contain the core elements and required statements, and a signed copy must be provided to the individual signing it if the covered entity itself is seeking the Authorization. The companion piece Sample Authorization Language contains language that illustrates the inclusion of core elements and required statements.
NOTE: If an Authorization permits disclosure of the individual's PHI to a person or organization that is not a covered entity or a business associate acting on behalf of a covered entity (such as a sponsor or funding source of the research), the Privacy Rule does not continue to protect the PHI disclosed to such entity. However, other applicable Federal and State laws between the disclosing covered entity and the PHI recipient may establish continuing protections for the disclosed information. Under the HHS Protection of Human Subjects Regulations or the FDA Protection of Human Subjects Regulations, an IRB may impose further restrictions on the use or disclosure of research information to protect subjects. 59ce067264