health information release

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\f1\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid13858039 A Privacy Rule Authorization is an individual\rquote s signed permission to allow a covered entity to use or disclose the individual\rquote s protected health information (PHI) that is described in the Authorization for the purpose(s) and to the recipient(s) stated in the Authorization. In contrast, an informed consent document is an individual\rquote s agreement to participate in the research study and includes a description of the study, anticipated risks and/or benefits, and how the confidentiality of records will be protected, among other things. An Authorization can b e combined with an informed consent document or other permission to participate in research. If a covered entity obtains or receives a valid Authorization for its use or disclosure of PHI for research, it may use or disclose the PHI for the research, but the use or disclosure must be consistent with the Authorization. \par }\pard \ql \li0\ri0\sb240\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\insrsid13858039 The Authorization must be written in plain language. A copy of the signed Authorization must be provided to the individual signing it if the covered entity itself is seeking the Authorization . The Privacy Rule does not specify who must draft the Authorization, so a researcher could draft one. The Privacy Rule specifies}{\b\insrsid13858039 }{\insrsid13858039 core elements and required statements that must be included in an Authorization. An Authorization is not valid unless it conta ins all of the required elements and statements. An Authorization form may also, but is not required to, include additional, optional elements so long as they are not inconsistent with the required elements and statements and are not otherwise contrary to the Authorization requirements of the Privacy Rule. An Authorization, whether prepared by a covered entity or by a person requesting PHI from a covered entity, must include the following core elements and required statements: \par }\pard \ql \li0\ri0\sa80\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\b\insrsid13858039 Authorization Core Elements}{\insrsid13858039 (see Privacy Rule}{\i\insrsid13858039 , 45 C.F.R}{\insrsid13858039 . \'a7164.508(c)(1)) \par {\listtext\pard\plain\s23 \f3\insrsid13858039 \loch\af3\dbch\af0\hich\f3 \'b7\tab}}\pard\plain \s23\ql \fi-360\li360\ri0\sa80\sl-240\slmult0\widctlpar\jclisttab\tx360\aspalpha\aspnum\faauto\ls4\adjustright\rin0\lin360\itap0 \f1\fs22\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24\insrsid13858039 Description of PHI to be used or disclosed (identifying the information in a specific and meaningful manner). \par {\listtext\pard\plain\s23 \f3\insrsid13858039 \loch\af3\dbch\af0\hich\f3 \'b7\tab}The name(s) or other specific identification of person(s) or class of persons authorized to make the requested use or disclosure. \par {\listtext\pard\plain\s23 \f3\insrsid13858039 \loch\af3\dbch\af0\hich\f3 \'b7\tab}The name(s) or other specific identification of the person(s) or class of persons who may use the PHI or to whom the covered entity may make the requested disclosure. \par {\listtext\pard\plain\s23 \f3\insrsid13858039 \loch\af3\dbch\af0\hich\f3 \'b7\tab}Description of each purpose of the requested use or disclosure. Researchers should note that this element must be research study specific, not for future unspecified research. \par {\listtext\pard\plain\s23 \f3\insrsid13858039 \loch\af3\dbch\af0\hich\f3 \'b7\tab}Authorization expiration date or event that relates to the individual or to the purpose of the use or disclosure (the terms \'93end of the research study\'94 or \'93none\'94 may be used for research, including for the creation and maintenance of a research database or repository). \par {\listtext\pard\plain\s23 \f3\insrsid13858039 \loch\af3\dbch\af0\hich\f3 \'b7\tab}}\pard \s23\ql \fi-360\li360\ri0\sa220\sl-240\slmult0\widctlpar\jclisttab\tx360\aspalpha\aspnum\faauto\ls4\adjustright\rin0\lin360\itap0 {\fs24\insrsid13858039 Signature of the individual and date. If the Authorization is signed by an individual\rquote s personal representative, a description of the representative\rquote s authority to act for the individual.}{\insrsid13858039 \par }\pard\plain \ql \li0\ri0\sa80\keepn\widctlpar\jclisttab\tx0\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \f1\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\b\insrsid13858039 Authorization Required Statements}{\insrsid13858039 (see Privacy Rule, }{\i\insrsid13858039 45 C.F.R.}{\insrsid13858039 \'a7 164.508(c)(2))}{\fs20\insrsid13858039 \par {\listtext\pard\plain\s23 \f3\insrsid13858039 \loch\af3\dbch\af0\hich\f3 \'b7\tab}}\pard\plain \s23\ql \fi-360\li360\ri0\sa80\sl-240\slmult0\widctlpar\jclisttab\tx360\aspalpha\aspnum\faauto\ls4\adjustright\rin0\lin360\itap0 \f1\fs22\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24\insrsid13858039 The individual\rquote s right to revoke his/her Authorization in writing and either (1) the exceptions to t he right to revoke and a description of how the individual may revoke his/her Authorization or (2) reference to the corresponding section(s) of the covered entity\rquote s Notice of Privacy Practices. \par {\listtext\pard\plain\s23 \f3\insrsid13858039 \loch\af3\dbch\af0\hich\f3 \'b7\tab}Notice of the covered entity\rquote s ability or inability to condi tion treatment, payment, enrollment, or eligibility for benefits on the Authorization, including research-related treatment, and, if applicable, consequences of refusing to sign the Authorization. \par {\listtext\pard\plain\s23 \f3\insrsid13858039 \loch\af3\dbch\af0\hich\f3 \'b7\tab}The potential for the PHI to be re-disclosed by the recip ient and no longer protected by the Privacy Rule. This statement does not require an analysis of risk for re-disclosure but may be a general statement that the Privacy Rule may no longer protect health information.}{\cs27\fs24\super\insrsid13858039 {\footnote \pard\plain \s26\ql \fi-180\li0\ri0\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \f1\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs27\super\insrsid13858039 }{\insrsid13858039 \tab If an Authorization permits disclosure of PHI to a person or organization that is not 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 the noncovered entity. However, other applicable Federal and State la ws as well as agreements between the disclosing covered entity and the PHI recipient may establish continuing protections for the disclosed information.}}}{\fs24\insrsid13858039 \par }\pard\plain \ql \li0\ri0\sb240\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \f1\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid13858039 A research subject may revoke his/her Authorization at any time. However, a covered entity may continue to use and disclose PHI that was obtained before the individual revoked his or her Authorization to the extent that the entity has taken action in reli a nce on the Authorization. In cases where the research is conducted by the covered entity, this would permit the covered entity to continue using or disclosing the PHI as necessary to maintain the integrity of the research, as, for example, to account for a subject\rquote s withdrawal from the research study, to conduct investigations of scientific misconduct, or to report adverse events. \par }\pard\plain \s24\ql \li0\ri0\sb240\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \f1\fs24\cf2\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cf0\insrsid13858039 The next section of this document provides sample language and issues to consider in developing a research Authorization. The sa mple language addressing the required elements is listed first, followed by a set of optional elements that may be useful in specific research situations. \par }\pard\plain \s20\ql \li0\ri0\widctlpar\tx1440\tx3750\aspalpha\aspnum\faauto\nosnaplinegrid\adjustright\rin0\lin0\itap0 \b\caps\f1\fs22\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\b0\fs24\insrsid13858039 \par }\pard \s20\qc \li0\ri0\widctlpar\tx1440\aspalpha\aspnum\faauto\nosnaplinegrid\adjustright\rin0\lin0\itap0 {\insrsid13858039 \page }{\caps0\fs28\insrsid13858039 SAMPLE AUTHORIZATION LANGUAGE FOR RESEARCH USES AND DISCLOSURES OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION BY A COVERED HEALTH CARE PROVIDER \par }{\fs24\insrsid13858039 \par \par }{\caps0\fs24\insrsid13858039 Authorization to Use or Disclose (Release) Health Information \par that Identifies You for a Research Study \par }\pard \s20\ql \li0\ri0\widctlpar\tx1440\aspalpha\aspnum\faauto\nosnaplinegrid\adjustright\rin0\lin0\itap0 {\fs24\insrsid13858039 \par }\pard\plain \ql \li0\ri0\sa120\widctlpar\tx720\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \f1\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\b\insrsid13858039 REQUIRED ELEMENTS: \par }{\insrsid13858039 If you sign this document, you give permission to }{\cf2\insrsid13858039 name or other identification of specific health care provider(s) or description of classes of persons, e.g., all doctors, all health care providers }{ \insrsid13858039 at}{\cf2\insrsid13858039 name of covered entity or entities}{\insrsid13858039 to use or disclose (release) your health information that identifies you for the research study described below: \par }\pard\plain \s24\ql \li360\ri0\sa120\widctlpar\tx720\aspalpha\aspnum\faauto\adjustright\rin0\lin360\itap0 \f1\fs24\cf2\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid13858039 Provide a description of the research study, such as the title and purpose of the research. \par }\pard\plain \ql \li0\ri0\sb240\sa120\widctlpar\tx720\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \f1\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid13858039 The health information that we may use or disclo se (release) for this research includes }{\cf2\insrsid13858039 complete as appropriate}{\insrsid13858039 : \par }\pard\plain \s24\ql \li360\ri0\sa120\widctlpar\tx720\aspalpha\aspnum\faauto\adjustright\rin0\lin360\itap0 \f1\fs24\cf2\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid13858039 Provide a description of information to be used or disclosed for the research project. This may include, for example, all information in a medical record, results of physical examinations, medical history, lab tests, or certain health information indicating or relating to a particular condition. \par }\pard\plain \ql \li0\ri0\sb240\sa120\widctlpar\tx720\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \f1\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid13858039 The health information listed above may be used by and/or disclosed (released) to: \par }\pard \ql \li360\ri0\sa120\widctlpar\tx720\aspalpha\aspnum\faauto\adjustright\rin0\lin360\itap0 {\cf2\insrsid13858039 Name or class of persons involved in the research; i.e., researchers and their staff}{\cs27\super\insrsid13858039 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \i\f1\fs22\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\i0\fs20\insrsid13858039 Where a covered entity conducts the research study, the Authorization must list ALL names or other identification, or ALL classes, of persons who will have access through the covered entity to the protected health information (PHI) for the research study (e.g., research collaborators, sponsors, and others who will have access to data that includes PHI). Examples may include, but are not limited to the following: \par {\listtext\pard\plain\s22 \f3\fs20\insrsid13858039 \loch\af3\dbch\af0\hich\f3 \'b7\tab}}\pard \s22\ql \li360\ri0\sl-240\slmult0\widctlpar\jclisttab\tx360\aspalpha\aspnum\faauto\ls13\adjustright\rin0\lin360\itap0\pararsid3164618 {\i0\fs20\insrsid13858039 Data coordinating centers that will receive and process PHI; \par {\listtext\pard\plain\s22 \f3\fs20\insrsid13858039 \loch\af3\dbch\af0\hich\f3 \'b7\tab}Sponsors who want access to PHI or who will actually own the research data; and/or \par {\listtext\pard\plain\s22 \f3\fs20\insrsid13858039 \loch\af3\dbch\af0\hich\f3 \'b7\tab}}\pard \s22\ql \li360\ri0\sa120\sl-240\slmult0\widctlpar\jclisttab\tx360\aspalpha\aspnum\faauto\ls13\adjustright\rin0\lin360\itap0\pararsid3164618 { \i0\fs20\insrsid13858039 Institutional Review Boards or Data Safety and Monitoring Boards. \par }\pard\plain \s26\ql \li0\ri0\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \f1\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid13858039 If the research study is conducted by an entity other than the covered entity, the authorization need onl y list the name or other identification of the outside researcher (or class of researchers) and any other entity to whom the covered entity is expected to make the disclosure.}}}{\cf2\insrsid13858039 \par }\pard \ql \li0\ri0\sb240\sa120\widctlpar\tx720\aspalpha\aspnum\faauto\nosnaplinegrid\adjustright\rin0\lin0\itap0 {\cf2\insrsid13858039 Name of covered entity}{\insrsid13858039 is required by law to protect your health information . By signing this document, you authorize }{\cf2\insrsid13858039 name of covered entity}{\insrsid13858039 to use and/or disclose (release) your health information for this research. Those persons who receive your health information may not be required by Federal privacy laws (such as the Privacy Rule) to protect }{\ulc1\insrsid13858039 it and may share}{ \insrsid13858039 your information with others without your permission, if permitted by laws governing them. \par \par }\pard \ql \li0\ri0\sa120\keepn\widctlpar\aspalpha\aspnum\faauto\nosnaplinegrid\adjustright\rin0\lin0\itap0 {\insrsid13858039 Please note that }{\cf2\insrsid13858039 include the appropriate statement}{\insrsid13858039 : \par {\listtext\pard\plain\f3\insrsid13858039 \loch\af3\dbch\af0\hich\f3 \'b7\tab}}\pard \ql \fi-360\li720\ri0\sa120\widctlpar\jclisttab\tx720\aspalpha\aspnum\faauto\ls11\nosnaplinegrid\adjustright\rin0\lin720\itap0 {\insrsid13858039 You do not have to sign this Authorization, but if you do not, you may not receive research-related treatment.\line }{\b\insrsid13858039 (When the research involves treatment and is conducted by the covered entity or when the covered entity provides health care solely for the purpose of creating protected health information to disclose to a researcher)}{\insrsid13858039 \par {\listtext\pard\plain\f3\cf2\insrsid13858039 \loch\af3\dbch\af0\hich\f3 \'b7\tab}}{\cf2\insrsid13858039 Name of covered entity}{\insrsid13858039 may not condition (withhold or refuse) treating you on whether you sign this Authorization. \line }{ \b\insrsid13858039 (When the research does }{\b\ul\insrsid13858039 not}{\b\insrsid13858039 involve research-related treatment by the covered entity or when the covered entity is }{\b\ul\insrsid13858039 not}{\b\insrsid13858039 providing healt h care solely for the purpose of creating protected health information to disclose to a researcher)}{\insrsid13858039 \par }\pard \ql \li0\ri0\sb240\sa120\widctlpar\aspalpha\aspnum\faauto\nosnaplinegrid\adjustright\rin0\lin0\itap0 {\insrsid13858039 Please note that }{\cf2\insrsid13858039 include the appropriate statement}{\insrsid13858039 \par {\listtext\pard\plain\f3\insrsid13858039 \loch\af3\dbch\af0\hich\f3 \'b7\tab}}\pard \ql \fi-360\li720\ri0\sa120\widctlpar\jclisttab\tx720\aspalpha\aspnum\faauto\ls12\nosnaplinegrid\adjustright\rin0\lin720\itap0 {\insrsid13858039 You may change your mind and revoke (take back) this Authorization at any time, except to the extent that }{\cf2\insrsid13858039 name of covered entity(ies)}{\insrsid13858039 has already acted based on this Authorization. To revoke this Authorization, you must write to: }{\cf2\insrsid13858039 name of the covered entity(ies) and contact information}{\insrsid13858039 .\line }{\b\insrsid13858039 (Where the research study is conducted by an entity other than the covered entity)}{\insrsid13858039 \par {\listtext\pard\plain\f3\insrsid13858039 \loch\af3\dbch\af0\hich\f3 \'b7\tab}}\pard \ql \fi-360\li720\ri0\sa120\widctlpar\jclisttab\tx720\aspalpha\aspnum\faauto\ls11\nosnaplinegrid\adjustright\rin0\lin720\itap0 {\insrsid13858039 You may change your mind and revoke (take back) this Authorization at any time. Even if you revoke this Authorization, name or class of persons at the covered entity involved in the research may still use or disclose health information they already have obtained about you as necessary to maintain the integrity or reliability of the current research. To revoke this Authorization, you mus t write to: }{\cf2\insrsid13858039 name of the covered entity(ies) and contact information}{\insrsid13858039 .\line }{\b\insrsid13858039 (Where the research study is conducted by the covered entity)}{\insrsid13858039 \par }\pard \ql \li0\ri0\sb240\sa120\widctlpar\tx720\aspalpha\aspnum\faauto\nosnaplinegrid\adjustright\rin0\lin0\itap0 {\insrsid13858039 This Authorization does not have an expiration date }{\cf2\insrsid13858039 or as appropriate, insert expiration date or event, such as \'93end of the research study.\'94 \par }\pard \ql \li0\ri0\sa120\widctlpar\tx720\aspalpha\aspnum\faauto\nosnaplinegrid\adjustright\rin0\lin0\itap0 {\b\insrsid13858039 \par }\pard \ql \li0\ri0\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\insrsid13858039 \sect }\sectd \psz1\sbknone\linex0\cols2\endnhere\titlepg\sectdefaultcl\sftnbj \pard\plain \ql \li0\ri0\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \f1\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid13858039 \par Signature of participant or participant\rquote s personal representative \par \par \par Printed name of participant or participant\rquote s personal representative \par \par \par Date\line \par \par \par If applicable, a description of the personal representative\rquote s authority to sign for the participant\sect }\sectd \psz1\sbknone\linex0\endnhere\titlepg\sectdefaultcl\sftnbj \pard\plain \s20\qc \li0\ri0\widctlpar \tx1440\aspalpha\aspnum\faauto\nosnaplinegrid\adjustright\rin0\lin0\itap0 \b\caps\f1\fs22\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\b0\insrsid13858039 \page }{\caps0\fs28\insrsid13858039 SAMPLE AUTHORIZATION LANGUAGE FOR RESEARCH USES AND DISCLOSURES OF INDIVIDUALLY IDENTIFIABLE HEALTH \par INFORMATION BY A COVERED HEALTH CARE PROVIDER \par }{\fs24\insrsid13858039 \par \par Authorization TO Use OR DisclosE (RELEASE) Health Information THAT IDENTIFIES YOU FOR A RESEARCH STUDY \par }\pard \s20\ql \li0\ri0\widctlpar\tx1440\aspalpha\aspnum\faauto\nosnaplinegrid\adjustright\rin0\lin0\itap0 {\b0\fs24\insrsid13858039 \par }\pard\plain \ql \li0\ri0\sa120\widctlpar\tx720\aspalpha\aspnum\faauto\nosnaplinegrid\adjustright\rin0\lin0\itap0 \f1\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\b\insrsid13858039 OPTIONAL ELEMENTS: \par }\pard \ql \li0\ri0\sa120\widctlpar\tx0\aspalpha\aspnum\faauto\nosnaplinegrid\adjustright\rin0\lin0\itap0 {\insrsid13858039 Examples of optional elements that may be relevant to the recipient of the protected health information: \par {\listtext\pard\plain\f3\insrsid13858039 \loch\af3\dbch\af0\hich\f3 \'b7\tab}}\pard \ql \fi-360\li720\ri0\sb240\sa240\widctlpar\jclisttab\tx720\aspalpha\aspnum\faauto\ls7\adjustright\rin0\lin720\itap0 {\insrsid13858039 Your health information will be used or disclosed when required by law. \par {\listtext\pard\plain\f3\insrsid13858039 \loch\af3\dbch\af0\hich\f3 \'b7\tab}Your health information may be shared with a public health authority that is authorized by law to collect or receive such information for the purpose of preventing or contr olling disease, injury, or disability, and conducting public health surveillance, }{\insrsid1274221 investigations or interventions.}{\insrsid13858039 \par {\listtext\pard\plain\f3\insrsid13858039 \loch\af3\dbch\af0\hich\f3 \'b7\tab}No publication or public presentation about the research described above will reveal your identity without}{\insrsid1274221 another authorization from you.}{\insrsid13858039 \par {\listtext\pard\plain\f3\insrsid13858039 \loch\af3\dbch\af0\hich\f3 \'b7\tab} If all information that does or can identify you is removed from your health information, the remaining information will no longer be subject to this authorization and may be used }{\insrsid1274221 or disclosed for other purposes.}{\insrsid13858039 \par {\listtext\pard\plain\f3\insrsid13858039 \loch\af3\dbch\af0\hich\f3 \'b7\tab}}\pard \ql \fi-360\li720\ri0\sb240\sa240\widctlpar\jclisttab\tx720\aspalpha\aspnum\faauto\ls7\nosnaplinegrid\adjustright\rin0\lin720\itap0 {\b\insrsid13858039 When the research for which the use or disclosure is made involves treatment and is conducted by a covered entity:}{\insrsid13858039 To maintain the integrity of this research study, you generally will not have access to your personal health information related to this research until the study is complete. At th e conclusion of the research and at your request, you generally will have access to your health information that }{\cf2\insrsid13858039 name of the covered entity }{\insrsid13858039 maintains in a designated record set, which means a set of data that includes medical information or billing records used in whole or in part by your doctors or other health care providers at }{\cf2\insrsid13858039 name of the covered entity}{ \insrsid13858039 to make decisions about individuals. Access to your health information in a designated record set is described in the Notice of Privacy Practices provided to you by }{\cf2\insrsid13858039 name of covered entity}{\insrsid13858039 . If it is necessary for your care, your health information will be pr}{\insrsid1274221 ovided to you or your physician.}{\insrsid13858039 \par {\listtext\pard\plain\f3\insrsid13858039 \loch\af3\dbch\af0\hich\f3 \'b7\tab}}\pard \ql \fi-360\li720\ri0\sb240\sa240\widctlpar\jclisttab\tx720\aspalpha\aspnum\faauto\ls7\adjustright\rin0\lin720\itap0 {\insrsid13858039 If you revoke this Authorization, you may no longer be allowed to participate in the research described in this Authorization. \par

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