Use and Disclosure of PHI for Training Health Care Professionals: Difference between revisions

no edit summary
No edit summary
No edit summary
Line 79: Line 79:
Individual descriptive case histories, even if published and/or presented at national or regional meetings or otherwise intended for an audience by individuals who are not members of the Workforce, are generally not considered research provided the case is limited solely to a description of the clinical features or findings and/or outcome of the individual patient. However, case series (generally involving more than three patients) where there is concomitant analysis and correlation of data as part of a systematic investigation are considered research and must be reviewed by the IRB. (See HRPP Policy 1.8 for additional information).
Individual descriptive case histories, even if published and/or presented at national or regional meetings or otherwise intended for an audience by individuals who are not members of the Workforce, are generally not considered research provided the case is limited solely to a description of the clinical features or findings and/or outcome of the individual patient. However, case series (generally involving more than three patients) where there is concomitant analysis and correlation of data as part of a systematic investigation are considered research and must be reviewed by the IRB. (See HRPP Policy 1.8 for additional information).
====Case Series====
====Case Series====
If cases are being sought for publication as part of a case series or a clinical study needing chart reviews, faculty and department staff will assist students in creating lists of possible diagnoses of interest along with possible International Classification of Diseases (ICD) codes. This list will be used by [https://www.unmc.edu/cctr/resources/crc/index.html Clinical Research Center] or [http://newintranet.nebraskamed.com/ AnalyticsRequest/ Analytics Work Request] to confirm the existence and number of such possible cases available for review within a specified timeframe. Following IRB approval, those designated by the IRB as being appropriate, including students, will be allowed to access the charts with the understanding of the need for full confidentiality in the handling and appropriate de-identification of any stored data onto a secure and HIPAA-compliant server. Individual cases may be reviewed prior to IRB consent only under supervision of the physician of record.  
If cases are being sought for publication as part of a case series or a clinical study needing chart reviews, faculty and department staff will assist students in creating lists of possible diagnoses of interest along with possible International Classification of Diseases (ICD) codes. This list will be used by [https://www.unmc.edu/cctr/resources/crc/index.html Clinical Research Center] or [http://newintranet.nebraskamed.com/AnalyticsRequest/ Analytics Work Request] to confirm the existence and number of such possible cases available for review within a specified timeframe. Following IRB approval, those designated by the IRB as being appropriate, including students, will be allowed to access the charts with the understanding of the need for full confidentiality in the handling and appropriate de-identification of any stored data onto a secure and HIPAA-compliant server. Individual cases may be reviewed prior to IRB consent only under supervision of the physician of record.  
===External Use of PHI for Educational Purposes===
===External Use of PHI for Educational Purposes===
Providers/faculty/staff/trainees/students or other members of the Workforce may not use PHI in case studies, Grand Rounds, community presentations, articles, industry conferences/lectures, posters, fliers or any other material or media that could be seen or accessed by individuals who are not a member of the Workforce unless:
Providers/faculty/staff/trainees/students or other members of the Workforce may not use PHI in case studies, Grand Rounds, community presentations, articles, industry conferences/lectures, posters, fliers or any other material or media that could be seen or accessed by individuals who are not a member of the Workforce unless:
Line 95: Line 95:
::*Patient name, MRN and/or SSN shall not be used without obtaining prior written patient authorization.
::*Patient name, MRN and/or SSN shall not be used without obtaining prior written patient authorization.
::*De-identified information should be used whenever possible (see [https://wiki.unmc.edu/index.php/Use_and_Disclosure_of_PHI_for_Training_Health_Care_Professionals#De-identification_of_PHI_for_Educational_Purposes 4.8 De-identification of PHI for Educational Purposes]).
::*De-identified information should be used whenever possible (see [https://wiki.unmc.edu/index.php/Use_and_Disclosure_of_PHI_for_Training_Health_Care_Professionals#De-identification_of_PHI_for_Educational_Purposes 4.8 De-identification of PHI for Educational Purposes]).
::*Patient’s or legal guardian’s written authorization is required to photograph or videotape a patient for training purposes. The patient or the patient’s legal guardian will complete the [ Education Authorization Form CON MR 1900] or other Privacy Office-approved form. Then, only the minimum amount of information shall be photographed/videotaped. (See [https://info.unmc.edu/its-security/policies/procedures/electronic-comm-phi.html Electronic Communication of Protected Health Information], Procedure for UNMC Policy No. 6051, for additional guidance.)
::*Patient’s or legal guardian’s written authorization is required to photograph or videotape a patient for training purposes. The patient or the patient’s legal guardian will complete the [ Education Authorization Form CON MR 1900] or other Privacy Office-approved form. Then, only the minimum amount of information shall be photographed/videotaped. (See Procedure for UNMC Policies No. 6051 and 6057, [https://info.unmc.edu/its-security/policies/procedures/electronic-comm-phi.html Electronic Communication of Protected Health Information], for additional guidance.)
*Individuals participating in clinical job shadowing shall follow [http://www.nebraskamed.com/careers/job-shadowing Nebraska Medicine’s job shadowing process] and visiting providers functioning as observers or trainees follow [Med Staff’s Visiting Staff policy, MS28].
*Individuals participating in clinical job shadowing shall follow [http://www.nebraskamed.com/careers/job-shadowing Nebraska Medicine’s job shadowing process] and visiting providers functioning as observers or trainees follow [Med Staff’s Visiting Staff policy, MS28].
===Use/Disclosure of PHI for Research ===
===Use/Disclosure of PHI for Research ===
*Research is not considered training or education within the meaning of this policy.
*Research is not considered training or education within the meaning of this policy.
*All research requests using PHI must be submitted to the UNMC IRB for review and approval. See UNMC Human Research Protection Policies and Procedures. The IRB-approved consent also contains the HIPAA-compliant authorization when required under HIPAA. The UNMC IRB operates as UNMC’s Privacy Board and approves all waivers of authorization as permitted under HIPAA.   
*All research requests using PHI must be submitted to the UNMC IRB for review and approval. See UNMC [https://guides.unmc.edu/books/hrpp-policies-and-procedures Human Research Protection Program Policies and Procedures]. The IRB-approved consent also contains the HIPAA-compliant authorization when required under HIPAA. The UNMC IRB operates as UNMC’s Privacy Board and approves all waivers of authorization as permitted under HIPAA.   
Review of PHI Preparatory to Research. UNMC staff and students who wish to review PHI to prepare a research proposal must submit a "Request for Electronic Health Data" form to the [www.unmc.edu/cctr/ehr_research.html Electronic Health Record Core].
*Review of PHI Preparatory to Research. UNMC staff and students who wish to review PHI to prepare a research proposal must submit a "Request for Electronic Health Data" form to the [www.unmc.edu/cctr/ehr_research.html Electronic Health Record Core].
===De-identification of PHI for Educational Purposes===
===De-identification of PHI for Educational Purposes===
PHI may be used to create information that is not individually identifiable health information (de-identified). The HIPAA privacy rules do not apply to information that does not identify an individual and with respect to which there is no reasonable basis to believe that the information can be used to identify an individual. However, de-identification to HIPAA standards is challenging and is not always possible, which often results in the need for written Individual authorization to use/disclose the patient’s PHI. Beyond the removal of identifiers, the following considerations are required by the Privacy Office:
PHI may be used to create information that is not individually identifiable health information (de-identified). The HIPAA privacy rules do not apply to information that does not identify an individual and with respect to which there is no reasonable basis to believe that the information can be used to identify an individual. However, de-identification to HIPAA standards is challenging and is not always possible, which often results in the need for written Individual authorization to use/disclose the patient’s PHI. Beyond the removal of identifiers, the following considerations are required by the Privacy Office:
Line 108: Line 108:
*Is the case geographically uncommon? (E.g., a case that is common in Brazil, but rarely seen/treated in Nebraska)
*Is the case geographically uncommon? (E.g., a case that is common in Brazil, but rarely seen/treated in Nebraska)
*Is the case procedurally uncommon? (E.g., the first double lung transplant, etc.)  
*Is the case procedurally uncommon? (E.g., the first double lung transplant, etc.)  
Some cases and images would be unique without any indication of the injury or disease (e.g., physical structures that are unusual). However, any image/case combined with the treatment location (e.g., UNMC/Nebraska Medicine), the facts of the case (e.g., how the injury occurred or the disease process), and/or the facts of the treatment (e.g., the number of screws in the injured ankle) tips the image/case toward identifiability. Additionally, cases/images are rarely presented in a vacuum – while identifiers are commonly removed, the presenter generally provides some background (e.g., a story about how the injury happened) or applicable facts about the patient (e.g., place/type of employment; medical history), adding additional risk of identifiability.<br />
Some cases and images would be unique without any indication of the injury or disease (e.g., physical structures that are unusual). However, any image/case combined with the treatment location (e.g., UNMC/Nebraska Medicine), the facts of the case (e.g., how the injury occurred or the disease process), and/or the facts of the treatment (e.g., the number of screws in the injured ankle) tips the image/case toward identifiability. Additionally, cases/images are rarely presented in a vacuum – while identifiers are commonly removed, the presenter generally provides some background (e.g., a story about how the injury happened) or applicable facts about the patient (e.g., place/type of employment; medical history), adding additional risk of identifiability.<br />


See UNMC Policy No. 6057, [[Use and Disclosure of Protected Health Information]], for additional information regarding de-identification.
See UNMC Policy No. 6057, [[Use and Disclosure of Protected Health Information]], for additional information regarding de-identification.
Line 117: Line 117:
*UNMC Policy No. 6051, [https://wiki.unmc.edu/index.php/Computer_Use/Electronic_Information Computer Use/Electronic Information]
*UNMC Policy No. 6051, [https://wiki.unmc.edu/index.php/Computer_Use/Electronic_Information Computer Use/Electronic Information]
*UNMC Policy No. 6057, [https://wiki.unmc.edu/index.php/Use_and_Disclosure_of_Protected_Health_Information Use and Disclosure of Protected Health Information]
*UNMC Policy No. 6057, [https://wiki.unmc.edu/index.php/Use_and_Disclosure_of_Protected_Health_Information Use and Disclosure of Protected Health Information]
*[https://info.unmc.edu/its-security/policies/procedures/electronic-comm-phi.html Electronic Communication of Protected Health Information], Procedure for UNMC Policy No. 6051
*Procedure for UNMC Policies No. 6051 and 6057, [https://info.unmc.edu/its-security/policies/procedures/electronic-comm-phi.html Electronic Communication of Protected Health Information]
*UNMC [https://guides.unmc.edu/books/hrpp-policies-and-procedures Human Research Protection Program Policies and Procedures]
*HRPP Policy 1.8
*HRPP Policy 1.8
*Med Staff’s Visiting Staff policy, MS28.
*Med Staff’s Visiting Staff policy, MS28.
*Education Authorization form CON MR 1900
*Education Authorization form CON MR 1900
*Request for Electronic Health Data Form
*Request for Electronic Health Data Form
*[http://newintranet.nebraskamed.com/AnalyticsRequest/ Analytics Work Request]
*[http://www.nebraskamed.com/careers/job-shadowing Nebraska Medicine’s job shadowing process]
*[http://www.nebraskamed.com/careers/job-shadowing Nebraska Medicine’s job shadowing process]


This page maintained by [mailto:dpanowic@unmc.edu dkp].
This page maintained by [mailto:dpanowic@unmc.edu dkp].