Access to Designated Record Set: Difference between revisions

no edit summary
No edit summary
No edit summary
Line 30: Line 30:
Policy No.: '''6059'''<br />
Policy No.: '''6059'''<br />
Effective Date: '''03/17/03'''<br />
Effective Date: '''03/17/03'''<br />
Revised Date: '''08/19/22 Draft'''<br />
Revised Date: '''09/09/22 Draft'''<br />
Reviewed Date:<br />
Reviewed Date:<br />


Line 39: Line 39:
It is the policy of Nebraska Medicine/UNMC to comply with the procedures set forth below.<br />
It is the policy of Nebraska Medicine/UNMC to comply with the procedures set forth below.<br />


Nebraska Medicine/UNMC ("Organization"), shall provide individuals access to inspect and obtain a copy of Protected Health Information (PHI) contained in the Designated Record Set (DRS) maintained by Nebraska Medicine/UNMC or its business associates, and to request amendment to such information, in accordance with the [https://www.cdc.gov/phlp/publications/topic/hipaa.html Health Insurance Portability and Accountability Act of 1996 (HIPAA)].   
Nebraska Medicine/UNMC shall provide individuals access to inspect and obtain a copy of Protected Health Information (PHI) contained in the Designated Record Set (DRS) maintained by Nebraska Medicine/UNMC or its business associates, and to request amendment to such information, in accordance with the [https://www.cdc.gov/phlp/publications/topic/hipaa.html Health Insurance Portability and Accountability Act of 1996 (HIPAA)].   
==Purpose==
==Purpose==
To establish guidelines for individual access to and request for amendment of Protected Health Information (PHI) contained in the Designated Record Set.
To establish guidelines for individual access to and request for amendment of Protected Health Information (PHI) contained in the Designated Record Set.
Line 62: Line 62:
#'''Fees'''. If an Individual requests a copy of the PHI, Nebraska Medicine/UNMC may impose cost-based fees, not to exceed $0.50 (50 cents) per page. The basis for calculating such fee must be documented and may include staff time to create and copy the electronic file, such as compiling, extracting, scanning and writing the information to portable media. The cost-based fee may also include the cost of the agreed-upon electronic media, such as a USB drive, or creating a paper copy. If a summary or explanation is requested in advance by the Individual and the Individual has agreed to the fee for such request, Nebraska Medicine/UNMC may charge a pre-determined fee for preparation of such summary or explanation. Reference the fee schedule attached to Nebraska Medicine HIM department policy, Responding to Requests for Clinical Information: External Requestors, ROI 050.
#'''Fees'''. If an Individual requests a copy of the PHI, Nebraska Medicine/UNMC may impose cost-based fees, not to exceed $0.50 (50 cents) per page. The basis for calculating such fee must be documented and may include staff time to create and copy the electronic file, such as compiling, extracting, scanning and writing the information to portable media. The cost-based fee may also include the cost of the agreed-upon electronic media, such as a USB drive, or creating a paper copy. If a summary or explanation is requested in advance by the Individual and the Individual has agreed to the fee for such request, Nebraska Medicine/UNMC may charge a pre-determined fee for preparation of such summary or explanation. Reference the fee schedule attached to Nebraska Medicine HIM department policy, Responding to Requests for Clinical Information: External Requestors, ROI 050.
#'''Production of Records'''. If access to the requested information is granted in whole or in part, HIM will arrange for a convenient time and place for the patient to inspect the records or obtain a copy.
#'''Production of Records'''. If access to the requested information is granted in whole or in part, HIM will arrange for a convenient time and place for the patient to inspect the records or obtain a copy.
#*Inspection will generally be during normal business hours of HIM, unless special circumstances are present. Consult the [mailto:privacy@nebraskamed.com Privacy Officer] if the patient requests to inspect the records or obtain a copy before or after normal business hours.
#*Inspection will generally be during normal business hours of Nebraska Medicine/UNMC, unless special circumstances are present. Consult the [mailto:privacy@nebraskamed.com Privacy Officer] if the Individual requests to inspect the records or obtain a copy before or after normal business hours.
#At the patient’s request, HIM will mail a copy of the records in the format requested to the patient at the address designated on the request form. If requested by the patient, HIM will email a copy of the records to the patient. If the patient requests the records be sent by unsecured email, HIM will confirm that the patient understands the information could be intercepted before complying with the request.  
#At the Individual’s request, HIM will mail a copy of the records in the format requested to the Individual at the address designated on the request form. If requested by the Individual, HIM will email a copy of the records to the Individual. ''If the Individual requests the records be sent by unsecured email, HIM will confirm that the Individual understands the information could be intercepted before complying with the request.''
#If the patient requests in advance an explanation or summary of the information and agrees to pay the fee for preparing the summary, HIM shall prepare the summary and provide it to the patient.
#If the Individual requests in advance an explanation or summary of the information and agrees to pay the fee for preparing the summary, HIM shall prepare the summary and provide it to the Individual.
#The patient will be notified when the records are available for inspection or that a copy is available for pick-up or mailing/e-mailing. The total cost to the Individual for producing and mailing/e-mailing a copy should be included. Payment for copying/mailing/e-mailing the requested records will be collected prior to the time the records are released. Patients generally have access to their own medical information during and after treatment via the One Chart | PATIENT portal. The One Chart | PATIENT portal is a secure online application that allows patients to view portions of their medical and billing record. Patients may give others proxy access to their portal account. Parents may obtain limited proxy access to the records of their children. Reference Nebraska Medicine’s One Chart | Patient (Electronic Health Record Portal) policy, IM45, for current information on eligibility for patient and proxy access.
#The Individual will be notified when the records are available for inspection or that a copy is available for pick-up or mailing/e-mailing. The total cost to the Individual for producing and mailing/e-mailing a copy should be included. Payment for copying/mailing/e-mailing the requested records will be collected prior to the time the records are released. Patients generally have access to their own medical information during and after treatment via the One Chart | PATIENT portal. The One Chart | PATIENT portal is a secure online application that allows patients to view portions of their medical and billing record. Patients may give others proxy access to their portal account. Parents may obtain limited proxy access to the records of their children. Reference Nebraska Medicine’s One Chart | Patient (Electronic Health Record Portal) policy, IM45, for current information on eligibility for patient and proxy access.
#'''Denials of Access'''. HIM should review the request to determine if one or more of the following grounds for denying access exists as to all or part of the requested records. Access may be denied, in coordination with HIM and the Privacy Office, for reasons listed under Sections 13 and 14 below. The patient must be provided with a written denial, including the basis for denial; a statement of their review rights under section 14 below if applicable; and a description of how the Individual may file a complaint to HIM/UNMC, along with name, title and telephone number, or to the Secretary Health and Human Services (see form at Attachment 1). If UNMC does not maintain the PHI that is the subject of the Individual's request for access, and knows where the requested information is maintained, UNMC will inform the Individual where to direct the request for access.
#'''Denials of Access'''. HIM should review the request to determine if one or more of the following grounds for denying access exists as to all or part of the requested records. Access may be denied, in coordination with HIM and the Privacy Office, for reasons listed under Sections 13 and 14 below. The Individual must be provided with a written denial, including the basis for denial; a statement of his/her review rights under n below if applicable; and a description of how the individual may file a complaint to Nebraska Medicine/UNMC, along with name, title, and telephone number, or to the Secretary Health and Human Services '''(see form at Attachment 1) please advise name of form and where located (URL)'''. If Nebraska Medicine/UNMC does not maintain the PHI that is the subject of the individual's request for access and knows where the requested information is maintained, Nebraska Medicine/UNMC will inform the Individual where to direct the request for access.
#'''Unreviewable Grounds for Denial of Access'''. HIM, in coordination with the Privacy Office, may deny the Individual the right to access his/her DRS for reasons listed below without providing the Individual with an opportunity for review.  
#'''Unreviewable Grounds for Denial of Access'''. HIM, in coordination with the Privacy Office, may deny the Individual the right to access their DRS for reasons listed below without providing the Individual with an opportunity for review.  
#*The information requested is not maintained by UNMC or ACE. If HIM knows where such information is maintained, the location should be noted in our response to the Individual;
#*The information requested is not maintained by Nebraska Medicine/UNMC or UNMC. If HIM knows where such information is maintained, the location should be noted in our response to the Individual;
#*The information requested is subject to the Privacy Act, 5 U.S.C. § 552(a);
#*The information requested is subject to the Privacy Act, 5 U.S.C. § 552(a);
#*The request is for access to [https://wiki.unmc.edu/index.php?title=Access_to_Designated_Record_Set&action=submit#Psychotherapy_Notes Psychotherapy notes];
#*The request is for access to [https://wiki.unmc.edu/index.php?title=Access_to_Designated_Record_Set&action=submit#Psychotherapy_Notes Psychotherapy notes];
#*The requested information was compiled in reasonable anticipation of, or for use in, a civil, criminal, or administrative action or proceeding;  
#*The requested information was compiled in reasonable anticipation of, or for use in, a civil, criminal or administrative action or proceeding;  
#*The information requested is maintained by a clinical laboratory subject to the [https://www.govinfo.gov/app/details/USCODE-2020-title42/USCODE-2020-title42-chap6A-subchapII-partF-subpart2-sec263a Clinical Laboratory Improvements Amendments of 1988, 42 U.S.C. § 263a], and access by the Individual is prohibited by law;  
#*The information requested is maintained by a clinical laboratory subject to the [https://www.govinfo.gov/app/details/USCODE-2020-title42/USCODE-2020-title42-chap6A-subchapII-partF-subpart2-sec263a Clinical Laboratory Improvements Amendments of 1988, 42 U.S.C. § 263a], and access by the Individual is prohibited by law;  
#*The information requested are records of a research laboratory exempt from the [https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493 Clinical Laboratory Improvements Amendments of 1988, 42 C.F.R. § 493];
#*The information requested are records of a research laboratory exempt from the [https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493 Clinical Laboratory Improvements Amendments of 1988, 42 C.F.R. § 493];
#*The request is for information regarding on-going research where treatment is being rendered as part of such research, provided that the Individual has agreed to the denial of access when consenting to participate in the research, and the health care provider providing treatment has informed the Individual that the right of access will be reinstated upon completion of the research;
#*The request is for information regarding ongoing research where treatment is being rendered as part of such research, provided that the Individual has agreed to the denial of access when consenting to participate in the research and the health care provider providing treatment has informed the Individual that the right of access will be reinstated upon completion of the research;
#*The information was obtained from someone other than a health care provider under a promise of confidentiality, and the access requested would be reasonably likely to reveal the source of the information; or
#*The information was obtained from someone other than a health care provider under a promise of confidentiality and the access requested would be reasonably likely to reveal the source of the information; or
#*The request is from an inmate of a correctional facility and treatment was provided to the inmate under the direction of the correctional facility. The correctional facility must notify HIM/UNMC that obtaining a copy would jeopardize the health, safety, security, custody or rehabilitation of the Individual. HIM may provide copies to the correctional facility to arrange for inspection by the inmate.
#*The request is from an inmate of a correctional facility and treatment was provided to the inmate under the direction of the correctional facility. The correctional facility must notify Nebraska Medicine/UNMC that obtaining a copy would jeopardize the health, safety, security, custody or rehabilitation of the Individual. Nebraska Medicine/UNMC may provide copies to the correctional facility to arrange for inspection by the inmate.
#'''Reviewable Grounds for Denial of Access'''. Departments, in coordination with HIM and the Privacy Office, may also deny the Individual access to the DRS for the following reasons, but must provide the Individual with an opportunity for secondary review:
#'''Reviewable Grounds for Denial of Access'''. Departments, in coordination with HIM and the Privacy Office, may also deny the Individual access to the DRS for the following reasons, but must provide the Individual with an opportunity for secondary review:
#*An attending physician has determined, in the exercise of professional judgment, that the access requested is reasonably likely to endanger the life or physical safety of the Individual or another person;
#*An attending physician has determined, in the exercise of professional judgment, that the access requested is reasonably likely to endanger the life or physical safety of the Individual or another person;
#*The PHI makes reference to another person (unless such other person is a health care provider) and a licensed health care professional has determined, in the exercise of professional judgment, that the access requested is reasonably likely to cause substantial harm to such other person; or  
#*The PHI makes reference to another person (unless such other person is a health care provider) and a licensed health care professional has determined, in the exercise of professional judgment, that the access requested is reasonably likely to cause substantial harm to such other person; or  
#*The request for access is made by the Individual's personal representative and a licensed health care professional has determined, in the exercise of professional judgment, that the provision of access to such personal representative is reasonably likely to cause substantial harm to the Individual or another person.
#*The request for access is made by the Individual's personal representative and a licensed health care professional has determined, in the exercise of professional judgment, that the provision of access to such personal representative is reasonably likely to cause substantial harm to the Individual or another person.
#'''Review of Denial'''. Upon request, the Individual has the right to have denials listed under section 14 above reviewed by another licensed health care professional who did not participate in the original denial. The Nebraska Medicine Chief Medical Officer is the designated reviewing official. If the Chief Medical Officer is not available, the Nebraska Medicine Clinical Governance Committee chair shall review the request. Requests shall be reviewed as soon as possible, but no later than thirty (30) days from submission of the request. HIM must promptly provide written notice to the Individual of the determination of the designated reviewing official, which is final. If access to any information is denied, HIM/UNMC will, to the extent possible, provide access to any remaining information after the information to which access was denied has been removed or redacted.
#'''Review of Denial'''. Upon request, the Individual has the right to have denials listed under section 14 above reviewed by another licensed health care professional who did not participate in the original denial. The Nebraska Medicine Chief Medical Officer is the designated reviewing official. If the Chief Medical Officer is not available, the Nebraska Medicine Clinical Governance Committee chair shall review the request. Requests shall be reviewed as soon as possible, but no later than thirty (30) days from submission of the request. HIM must promptly provide written notice to the Individual of the determination of the designated reviewing official, which is final. If access to any information is denied, Nebraska Medicine/UNMC will, to the extent possible, provide access to any remaining information after the information to which access was denied has been removed or redacted.
===Amendment of Designated Record===
===Amendment of Designated Record===
Individuals have the right to request amendment of PHI about them which is maintained by UNMC or its business associates in the DRS. HIM/UNMC shall receive and process such requests according to the following procedures:
Individuals have the right to request amendment of PHI about them which is maintained by Nebraska Medicine/UNMC or its business associates in the DRS. Nebraska Medicine/UNMC shall receive and process such requests according to the following procedures:
#Individuals may submit a written Request for [Correction/Amendment of Medical/Billing Information form] to HIM, providing rationale for the requested amendment.   
#Individuals may submit a written Request for [Correction/Amendment of Medical/Billing Information form] '''(URL please)''' to HIM, providing rationale for the requested amendment.   
#*HIM will review the form for completion. If any information is incomplete, HIM will notify the Individual that UNMC cannot process the incomplete request. HIM will document on the Request form the attempts to contact the Individual.
#*HIM will review the form for completion. If any information is incomplete, HIM will notify the Individual that Nebraska Medicine/UNMC cannot process the incomplete request. HIM will document on the Request form the attempts to contact the Individual.
#*HIM shall contact the author of clinical PHI to approve/deny the requested amendment. If the author is a medical student, resident or allied health professional with a supervising physician, the supervising physician shall approve/deny the requested amendment. If the request involves billing or payment information, Patient Financial Services should be consulted.
#*HIM shall contact the author of clinical PHI to approve/deny the requested amendment. If the author is a medical student, resident or allied health professional with a supervising physician, the supervising physician shall approve/deny the requested amendment. If the request involves billing or payment information, Patient Financial Services should be consulted.
#'''Approval'''. If the amendment is accepted in whole or in part, HIM must identify the records containing the information. Such records will be amended by lining through the information and appending the amendment, or by providing a link to the location of the amendment. The original information should never be erased or removed from the record.   
#'''Approval'''. If the amendment is accepted in whole or in part, HIM must identify the records containing the information. Such records will be amended by lining through the information and appending the amendment, or by providing a link to the location of the amendment. The original information should never be erased or removed from the record.   
#'''Notifying Third Parties'''.   
#'''Notifying Third Parties'''.   
#*UNMC will make reasonable attempts to notify those persons/entities who are identified by the patient of the amendment.
#*Nebraska Medicine/UNMC will make reasonable attempts to notify those persons/entities who are identified by the patient of the amendment.
#*HIM and UNMC will identify other persons/entities (including business associates of UNMC) that HIM/UNMC knows to be in possession of the information and who may have relied on the information or could foreseeably rely on the information to the detriment of the patient. HIM/UNMC will obtain the patient’s permission to notify parties identified by HIM/UNMC as described above and will make reasonable attempts to notify those third parties of the amendment.
#*Nebraska Medicine/UNMC will identify other persons/entities (including business associates of Nebraska Medicine/UNMC) that Nebraska Medicine/UNMC knows to be in possession of the information and who may have relied on the information or could foreseeably rely on the information to the detriment of the patient. Nebraska Medicine/UNMC will obtain the patient’s permission to notify parties identified by Nebraska Medicine/UNMC as described above and will make reasonable attempts to notify those third parties of the amendment.
#'''Denial'''. Requests for amendment may be denied if one of the following grounds for denial exists:
#'''Denial'''. Requests for amendment may be denied if one of the following grounds for denial exists:
#*The information or record was not created by UNMC. '''Note:''' Continue to process the request if the Individual provides credible information that the creator of the information or record is not available to act on a request for amendment.
#*The information or record was not created by Nebraska Medicine/UNMC. '''Note:''' Continue to process the request if the Individual provides credible information that the creator of the information or record is not available to act on a request for amendment.
#*The disputed information or record is not part of a designated record set.
#*The disputed information or record is not part of a designated record set.
#*The disputed information is not subject to access by the Individual. (Refer to the section on Requests for Access above.)
#*The disputed information is not subject to access by the Individual. (Refer to the section on [ Requests for Access] above.)
#*The information is accurate and complete as written. '''Note:''' If the requested amendment relates to clinical information, HIM must consult with the licensed health care professional who created the information or an appropriate alternate if such person is not available to determine whether the information is accurate and complete.
#*The information is accurate and complete as written. '''Note:''' If the requested amendment relates to clinical information, Nebraska Medicine/UNMC must consult with the licensed health care professional who created the information or an appropriate alternate if such person is not available to determine whether the information is accurate and complete.
#'''Notifying the Individual of the Denial'''. If one of the above grounds exists, HIM will notify the Individual that UNMC has denied the request for amendment, using the Notice of Approved/Denied Request for Amendment form. The notice should inform the Individual of their rights regarding the denied request for amendment.
#'''Notifying the Individual of the Denial'''. If one of the above grounds exists, Nebraska Medicine/UNMC will notify the Individual that Nebraska Medicine/UNMC has denied the request for amendment, using the [ Notice of Approved/Denied Request for Amendment form. The notice should inform the Individual of their rights regarding the denied request for amendment.
#'''Rights of Individual if the Request is Denied'''. UNMC must permit the Individual to submit a written statement of disagreement to UNMC. The statement of disagreement must be in writing and limited to one page.
#'''Rights of Individual if the Request is Denied'''. Nebraska Medicine/UNMC must permit the Individual to submit a written statement of disagreement to Nebraska Medicine/UNMC. The statement of disagreement must be in writing and limited to one page.
#*If a statement of disagreement is submitted, all future disclosures of the disputed information must include the following: Request for Amendment; Denial Notice; Statement of Disagreement; and UNMC’s Rebuttal (if any).
#*If a statement of disagreement is submitted, all future disclosures of the disputed information must include the following: Request for Amendment; Denial Notice; Statement of Disagreement; and Nebraska Medicine/UNMC’s Rebuttal (if any).
#*If a statement of disagreement is not submitted, the Individual has the right to request that UNMC attach the Request for Amendment and Denial Notice to any future disclosures of the disputed information. Attach such Request only upon request of the Individual.
#*If a statement of disagreement is not submitted, the Individual has the right to request that Nebraska Medicine/UNMC attach the Request for Amendment and Denial Notice to any future disclosures of the disputed information. Attach such Request only upon request of the Individual.
#'''Rebuttal by UNMC'''. UNMC will generally not issue a rebuttal statement unless special circumstances warrant. The author of the information should be consulted if HIM believes that a particular statement of disagreement submitted by a patient warrants a rebuttal by UNMC.  
#'''Rebuttal by Nebraska Medicine/UNMC'''. Nebraska Medicine/UNMC will generally not issue a rebuttal statement unless special circumstances warrant. The author of the information should be consulted if HIM believes that a particular statement of disagreement submitted by a patient warrants a rebuttal by Nebraska Medicine/UNMC.  
#'''Timeframe for Response'''. HIM shall respond back to the requestor in writing within 60 days of the date UNMC received the amendment request. If HIM determines that UNMC is unable to respond to the request within sixty (60) days, HIM must notify the Individual in writing that one 30-day extension is necessary to respond to the request and shall provide the reasons the extension is necessary. The extension notice must state the date by which action on the request will be taken.
#'''Timeframe for Response'''. HIM shall respond back to the requestor in writing within 60 days of the date Nebraska Medicine/UNMC received the amendment request. If HIM determines that Nebraska Medicine/UNMC is unable to respond to the request within sixty (60) days, HIM must notify the Individual in writing that one 30-day extension is necessary to respond to the request and shall provide the reasons the extension is necessary. The extension notice must state the date by which action on the request will be taken.
#'''Recordkeeping'''. The request for amendment, denial of the request, and statement of disagreement/rebuttal statement (if any) must be placed (append or otherwise linked in the electronic record) in the DRS and provided to the Individual as a part of a request for access.  
#'''Recordkeeping'''. The request for amendment, denial of the request, and statement of disagreement/rebuttal statement (if any) must be placed (append or otherwise linked in the electronic record) in the DRS and provided to the Individual as a part of a request for access.  
Nebraska Medicine/UNMC implements reasonable and appropriate access controls in alignment with National Institute of Standards and Technology (NIST) standards and guidance to maintain the minimum necessary access. [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST Special Publication 800-53] and the [https://www.cdc.gov/phlp/publications/topic/hipaa.html#security-rule HIPAA Security Rule] outline considerations for the access control family of security controls.
== Policy ==
Nebraska Medicine/UNMC shall limit the use and disclosure of Protected Health Information (PHI) to the right people, for the right purposes, with the right authority, and always subject to reasonable safeguards -- all as defined by the [https://www.cdc.gov/phlp/publications/topic/hipaa.html Health Insurance Portability and Accountability Act of 1996 (HIPAA)]. Health Insurance Portability and Accountability Act of 1996 (HIPAA)] and Nebraska Medicine/UNMC policies.
==Purpose==
To establish guidelines for the use and disclosure of PHI.
==Definitions==
==Definitions==
===Affiliated Covered Entity (ACE)===
===Affiliated Covered Entity (ACE)===
Line 148: Line 143:
*[Complaint form referenced in #12, called attachment 1 - we'll want to use actual form name]
*[Complaint form referenced in #12, called attachment 1 - we'll want to use actual form name]
*[Extension Notice]
*[Extension Notice]
*Notice of Approved/Denied Request for Amendment form


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