DRAFT Version 1/FINAL: 3/1/12 Based on Final HIPAA Security Rule & HITECH Interim Rules (8/24/09) HIPAA COW PRIVACY AND SECURITY NETWORKING GROUPS PRIVACY BREACH PRIVACY OFFICER’S RESPONSE & INVESTIGATION CHECKLIST This checklist has been created to provide outlined guidance in responding to a large scale/high impact privacy breach due to loss, theft, or other unauthorized access, use or disclosure of patient protected health information (PHI). More detail is provided in the HIPAA COW Breach Notification Policy available at www.hipaacow.org. The Privacy Officer is responsible for managing privacy breaches. Action Step Responsible Contact Notes (Include Date Action Carried Out) Description of Incident Incident Received and Documented Reported By (and contact information) Date and Time Report Received Date and Time of Incident Date and Time Incident Discovered Location/Department/Building Source/Media (e.g., EHR, Paper, Fax, etc.) Business Associate (BA) /Vendor Involvement Description of Incident Privacy Breach Investigation Record Initiated Request Originals/Media to be Returned or Destroyed with Written Verification of Such If Applicable, Security Incident Initiated Privacy Officer Privacy Officer Locate Signed BA Agreement; If No BA with Vendor, Document Why Not Include Name of Individual(s) Involved, PHI, How and Why the Incident Happened, etc. Privacy Officer Privacy Officer Security Officer See HIPAA COW Security Incident Response Policy Internal Notification (as Appropriate) IT Leadership Risk Management, Compliance Officer, Human Resources, Leadership, etc. Internal Legal Counsel Publication Relations & Communications/ Customer Service Building Services/Facilities Name, Title, Email Address and Phone Name, Title, Email Address and Phone Name, Title, Email Address and Phone Name, Title, Email Address and Phone Name, Title, Email Address and Phone Create an Immediate Script for Response tor Incoming Inquiries About Incident External Notification (as Appropriate) External Legal Counsel Law Enforcement Officials Date/Time Copyright 2012 HIPAA COW Name, Title, Email Address and Phone To be Notified by Privacy Officer or Risk Management Based on Geographic Location; Nature of Crime Page 1 DRAFT Version 1/FINAL: 3/1/12 Based on Final HIPAA Security Rule & HITECH Interim Rules (8/24/09) Action Step Responsible Contact Notes (Include Date Action Carried Out) Agency Officer Insurance Carrier (e.g., Facility, Cyber, Malpractice, etc.) Date/Time Agency Agent Office for Civil Rights (see separate section) State and/or Federal Agency, if Required (e.g., Health Plans with Medicare Plans – Contact CMS) To be Notified by Privacy Officer or Risk Management Privacy Officer Investigation Components Complete Risk Assessment to Determine Potential for Significant Risk of Financial, Reputational, or Other Harm (see Attachment A for PHI Data Elements) See HIPAA COW Breach Notification Policy - Risk Assessment Tool Privacy Officer Chief Information Officer Assess/Engage Need for Forensics Assess/Engage Need for Private Investigator (e.g., research Craigslist, E-Bay, etc. for stolen equipment) Privacy Officer or Risk Management Another Option: NCHICA HITECH Breach Notification Assessment Tool Considerations: Does a Contract with a Vendor Exist? If Not, Approval of Senior Leadership? Considerations: Does a Contract with a Vendor Exist? If Not, Approval of Senior Leadership? Office for Civil Rights Breach Notification Requirements < 500 Individuals (Year End Reporting) Notify OCR Reasonable Time Period or < 60 Days > 500 Individuals Notify OCR Reasonable Time Period or < 60 Days Notify Individuals Privacy Officer Privacy Officer Privacy Officer Privacy Officer Oversight Public Relations Notify Media Outlets Report by March 1 of Following Year In Consultation with Senior Leadership, Legal Counsel. Refer to the Sample Notification Letter in the HIPAA COW Breach Notification Policy. In Consultation with Senior Leadership, Legal Counsel. Consideration: Notification by Business Unit Responsible - Leadership Decision? Senior Leadership Decision Based on Organizational Policy, Geographical Location; See HIPAA COW Breach Notification Policy. Mitigation/Follow-Up Activities Business Associate (as Applicable): Request a document from the BA outlining the mitigation plan, BA responsibilities for breach management, and documentation of steps on how the BA will ensure the event does not Copyright 2012 HIPAA COW Privacy Officer Page 2 DRAFT Version 1/FINAL: 3/1/12 Based on Final HIPAA Security Rule & HITECH Interim Rules (8/24/09) Action Step Responsible Contact Notes (Include Date Action Carried Out) Privacy Officer Cyber-Insurance Vendor/Senior Leadership to Approve reoccur. Consideration of External Vendor Specializing in Breach Notification Consideration of External Vendor Specializing in Credit Card Monitor Prepare Communication Plan to Cover Oral, Electronic and Written Communications to Victims as Well as Information to Assist with Personal Needs; Include Organizational Contact Information. Report to Senior Leadership/BOD Completion of Investigation Report Completion of Workforce Member Sanctions Communication to Staff – Learning Opportunity (e.g., newsletter article, meeting presentation, etc.) Record Disclosure Information in Accounting of Disclosures Records. Completed Checklist Retained with Supporting Documentation for six years Privacy Officer/Public Relations Leader Privacy Officer Privacy Officer Director of Human Resources Privacy Officer Privacy Officer; Director of HIM/MR Department Privacy Officer HIPAA Defined PHI Data Elements Note: Any single or combination of PHI data elements used, accessed, or disclosed without an individual’s authorization is a breach. A risk assessment must be carried out to determine if there is potential harm to the individual and whether or not notification should be carried out (e.g., Identity Information Trifecta: Name, DOB, SSN#). 1 2 3 4 5 6 7 8 9 Name Geographic Subdivision Smaller than a State All Elements of Dates Related to Individual (birth, death, adm) Telephone Numbers Fax Numbers Electronic Mail Address Social Security Number Medical Record Numbers Health Plan Beneficiary Numbers 10 Account Numbers 11 Certification/License Numbers Vehicle Identifiers and Serial Numbers Including License 12 Plates 13 Device Identifiers and Serial Numbers 14 Web URLs 15 Internet Protocol Addresses 16 Biometric Identifiers, Including Finger and Voice Prints 17 Full Face Photos and Comparable Images 18 Any Unique Identifying Number, Characteristic or Code Key Contacts/Information Sources Name Title Privacy Officer Copyright 2012 HIPAA COW Location Office Cell Phone # E-Mail Address Page 3 DRAFT Version 1/FINAL: 3/1/12 Based on Final HIPAA Security Rule & HITECH Interim Rules (8/24/09) Name Title Security Officer Location Office Cell Phone # E-Mail Address Compliance Leader Legal Counsel Director, Human Resources Director, Health Information Mgmt Director, Risk Management Chief Information Officer Director, Facility Management Supporting Resources List Relevant Internal Policies and Procedures and Web Sites - Provide Web Links External Resources HIPAA COW Breach Notification Sample Policy, Available at: http://www.hipaacow.org/Docs/BreachNotificationPolicy0111.doc North Carolina Healthcare Information & Communications Alliance, Inc. (NCHICA) Breach Notification Risk Assessment http://www.nchica.org/HIT_HIE/ARRA/Improper%20Disclosures%20Assessment%20november%205%2009%20v7%20(3)%20(3).doc OCR Breach Notification Resources, Available at: http://www.hhs.gov/ocr/privacy/hipaa/administrative/breachnotificationrule/index.html OCR Breach Notification Reporting, Submit Breach at: http://www.hhs.gov/ocr/privacy/hipaa/administrative/breachnotificationrule/brinstruction.html Primary Authors Nancy Davis, MS, RHIA, Ministry Health Care Chrisann Lemery, MS, RHIA, FAHIMA, WEA Insurance Reviewed By: HIPAA COW Privacy Networking Group Disclaimer This 2012 Privacy Officer Breach Checklist is Copyright 2012 by the HIPAA Collaborative of Wisconsin (“HIPAA COW”). It may be freely redistributed in its entirety provided that this copyright notice is not removed. When information from this document is used, HIPAA COW shall be referenced as a resource. It may not be sold for profit or used in commercial documents without the written permission of the copyright holder. This2012 Privacy Officer Breach Checklist is provided “as is” without any express or implied warranty. This 2012 Privacy Officer Breach Checklist is for educational purposes only and does not constitute legal advice. If you require legal advice, you should consult with an attorney. Unless otherwise noted, HIPAA COW has not addressed all state pre-emption issues related to this 2012 Privacy Officer Breach Checklist. Therefore, this document may need to be modified in order to comply with Wisconsin/State law. Copyright 2012 HIPAA COW Page 4