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Insight into DHHS OCR Audit Protocols

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David Sweigert
David Sweigert

This document summarizes recent HIPAA enforcement actions, lessons learned from breaches, and updates on OCR guidance and auditing. It finds that theft and loss account for most large breaches, and laptops and portable devices account for a third of large breaches. Recent enforcement actions targeted entities with security failures during system changes. OCR will expand auditing to include business associates and focus on areas like security and individual rights compliance.

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Lessons Learned from Recent HIPAA Enforcement Actions, Breaches, and Pilot Audits Iliana L. Peters, J.D., LL.M. Senior Advisor for HIPAA Compliance and Enforcement
OCR RULEMAKING UPDATE What’s Done? What’s to Come? OCR/NIST 2 • What’s Done: – Interim Final Rules • Enforcement penalties • Breach Notification – Omnibus Final Rule • HITECH provisions, including final rulemaking on IFR above • GINA provisions • Other rule changes – NICS NPRM – CLIA Final Rules • Access to test results directly from labs • What’s to Come: – From HITECH • Accounting of Disclosures • Methods for sharing penalty amounts with harmed individuals – NICS Final Rule
OCR GUIDANCE UPDATE What’s Done? What’s to Come? OCR/NIST 3 What’s Done: Omnibus Final Rule • De-identification • Combined Regulation Text • Sample BA provisions • Refill Reminder • Factsheets on Student immunizations and Decedents Model Notice of Privacy Practices in English and Spanish Guide to Law Enforcement Permitted Mental Health Disclosures Letters from Leon • Dear Provider – duty to warn, serious and imminent threats • Right to access – updated for e-access requirements What’s to Come: Omnibus Final Rule • Breach Safe Harbor Update • Breach Risk Assessment Tool • Minimum Necessary • More on Marketing • More Factsheets on other provisions Model Notice • On line version Other Guidance • Security Rule guidance updates
Changes to the Rules: • Security Rule: BAs (and subcontractors) now directly liable • Privacy Rule: BAs (and subcontractors) now directly liable for: – impermissible uses and disclosures; – non-compliance with their BA Agreements; and – certain individual rights. BUSINESS ASSOCIATES OCR/NIST 4
Revised Definition of “Breach:” Breach Presumed UNLESS: • “LoProCo:” The CE or BA can demonstrate that there is a low probability that the PHI has been compromised based on: – Nature and extent of the PHI involved (including the types of identifiers and the likelihood of re-identification); – The unauthorized person who used the PHI or to whom the disclosure was made; – Whether the PHI was actually acquired or viewed; and – The extent to which the risk to the PHI has been mitigated. Focus on risk to the data, instead of risk of harm to the individual. Risk Assessment must be documented. BREACH NOTIFICATION RULE OCR/NIST 5
500+ Breaches by Type of Breach as of 8/31/2014 OCR/NIST 6 Theft 51% Loss 9% Unauthorized Access/Disclosure 18% Hacking/IT 8% Improper Disposal 4% Other 9% Unknown 1%
500+ Breach by Location of Breach as of 8/31/2014 OCR/NIST Paper Records 21% Desktop Computer 13% Laptop 22% Portable Electronic Device 11% Network Server 12% Email 6% EMR 4% Other 11%
8 BREACH HIGHLIGHTS September 2009 through August 31, 2014 • Approximately 1176 reports involving a breach of PHI affecting 500 or more individuals – Theft and Loss are 60% of large breaches – Laptops and other portable storage devices account for 33% of large breaches – Paper records are 21% of large breaches • Approximately 122,000+ reports of breaches of PHI affecting less than 500 individuals OCR/NIST
LESSONS LEARNED Appropriate Safeguards Prevent Breaches • Evaluate the risk to e-PHI when at rest on removable media, mobile devices and computer hard drives • Take reasonable and appropriate measures to safeguard e-PHI – Store all e-PHI to a network – Encrypt data stored on portable/movable devices & media – Employ a remote device wipe to remove data when lost or stolen – Consider appropriate data backup – Train workforce members on how to effectively safeguard data and timely report security incidents OCR/NIST 9
COMPLAINTS RECEIVED OCR/NIST 10
2013 CLOSED CASES OCR/NIST 11
RECENT ENFORCEMENT ACTIONS OCR/NIST 12 • Parkview • NYP/Columbia • Concentra • QCA • Skagit County • Adult & Pediatric Dermatology, P.C. • Affinity Health Plan, Inc.
Lessons Learned: • HIPAA covered entities and their business associates are required to undertake a careful risk analysis to understand the threats and vulnerabilities to individuals’ data, and have appropriate safeguards in place to protect this information. • Take caution when implementing changes to information systems, especially when those changes involve updates to Web-based applications or portals that are used to provide access to consumers’ health data using the Internet. • Senior leadership helps define the culture of an organization and is responsible for knowing and complying with the HIPAA privacy and security requirements to ensure patients’ rights are fully protected as well as the confidentiality of their health data. RECENT ENFORCEMENT ACTIONS OCR/NIST 13
AUDIT PILOT FINIDNGS AND OBSERVATIONS No findings or observations for 13 entities (11%) •2 Providers, 9 Health Plans, 2 Clearinghouses Security accounted for 60% of the findings and observations— although only 28% of potential total. Providers had a greater proportion of findings & observations (65%) than reflected by their proportion of the total set (53%). Smaller, Level 4 entities struggle with all three areas OCR/NIST 14
AUDIT PROGRAM NEXT STEPS Internal analysis for follow up and next steps •Creation of technical assistance based on results •Determine where entity follow up is appropriate •Identify leading practices Protocol Updates •Revise CE Protocol to reflect Omnibus Rule •Develop BA Protocol Future program design and focus •Business Associates: Identify the population. •Identify areas of focus for future audits. •Accreditation /Certification correlations? OCR/NIST 15
AUDIT PHASE 2 APPROACH • Primarily internally staffed • Selected entities will receive notification and data requests • Entities will be asked to identify their business associates and provide their current contact information • Will select business associate audit subjects for first wave from among the BAs identified by covered entities • Desk audits of selected provisions • Comprehensive on-site audits as resources allow OCR/NIST
PHASE 2 DESK AUDITS OCR/NIST Pre-audit survey links to pool Summer 2014 Notification and data request to selected entities Fall 2014 Desk review and draft findings Entity provides management review Final report
AUDITS PHASE 2 EXPECTATIONS OCR/NIST Data request will specify content & file organization, file names, and any other document submission requirements Only requested data submitted on time will be assessed. All documentation must be current as of the date of the request. Auditors will not have opportunity to contact the entity for clarifications or to ask for additional information, so it is critical that the documents accurately reflect the program. Submitting extraneous information may increase difficulty for auditor to find and assess the required items. Failure to submit response to requests may lead to referral for regional compliance review
New Guidance: BUSINESS ASSOCIATES The HIPAA Omnibus Rule https://www.youtube.com/watch?v=mX-QL9PoePU OCR/NIST 19
Consumer Awareness: PUBLIC OUTREACH INITIATIVES OCR/NIST Your New Rights Under HIPAA - Consumers https://www.youtube.com/watch?v=3-wV23_E4eQ Over 262,000 views since September 4, 2013 20
Mobile Devices: http://www.healthit. gov/mobiledevices MOBILE DEVICES OCR/NIST 21
NOTICE OF PRIVACY PRACTICES http://www.hhs.gov/ocr/privacy/hipaa/modelnotices.html OCR/NIST 22
Medscape Resource Center: PUBLIC OUTREACH INITIATIVES OCR/NIST http://www.medscape.org/sites/advances/patients-rights 23
More Guidance: • Business Associates • Breach Notification Rule • Security Rule • Individual Rights • Other Privacy Rule Topics More Training: • Online Training Modules Audit Program WHAT’S TO COME OCR/NIST 24
QUESTIONS? OCR/NIST 25

More Related Content

Insight into DHHS OCR Audit Protocols

  • 1. Lessons Learned from Recent HIPAA Enforcement Actions, Breaches, and Pilot Audits Iliana L. Peters, J.D., LL.M. Senior Advisor for HIPAA Compliance and Enforcement
  • 2. OCR RULEMAKING UPDATE What’s Done? What’s to Come? OCR/NIST 2 • What’s Done: – Interim Final Rules • Enforcement penalties • Breach Notification – Omnibus Final Rule • HITECH provisions, including final rulemaking on IFR above • GINA provisions • Other rule changes – NICS NPRM – CLIA Final Rules • Access to test results directly from labs • What’s to Come: – From HITECH • Accounting of Disclosures • Methods for sharing penalty amounts with harmed individuals – NICS Final Rule
  • 3. OCR GUIDANCE UPDATE What’s Done? What’s to Come? OCR/NIST 3 What’s Done: Omnibus Final Rule • De-identification • Combined Regulation Text • Sample BA provisions • Refill Reminder • Factsheets on Student immunizations and Decedents Model Notice of Privacy Practices in English and Spanish Guide to Law Enforcement Permitted Mental Health Disclosures Letters from Leon • Dear Provider – duty to warn, serious and imminent threats • Right to access – updated for e-access requirements What’s to Come: Omnibus Final Rule • Breach Safe Harbor Update • Breach Risk Assessment Tool • Minimum Necessary • More on Marketing • More Factsheets on other provisions Model Notice • On line version Other Guidance • Security Rule guidance updates
  • 4. Changes to the Rules: • Security Rule: BAs (and subcontractors) now directly liable • Privacy Rule: BAs (and subcontractors) now directly liable for: – impermissible uses and disclosures; – non-compliance with their BA Agreements; and – certain individual rights. BUSINESS ASSOCIATES OCR/NIST 4
  • 5. Revised Definition of “Breach:” Breach Presumed UNLESS: • “LoProCo:” The CE or BA can demonstrate that there is a low probability that the PHI has been compromised based on: – Nature and extent of the PHI involved (including the types of identifiers and the likelihood of re-identification); – The unauthorized person who used the PHI or to whom the disclosure was made; – Whether the PHI was actually acquired or viewed; and – The extent to which the risk to the PHI has been mitigated. Focus on risk to the data, instead of risk of harm to the individual. Risk Assessment must be documented. BREACH NOTIFICATION RULE OCR/NIST 5
  • 6. 500+ Breaches by Type of Breach as of 8/31/2014 OCR/NIST 6 Theft 51% Loss 9% Unauthorized Access/Disclosure 18% Hacking/IT 8% Improper Disposal 4% Other 9% Unknown 1%
  • 7. 500+ Breach by Location of Breach as of 8/31/2014 OCR/NIST Paper Records 21% Desktop Computer 13% Laptop 22% Portable Electronic Device 11% Network Server 12% Email 6% EMR 4% Other 11%
  • 8. 8 BREACH HIGHLIGHTS September 2009 through August 31, 2014 • Approximately 1176 reports involving a breach of PHI affecting 500 or more individuals – Theft and Loss are 60% of large breaches – Laptops and other portable storage devices account for 33% of large breaches – Paper records are 21% of large breaches • Approximately 122,000+ reports of breaches of PHI affecting less than 500 individuals OCR/NIST
  • 9. LESSONS LEARNED Appropriate Safeguards Prevent Breaches • Evaluate the risk to e-PHI when at rest on removable media, mobile devices and computer hard drives • Take reasonable and appropriate measures to safeguard e-PHI – Store all e-PHI to a network – Encrypt data stored on portable/movable devices & media – Employ a remote device wipe to remove data when lost or stolen – Consider appropriate data backup – Train workforce members on how to effectively safeguard data and timely report security incidents OCR/NIST 9
  • 11. 2013 CLOSED CASES OCR/NIST 11
  • 12. RECENT ENFORCEMENT ACTIONS OCR/NIST 12 • Parkview • NYP/Columbia • Concentra • QCA • Skagit County • Adult & Pediatric Dermatology, P.C. • Affinity Health Plan, Inc.
  • 13. Lessons Learned: • HIPAA covered entities and their business associates are required to undertake a careful risk analysis to understand the threats and vulnerabilities to individuals’ data, and have appropriate safeguards in place to protect this information. • Take caution when implementing changes to information systems, especially when those changes involve updates to Web-based applications or portals that are used to provide access to consumers’ health data using the Internet. • Senior leadership helps define the culture of an organization and is responsible for knowing and complying with the HIPAA privacy and security requirements to ensure patients’ rights are fully protected as well as the confidentiality of their health data. RECENT ENFORCEMENT ACTIONS OCR/NIST 13
  • 14. AUDIT PILOT FINIDNGS AND OBSERVATIONS No findings or observations for 13 entities (11%) •2 Providers, 9 Health Plans, 2 Clearinghouses Security accounted for 60% of the findings and observations— although only 28% of potential total. Providers had a greater proportion of findings & observations (65%) than reflected by their proportion of the total set (53%). Smaller, Level 4 entities struggle with all three areas OCR/NIST 14
  • 15. AUDIT PROGRAM NEXT STEPS Internal analysis for follow up and next steps •Creation of technical assistance based on results •Determine where entity follow up is appropriate •Identify leading practices Protocol Updates •Revise CE Protocol to reflect Omnibus Rule •Develop BA Protocol Future program design and focus •Business Associates: Identify the population. •Identify areas of focus for future audits. •Accreditation /Certification correlations? OCR/NIST 15
  • 16. AUDIT PHASE 2 APPROACH • Primarily internally staffed • Selected entities will receive notification and data requests • Entities will be asked to identify their business associates and provide their current contact information • Will select business associate audit subjects for first wave from among the BAs identified by covered entities • Desk audits of selected provisions • Comprehensive on-site audits as resources allow OCR/NIST
  • 17. PHASE 2 DESK AUDITS OCR/NIST Pre-audit survey links to pool Summer 2014 Notification and data request to selected entities Fall 2014 Desk review and draft findings Entity provides management review Final report
  • 18. AUDITS PHASE 2 EXPECTATIONS OCR/NIST Data request will specify content & file organization, file names, and any other document submission requirements Only requested data submitted on time will be assessed. All documentation must be current as of the date of the request. Auditors will not have opportunity to contact the entity for clarifications or to ask for additional information, so it is critical that the documents accurately reflect the program. Submitting extraneous information may increase difficulty for auditor to find and assess the required items. Failure to submit response to requests may lead to referral for regional compliance review
  • 19. New Guidance: BUSINESS ASSOCIATES The HIPAA Omnibus Rule https://www.youtube.com/watch?v=mX-QL9PoePU OCR/NIST 19
  • 20. Consumer Awareness: PUBLIC OUTREACH INITIATIVES OCR/NIST Your New Rights Under HIPAA - Consumers https://www.youtube.com/watch?v=3-wV23_E4eQ Over 262,000 views since September 4, 2013 20
  • 21. Mobile Devices: http://www.healthit. gov/mobiledevices MOBILE DEVICES OCR/NIST 21
  • 22. NOTICE OF PRIVACY PRACTICES http://www.hhs.gov/ocr/privacy/hipaa/modelnotices.html OCR/NIST 22
  • 23. Medscape Resource Center: PUBLIC OUTREACH INITIATIVES OCR/NIST http://www.medscape.org/sites/advances/patients-rights 23
  • 24. More Guidance: • Business Associates • Breach Notification Rule • Security Rule • Individual Rights • Other Privacy Rule Topics More Training: • Online Training Modules Audit Program WHAT’S TO COME OCR/NIST 24