Raj Chaudhary, PE, CGEIT Partner, Crowe Horwath LLP. Chris Reffkin, CISSP Manager, Crowe Horwath LLP
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1 HIPAA/HITECH Security and Privacy A Practical Approach Presented by: Raj Chaudhary, PE, CGEIT Partner, Crowe Horwath LLP Chris Reffkin, CISSP Manager, Crowe Horwath LLP
2 Learning Objectives and Agenda Introduction Holistic View of HIPAA A Picture is Worth a Thousand Words Overall 5-Step Approach to HIPAA Compliance Top 5 HIPAA Security and Privacy Gaps Meaningful Use/CMS Incentives/EHR Certification Approach to EHR Certification and Compliance (Security) Top 5 Considerations for Self EHR Certification (Security) Q&A 2011 Crowe Horwath LLP 2
3 Holistic View of HIPAA There is more than just EHRs with PHI Workstations Network Devices EHRs Other Applications (e.g. Radiology, Lab) File Servers and Shares Faxes and Mail 2011 Crowe Horwath LLP 3
4 A Picture is Worth a Thousand Words WorkstationintheOn in the Call room had been left logged in for 40 minutes and was discovered unattended. Unlocked and unattended file cabinets with PHI. Labs left unattended d and unlocked Crowe Horwath LLP 4
5 Overall 5-Step Approach to HIPAA Compliance Security 1. Policy Gap Analysis 2. Application Inventory (50-70 Apps w/phi) and Risk Rating 3. Gap Analysis a) Top x # (6-10) High-Risk-Applications Application Control Gap Analysis b) Entity Level Controls Gap Analysis 4. Survey Based Gap Analysis of Remaining Applications Privacy 1. Policy Gap Analysis 2. Agree on privacy survey participants with CMO 3. Conduct privacy survey of selected departments 5. Common Step for Security and Privacy Walk Through Observations Picture is worth a thousand words 4. Update Gap Analysis from Step 1 with Results of Survey End Result: Risk Ranked Remediation Plan 2011 Crowe Horwath LLP 5
6 Top 5 HIPAA Security and Privacy Gaps 1. Safeguarding Data from Unauthorized Individuals/Physical Security 2. Vendor Management Function/Business Associate Processes 2011 Crowe Horwath LLP 6
7 Top 5 HIPAA Security and Privacy Gaps 3. Entity Level IT Security Governance 4. Inadequate Application Logging and Monitoring 5. Weak Application Access Control Processes 2011 Crowe Horwath LLP 7
8 Meaningful Use/CMS Incentives/EHR Certification 2011 Crowe Horwath LLP 8
9 Meaningful Use -15 Core Objectives NUMBER DESCRIPTION METRIC OR % OF PATIENTS Core 1 Record Patient Demographics >50% Structured Data Core 2 Record Vital Signs/Chart Changes >50% Structured Data Core 3 Up-to-date List of Current Diagnosis >80% - at least one entry Core 4 Maintain Active Medication List >80% - at least one entry Core 5 Maintain Active Medication Allergy >80% - at least one entry Core 6 Record Smoking Status >13 Years Age >50% Structured Data Core 7 (Hosp.) On Request E-Copy of Hospital Discharge >50% Patients Discharged Core 7 (Phys.) Clinical Summary of Office Visit >50% Patients Within 3 Days Core 8 On Request Electronic Copy of Health Inf. >50% Requesting Within 3 Days Core 9 Generate/Transmit Permissible Prescriptions >40% E-Transmit Certified EHR Core 10 CPOE for Medication Orders >30% At Least 1 Medication Core 11 Implement Drug-Drug/Allergy Interaction Functionality is Enabled Core 12 E-Exchange of Clinical Information 1 Test of E-Exchange of HER Core 13 Implement 1 Clinical Decision Support Rule 1 Rule Implemented Core 14 Implement Security/Privacy of Patient Data Review Security Risk Analysis Implement Security Updates Correct Security Deficiencies Core 15 Report Clinical Quality Measures to CMS 2011 Crowe Horwath LLP 9
10 Approach to EHR Certification and Compliance (Security) Vendor Supplied/Certified EHR Technology Upgrade to certified version Verification of Vendor Certification In-House Developed EHR Technology CCHIT EHR Alternative Certification for Hospitals (EACH) Program Approved Test Procedures v1.1 (NIST) 45 Certification Criteria to be tested 8 of which are security-focused 2011 Crowe Horwath LLP 10
11 Approach to EHR Certification and Compliance (Security) Security Focused Certification Criteria Access Control Emergency Access Automatic Log-Off Audit Log Integrity Authentication General Encryption Encryption when Exchanging Electronic Health Information Should look familiar in regards to your overall HIPAA Security and Privacy Compliance Program 2011 Crowe Horwath LLP 11
12 Approach to EHR Certification and Compliance (Security) The requirements for EHR Certification correlate to Standards and Implementation Specifications from the HIPAA Security Rule Approved Test Certification Criteria / HIPAA HIPAA/HITECH Procedures v 1.1 (Standard or Imp. Spec.) Reference (o) Access Control (a)(1) (p) Emergency Access (a)(2)(iii) (q) Automatic Log-Off (a)(2)(iii) (r) Audit Log (b) (s) Integrity (c)(1) (t) Authentication (d) (u) General Encryption (a)(2)(iv) (v) Encryption when Exchanging (e)(2)(ii) Electronic Health Information 2011 Crowe Horwath LLP 12
13 Top 5 Considerations for Self EHR Certification (Security) Independence and Developers Consider implications of in-house testing the Tester remains in full control of the testing process, directly observes the test data being entered by the Vendor, and validates that the test data are entered correctly as specified in the test procedure. Audit Logs A developer/debug log is generally not the same as an audit log; specific requirements for log details are provided by certification criteria Consider overall benefits to organization versus just meeting the requirements; a tool or utility may be useful in general to manage logging and monitoring of events Encryption Balanced knowledge of HIPAA/Meaningful Use as well as technology required to fully understand in order to apply common sense 2011 Crowe Horwath LLP 13
14 Top 5 Considerations for Self EHR Certification (Security) Integration with Overall HIPAA Compliance Efforts Ensure all members of the HIPAA Compliance Committee and/or the HIPAA Security and Privacy Officers are collaborating on certification efforts Verify direction of overall HIPAA compliance efforts align with certification efforts Want to avoid designing a control for certification that contradicts efforts or not does not follow direction of overall HIPAA compliance program Ongoing Maintenance Release version 2 of Approved Test Procedures anticipated April Crowe Horwath LLP 14
15 Q&A 2011 Crowe Horwath LLP 15
16 For more information, contact or visit: Raj Chaudhary Direct: Mobile: Chris Reffkin Direct: Mobile: Or visit: Crowe Horwath LLP is an independent member of Crowe Horwath International, a Swiss verein. Each member firm of Crowe Horwath International is a separate and independent legal entity. Crowe Horwath LLP and its affiliates are not responsible or liable for any acts or omissions of Crowe Horwath International or any other member of Crowe Horwath International and specifically disclaim any and all responsibility or liability for acts or omissions of Crowe Horwath International or any other Crowe Horwath International member. Accountancy services in Kansas and North Carolina are rendered by Crowe Chizek LLP, which is not a member of fcrowe Horwath International. ti This material is for informational purposes only and should not be construed as financial i or legal l advice. Please seek guidance specific to your organization from qualified advisers in your jurisdiction Crowe Horwath LLP 2011 Crowe Horwath LLP 16
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