ROUNDTABLE New Tools & Initiatives for Addressing Medical Device Security Thursday, February 17, 9:45am ROUNDTABLE New Tools & Initiatives for Addressing.

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Presentation transcript:

ROUNDTABLE New Tools & Initiatives for Addressing Medical Device Security Thursday, February 17, 9:45am ROUNDTABLE New Tools & Initiatives for Addressing Medical Device Security Information Security for Biomedical Technology: A HIPAA Compliance Guide™ Thursday, February 17, 9:45am Jim Keller Director, Health Devices ECRI 2005 Annual Conference and Exhibition Dallas, TX HIMSS 2005 Annual Conference and Exhibition Dallas, TX

February 17, 2005 © HIMSS / ACCE / ECRI ~ 2 ACCE / ECRI Information Security for Biomedical Technology: A HIPAA Compliance Guide ™ Details compliance process Security Management Security Management Risk Analysis & Management Risk Analysis & Management Provides variety of compliance tools, including Matrix of security standards & implementation specifications Matrix of security standards & implementation specifications Biomedical Equipment Survey Form & Questionnaire Biomedical Equipment Survey Form & Questionnaire Risk Mitigation Worksheet Risk Mitigation Worksheet Security Assessment Survey Questionnaire Security Assessment Survey Questionnaire Sample policies/procedures Sample policies/procedures Security incident report Security incident report Business associate agreement with security provisions Business associate agreement with security provisions Management templates for project planning and budgeting Management templates for project planning and budgeting Bibliography, Definitions, and relevant On-line Resources Bibliography, Definitions, and relevant On-line Resources

February 17, 2005 © HIMSS / ACCE / ECRI ~ 3 HIPAA’s Final Security Rule “Standards & Implementation Specifications ” Key elements/tools Standards & Implementation Specifications laid out in Matrix

February 17, 2005 © HIMSS / ACCE / ECRI ~ 4 ACCE / ECRI Information Security for Biomedical Technology: A HIPAA Compliance Guide ™ Key elements/tools Biomedical Equipment Survey Form to identify systems with ePHI, system vulnerabilities, and system security measures available

February 17, 2005 © HIMSS / ACCE / ECRI ~ 5 ACCE / ECRI Information Security for Biomedical Technology: A HIPAA Compliance Guide ™ Key elements/tools Security Assessment Survey Questionnaire addressing level of compliance on Standards and Implementation Specifications for Administrative, Physical & Technical Safeguards

February 17, 2005 © HIMSS / ACCE / ECRI ~ 6 ACCE / ECRI Information Security for Biomedical Technology: A HIPAA Compliance Guide ™ Key elements/tools Management templates for project scheduling and budgeting

February 17, 2005 © HIMSS / ACCE / ECRI ~ 7 ACCE / ECRI Information Security for Biomedical Technology: A HIPAA Compliance Guide ™ Key elements/tools Risk Mitigation Worksheet for Medical Devices/Systems 1 Identify ePHI 2 Identify & Assess Risks 3 Establish Priorities 4 Determine Gap 5 Formulate & Implement Plan 6 Test & Measure Effectiveness of Plan

February 17, 2005 © HIMSS / ACCE / ECRI ~ 8 ACCE / ECRI Information Security for Biomedical Technology: A HIPAA Compliance Guide™ Key elements/tools Policies & Procedures, Incident Reporting Form, and Business Associate Agreements

February 17, 2005 © HIMSS / ACCE / ECRI ~ 9 ACCE / ECRI Security Process Training Administrative Safeguards Physical Safeguards Technical Safeguards Policies & Procedures; Contingency Plans Security Assessment Survey Questionnaire (process analysis) Manufacturer- supplied MDS 2 Forms Biomedical Equipment Survey Forms (sources of ePHI) Information Security Officer & Committee (risk assessment) Risk Mitigation Worksheets (plan & priorities) Security Management Schedule & Budget Encryption Incident Reports & Audits Data Backup Lock & Key Intrusion & Environmental Alarms Business Associate Agreements Biometrics Tokens Firewalls Error Correction Criteria & Guidelines

February 17, 2005 © HIMSS / ACCE / ECRI ~ 10 MDS 2 supplies key data to the ACCE / ECRI Biomedical Equipment Survey Form MDS 2 Developed by HIMSS Medical Device Security Workgroup

February 17, 2005 © HIMSS / ACCE / ECRI ~ 11 Discount for Members

February 17, 2005 © HIMSS / ACCE / ECRI ~ 12 ACCE / ECRI on Medical Device Security Product Description Guide/Default.aspx Table of Contents Brochure and Order Form Brochure and Order Form Press Release CD-ROM based Information Security for Biomedical Technology: A HIPAA Compliance Guide™ Discount for Members