Understanding a Networked Laboratory
Jeff Shockley
Understanding a Networked Laboratory
Objectives
„ Understand the key functional benefits realized by a networked laboratory
„ Understand the B2B Gateway implementation that allowed WAMC to achieve these benefits „ Understand how to implement the B2B Gateway in your laboratory
Understanding a Networked Laboratory
History
„ Roche sells the cobas product line with features that require remote connectivity to Roche, such as automatic download.
„ Remote connectivity for previous installations of Roche Hitachi analyzers was more of a “nice to have” rather than a requirement for effective operation.
„ In DoD network, medical devices are treated like any other IT system with requirements for patching, anti-virus protection and security hardening or appropriate risk mitigation.
Understanding a Networked Laboratory
Benefits
„ Remote Help Desk Session
‟ Screen sharing from Roche workstation to instrument
‟ Attended session usually in response to user’s reported problems
‟ Allows Roche to remotely take control of instrument to perform troubleshooting, calibrations, diagnostic procedures, and performance monitoring resulting in the potential for quicker resolution of issues.
„ Data download for e-library
‟ Download of instrument parameters, chemistry lot data of reagent / calibrators / controls ‟ Download of software patches / upgrades
‟ Download of Human Readable Data (electronic Package Insert) „ Data upload for monitoring
‟ On-line Monitoring of Instruments ‟ Performance Evaluation
Understanding a Networked Laboratory
B2B Gateway Overview
„ Provides authorized MHS Business Partners secure access to DoD Network
−Connects MHS information systems on Defense Information System Network (DISN) infrastructure and
MHS Business Partners on commercial infrastructure in support of DoD healthcare mission
−Complies with DISN policy
−Provides support for non-Web based applications
−Supports secure e-commerce for client/server and system-to-system interfaces
„ Enterprise solution
Understanding a Networked Laboratory
B2B Gateway Overview
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MCiS VPN Team .Mil Location
MHS Business Partner DISA
Montgomery/Columbus
Procurement of VPN and Internet Service Provider. Manages their LAN
Manages VPNs at MHS Business Partner location, DISA DECC Montgomery and Columbus
Manages MHS VPN domain. VPNs between DISA Columbus and the .Mil location
Understanding a Networked Laboratory
B2B Gateway - Security Features
„ Controlled access to the Non-classified Internet Protocol Router Network (NIPRNet) „ Encryption
– Triple Data Encryption Standard (3DES) Internet Protocol Security (IPSec) VPN – Contractor site to gateway
– Gateway to DoD destination „ Traffic/transaction inspection
„ Address translation simplifies DoD traffic filtering
„ User authentication to the Gateway „ Audit capability
B2B Gateway Implementation
Roche teams with Womack Army Medical Center to become first IVD
manufacturer approved for remote network connectivity with DoD via B2B
Gateway.
“The B2B approval process is quite rigorous because of our strict security protocols, but the benefits are well worth the effort. Having remote access to the analyzers will enable Roche to identify and resolve potential issues faster, and for us it will eliminate the need for a lot of our manual data entry, which can help us save time and reduce the potential for error.” -‟ LTC Linda Guthrie, Former WAMC laboratory manager
B2B Gateway Implementation
Stakeholders - DoD
„ TMA Falls Church
„ Joint Medical Information Systems Program Office (JMIS) „ Defense Health Information Management System „ Defense Health Services Systems (DHSS)
„ Military Health System Cyberinfrastructure Services (MCiS)
-Formerly Tri-Service Infrastructure Management Program Office (TIMPO)
„ Information Assurance (IA) Program Office
„ Military Medical Departments/MTF
„ Defense Information System Agency (DISA) „ Commercial Partners ‟ i.e. Roche
B2B Gateway Implementation
Stakeholders – Vendor perspective
„ Strong Gov’t Sponsor Commitment „ Strong Vendor
Commitment „ Project Management
„ Application Engineers „ Network Administration „ Security Management „ Legal „ Human Resources „ Instrumentation SMEs „ Call Center / Service
B2B Gateway Implementation
High Level Requirements
B2B Gateway Implementation
Contract / SOW
„ Fairly Straightforward
„ Contractor responsible for their VPN Hardware & ISP access „ Background Checks for all resources accessing systems
B2B Gateway Implementation
CON / DIACAP
„ Sub-requirement for B2B Gateway
„ Requirement may be different per site or branch –CON vs DIACAP
–Proposed Mitigations
B2B Gateway Implementation
Vendor Personnel Security – Process
„ Establish POC in Security Office
„ Business Partner (BP) employee completes DD85P (Works directly with security office)
„ BP employee provides finger prints to security officer on DoD supplied cards / IA Training Certificate
„ Security officer submits package to OPM „ BP employee completes DD2875
‟ System Authorization Access Request (SAAR) „ Annual Information Assurance Training (Recurring)
B2B Gateway Implementation
Vendor Personnel Security - Considerations
„ Phased / Batch Approach
„ US Citizens vs. non-US Citizens „ Annual Security Awareness Training
B2B Gateway Implementation
Overall Process
1. B2B Kickoff2. Vendor completes B2B Questionnaire ‟ Submitted to WAMC
– System Performance Requirements
– VPN Implementation form
– Network Infrastructure diagrams
– Vendor IP adresses / port usage
– CON/DIACAP & Vendor Security (in parallel)
3. WAMC reviews/updates B2B Questionnaire‟ Submitted to MCiS
– POC Information
– Local IP Addresses
4. VPN Device Procured & Shipped to DISA for configuration 5. VPN Device Returned & Installed
6. Front-end Connectivity Testing (Between DISA and Roche) 7. End-to-End Testing (brings MTF into testing)
B2B Gateway Implementation
Going Forward – Setting the Foundation
„ Contract modification (may be required at each site) „ CON / DIACAP (may be required at each site)
„ Vendor Personnel Security (typically no changes/ possible adds) „ B2B Gateway Documentation (minor modifications)
–IP addresses change to new site –.mil POC information updated –Government sponsor name update
MCiS Point of Contact
„ Christopher McDonald
KSJ & Associates, Contractor Program Management Support
Military Health System Cyberinfrastructure Services (MCiS) 5205 Leesburg Pike, Suite 1301
Falls Church, VA 22041 703-399-2276 Fax: x2260
Thank you for your attention.
Roche Diagnostics 9115 Hague Rd Indianapolis, IN USA
COBAS and LIFE NEEDS ANSWERS are trademarks of Roche
This presentation is our intellectual property. Without our written consent, it shall neither be copied in any manner, nor used for manufacturing, nor communicated to third parties.
