Red de grado médico
 

Red de grado médico

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Presentación del Healthcare Industry Day en México.

Presentación del Healthcare Industry Day en México.
Red de grado médico.

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Red de grado médico Red de grado médico Presentation Transcript

  • Medical Grade Network:Healthcare Information Technology Erick Ortiz Healthcare Systems Engineer eriortiz@cisco.com© 2010 Cisco and/or its affiliates. All rights reserved. Cisco Confidential 1
  • A better understanding of:• Healthcare provider technical protocols, systems and applications• How Cisco differentiates from competitors• How to further define Cisco’s role in a hospital’s success© 2010 Cisco and/or its affiliates. All rights reserved. Cisco Confidential 2
  • © 2010 Cisco and/or its affiliates. All rights reserved. Cisco Confidential 3
  • Miguel Hospital X Hidalgo’s Doctor Y John Doe’s Healthcare John Doe’s Medical Records Network Medical Records• Optional – Use if needed Hospital Y Retail Clinic John Doe’s John Doe’s Medical Medical Records Records Continuity of Continuity of Care Data Care Data Continuity of Continuity of Care Data Care Data Health Center HIE VPN Health Insurance John Doe’s John Doe’s John Doe’s John Doe’s Medical Medical Medical Medical Records Records Records Records Manual Entries John Doe’s John Doe’s Medical Medical Records Records© 2010 Cisco and/or its affiliates. All rights reserved. Cisco Confidential 4
  • Heath Information Exchange - HIE Data Warehouse / Portal Patient Patient Care Clinical Support Business Revenue Administration Support Management • Registration • CPOE • Radiology/ • Purchase • Billing PACS Management • Bed Bureau • EMR • Insurance • Laboratory • Inventory Billing • A/D/T • Diet Control Management • Pharmacy • Accounting • Appointment • Materials and • Charting and • O/R • Revenue Distribution Scheduling Medication Management HL7, DICOM Protocols and Routing TCP/IP, Proprietary Protocols Medical Grade Network© 2010 Cisco and/or its affiliates. All rights reserved. Cisco Confidential 5
  • Heath Information Exchange - HIE DBMOTION EPIC CERNER AXOLOTL Data Warehouse / Portal MICROSOFT ORACLE HEALTHCARE Patient Business Revenue Patient Care Clinical Support Administration Support Management • RX STATION • EPIC • SIEMENS • MICROSOFT • EPIC • AFFINITY • MCKESSON • AGFA • SAP • LAWSON HEALTHCARE • IDX • ALLSCRIPTS • ORACLE • CERNER • STORZ HEALTHCARE • EPIC • MEDITECH • MCKESSON • GE • CERNER • CERNER • STRYKER HL7, DICOM Protocols and Routing MEDICITY RHAPSODY CLOVERLEAF SUN TCP/IP, Proprietary Protocols Medical Grade Network© 2010 Cisco and/or its affiliates. All rights reserved. Cisco Confidential 6
  • Biomedical Domain IT Department & Telecommunication Domain Telephony Wireless Convergence EHR Infusion Pump Network Patient Monitor Network Nurse Call Network Radiology Network Ventilator Network 3 Transforming the Patient Clinical Process Improvement Care Experience IP Video OR New Imaging Models of Storage Patient Care© 2010 Cisco and/or its affiliates. All rights reserved. Cisco Confidential 7
  • • Vendor/ ISV Affiliations• Personnel• Company Assure wave Healthcare Mobility Advisory Board Enterprise Technical Advisory Board Global Innovations Council VTG SAVBU Healthcare BU• Sales Organization – BTx, Sales Org• Industry affiliations© 2010 Cisco and/or its affiliates. All rights reserved. Cisco Confidential 8
  • Institute of Electrical and American Telemedicine Association Electronics Engineers International Organization American Hospital Association for Standardization American Medical Informatics Clinical Engineering – IT Association Community Healthcare Information and Continua Alliance Management Systems Society American Organization Integrating the Healthcare of Nursing Executives Enterprise Department of Health and International Human Services Electrotechnical Commission Health information Trust Health Management Academy Alliance© 2010 Cisco and/or its affiliates. All rights reserved. Cisco Confidential 9
  • © 2010 Cisco and/or its affiliates. All rights reserved. Cisco Confidential 10
  • 3. Enable new1. Enable data to become business models information and Care at a Distance PROCESS information to become Solutions knowledge KNOWLEDGE Healthcare Technologies INFORMATION Foundation Medical Grade Network PATIENT Specialty Care Primary Care Home Health Acute Care2. Allow information to follow the patient and Care Continuum clinicians Clinical Workflow Solutions Patient Centered Framework© 2010 Cisco and/or its affiliates. All rights reserved. Cisco Confidential 11
  • By understanding: • the critical systems and applications • the impact these applications have on your customers success • Cisco’s value in enabling these applicationsyou can expand you relationships outside of IT and look for newpartner opportunities.© 2010 Cisco and/or its affiliates. All rights reserved. Cisco Confidential 12
  • An Overview of IEC 80001-1 December 2nd 13 2010
  • A better understanding of: History and Overview of IEC 80001-1 • What is it? • Does it apply in all situations? Impact on the Hospital Organization • Responsible Organization • Risk Manager Impact on Hospital Medical Device and IT Vendors Wired and Wireless Network Considerations Risk Management Process Framework © 2010 Cisco / Philips and/or its affiliates. All /rights reserved. Cisco Philips Confidential 14
  • History and Overview of IEC 80001-1© 2010 Cisco / Philips and/or its affiliates. All /rights reserved. Cisco Philips Confidential 15
  • History of IEC 80001-1Hospitals were implementing a growing number ofnetworked medical devices, lack of oversightThe standard was originated by anFDA call for action in 2005, and theFDA has been an active participant,monitoring the progression of thisstandard.Started with a New Work Item Proposalin June 2006, approved in September2010First Committee Draft (CD 1) releasedin December 2007 © 2010 Cisco / Philips and/or its affiliates. All /rights reserved. Cisco Philips Confidential 16
  • What is IEC 80001-1A voluntary, new international standard applying a risk management process forIT networks incorporating medical devices (a Medical IT-Network) Spanning operational phases from planning to decommissioning Sibling documents called “Technical Reports” for further detailsThree “Key Properties” – Safety, Effectiveness, Data & System SecurityCreates a “Responsible Organization” that establishes a “Risk ManagementProcess” and appoints a Risk Manager that maintains a “Medical IT-Network RiskManagement File”Accompanying Technical reports (TR): Wireless Guidance TR Healthcare Delivery Organization Guidance TR Security TR Step by Step Risk Management Process TR OtherISO 14971-Corollary to this process© 2010 Cisco / Philips and/or its affiliates. All /rights reserved. Cisco Philips Confidential 17
  • Not Applicable to ISO/IEC 80001-1© 2010 Cisco / Philips and/or its affiliates. All /rights reserved. Cisco Philips Confidential 18
  • ISO/IEC 80001-1 Applies Here© 2010 Cisco / Philips and/or its affiliates. All /rights reserved. Cisco Philips Confidential 19
  • Why IEC 80001-1? Real Examples of Networked Medical Devices It is not feasible that a single medical device mfr can dictate or manage a Medical IT-Network 13-July, 2010 FDA Infusion Pump Class I Recall NoticeReason for Recall:“Under certain wireless network conditions, a communicationerror can occur, which freezes the PC Unit screen. This errormay result in a delay of therapy and inability to makeprogramming changes to current infusions.If the communication error occurs during infusion, infusioncontinues on all channels, as originally programmed, but cannotbe modified. When this error occurs, stopping the infusion tomake any modification or programming changes causes the PCunit to shut down resulting in a delay or interruption in therapy.This could lead to serious injury and/or death.” © 2010 Cisco / Philips and/or its affiliates. All /rights reserved. Cisco Philips Confidential 20
  • Impact on the Hospital Organization© 2010 Cisco / Philips and/or its affiliates. All /rights reserved. Cisco Philips Confidential 21
  • IEC 80001-1 Responsible Organization Executive mgmt or C-level Approval or mandate RESPONSIBLE ORGANIZATION Establishes policies TOP MANAGEMENT responsibilities Risk acceptability Policies for • RISK MANAGEMENT PROCESS • RISK acceptability criteria Assigns resources • Balancing the three KEY PROPERITIES with the mission of the RESPONSIBLE ORGANIZATION Appoints Risk Manager Resources Creates accountability • Provision of adequate resources • Assignment of qualified personnel • Appointment of the MEDICAL IT-NETWORK RISK Cross functional organization MANAGER • Enforcement of RESPONSIBILITY AGREEMENTS Documentation RISK MANAGEMENT PROCESS • Clear connection to other PROCESSES Defines responsibility • Ensuring continuing suitability and effectiveness agreement • Reviewing results at defined intervals Risk assessment record © 2010 Cisco / Philips and/or its affiliates. All /rights reserved. Cisco Philips Confidential 22
  • Risk Manager: Front and CenterReports to Responsible Org.Mgmt The RESPONSIBLE ORGANIZATIONEstablishes and manages Risk TOP MANAGEMENTManagement file Clinical Area of expertise Appoints r ts s pe de to ex rovi Biomedical GuEngages and works with CE, P ide Policies Engineering es act area of ov ivit pr expertise ert s Ap s to ies exp videBiomed, IT/IS, HIT vendors, Processes of Pro Procedures s IT area of ide to expertise ov P r e r tsMDM, Network vendors Sup e rv ises cre atio n of MEDICAL IT-NETWORK RISK ex p MEDICAL IT- MANAGER Provides Other... experts to NETWORK RISK RiskAssists in establishing MANAGEMENT Management FILE File to Provides input to put Pro s in Residual Risk vidprocesses, policies and vide es in Pro put toproceduresEvent management Medical device Medical device Sub- contractorcoordination and manufacturer or provider of other IT manufacturer or provider of other ITdocumentation technology technology A B © 2010 Cisco / Philips and/or its affiliates. All /rights reserved. Cisco Philips Confidential 23
  • Impact on Hospital Medical Device and IT Vendors© 2010 Cisco / Philips and/or its affiliates. All /rights reserved. Cisco Philips Confidential 24
  • IEC 80001-1 – Medical Device ManufacturersMedical Device Manufacturers For a Medical Device whose Purpose includes connection to an IT Network, the Medical Device manufacturer shall provide, as part of the products “accompanying documents”, instructions for implementing such connectivity including but not limited to the following: • The purpose of the Medical Device’s connection to an IT Network • The required characteristics of the IT Network incorporating the Medical Device • The required configuration of the IT Network incorporating the Medical Device • The technical specifications of the network connection of the Medical Device including security specifications • The intended data flows between the Medical Device, the Medical IT Network and other devices on such network. © 2010 Cisco / Philips and/or its affiliates. All /rights reserved. Cisco Philips Confidential 25
  • IEC-80001 Medical IT-Network Risk Management File Required for each IT-Medical Network • Asset Descriptions for devices in the Medical-IT network – Operational Characteristics, Configuration Management, Software Itself, Configuration Details, History of use, Operator/User details, Security Description • Medical IT Network documentation – Physical and logical network configuration, applied standards & conformance, client/server structure, network security, reliability, data integrity, network communication flows, planned enhancements and upgrades• Responsibility Agreements - one or more documents that together fully define the responsibilities of all relevant stakeholders. This document can be a legal contract• Risk Management Plan – requirements for monitoring Medical IT Network, criteria for risk management acceptance, description of roles and responsibilities of all parties involved, reason for each medical device added to Medical IT Network © 2010 Cisco / Philips and/or its affiliates. All /rights reserved. Cisco Philips Confidential 26
  • IEC-80001 – Other Providers of Information TechnologyEach provider of “Other Information Technology (equipment and/orsoftware) shall provide documentation to the RO as follows: • Technical descriptions and technical manuals • Recommended product configurations • Any known incompatibilities and restrictions • Operating requirements • Product corrective actions and recalls; and • Cyber security noticesThe “Provider of Information Technology” may providesupplementary information to the RO if required to support the riskmanagement assessment activity • Test strategies and test acceptance criteria • Disclosure of failure modes • System reliability statistics • Safety cases and performance © 2010 Cisco / Philips and/or its affiliates. All /rights reserved. Cisco Philips Confidential 27
  • Wired and Wireless Network Considerations© 2010 Cisco / Philips and/or its affiliates. All /rights reserved. Cisco Philips Confidential 28
  • Wired Networking ConsiderationsUnderstanding The requirements of medical devices as described by the Medical Device Manufacturer and implement accordingly The topology and Configuration of the Campus, Datacenter and Branch, Wireless network architectures etc How changes to one component can affect availability in other seemingly non- related componentsDocumentation Maintain a list of network infrastructure components including serial numbers Maintain a list of support vendors, support contract numbers Keep track of and understand the support process for each vendor (P1, P2, P3 )Design to mitigate risk Follow vendors best practices for high availability, security, scalability (ie: Cisco Medical-Grade Network 2.0) Reduce Complexity (FCoE, VSS, DHCP) Establish a QA / Acceptance Lab All changes must have an approved implementation AND backoff plan © 2010 Cisco / Philips and/or its affiliates. All /rights reserved. Cisco Philips Confidential 29
  • Wireless Network Considerations Understand RF is a shared resource – Mitigate Risk! Different devices have different RF characteristics – plan for worst case RFID location accuracy will depend on design and requirements will vary based on application usageDocumentation (asset tracking, inventory etc) RF Site Survey Create a policy for mobile wireless devices (iPhones, iPad, Blackberry etc) – Security, Ownership, Encryption, Allowable UsageDesign to Mitigate Risk Detect and isolate sources of interference in an ongoing and dynamic manner Design network to deliver highest level of availability during failures and interference Establish a QA / Acceptance Lab © 2010 Cisco / Philips and/or its affiliates. All /rights reserved. Cisco Philips Confidential 30
  • Risk Management Framework Examples© 2010 Cisco / Philips and/or its affiliates. All /rights reserved. Cisco Philips Confidential 31
  • IEC 80001-1 Risk Mgmt Process Map a risk management process into clinical terminology Hazardous Hazard Cause Situation Risk Risk Patient Mitigations Analysis Harm© 2010 Cisco / Philips and/or its affiliates. All /rights reserved. Cisco Philips Confidential 32
  • IEC 80001-2-x Wireless GuidanceExample applying risk management to wireless networkingHazardous situation is the intersection of clinical functionality and the network connectivity Loss of Connectivity Ex. AP Outage Missed Treatment Cause: Clinical Hazardous Network Hazard Situation Upgrade Severity & Potential Mitigations Probability Harm Est. RF Redundancy Catastrophic & Patient Injury Low Probability Med. Probability© 2010 Cisco / Philips and/or its affiliates. All /rights reserved. Cisco Philips Confidential 33
  • By understanding: • IEC 80001 is willing to be a standard for Medical Networks • Converged network for HC apps, medical devices and enterprise services • Map Risk Management process to network lifecycle © 2010 Cisco / Philips and/or its affiliates. All /rights reserved. Cisco Philips Confidential 34
  • Medical Grade Network Thank you!© 2010 Cisco and/or its affiliates. All rights reserved. Cisco Confidential 35