AAMI Wireless Workshop: Systems of Systems & based Risk Management

Transcription

1 AAMI Wireless Workshop: Systems of Systems & based Risk Management ~ Herndon, VA ~ Todd Cooper Co-Chair, ISO/IEC Joint Working Group 7 Copyright 2012, Experts, LLC. All rights reserved.

2 Problem?

3 Problem of Systems of Systems Increasing drive toward heterogeneous networks Increasing deployment of devices in multi-vendor / multi-modality networking environments Increasing mix of medical device & I.T. technologies Systems of Systems Result in Unanticipated Emergent Behaviors! Wireless networks demand a solution because you can t cable around the problem! 3

4 Everyone EVERYONE! has a Story SAFETY: Secondary alarm communication failure when then entire wireless network crashes for days after smart pump drug libraries are pushed out simultaneously! EFFECTIVENESS: PBX and an entire public phone exchange used to monitor home health patients is taken down when Microsoft Office is installed on the server to read documentation for how to configure the server! SECURITY: Why did that system reboot right in the middle of surgery?! Conflicker infects systems including medical devices throughout the hospital when security patch application is suspended after a system actively used in surgery is updated and resets! 4

5 Case Study: Application Virtualization Situation: Problem: Use 80001: Hospital wants to virtualize infusion pump server To save money, hospital allows over subscription in order to increase average utilization. For 18 months, hospital & technology providers chased intermittent system malfunctions! Critical operational requirements defined Hazards & hazardous situations identified Risks (severity & probability) identified Risk controls (e.g., bandwidth alerts) deployed 5

6 Case Study: Go live now! Situation: Problem: Use 80001: New radiology system has been acquired and is being integrated & tested End of year is coming and management wants to meet annual goals. Top Management pushes to have the system go live even though the deployment processes have not been completed. Organizational roles & responsibilities defined RM Policy & Process defined Violation of the P&P would have been identified Executive signs off & assumes responsibility 6

7 IOM Report a Game Changer? Key findings: Health IT may lead to safer care and/or introduce new safety risks Safety is a characteristic of a sociotechnical system that includes people, process, environment, organization and technology System-level failures occur almost always because of unforeseen combinations of component failures Recommendations: Health care accrediting organizations should adopt criteria relating to EHR safety. All health IT vendors should be required to publicly register and list their products Health IT vendors should be required to adopt quality and risk management processes Reporting of health IT related adverse events should be mandatory for vendors and voluntary and confidential for users. 7

8 Great standard, but Published 2010 November (The Washington Post Express, , page 6) 8

9

10 80001 Basics: Scope These are the elements of

11 80001 Basics: Scope - Networks Regulated by the FDA (IEC :2010, Table C.1) 11

12 Network key properties (in order of priority) SAFETY: Freedom from unacceptable risk of physical injury or damage to the health of people or damage to property or the environment EFFECTIVENESS: Ability to produce the intended result for the patient and the responsible organization DATA AND SYSTEM SECURITY: An operational state of a medical IT-Network in which information assets (data and systems) are reasonably protected from degradation of confidentiality, integrity, and availability (+ accountability) Note: ISO for medical devices is focused on patient safety risk management 12

13 Stakeholder partnerships: Roles & Responsibilities Healthcare Provider / Responsible Organization Medical Device Manufacturers I.T. Technology Vendors 3 rd Party Integrators Risk Management Experts Approves MEDICAL IT- NETWORK RISK Risk MANAGEMENT Management FILE File Residual Risk The RESPONSIBLE ORGANIZATION Policies Processes Procedures Supervises creation of TOP MANAGEMENT Provides input to Appoints Guide activities of MEDICAL IT-NETWORK RISK MANAGER Provides input to Provides experts to Provides experts to Provides experts to Provides experts to Provides input to Clinical Area of expertise Biomedical Engineering area of expertise IT area of expertise Other... shared vision & mission! (IEC :2010, Figure B.1) Medical device manufacturer or provider of other IT technology A Medical device manufacturer or provider of other IT technology B Subcontractor 13

14 From Hazards to Harms Hazard potential source of harm R I S K Hazardous Situation Sequence of Events w/ Root Cause circumstances in which people, property, or the environment are exposed to one or more hazard(s) A N A L Y S I S systematic use of available information to identify hazards and to estimate the risk Probability Harm / Unintended Consequence Risk Risk Evaluation Severity physical injury or damage to the health of people, or damage to property or the environment, or reduction in effectiveness, or breach of data and system security combination of the probability of occurrence of harm and the severity of that harm process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk 14

15 10 Step RM Process 1. Hazard Identification 2. Hazardous Situations & Root Cause Analysis 3. Harm Identification + Severity Estimation 4. Harm Probability Estimation Note: Though generally sequential, these steps iterate until acceptable completeness has been achieved. 5. Risk Acceptability Evaluation 6. Risk Control Measure ID & Residual Risk Eval. 7. RCM Implementation 8. Verify RCMs 9. RCM Risk Evaluation 10. Residual Risk Evaluation & Report (from draft IEC , Step by Step Risk Management) (IEC :2010, Figure 2) 15

16 80001 Risk Management Process Identify Hazards Loss of data Incorrect data Incorrect timing of data Degraded function of devices Unauthorized access to private data Etc Identify Causes Overloaded link Network configuration error Wireless dropout Network hardware failure IP Addressing conflict Security too aggressive Faulty cabling User/procedural error Etc Identify Risk Control Measures Network design, best practices Pre-go-live testing Redundancy IT procedures, Clinical procedures Etc Go Live! 16

17

18 is just the start! x: Emerging Guidance Published Summer 2012 Technical Guidance Reports (TRs) in process: : Step-by-Step Risk Management (w/examples) : Communication of Medical Device Security Needs, Risks & Controls : Wireless Networking 18

19 x: Emerging Guidance Additional projects (in publication!) Implementation guidance for Healthcare Delivery Organizations Guidance for Responsibility Agreements & ISO/IEC Coordinated Usage (+ ITIL) HDO Conformance Self-assessment Distributed alarm systems 19

20 Wireless Guidance

21 Wireless Guidance 21

22 Wireless Guidance 22

23 Wireless Guidance 23

24 Collaboration for Key Properties HDO Technology Suppliers Information exchange (disclosure & dialog) focused on a shared vision Safe, Effective & Secure Networked Medical Technology 24

25 Key Collaboration Concepts #1 Disclosure & Dialog (D&D) Risk Assessment & Controls information from manufacturers Design, deployment & monitoring #2 Leverage Best Practices Networked technology management Organizational Governance Involve All Subject Matter Experts 25

26 Example: West MGWU Created by providers via the West Wireless Health Council Infrastructure Independence Ubiquitous coverage inside & outside Bluetooth ANT Zigbee UWB Future Wireless Local Area Network Room Area Network Personal Area Network Body Area Network Democratize Healthcare Data Pervasive, open, low cost monitoring Break the proprietary hold on healthcare PCS/Cellular Paging Fire Life Safety 2 Way Radio Future Wireless Wide Area Network Medical Grade Wireless Utility Reference Architecture Wireless Clinical Data Network Wireless Medical Telemetry Wireless Medical Monitoring Future Pervasive Clinical Apps Voice, Data, Video, Location Zigbee IR Ultrasound UWB RFID Future Location Local Area Network Assets People Clinically Relevant Information Pervasive, low cost medical sensors Turn data into wisdom 26

27 Thank You! Copyright 2011, Experts, LLC. All rights reserved.