Open Source Technologies in Safety- critical Medical Device - PowerPoint PPT Presentation

Open Source Technologies in Safety- critical Medical Device Platforms Using Open Source to Design Connected Medical Devices to Help Fill EHRs with Clinically Useful Data Shahid N. Shah, CEO

Who is Shahid? • 20+ years of software engineering and multi-site healthcare system deployment experience • 12+ years of healthcare IT and medical devices experience (blog at http://healthcareguy.com) • 15+ years of technology management experience (government, non-profit, commercial) • 10+ years as architect, engineer, and implementation manager on various EMR and EHR initiatives (commercial and non- profit) Author of Chapter 13, “You’re the CIO of your Own Office” 2 www.netspective.com

Healthcare landscape background • The government (through Meaningful Use & ACO incentives) is paying for the collection of clinical data. • Medical devices are the best sources of quantifiable, analyzable, and reportable clinical data. • Most medical devices today are not connected so you do not have access to the best data. • New devices are being design and deployed to support connectivity. 3 www.netspective.com

What if we had access to all this data? 4 www.netspective.com Source: Jan Whittenber, Philips Medical Systems

Where does patient data come from? Patient Health Labs & Medical Professional Diagnostics Devices Source Self reported by Observations by Computed from Computed real- patient HCP specimens time from patient    Unstructured Data Errors High Medium Low Time Slow Slow Medium Reliability Low Medium High Data size Small Small Large Availability Common Common Common Uncommon 5 www.netspective.com

Where does patient data come from? Patient Health Labs & Medical Devices Professional Diagnostics Source Self reported by Observations by Computed from Computed real- patient HCP specimens time from patient     Structured Data Errors High Medium Low Low Time Slow Slow Medium Fast Reliability Low Medium High High Discrete size Small Small Small Small Streaming size Large Availability Uncommon Common Somewhat Uncommon Common 6 www.netspective.com

Patient data source analysis • Meaningful Use and CER advocates are promoting (structured) data collection for reduction of medical errors, analysis of treatments and procedures, and research for new methods. • All the existing MU incentives promote the wrong kinds of collection: unreliable, slow, and error prone. • Accurate, real-time, data is only available from connected medical devices 7 www.netspective.com

Connectivity is a must, OSS is answer Most obvious benefit Least attention Most promising capability This talk focuses on 8 www.netspective.com connected devices

Key OSS questions Will the FDA accept Are open source open source in systems safe safety-critical enough for medical systems? devices? 9 www.netspective.com

Simple answer Yes! Proof: we did it at American Red Cross in 1996 10 www.netspective.com

It’s not as hard as we think… • Modern real-time operating systems (open source and commercial) are reliable for safety- critical medical-grade requirements. • Open standards such as TCP/IP, DDS, HTTP, and XMPP can pull vendors out of the 1980’s and into the 1990’s.  • Open source and open standards that promote enterprise IT connectivity can pull vendors into the 2010’s and beyond. 11 www.netspective.com

But it’s not easy either…we need Risk Design for Design for Hazard Analysis Assessments Testability Simulations Mathematical Documentation Traceability Determinism Proofs Theoretical Instrumentation foundations 12 www.netspective.com

OSS hazard and risk assessment • What is the intended use for the device or system? • How will the OSS product you’re planning to use going to be tied to your intended use? • What is the risk associated with the OSS product for that particular intended use? R = S h x P h 13 www.netspective.com

Risk is related to severity and harm R = S h x P h R = risk S h = severity of harm P h = probability of harm • Harm is damage done to a person • Severity is the degree of harm done • Probability is the frequency and duration of exposure 14 www.netspective.com

Examples of Severity & Probability Severity Probability • multiple fatalities • Constant exposure • fatalities • Hourly • severe injury (non- • Daily reversible, requires • Weekly hospitalization) • Monthly • moderate injury (reversible, • Yearly requires hospitalization) • minor (reversible, requires • Never first aid) • very minor (no first aid) 15 www.netspective.com

Formal risk assessment methods Preliminary Failure modes What-if analysis hazard analysis and effects (PHA) analysis (FMEA) Hazard and Fault tree operability analysis (FTA) studies 16 www.netspective.com

OSS Risk analysis steps - FMEA • Define the function of the OSS product being analyzed. • Identify potential failures of the OSS. • Determine the causes of each failure types. • Determine the effects of potential failures. • Assign a risk index to each of the failure types. • Determine the most appropriate corrective/preventive actions. • Monitor the implementation of the corrective/preventive to ensure that it is having the desired effect. 17 www.netspective.com

Good summary of FMEA • http://en.wikipedia.org/wiki/ Failure_mode_and_effects_analysis 18 www.netspective.com

Sampling of OSS / open standards Project / Standard Subject area D G Comments   Linux or Android Operating system   Open standard with open OMG DDS (data Publish and subscribe source implementations distribution service) messaging   AppWeb, Apache Web/app server  Open source project OpenTSDB Time series database  Built on Mule ESB Mirth HL7 messaging engine  Successor to CONNECT Alembic Aurion HIE, message exchange   HTML5, XMPP, JSON Various areas Don’t reinvent the wheel   SAML, XACML Security and privacy   Build for extensibility DynObj, OSGi, JPF Plugin frameworks 19 www.netspective.com

OSS applicability to connectivity Physical • Wired, wireless (WiFi, cellular, etc.) Logical • Device  Gateway  Data Routers  Systems Structural • Security, Numbers, Units of Measure, etc. Semantic • Presence, Vitals, Glucose, Heartbeats, etc. 20 www.netspective.com

OSS applicability to manageability Security • Is the device authorized? Teaming Inventory • Device grouping • Where is the device? Presence • Is a device connected? 21 www.netspective.com

OSS enables extensible devices Legacy Future Devices Devices 22 www.netspective.com

The more connection- Appreciate tradeoffs friendly a device, the harder it is to validate it Integration- Ease of friendliness validation Lesson: Demand Testability 23 www.netspective.com

Shahid’s “Ultimate Connectivity Architecture” 5 Device Components Web Server, IM Client 3 rd Party Plugins • Presence 6 • Messaging App App • Registration #1 #2 • JDBC, Query Sensors Storage Display Plugins 7 4 Event Architecture Connectivity Layer (DDS, HTTP, XMPP) Location 3 Plugin Container Aware 1 2 Security and Management Layer Device OS (QNX, Linux, Windows) SSL VPN Healthcare Enterprise Workflow Cloud 8 Device Gateway (DDS, ESB) Services Notifications Patient Context Data Transformation (ESB, HL7) Inventory 9 Management Enterprise Dashboards Data 24 www.netspective.com

OSS in Ultimate Architecture Core Connectivity is Think about built-in, not added Device Components Plugins from day 1 Connectivity Layer (DDS, HTTP, XMPP) Plugin Container Security and Management Layer Device OS (QNX, Linux, Windows) Security isn’t Build on Don’t create added later your own OS! Open Source Create code as a last resort 25 www.netspective.com

OSS enables plugin architecture Device Components 3 rd Party Plugins App App #1 #2 Plugins Event Architecture Connectivity Layer (DDS, HTTP, XMPP) Location Plugin Container Aware Security and Management Layer Device OS (QNX, Linux, Windows) 26 www.netspective.com

OSS in connectivity components Surveillance & Design all Remote Access “remote display” functions as Event Viewer Alarms plugins Device Components Web Server, IM Client • Presence • Messaging • Registration • JDBC, Query Connectivity Layer (DDS, HTTP, XMPP) Plugin Container Security and Management Layer Device OS (QNX, Linux, Windows) 27 www.netspective.com

OSS in device components Virtualize! 3 rd Party Plugins Device Components Web Server, IM Client Sensors Storage Display Plugins Event Architecture Connectivity Layer (HTTP, XMPP) “On Device” Workflow Location Plugin Container Aware Patient Security and Management Layer Device OS Context, too (QNX, Linux, Windows) 28 www.netspective.com

OSS enables enterprise integration Device Teaming Cloud Services SSL VPN Device Device Gateway Cross Device Data (DDS, XMPP, ESB) Patient Context App Workflows Monitoring Data Transformation (ESB, HL7) Remote Management Enterprise Alarm Surveillance Dashboards Data Notifications HIT Device Integration Management Report Generation Inventory 29 www.netspective.com