Building safety-critical medical device platforms and Meaningful Use EHR gateways


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This is an in depth technical presentation delivered at OSCon 2012 on how to define, design, and build modern safety-critical medical device platforms and Meaningful Use compliant EHR gateways. The talk starts with a quick background on comparative effective research (CER) and patient-centered outcomes research (PCOR) and the kinds of data the government is looking to leverage in the future to help reduce healthcare costs and improve health outcomes. After defining why data is important, the workshop will cover the different techniques for collecting medical data – such as directly from a patient, through healthcare professionals, through labs, and finally through medical devices; the presentation will cover which kinds of data are easy to collect and what are more difficult and how technical challenges to collection can be overcome.

After covering the data collection area the workshop will dive deep into a modern medical device platform architecture which the speaker calls “The Ultimate Medical Device Connectivity Architecture” – providing an in-depth overview and answering questions around architecture, specifications, and design or modern (connected) medical devices.

Presentations of open source software and other inexpensive design techniques for implementing connected architectures will be covered. Finally, the talk will cover details about medical device gateways, what new Meaningful Use rules might require when connecting EHRs to gateways, and how to design and architect gateways that can stand the test of time and be interoperable over the long haul.

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Building safety-critical medical device platforms and Meaningful Use EHR gateways

  1. 1. Building open source safety-critical medical device platforms and Meaningful Use EHR gateways Inherent connectivity creates significant opportunities in medical science
  2. 2. NETSPECTIVE 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 • 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 nonprofit) Author of Chapter 13, “You’re the CIO of your Own Office” 2
  3. 3. NETSPECTIVE What’s this talk about? Health IT / MedTech Landscape Key Takeaways • Data has potential to solve some hard healthcare problems and change how medical science is done. • The government is paying for the collection of clinical data (Meaningful Use or “MU”). • All the existing MU incentives promote the wrong kinds of data collection: unreliable, slow, and error prone. • Medical devices are the best sources of quantifiable, analyzable, and reportable clinical data. • New devices must be designed and deployed to support inherent connectivity. • OSS is ideal for next generation and innovative medical devices and gateways 3
  4. 4. NETSPECTIVE What if we had access to all this data? • Cardiac output monitors • Defibrillators • Fetal monitors • Electrocardiographs • Infant incubators • Infusion pumps • Intelligent medical device hubs • Interactive infusion pumps • MRI machines • X-Ray machines • Physiologic monitors • Ventilators • Vital signs monitors Source: Jan Whittenber, Philips Medical Systems 4
  5. 5. NETSPECTIVE What problems can data help solve? Cost per patient per procedure / treatment going up but without ability to explain why Cost for same procedure / treatment plan highly variable across localities Unable to compare drug efficacy across patient populations Unable to compare health treatment effectiveness across patients Variability in fees and treatments promotes fraud Lack of visibility of entire patient record causes medical errors 5
  6. 6. NETSPECTIVE Data changes the questions we ask Simple visual facts Complex visual facts Complex computable facts 6
  7. 7. NETSPECTIVE Data can change medical science The old way The new way Identify problem Identify data Ask questions Generate questions Collect data Mine data Answer questions Answer questions 7
  8. 8. NETSPECTIVE Evidence-based medicine is our goal Eminence Evidence • Trust me • Prove it 8
  9. 9. NETSPECTIVE Types of medical data we care about Phenome Genome Proteome Phenotype is a composite of our observable characteristics or traits Genotype is the entirety of our hereditary information (DNA, RNA, etc.) Proteome is our set of proteins expressed by our genome and changes regularly over time This is what we’ve been studying for centuries Genetics is the study of the genome Proteomics is the study of the proteome 9
  10. 10. NETSPECTIVE Unstructured patient data sources Patient Source Self reported by patient Health Professional Observations by HCP Labs & Diagnostics Computed from specimens Errors High Medium Slow Slow Low Medium Megabytes Megabytes Megabytes Data type PDFs, images PDFs, images PDFs, images Availability Common Common Common Computed from specimens High Data size Computed realtime from patient Medium Reliability Biomarkers / Genetics Low Time Medical Devices Uncommon Uncommon 10
  11. 11. NETSPECTIVE Structured patient data sources Patient Source Self reported by patient Health Professional Observations by HCP Labs & Diagnostics Specimens Medical Devices Real-time from patient Biomarkers / Genetics Specimens Errors High Medium Low Low Low Time Slow Slow Medium Fast Slow Reliability Low Medium High High High Kilobytes Kilobytes Kilobytes Megabytes Gigabytes Gigabytes Gigabytes Uncommon Uncommon Discrete size Streaming size Availability Uncommon Common Somewhat Common 11
  12. 12. NETSPECTIVE Predictions for Device Hardware Consumerization of Devices Thick Devices Thin Devices Virtual Devices Sensors Only with Built-in Wireless Sensors on mobile phones, platforms 12
  13. 13. NETSPECTIVE Predictions for Device Software Consumerization of Apps Software for algorithms Software for functionality Software for connectivity Software only 13
  14. 14. NETSPECTIVE Predictions for Device Connectivity Consumerization of IT Stand-alone and monolithic Connectivity within own organization Multi-vendor connectivity System of Systems (SoS) 14
  15. 15. NETSPECTIVE Predictions for Gateways Changes in Practice Models Single-purpose devices standalone Multi-purpose standalone Multi-purpose with documentation connectivity Multi-purpose with cooperating connectivity Multi-purpose with analytical connectivity 15
  16. 16. NETSPECTIVE Predictions for Self-Management The Patient is in charge Physicians manage paper “charts” independently Physicians and Hospitals manage paper charts together Electronic Health Records (EHRs) manage data in systems Health Information Exchange allow coordination Patients manage their own data 16
  17. 17. NETSPECTIVE Implications Make sure the patient is in the middle Move from hardware to software focus Move to algorithms and analytics Understand system of systems (SoS) Plan for integration and coordination Start building simulators 17
  18. 18. NETSPECTIVE OSS revolution in device design 5 Device Components • Presence • Messaging • Registration • JDBC, Query Sensors Storage Event Architecture Display 6 App #1 App #2 Plugins 4 Location Aware Connectivity Layer (DDS, HTTP, XMPP) 3 Device OS (QNX, Linux, Windows) 3rd Party Plugins Web Server, IM Client 1 7 Plugin Container 2 Security and Management Layer 18
  19. 19. NETSPECTIVE OSS revolution in device capabilities Most obvious benefit Least attention Most promising capability 19
  20. 20. NETSPECTIVE OSS revolution in Gateways Corporate Cloud (Data Center) Development HTTPS, SOAP, REST, HTTP SFTP, SCP, HL7, X.12 SMTP, XMPP, DDS Customers & Partners Apps MQs Services VPN Services Remote Facilities Apps Registry HTTPS, REST, SOAP SFTP, SCP, HL7, X.12 SMTP, XMPP, DDS Corporate Gateway (ESB) Central DB Security Service DB Management Services Firewall App DB NOTE: Initial design is for a non-federated backbone. If performance or security demands require it, a federated solution will be deployed. 20
  21. 21. NETSPECTIVE OSS revolution in integration Device Teaming Cloud Services Patient Self-Management Platforms SSL VPN Patient Context Monitoring Device Gateway (DDS, XMPP, ESB) Device Data Cross Device App Workflows Data Transformation (ESB, HL7) Remote Surveillance Management Dashboards HIT Integration Report Generation Enterprise Data Alarm Notifications Device Management Inventory 21
  22. 22. NETSPECTIVE OSS revolution in manageability Security • Is the device authorized? Teaming Inventory • Device grouping • Where is the device? Presence • Is a device connected? 22
  23. 23. NETSPECTIVE Key OSS questions Will the FDA accept open source in safety-critical systems? Is open source safe enough for medical devices? 23
  24. 24. NETSPECTIVE Simple answers Will the FDA accept OSS in safetycritical systems? Is OSS safe enough for medical devices? Yes Yes but you must prove it 24
  25. 25. NETSPECTIVE It’s not as hard as we think… • Modern real-time operating systems (open source and commercial) are reliable for safetycritical 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. 25
  26. 26. NETSPECTIVE But it’s not easy either…we need Risk Assessments Hazard Analysis Design for Testability Design for Simulations Documentation Traceability Mathematical Proofs Determinism Instrumentation Theoretical foundations 26
  27. 27. NETSPECTIVE OSS / open standards applicability Project / Standard Subject area D G Comments Linux or Android Operating system   Various distributions OMG DDS (data distribution service) Publish and subscribe messaging   Open standard with open source implementations AppWeb, Apache Web/app server   OpenTSDB Time series database  Open source project Mirth HL7 messaging engine  Built on Mule ESB Alembic Aurion HIE, message exchange  Successor to CONNECT HTML5, XMPP JSON , Various areas   Don’t reinvent the wheel SAML, XACML Security and privacy   DynObj, OSGi, JPF Plugin frameworks   Build for extensibility 27
  28. 28. @ShahidNShah Thank you Conclusion and Questions