Update : Joint Mobile Health and Health Care Devices WG’s Shared Use Cases (Health Care Device & Mobile Device) ECG Holter Monitor Glucose Meter Telematics ( Automated Vehicle First Responder) Appendix: FHIR References

Shared Use Cases (Health Care Device & Mobile Device) ECG Holter Monitor Glucose Meter Telematics ( Automated Vehicle And First Responder – FIHR Application )

Holter Monitor Test Patient is due for Holter test in preparation for annual checkup. Patient elects to have remote Holter test from their patient portal. Patient receives Holter Monitor at home mail. Patient reviews video on how to setup Holter test monitor. Patient is instructed to install Holter application on their smart phone. Patient applies Holter monitor device and sync device with mobile device. 3

Holter Monitor Test - continued Mobile device verifies that Holter Monitor is active and properly setup. Patient is given confirmation status ready. Patient has been instructed to journal activities while Holter monitor is active. Patient accidently disconnect lead. Patient reconnects lead and journals event and verifies Holter monitor is back to ready. 4

Holter Monitor Test - continued After 24 hours of monitoring, mobile device indicates test completed. Mobile device indicates that test data is ready to upload to patient portal. Patient verifies upload to proceed and receives confirmation upon completion. Patient returns Holter monitor via mail. 5

Diabetes Management EHR / PHR Mobile App Smart Phone/Tablet Glucose Meter IEEE 11073

Glucose Monitor Patient is newly diagnosed with diabetes. Patient has gone through a diabetes education program and has chosen to use mobile diabetes application to assist in behavioral changes, journaling diet and activities. Glucose meter is paired to mobile device to facilitate exchange of data and journal with patient portal. Patient records glucose data, eating habits but has questions about how they are doing? 7

Glucose Monitor - continued Patient accesses their patient portal and seeks feedback from their care team. Care team request user to upload diabetes meter and journal data from mobile device. Care team reviews data and suggest changes to medication regiment. Mobile device can use alerts or reminders to better manage their medication and behavior. 8

Glucose Monitor - continued Patient learns through many iterations how to manage their diabetes effectively. 9

Diabetes Management Use Case User installs Mobile Application recommended by Care Team with access to Patient Portal (EHR). User defines relationships (Patients and Care Team). Mobile App gets Care Plan from EHR (Goals, Recommendations and Instructions).

Diabetes Management Use Case User pairs Glucose Meter (IEEE device). User links device and sets patient context? Glucose meter records glucose observations. User/Patient syncs glucose meter with mobile app and reviews data.

Diabetes Management Use Case User/Patient uploads recorded observations to EHR /PHR. Care team for reviews uploaded observations. Care team modifies care plan based patient uploaded data. User/Patient receives alert that care plan has been updated.

TAN-Interface WAN-Interface LAN-Interface PAN-Interface HRN-Interface Application Hosting Device LAN Device Scope PAN Device WAN Device HRN Device PAN Device TAN Device Interface Teams define Certified Device Classes within constraints set by E2E Architecture, then select standards and create guidelines for these Certified Device Classes E2E Architecture Team Services Team: Focus on WAN and HRN IFs Devices Team: Focus on PAN and LAN and TAN IFs

Next Steps Holter Monitors and Glucometers Identify current standards for interoperability. Identify Patient / Device paring and matching. Further define context specific use cases Define FHIR resources in context of use case. Explore current Continua Alliance capabilities Develop Project Scope Statements Identify Stakeholders

Telematics and Digital Health Allen Hobbs, Ph.D. Co-Chair HL7 Health Devices Draft

Introduction Modern automobiles are becoming increasingly computerized with many components partially or entirely controlled by computers and networked both internally and externally. There are over 250 million registered passenger automobiles in the U.S.. Virtually all new automobiles are now computerized. The architecture is based on significant advances in safety (e.g. anti-lock brakes), fuel efficiency, and convenience. Increasing computerization also creates new risks to be addressed. Recent research has been focused on helping people enjoy the benefits of a computerized architecture while providing strong assurance of safety, security and privacy.

Digital I/O channels appearing on a modern car.

Intelligent Systems

Computerization also Creates New Risks Recent research has been focused on helping people enjoy the benefits of a computerized architecture while providing strong assurance of safety, security and privacy. Two papers exploring safety, security and privacy are worth noting here. The first is the “Comprehensive Experimental Analysis of Automotive Attack Surfaces “ and the second is the “Experimental Security Analysis of a Modern Automobile” Comprehensive Experimental Analysis of Automotive Attack Surfaces, USENIX Security Symposium, August 2011 Experimental Security Analysis of a Modern Automotive, IEEE Symposium on Security and Privacy, May 2010

Conclusion of Comprehensive Studies Authors of the experimental studies note that automobile owners should not be overly concerned about attacks to automotive architectures. Rather, they focus squarely on addressing potential automotive security and privacy issues that future cars will have – with even more sophisticated computer control and broader wireless connectivity. Security and privacy protections will need to be addressed for voice, data and location. For example, experimental analysis of remote exploit controls has found that an attacker who has compromised a automobiles’ telematics unit can record data from the in-cabin microphone (normally reserved for hands free calling) and exfiltrate data over the connected IRC channel. It is easy to capture the location of the automobile and track where a driver goes.

Next Steps IEEE, the world's leading professional association for the advancement of technology, announced the completion of IEEE 1616a, a new standard based on IEEE 1616, the first universal standard for motor vehicle event data recorders (MVEDRs), similar to units found on aircraft and trains. An adjunct to IEEE 1616, the new standard helps to provide greater consumer protections by improving the effectiveness of these automotive “black boxes” with new lockout functionality designed to prevent data tampering, such as Vehicle Identification Number (VIN) altering and odometer fraud. It also addresses concerns over privacy rights by establishing standards protecting data from misuse. Explore interface of IEEE 1616 with IEEE ( personal health devices ), Interoperability Standards ( ICE ). Explore Autonomous Vehicle - First Responder Use Case Requirements

Emerging Trend Autonomous vehicles are predicted to be the norm by the year 2020 as automakers such as GM, Mercedes and BMW race to become technology leaders in the driverless vehicle market. Autonomous vehicles for First Responders will likely be an added value to Emergency Medicine Pilots studies are being conducted in California, Nevada and Florida

Self-Driving Cars: The Next Revolution In 2010, an estimated 86.3 percent of all workers 16 years of age and older commuted to work in a car, truck, or van, and 88.8 percent of those drove alone, while the remaining 11.2 percent traveled in a carpool. Congestion costs Americans 4.8 billion hours of time and 1.9 billion gallons of wasted fuel. Self-driving cars: The next revolution kpmg.com | cargroup.org, 2013

Autonomous Vehicles

Autonomous Vehicle

Benefits of Autonomous Vehicles Reduce high cost of traffic crashes and transportation infrastructure Reduce the millions of hours wasted in traffic jams. Convergence of sensor-based and connected- vehicle technologies will happen and will have a positive effect on the adoption of both systems Convergence will bring enhanced mobility and safety and reduced environmental impacts

Autonomous Vehicle and First Responder

Next Steps Telematics Use Case Identify current interoperability standards for First Responders Further define context specific use cases Identify requirements for device interoperability for Autonomous Vehicles for First Responders. Define FHIR resources relative to use case. Develop Project Scope Statements Identify HL7 and Industry Stakeholders

Appendix FHIR Administrative FHIR Infrastructure FHIR Clinical

FHIR Administrative Attribution –Patient –RelatedPerson –Practitioner –Organization Resources –Device –Location –Substance –Group Workflow Management – Encounter – Alert – Supply – Order – OrderResponse Financial – Coverage 31

FHIR Infrastructure Support –List –Media –Other –DocumentReference –(Binary) Audit –Provenance –SecurityEvent Exchange –Document –Message –OperationOutcome –Query Conformance –Conformance –ValueSet –Profile 32

FHIR Clinical General –AdverseReaction –AllergyIntolerance –CarePlan –FamilyHistory –Condition –Procedure –Questionaire Medications –Medication –MedicationPrescription –MedicationAdministration –MedicationDispense –MedicationStatement –Immunization –ImmunizationProfile 33

FHIR Clinical - continued Diagnostic –Observation –DiagnosticReport –DiagnosticOrder –ImagingStudy –Specimen Device Interaction –DeviceCapabilities –DeviceLog –DeviceObservationReport 34