Continua Certified. Solving Device Interoperability for Remote Monitoring

Transcription

1 Continua Certified Solving Device Interoperability for Remote Monitoring

2 The Problem that Continua has/is Solving Solving Device Interoperability There are too many medical mysteries out there to solve, too many diseases to cure and so much data that could be shared to improve personal outcomes, enable holistic understanding and make big data research possible worldwide that it is our benevolent responsibility to ensure that this is achieved, and sooner than later.

3 This is no longer a Technical Problem It s actually a social opportunity to fully simplify and agree on seamless connectivity. PCHAlliance, through its Continua Design Guidelines (CDG), has developed an open platform for plug-and-play remote connectivity now covering 22 personal health, medical and fitness monitoring device types whose data is seamless from the person though to the health information exchange.

4 PCHAlliance Thought Leadership Healthcare IoT Leadership Thought Leadership Training Programs Events Plugfests & Hackathons All Continua Work Groups Lifecycle Process Member Collaboration Web Sites Policy & Advocacy Raising the Bar & Monitoring Progress Awareness & Understandin g Certified Product Showcase Global Product Marketing CDG Coordination & Collaboration Test and Cert Program Test Tools Test Labs Convening Role Galvanizing Collective Action

5 Guiding Principles Success with the CDGs mean: Unity Benevolent Inclusive Holistic What We ve Built

6 Data from Devices to Services all aligned with the same syntax, semantics and format into the EHR Remote monitoring encompasses capturing and securing data in dynamic environments; such as tracking the data & their timestamps over different time-zones, in environments with no connectivity and in instances of an immediate or abrupt loss of connectivity.

7 Just One Example Capture & Collect Heart Failure Hypertension, COPD, Heart Failure 2 1 Aggregate, Normalize, Store & Forward 3 Display & Consume Use-Cases 1.Diabetes: Glucose meter, Continuous Glucose Monitor, Insulin Pump, Weight Scale, Blood Pressure Monitor, Heart rate monitor (optional) 2.Hypertension: Blood Pressure Monitor, Weight Scale, Heart Rate Monitor 3.Heart Failure: Weight Scale, Blood Pressure Monitor, ECG (Electrocardiogram), Heart rate monitor 4.COPD: Spirometer, Peak Flow, Thermometer, Pulse Oximeter, Heart rate monitor, CO2 monitor (optional) 5.Health & Fitness and many other use-cases -case spectrum, such that any organization with a vision for solving real solutions can realize that vision...

8 Truly Open Design Guidelines Continua guidelines are endorsed by a neutral leader International Telecommunication Union (ITU), the global standards agency of the United Nations Anyone can get the Continua guidelines for FREE In six languages Download via ITU or: Anyone can submit comments Via Continua or ITU Any party can easily join the Personal Connected Health Alliance at the level of choice Easy market access for vendors, no vendor lock-in for users Contribute to new versions

9 Guideline Development Process Use Case Requirements Base Standards Design Guidelines ITU-T Standard Development Cycle 1. Submission of Activity Request 2. Activity development 3. Balloting 4. Sponsorship 5. Review architecture, regulatory, feasibility, effort 6. Decomposition 7. Gap Analysis 8. Guidelines Development 9. Balloting 10. Approval 11. Testing, test tools development 12. Public Release & Comment Period 13. Certification Program Certification Program

10 Our Alignment with HIMSS PCHAlliance Arms the Person with Knowledge Person Person is apart of the Decision Be Prepared Healthcare Maturity Continuum Patient Driven Patient Empowered Person Aspect Provider Driven Healthcare System Clinical Aspect Better Outcomes Clinician Patient Driven Decisions Holistic Care HIMSS Arms the Clinician with Knowledge

11 And Our Alignment with IHE IHE Profiles and PCHAlliance s Continua Guidelines Personal Health Device (Health, Medical and Fitness devices) Personal Health Gateway (Hub, phone, tablet, etc) Health Information Service Health & Fitness Service (Care Management Services) Ambulatory EMR Health Information Exchange Hospital Device Hospital Device Hospital Device Gateway Hospital EMR Hospital EMR (Nursing Station, Gateway) Defined in IHE Profiles Defined in Continua Guidelines Defined & aligned in both Continua Guidelines & IHE Profiles

12 What we can do, together Standards free up creativity (think Lego's) allowing organizations the freedom to grow what they want. Standards provide repeatability and reliability - they are transparently clear to others and often tested with open tools. Standards lower the risk to organizations while streamlining their project development. We each have our own perspective and view of things, some more mature than others. When creating a standard that everyone can understand you need only normalize into mirror images understood worldwide -- something that everyone can visually understand. To learn to do this, to be able to vision or picture the vision we all understand, one need only see - often with very few and little words.

13 Cyber-security IEEE PHD Cybersecurity Team Whitepaper to be published mid-year Further assessment toward implementing recommendations within the IEEE PHD Protocols and Device Specializations The additions of Cybersecurity will enable command-and-control of devices via the gateway (so bi-directional) Updates to the IEEE PHD standards will likely be adopted by Continua. Continua also working on the commandand-control from a Health & Fitness Server.

14 Global Adoption of Continua Design Guidelines Norway: (Dec. 2014) Parliament adopted Continua standards as the framework for its new national health program. Ministry of Health is Continua member Denmark: (2012) Nationwide health IT framework mandates compliance with interoperability standards (Continua). Sweden is on its way to follow its neighbors in 2015/2016 Finland (May 2015) announced adoption of the Continua Guidelines in its HIT framework Latvia: ehealth Week closing plenary: Continua Commitment to support ecosystems with Continua Guidelines Brussels: EC Commissioner invited Continua to cooperate to create a Europe wide Health agenda with focus on Health IT USA: FDA shows keen interest to collaborate in Guidelines and Certification program development. ONC: Continua now recognized within the Interoperability Roadmap (Dec 2016) UAE / Qatar: Discuss PCH/Continua as part of HIT plans Singapore: Continua based HIT to serve SE-Asian region Japan: Japan WG active. New members. Taiwan: New promoter member planning of an Asian Summit to promote standards China: Momentum is building toward utilization of standards in HIT - more members from China and new China WG.

15 Continua Certification Code, Binaries SDK Automated Continua Test Tool Cloud Infrastructure Service Event Based Microservice Framework Consent Management Container Patient Record System Container Persistent PHG Access store service Control container Container FHIR Resource Manager Container Capability Exchange Container API Gateway Microservice Micoservice Event Store Broker Discovery Microservice Aggregator Load Balancer OAuth Resource Server Microservice Framework Support tooling Edge Server Load Balancer OAuth Token Relay Development & Testing Tools Code for Healthcare (FHIR Based Commercial Ready Code for Open-Source)

16 Continua Test Labs Herndon, VA, USA Berkshire UK Basingstoke, UK Beijing, China Korea Malaga, Spain Taipei, Taiwan

17 Continua Certified Experts Worldwide Individual recognized by Continua as an expert on topics related to Continua Certification. Elisabeth J. (AT4 Wireless) Diego B. (AT4 Wireless) Xiaochen C. (TMC) Jeppe B. (Delta) Raul G. (AT4 Wireless) Bjørnar Henriksen Kanghae L. (TTA) Sri P. (Sharp) Felix K. (Allion Taipei) Donorov Mitsui (Allion Japan) Thommy Evensen

18 Thank You!

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20 Solving Device Interoperability Certified Connectivity. Finely Tuned Simplicity.

21 Three Distinct Certification Programs (Currently) Certification Marks signify compliance and proof that a product has all of the requirements to be interoperable with other certified ConCert by HIMSS products. for EHR systems providing a simplified way for providers to send secure health information directly to trusted recipients for HIE systems that enable clinicians to share health information within and across care delivery communities for Health Information Services Provider systems to send secure health information directly to trusted recipients, including patients

22 Value to Healthcare Industry Care Providers Simplify purchase decisions by enabling objective evaluation of device-connectivity solutions Transparent and collaborative process and commitment supporting the evolution of reliable, interoperable solutions HIT Product Companies Only private-sector, standards-based ISO-accredited level of testing and certification program; reciprocity opportunities with other testing/certification programs Improves return on interface development time/cost; reduction in custom solutions Reduces implementation time/cost at customer installations

23 Common Device Connectivity Topological Scope Source: HITSP V1.0 _2010_TN905 Device Connectivity / IEEE Health informatics PoC medical device communication Part 00101: Guide

24 Inter-Institutional Domain Target HIT Participants Home-based Medical Device Ambulance-based Medical Device Device Intermediary* Remote Monitoring Management System (RMMS)* Health Information Exchange Electronic Health Record System Personal Health Record System App-API Interface Service PCHA / Continu a Realm * Described in HITSP V1.0 _2008_IS77 Remote Monitoring

25 Institutional Domain Target HIT Participants Hospital Medical Device ED Medical Device Ambulatory Clinic Medical Device Physician Practice Medical Device Clinical Information System Electronic Health Record System ICU Device Management Monitoring Stations

26 Medical Device Certification Program (New in 2017) Certification Marks signify compliance and proof that a product has all of the requirements to be interoperable with other certified ConCert by HIMSS products. for medical devices and EHR systems to provide a standardized way to exchange programming order information and clinical information at the point of care

27 DEC Device Observatio n Reporter ConCert Medical Device PIV Infusion Order Programm er DEC Device Observatio n Consumer PIV Infusion Order Consumer = IHE Profile = Other HIT Standard

28 Testing There are nnn-mmm tests within those profiles that need to be passed to receive this certification. Device Observation Reporter (DOR) = Evaluates the capability to transmit valid PCD-01 messages to a DOC and consume the ACKs. Includes validation of Pulse Oximetry Integration messages. Device Observation Consumer (DOC) = Evaluates the capability to consume valid PCD-01 messages from a DOR and transmit the Accept ACKs. Includes validation of Pulse Oximetry Integration messages. Infusion Order Programmer = Evaluates the capability to transmit valid PCD-03 messages to a IOC and consume the Application Acknowledgement messages. Infusion Order Consumer = Evaluates the capability to receive valid PCD- 03 messages from an IOP and transmit the Application Acknowledgement messages.

29 IHE PCD-DEC Profile (Device to Enterprise Communications) The PCD-DEC (Device to Enterprise Communications) profile allows a consuming system (DOC) to receive patient clinical information including vitals, demographics, settings, and location from a reporting device/system (DOR). *Slide Content developed by IHE and the PCD Technical Committee

30 PCD-PIV Profile (Point-of-Care Infusion Verification) The PCD-PIV (Point-of-Care Infusion Verification) profile supports the electronic transfer of infusion parameters from a Bedside Computer-assisted Medication Administration (BCMA) system or EMR to a general-purpose infusion pump, enhancing patient safety by effectively eliminating keystroke errors. *Slide Content developed by IHE and the PCD Technical Committee

31 Testing Grounded in IHE PCD transactions HL7 v2.x message types DEC: Test data is supported from periodic, near-periodic and infrequent senders PIV: Test data is supported from LVP, PCA, and Syringe Type Pumps DEC/PIV: Test data tailored to specific characteristics of system under test, e.g. e.g. Bedside monitors will support heart rate, blood pressure (systolic, diastolic, mean, etc)

32 ConCert - IHE CA Harmonization IHEUSA Deployment Committee Sponso r of IHEUSA Certification (XDS.b, Devices) IHE CAsC Gazell e -CA ITT PCD Test Results 1 Test Results 2 Test Results C o n C e r t 1 Other Gazelle-CA Profiles to be included as 2 approved - IHE Profiles in the ITT that overlap with those in IHE CA program will transition to be tested in the Gazelle- CA

33 Testing Test tools and transactions developed and supported by NIST in conjunction with IHE Patient Care Device (PCD) domain Tight alignment with IHE Pre-Connectathon testing requirements Test requirements bundled with other IHE transaction requirements as appropriate Time Clock, Patient Identity, etc Some test data tailored to specific device type and/or parameters

34 Certification ISO/IEC accredited program in 2017 Recognizes IHE-CA Test Report for conformance to ConCert testing requirements In the field surveillance for ongoing assurance of deployed certified products functioning as expected Cybersecurity attestation report for added assurance of security protection Cybersecuity IoT testing and validation under review for program inclusion

35 ICSA Labs Partnership 25+ years of security testing and certification. 6 years Health IT (ONC Meaningful Use) testing and certification. 3 years IHE USA testing and certification. Partner for ConCert by HIMSS testing and certification. EHR, HIE, HISP

36 ICSA Labs Partnership Medical Device Certification 2017 Execution of Pilot Q target completion by HIMSS17 Help from leading Medical Device companies Baxter, B.Braun, Care Fusion Validation of Testing Tool and Certification Program prior to full operation in Q Program expansion for additional Device related profile and testing requirements going forward

37 ConCert by HIMSS Roadmap & Next Steps Pilot testing will validate the new set of tools and interoperability requirements. Pilot participants will be encouraged to provide input on the ConCert 2018 cycle Cyber security-centered certification testing Capabilities to test a wide range of IoT devices & sensors Targeting device and its component parts Requirements derived from a 6-category IoT Framework Can be mapped to ANY device type 1. Alerting/Logging 2. Authentication 3. Communications 4. Cryptography 5. Physical Security 6. Platform Security

38 Thank You! More information about the program can be found at: enter.org/concert-himss