Continua CertifiedSolving Device Interoperability for
Remote Monitoring
The Problem that Continua has/is Solving
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.
Solving Device Interoperability
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.
All Continua Work Groups
Lifecycle Process
Test and Cert ProgramCertified Product Showcase
Training Programs
PCHAlliance Thought Leadership
Events
Plugfests & Hackathons
Web Sites
Member Collaboration
Test Tools
Test Labs
Healthcare IoT Leadership
CDG
Global Product Marketing
Awareness &Understandin
g
ThoughtLeadership
Coordination &
Collaboration
Policy & AdvocacyRaising the Bar & Monitoring
Progress
Convening RoleGalvanizing Collective Action
Success with the CDGs mean:
• Unity• Benevolent• Inclusive• Holistic
What We’ve Built
Guiding Principles
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.
Heart FailureHypertension, COPD, Heart Failure
Capture &Collect
Display &Consume
1 3Aggregate, Normalize,
Store & Forward
2
Use-Cases1.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……………...........
Just One Example
Truly Open Design GuidelinesContinua 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: www.pchalliance.org
• 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
Guideline Development Process
Development Cycle
1. Submission of Activity Request
2. Activity development3. Balloting4. Sponsorship5. Review – architecture,
regulatory, feasibility, effort6. Decomposition7. Gap Analysis8. Guidelines Development9. Balloting10. Approval11. Testing, test tools
development12. Public Release & Comment
Period13. Certification Program
Use Case
Requirements
Base Standards
Design Guidelines
Certification Program
ITU-T Standard
PCHAlliance Arms the Person with Knowledge
HIMSS Arms the Clinician with Knowledge
Person
Clinician
Healthcare Maturity Continuum
Be Prepared
Holistic Care
OutcomesBetter
Person is apart of the Decision
Patient Driven Decisions
Patient DrivenPatient Empowered
Provider DrivenHealthcare System
Clinical Aspect
Person Aspect
Our Alignment with HIMSS
(Nursing Station, Gateway)
Hospital Device
Personal Health Device
HealthInformationExchange
HospitalEMR
Hospital Device
Gateway
AmbulatoryEMR
HospitalEMR
Personal Health
Gateway
(Hub, phone, tablet, etc)
(Health, Medical and Fitness devices) (Care Management Services)
Health Information Service
Health & Fitness Service
Hospital Device
Defined in IHE ProfilesDefined in Continua GuidelinesDefined & aligned in both Continua Guidelines & IHE Profiles
IHE Profiles and PCHAlliance’s Continua Guidelines
And Our Alignment with IHE
• 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”.
What we can do, together
Cyber-security
• IEEE 11073 PHD Cybersecurity Team• Whitepaper to be published mid-year• Further assessment toward implementing
recommendations within the IEEE 11073 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 11073 PHD standards will likely be adopted by Continua.
• Continua also working on the command-and-control from a Health & Fitness Server.
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
Latvia: eHealth Week closing plenary: Continua Commitment to support ecosystems with Continua Guidelines
UAE / Qatar: Discuss PCH/Continua as part of HIT plansSingapore: 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 standardsChina: Momentum is building toward utilization of standards in HIT - more members from China and new China WG.
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
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)
Code, Binaries
SDK
AutomatedContinuaTest Tool
Development & Testing Tools
Microservice Aggregator
Persistent store service
container
FHIR Resource ManagerContainer
PHG Access Control
Container
Patient Record System
Container
Micoservice Discovery Event Store
OAuth Token Relay
Load BalancerEdge Server
API Gateway
OAuth Resource Server
Load Balancer
Event Based Microservice Framework
Microservice Broker
Consent Management
Container
Mic
rose
rvic
e Fr
amew
ork
Supp
ort t
oolin
g
Cloud Infrastructure Service
Capability Exchange Container
Code for Healthcare(FHIR Based Commercial
Ready Code for Open-Source)
Continua Certification
Continua Test Labs
Herndon, VA, USA
Malaga, Spain
Taipei, Taiwan
KoreaBeijing, China
Basingstoke, UKBerkshire UK
http://www.at4wireless.com/
http://test.tta.or.kr/English/http://emcite.com/english/
http://ul.com/
http://www.scc.sharp-eu.com/
Continua Certified Experts WorldwideIndividual recognized by Continua as an expert on topics related to Continua Certification. http://bit.ly/certexpert
Donorov Mitsui(Allion Japan)Felix K. (Allion Taipei)
Diego B. (AT4 Wireless)Raul G. (AT4 Wireless)Elisabeth J.
(AT4 Wireless)
Jeppe B. (Delta)
Sri P. (Sharp)
Xiaochen C. (TMC)
Kanghae L. (TTA)
Bjørnar Henriksen
Thommy Evensen
Thank You!
Solving Device Interoperability
Certified Connectivity.Finely Tuned Simplicity.
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
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 solutionsHIT 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
Common Device Connectivity Topological Scope
Source: HITSP V1.0 _2010_TN905 Device Connectivity / IEEE 11073-00101™-2008
Health informatics – PoC medical device communication Part 00101: Guide
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
* Described in HITSP V1.0 _2008_IS77 Remote
Monitoring
PCHA / Continua Realm
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
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
ConCertMedical Device
DEC Device
Observation Reporter
PIV Infusion Order
Programmer
PIV Infusion Order
ConsumerDEC
Device Observatio
n Consumer
= IHE Profile= Other HIT Standard
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.
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
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
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)
ConCert - IHE CA Harmonization
ITT
Gazelle- CA
IHE CAsC
IHEUSA Deployment Committee
IHEUSACertification (XDS.b, Devices)
Test Results2
Test Results
ConCert
Sponsor of
PCDTest Results1
2 - IHE Profiles in the ITT that overlap with those in IHE CA program will transition to be tested in the Gazelle-CA
1 – Other Gazelle-CA Profiles to be included as approved
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
Certification
• ISO/IEC 17065 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
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
ICSA Labs Partnership• Medical Device Certification 2017
– Execution of Pilot Q1 2017…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 Q2 2017
• Program expansion for additional Device–related profile and testing requirements going forward
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/Logging2. Authentication3. Communications4. Cryptography5. Physical Security6. Platform Security
Thank You!
More information about the program can be found at: http://www.himssinnovationcenter.org/concert-himss