Continua Certified - HIMSS20 · Hospital Device Personal Health Device Health Information Exchange Hospital EMR Hospital Device Gateway Ambulatory EMR Hospital EMR Personal Health

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