PCHAlliance’s Continua Design Guidelines ensure a direct path into an electronic health record (EHR) for IoT Michael J. Kirwan

Vice President of Continua at PCHAlliance

Agenda

• PCHAlliance & Continua

• Continua Design Guidelines

1. Architecture

2. Structure

3. Internet of Healthy Interoperability Roadmap

• Continua Conformance

1. Certification

2. Compliance

3. Where to start

• Q&A and How to get involved

Health &

Fitness

COPD

Hyper-

Tension

Heart

Failure

Diabetes

Care

IoT

Published annually, PCHAlliance’s Continua Design Guidelines define a flexible framework for user friendly end-to-end interoperability of personal connected health devices and systems. Continua certified products bear the globally recognized Continua logo, which signals market-readiness for 21st century health data exchange. The Guidelines are recognized as an international standard by the United Nations’ International Telecommunication Union (ITU-T) and available free in six languages.

PCHAlliance’s flagship event, the Connected Health Conference, is the premier international conference and expo for the exchange of research, evidence, ideas, innovations and opportunities in connected health. Formerly the mHealth Summit, and now in its ninth year, the event features industry-leading keynote presentations, dynamic programming, poster presentations, an interactive exhibit floor, and high-value networking sessions. www.ConnectedHealthConf.org

Continua Design Guidelines

Secure Medical Data Exchange

CDG’s foster integration to enable medical-grade health/sensor data to flow from a multitude of vital signs

devices used by consumers to health services, all the way into local,

regional or national EHRs and data lakes in a safe and secure manner.

IoT

Key Goals

Significant membership

growth, global confidence in

the CDGs and the attainment of

a worldwide ecosystem of

Continua Certified Products.

NEW CONTINUA DESIGN GUIDELINES ENABLE INTEGRATION OF PATIENT GENERATED DATA INTO ELECTRONIC HEALTH RECORDS TO SUPPORT CHRONIC DISEASE MANAGEMENT BUILT ON HL7 FHIR SPECIFICATIONS

6

Health &

Fitness

COPD

Hyper-Tension

HeartFailure

Diabetes Care

We’ve completed coverage for all use-cases initially targeted. We are now in a new period where, with several new PCHAlliance initiatives, we can now focus on new use-cases, new stakeholder needs and in improving what we’ve built.

http://www.pchalliance.org/news/new-continua-design-guidelines-enable-integration-patient-generated-data-electronic-health

H.811 H.812 H.813

H.810

ITU Global Standard = Continua Design Guidelines

http://www.itu.int/rec/T-REC-H.810-201312-I

CDG Architecture

H.812.5

CDG Technical Foundation

What We Have Built!

Continua Design Guidelines Annual Updates & UpgradesGuidelines Lifecycle Process*

Development Cycle

1. Submission of use case ideas

2. Use Case development

3. UC balloting

4. UC sponsorship

5. UC review – architecture, regulatory, feasibility, effort

6. Decomposition (Work items)

7. Gap Analysis

8. Guidelines Development

9. Balloting

10. Approval

11. Testing, test tools development

12. Public Release & Comment Period

13. Certification Program

Use Case

Requirements

Base Standards

Design Guidelines

ITU-T Standard

* Follows EIF rules for open standards development

Certification Program

IoT Direct-to-Cloud

Health

&

Fitness

COPD

Hyper-

Tension

Heart

Failure

Diabete

s

Care

Devices Gateways Services

What We’ve Achieved to Date

http://www.pchalliance.org/news/new-continua-design-guidelines-enable-integration-patient-generated-data-electronic-healthFree CDG:

Healthcare interoperability standards

Specs for payload data represent decades of experts work on modelling clinical concepts and ICT data models to represent them.

Clinical concepts evolve, but smoothly and slowly.The models are being re-used across standards and over time.

The ICT vehicles to capture, move, store, manage and access health data keep changing rapidly.

- Quite strongly driven by “consumer markets” who are driving technology changes- In institutional healthcare, this slowed down by regulations and legacy systems

Our Biggest Challenge

Continua makes it possible to collect vitals data in remote & dynamic

environments

What We’ve Done About it

How Data get from Devices to Services

2017 Device-side Expansion

1. Power Status Monitor2. Drop-in Commercial Ready Code

2017 Bluetooth low energy Fixes

1. Current Time Service & Time-stamping (Sensor disconnect, inconsistent setting of time)

2. Handling of duplicate data3. Pairing issues4. Uploads to servers that either do or

do not store data5. ASN.1 Bits

2018 IoT Development2017 Service-side Expansion

1. FHIR H.821.5 Observation Upload2. Drop-in Commercial Ready Code3. Errata updates

2019 IoT Integration

20172017 2017

20182018 2018

2018 Architecture Improvements

1. Better Alignment with ITU2. Full Open-Source of Continua 3. Improving our key SDO’s RPM

standardization for Continua4. Redundant pathways5. Decentralization of information

1. Enabling any Transport Technology2. BTLE Physical Activity Monitor 3. Urine Analyzer4. Device Cyber-Security5. Command and Control6. Updates for many device

specializations/Profiles• for better time stamping and

synchronization, better error reporting, cybersecurity, errata, etc.

7. Updates for the IoT & Healthy Longevity Initiatives

2018 Device-side Expansion

2018 Service-side Expansion

1. Direct-to-Cloud2. Commercial Ready Drop-in Code3. PHD over IP Connectivity project4. E2E Cyber-security integration5. Command and Control6. IoT (Cellular and IP based development)

Continua’s Contribution

Key Alliances

Many Others…

Open-Source

FHIR

IoT

Microservice Aggregator

Persistent

store service

container

FHIR

Resource

Manager

Container

PHG Access

Control

Container

Patient

Record

System

Container

Micoservice

DiscoveryEvent 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 F

ram

ew

ork

Su

pp

ort

to

oling

Cloud Infrastructure Service

Capability

Exchange

Container

Management

Certification

Education

Listing

CD

GConvening Role, Galvanizing Collective ActionRaising the Bar & Monitoring Progress

IoT Thought Leadership: Continua Technical Achievements

CODE FOR

HEALTHCARE

Continua Test Tool

Continua Certified

Product Showcase

Membership

Value

CDG FHIR Strategies

Country

Adoption

Aw

are

ne

ss

an

d A

dvo

ca

cy

Co

ord

ina

tio

n &

Co

lla

bo

rati

on

You CDG2017

ITU H.8**

What we’ve completed since Vienna.

CAS by Continua

CATP by Continua

PCHAlliance Match-making

Continua Certification now Fully Open

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1. Continua Design Guidelines freely available.• Members may certify to them immediately.

2. Adopter members can join for only $1500 level and Certify• And are allowed to certify. • And all Certification listing fees are now only $1000 USD.• Certifications will be heavily marketed to governments, health ministries

and other large organizations via PCHAlliance Match-making program (matching buyers to sellers) as well as accessible via the new Certified Product Showcase (CPS).

• The CPS is search engine optimized, shows all commercially available products, is mobile format ready and includes the ability to download as a .CSV any filtered searches.

3. If not ready to certify, we have also created a new program called

Continua Compliant. • This program allows any vendor to self-declare that they are compliant

if you’re not ready to become a member and get fully certified. • We will give away the test tool for free. Venders need only share their

completed summary test report with PCHAlliance to be listed on the Continua Compliant listing (at no cost).

Committed to Complete Device Certifications by 2020

21

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Continua Conformity Assessment

Global Demand

Denmark: (2012) National health IT strategy sets out reliance on (Continua); roll out of national COPD services in 2018.

Norway: (Dec 2014) MoH announced Continua standards as the framework for new national remote health and social care program

Sweden (June 2016) Inera signed letter from six governments asking eHealth Network to work towards EU interoperability framework

European Commission: (2013) Continua referenced alongside IHE in European eHealth Interoperability Framework

Finland: (Oct 2017) MoH launches personal health record in Dec 2017, expressed interest in diabetes pilot with Continua in 2018.

eHealth Network: (May 2017) Invited six governments to present at Malta meeting; new MWP being prepared, led by SPMS

Austria: (Oct 2017) MoH published technical framework directive for telemonitoring with Continua

Catalonia (July 2017) MoH mandates Continua compliance for glucose meters to connect with personal health record

Portugal: (Aug 2017) SPMS (division of MoH) joined PCHAlliance, is exploring Continua compliance for devices

EE Presidency/Digital Health Society: (Oct 2017) PCHAlliance joins DHS Task Force on interoperability led by Dutch MoH

Remote monitoring encompasses capturing and securing data in dynamic mobile environments outside of the clinical environment: such as the

tracking, storing and forwarding of a person’s vital signs data and their measurement timestamps as they travel over different time zones, in

environments with no connectivity and in instances of an abrupt loss of connectivity or power. This includes protecting and securing the person’s

privacy while ensuring responsiveness of concerns encountered during the monitoring of their data.

1. Achieving medical-grade interoperability means that multiple sensor types of data, e.g., vital signs sensor data from a glucose monitor, a

blood pressure cuff, a pulse-oximeter, thermometer or any other CDG remote monitoring device, may be sent separately or combined as

multi-measurements and be clearly understood by healthcare providers end-to-end – all the while the context of the data remains.

2. This offers healthcare providers an authentic and holistic view and understanding of the data because the chemical, biological and medical

science data is understood through its comprehensive nomenclature coding system. Medical-grade interoperability can only be achieved

through harmonization with existing adopted healthcare standards and protocols understood by regulatory agencies, governments, EHRs,

clinicians, etc. and as validated with the muster and rigor of a globally accepted conformity acceptance scheme requiring the very best

practices for compliance and interoperability.

3. Therefore, medical-grade interoperability is only validated by demonstrating compliance with both the IEEE 11073 Personal Health Device

specifications (protocols and specializations for health, medical and fitness remote monitoring) and the CDG through the Continua

certification process.

4. PCHAlliance believes that any organization interested in being part of the health IoT ecosystem should be able to achieve medical-grade

interoperability and claim compliance to the CDG. To make this possible, PCHAlliance provides both the CDG and its automated Continua

test tool freely to any organization.

CDG MEDICAL-GRADE INTEROPERABILITY

Contact Us!

Continua

• Michael J Kirwan

• mkirwan@pchalliance.org

• http://www.pchalliance.org

Thank You