Personal health monitoring– interoperability challengesIHE Finland 12.6.2018, Kuntatalo

Jaakko LähteenmäkiVTT Technical Research Centre of Finland

jaakko.lahteenmaki@vtt.fi

212.06. 2018 2

Concepts hierarchy

Telehealth

Telecare

eHealthPersonalHealthSystems

Clinical InformationSystems

Telemedicine

Support for independentliving (e.g. safety, medicinedispencer)

TeleradiologyRemoteintensive care

Telecardiology Tele-education

Teleconsultation

Teleophthalmology

Remote surgery

Telepatology

Teledermatology

Electronic Health Record (EHR)

ePrescription

Regional archives

PACS

Laboratory systems

National EHR (Kanta)

RadiologyInformationSystem (RIS)

Intensive care

Surgery & anestesia

Clinical Decision SupportSystem (CDSS)

Patient portals

Health kiosksPeer-to-peercommunities

Information resources

Health and wellnessapplications

Personal health record (PHR)

Video visits

Web doctor

Personal health monitoring

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Examples of health monitoring devices

source: iHealth Labs

source: FitBitsource: Aviva

ECG meter

source: Vitalograph

SpirometerPulseoximeter

Activitytracker

Glucometer

source: Blausen gallerysource: Wikipedia

Smartwatch

source: Fitbit source: Evondos

Medicinedispencer

Pacemaker

source: CambridgeConsultants

source: Oura

Smartring

Elder carewatch

source: Vivago

Blood pressuremeter

Homediagnostics

source: VTT

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Health monitoring parametersMonitoring parameter Measured quantity Examples of related

diseases

Blood pressure Systolic and diastolic BP [mmHg]Heart rate [1/min] Hypertension, Type 2 Diabetes (T2D), …

Weight Body weight [kg]Waist circumference [cm] Hypertension, Heart failure, T2D, …

Length Body length [cm] Child growth disorders

Physical activity Step count (pedometer), energy consumption, oxygen intake (e.g. basedon accelererometry and/or heart rate) Cardiovascuar diseases (CVD) monitoring&rehabilitation

Life-style Notes on usage of alcohol, cigarettes, nutrition, physical exercise T2D, Cardiovascular diseases, cancers

Blood glucose BG [mmol/l] (before/after meal) Diabetes (Type 1 and Type 2)

Spirometry Peak expiratory flow (PEF) [l/min] , Forced expiratory volume (FEV) [l] Chronic obstructive pulmonary disease (COPD), Asthma

Oxygen saturation SpO2 (pulse oximetry) [%] COPD

Symptoms and pain Subjective observation based on disease-specific classifications Heart failure, cancers, mental health

Independent living compliance Falls detection, motor and cognitive performance Musculoskeletal disorders, Parkinson's disease,Alzheimer's disease

Medication use Track and control medicine in-take (automatic medicine dispensers,insulin pump)Diseases with drug therapy (especially for elderlypatients)

Sleep Heart rate, respiration, sleep cycles, sleep time (e.g. based onballistocardiography) Sleep disorders (e.g. sleep apnea)

Anticoagulation therapy Prothrombin time, International normalized ratio (INR) Heart diseases

Electrical activity of heart Electrocardiogramme , e.g. ambulatory ECG (Holter) or pacemaker. Heart diseases

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Generic personal health monitoring architecture

J. Lähteenmäki

MonitoringDevice

Gatewaydevice(e.g. phone)

Back-endserver

EHR or PHRsystem

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Levels of interoperability1

ß Foundational interoperabilityÿAllows data exchange but does not require the ability for the

receiving information technology system to interpret the data.ß Structural interoperabilityÿDefines the structure or format of healthcare data enabling its

movement from one system to another for a clinical or operationalpurpose.

ß Semantic interoperabilityÿDefines both the structuring of the data exchange and the

codification of the data including vocabulary so that the receivinginformation technology systems can interpret the data.

J. Lähteenmäki

1HIMSS: http://www.himss.org/library/interoperability-standards/what-is-interoperability

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Interoperability of personal health devices –why?

ß Cost-efficient integration of personal health monitoring systemswith clinical information systemsß Monitoring data available for healthcare personnel

ß Parallel use of devices and applications (client and server) fromdifferent vendorsß Avoiding vendor locks

ß Let the end-user transfer data between personal health systemsß Freedom of choice for citizen

J. Lähteenmäki

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Continua Design Guidelines*

J. Lähteenmäki

ßMaintained and developed by PCHA

ß Implementation guide for user-friendly, secure and interoperabledata exchange for personal healthß Reference to several standards/specifications:

HL7, IHE, ISO/IEEE, Bluetooth, ZigBee, IETF, W3C, OASIS, OMG

* http://www.pchalliance.org/

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Continua end-to-end reference architecture

J. Lähteenmäki

HL7 PHMRIHE PCD-01or FHIR

ISO/IEEE 11073 PHDor Bluetooth LE

source:PCHA / ContinuaDesign Guidelines

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Personal Health Devices interface

ß Scope: transfer data from personal health devices to gatewaydevice (e.g. a smart phone)ß Core standard: IEEE 11073 PHDß emphasis on personal useß simple communication model

ß IEEE 11073 family includes:ß nomenclatureß domain information modelß optimized exchange protocolß device specializations (32 profiles: blood pressure monitor, etc. )

J. Lähteenmäki

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IEEE 11073 object model

J. Lähteenmäki

Source: Clarke &al. Interoperable End-To-End Remote Patient Monitoring Platform Based onIEEE 11073 PHD and Zigbee Health Care Profile

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IEEE 11073 protocol stack

J. Lähteenmäki

Continua Design GuidelinesH.811 PHD interface designguidelines, version 8.1

IEEE 11073 applicationprotocol(ISO layer 6,7)

Transport specificadaptation layer(ISO layer 5)

Base transport protocol(ISO layer 4)

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Services interface

ß Scope: Connection between Gateway Device andHealth&Fitness Service for data upload (observations),exchange (questionnaires/responses, capabilities), consentmanagement and persistent sessionsß Device observation optionsß IHE PCD-01(HL7 V2.6) + SOAPß HL7 FHIRß IHE PCD-01(HL7 V2.6) + HL7 hData + REST

J. Lähteenmäki

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HIS interface

ß Scope: Transfer observations to health records (EHR or PHR)ß Core standards:ß Data transfer: PCD-01 messages + PHMR + IHE XDS or ONC

DIRECTß Security:

ß confidentiality, integrity and authentication (TLS v1.1, XDM S/MIME)ß entity authentication (IHE XUA, XUA++)ß identity managementß consent managementß consent enforcementß non-repudiation of originß auditing

J. Lähteenmäki

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Interest towards PCHA and Continuaarchitecture in Nordic countries*

J. Lähteenmäki

* Towards a Nordic Reference Architecture for Personal Connected Health and Care Technology:https://www.inera.se/globalassets/tjanster/tjansteplattform/dokumentblock/nyhetsbrev/nordic_reference_architecture_for_personal_connected_health_technology_2017-03-19.pdf

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Continua Design Guidelines conformance

ß Continua certified products showcase:http://www.pchalliance.org/product-showcase

ß Number of certified products claimed to be commercially available:ß Total: 62

ß Personal health devices: 38ß Personal health gateways: 18ß Health&Fitness Services: 5ß Health Information Systems: 1

ß Year 2018: 4 new products

ß Continua compliant products list (self assessment):http://www.pchalliance.org/continua-compliant-products

ß list since 2018 (6 products)

J. Lähteenmäki

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Prevailing approach for sharing health/fitness databetween applications

J. Lähteenmäki

MonitoringDevice(e.g. tracker)

Personaldevice (e.g.phone)

Back-endserver

Externalapps(server side)

e.g.BluetoothLE

Proprietary

Application X

RESTAPI(exposedby App Xprovider)

No end-to-end interoperability specification used‡ instead: integration via product specific open API’s and SDK’s

Externalapps(client side)

SDK (by App Xprovider)

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Examples of Wellness application API’s and SDK’s

J. Lähteenmäki

API / SDK Scope Methods(data exchange /authentication&authorization)

Apple Health Kit SDK Share health and fitness data with other Health Kit apps. SDK

Samsung Health SDK’s Accessing local or server data of Samsung Health application. REST + JSON / OAuth2

Fitbit API Fitbit provides a Web API for accessing data from Fitbit activitytrackers, Aria & Aria 2 scales, and manually entered logs.

REST + JSON / OAuth2

Nike+ API & SDK API returns detailed information aggregated from a user’s activitywith Nike+.

REST + XML/JSON /OAuth2

Nokia Health API API provides access to personal activity and measurement data. REST + JSON / OAuth1

Google Fit API The API can be used by fitness applications to create, obtain, list,aggregate, delete, and modify datasets in Google Fit platform.

REST + JSON /OAuth2

Moves API API allows access to personal movement (activity) data. REST + JSON /OAuth2

Microsoft HealthVault API API for accessing the data in HealthVault and sharing data withHealthVault-compatible apps.

REST + XML /App ID

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How to connect with EHR systems?

J. Lähteenmäki

http://www.mobihealthnews.com/content/new-api-developers-can-access-apple-health-records-data

Apple Health Recordsapproach:- Apple enters into contracts

with health providers- Apple Health App retrieves

EHR data via FHIR fromhealth providers under userconsent

- Other applications canaccess the EHR data viaApple Health Kit under userconsent

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Ecosystems developing around EHR’s (andPHR’s)

ß Enable data exchange to external applications (fulfilling criteria toconnect)ßOpen FHIR API’s increasingly available in EHR’s, for exampleß Allscriptß Cernerß Epicß McKesson

ß Use of FHIR accelerated by the HL7 Argnonaut project* (e.g.implementation guides, authorization, ... )

ß Finland: Omakanta PHR ecosystem (enabled by open FHIR API)

J. Lähteenmäki* http://argonautwiki.hl7.org

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Conclusions

ß Personal Health Monitoring interoperability challenge:How to enable data exchange between monitoring applications andEHR systems?ß Continua Design Guidelinesß end-to-end approachß no breakthrough yet

ß Prevailing aproachß Device connectivity: Bluetooth LEß Exposing API’s and SDK’s to share dataß FHIR to connect with EHR’s

ß To improve:ß FHIR resources clinically oriented‡ more support for personal health

neededß Still limited support by EHRs to allow data exchange with external

applicationsJ. Lähteenmäki

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THANK YOU!