Discovering the Many Tools Available in Your Testing and ...s3.amazonaws.com/rdcms-himss/files/production... · •HL7 v2.5.1, PHIN Messaging Guide R1.1 •Validates message content

Discovering the Many Tools Available in Your Testing and Certification Toolbox

Michelle Knighton, MBA, RHIA Health IT Test Lab Manager, ICSA Labs

• Testing and Certification Framework

• Overview of Testing/Certification Programs

• Interconnectivity of Programs

• Test Tools

Agenda

• Understand how the various testing and certification programs relate

• Identify the testing and certification tools available to implementers and developers today

• Understand how to apply the various tools and technologies that

are readily and freely available in the marketplace currently • Describe the many reasons and ways organizations can benefit

when using the tools and resources that are available

Learning Objectives

• Trusted institute since 1989 – over 25 years’ experience

• First commercial lab to receive ISO/IEC 17025 accreditation for information security testing

• Providing organizations with expert, objective, third-party evaluations of deployed and proposed technologies

• Testing and evaluation of IT security products, applications, devices, and solutions against industry accepted criteria

• Significant involvement in health IT testing and certification for ONC Health IT, ConCert by HIMSS, IHE International Conformity Assessment

Trusted authority for testing and certification

About ICSA Labs

ISO 9001:2008 registered for quality management systems ISO 17065 accredited Certification Body by the American National Standards Institute (ANSI)

ISO 17025 accredited Test Lab by the National Voluntary Lab Accreditation Program (NVLAP)

ONC-Authorized Certification Body (ONC-ACB) and Accredited Testing Laboratory (ATL)

ICSA Labs’ International Accreditations

International Certification Framework

Standards body (Guide 7) • IETF • IEEE • HL7

• ONC • NIST • IHE • ICSA Labs • Continua • HIMSS

Accreditation • Process/Quality Mgmt • Certification Program

Standards Requirements

ISO User Defined

“Scheme”

Testing Organization ISO9001:2008 ISO17025:2005

Tools Methodology Testing Processes

Test Results

Certification Body ISO17065

Certification Report

Certification Award/Certificate

Certification Benefit Statement • Trusted, credible structure • Parallels government

accreditation requirements • Internationally recognized and

accepted

Standards Development Advisory Council Compliance Standards Consortia

Testing Lab Conducts Testing

Iterative Updates

Certification Criteria

Testing Lab Authorized labs implement test methods

Certification Body Reviews test report, awards certification, and conducts post-market surveillance

Publication Publishes results, test reports, whitepapers and lessons learned – drive improvements in tools, test requirements and specifications

Dynamic Certification Life Cycle

Validation Metrics

Testing/Certification Programs

IHE North American (NA) Connectathon

ONC Health IT Certification

ConCert by HIMSS™ Certification

Continua Plugfest and Continua Certification

IHE International Conformity Assessment

ConCert by HIMSS™ 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

Programs as Building Blocks

Structured Testing Events

• IHE NA Connectathon

Conformity Assessment

• IHE International Conformity Assessment

Certification Programs

• ONC HIT Certification • ConCert by HIMSS™

Continua Plugfest Continua Certification

Interconnectivity of Programs

HIMSS and IHE

•Adds certification component

•Beyond meaningful use •Based on IHE and federal

standards •U.S. based

•Formal testing conformity assessed

•Based on IHE specs • International scope

•Focus on interoperability •Works out kinks in new

products and standards •Based on IHE specs •U.S. and Europe

Connectathon

International Conformity Assessment

ConCert by HIMSS™

•Federally-driven •U.S. based

ONC HIT Certification

Tools to Advance Interoperability

HIMSS and IHE ONC HIT Certification

Reduce adoption barriers

Reliable exchange of

data

Connectivity across org/state

boundaries

Progress implementation

standards

Encourage innovation

Continua Enabling Software Library (CESL)

Speed the adoption Reference

source code

Testing Prototypes

Basis for Continua Test Tool

Creation of reference

devices for IOP

CESL

Patient Information • Gazelle Demographic Data Server

(DDS) • Send data to SUT using an HL7v2

message

Generate demographics data

• Gazelle XCPD simulator • RI to test patient lookup across

communities

Cross-community patient lookup

• Gazelle Patient Manager • RI to test PAM, PDQ, and PIX profile

functionality

Lookup patient demographics, IDs,

etc.

Patient Information • PIX/PDQ Pre-CAT Test Tool • RI that allows SUT to submit query

for patient ID or patient demographics data

Query for patient demographics or

patient ID

• Interoperability Testing Tool (ITT) • Acts as RI and validates message

content/structure

Lookup and query for patient

demographics or patient ID

Orders • Gazelle Order Manager • Simulator for placing and

filling orders for eye care, radiology, cardiology, and lab

Manage orders

Imaging: DICOM

DICOM viewer

• OFFIS DICOMscope • Must install locally

• EVS Client

DICOM validator

• EVS Client

Imaging: Other

Radiology Reports

• RSNA MRRT Template Validation • Validates radiology report templates

Portable Data for Imaging

• Northwestern University • Validates PDI media

ePrescribing

2014 Edition

• EDI Validation NCPDP SCRIPT 10.6 • Validates message content

and structure for NewRx • XML Validation NCPDP

SCRIPT 10.6 • Validates message content

and structure for NewRx

2015 Edition

• EDI/XML Validation NCPDP SRIPT 10.6 • Validates transport,

message content, and structure for NewRx, Change, Cancel, Refill, and MedHx

Documents Document Sharing • NIST Document Sharing Test Facility • RI to test cross-enterprise document sharing (XDS) and related

profiles • Interoperability Testing Tool (ITT) • Acts as RI for document sharing, XDS, XCA, XCPD and DIRECT • Validates message content and structure

Notification of Document Modification • Gazelle Document Metadata Subscription (DSUB) • Validates messages for structure

Patient Summaries

Cons

olid

ate

CDA

(CCD

A)

Cont

inui

ty o

f Car

e D

ocum

ent (

CCD

)

Cont

inui

ty C

are

Reco

rd (C

CR) CCR

Validator Validates message structure

CDA Validator •Validates message structure

EVS Client •Validates message structure

Transport Testing Tool (TTT) •Validates message structure

Clinical Quality Measures

Cypress QRDA Validators • v2.4.1 for 2012 or 2013 eCQM

specs • Must install locally

• v2.6.1 for 2014 eCQM specs • v2.7.0 for 2015 eCQM specs • Must install locally

Lab Tests and Values/Results

Transmit and incorporate labs HL7v2.5.1

• Lab Results Interface (LRI) •Acts as RI for incorporation of labs within

SUT, as well as sending labs from SUT to external system

•Validates message content and structure

Public Health: Reportable Labs

• Electronic Lab Reporting (ELR) • Validates message content and structure

Transmit reportable labs HL7 v2.5.1

Public Health: HC Surveys

• CDA Validator • Validates message structure

National Health Care Surveys HL7 CCDA R2

Public Health: Immunizations

• Immunization Validator • Validates message content and structure

ONC 2014 Edition Immunizations HL7v2.5.1

• Immunization Validator • Validates transport (SOAP), messaging content and

structure

ONC 2015 Edition Immunization Test Suite

Public Health: Syndromic

• Syndromic Validator • HL7 v2.5.1, PHIN Messaging Guide R1.1 • Validates message content and structure for UC and ED

ONC 2014 Edition Syndromic Surveillance

• Syndromic Validator • HL7 v2.5.1, PHIN Messaging Guide R2.0 • Validates transport (SOAP), messaging content and structure for

UC, ED, and IP

ONC 2015 Edition Syndromic Test Suite

Public Health: Cancer Registry

•Cancer Registry Validator •Reporting to Public Health Cancer Registries from Ambulatory Healthcare

Providers Implementation Guide R1 •Validates message structure

ONC 2014 Edition Cancer Registry HL7 CDA Release 2.0

•Cancer Report Validator •Reporting to Public Health Cancer Registries from Ambulatory Healthcare

Providers Implementation Guide R1.1 •Validates message content and structure

ONC 2015 Edition Cancer Registry HL7 CDA Release 2.0

Patient Care Devices Pre-CAT test tool and CAT test tool

Alert management

Device enterprise communications

Implantable device cardiac observations

Infusion pump events

Point-of-care infusion verifications

Retrospective data queries

Medical equipment management

Provider Directory

ONC Provider Directory Test

Tool

Provider Info Directory (server) tests response to various use cases Provider Info Consumer (client) tests ability to generate requests and consume responses Includes Federation Option

Interoperability Testing Tool

(ITT)

Tests conformance to IHE HPD profile

Security Exchange eHI securely using Direct

Direct Certificate Discovery Tool (DCDT) • Acts as RI for hosting, discovering, and exchanging certificates with other Direct

implementations

Transport Testing Tool (TTT) • Acts as RI for exchanging patient summaries between Direct Backbone

implementations; validates message structure

Interoperability Testing Tool (ITT) • Acts as RI, requiring TLS for all eHI exchanges; validates message structure and

content

Security cont’d • Edge Testing Tool (ETT) • Acts as RI for exchanging patient summaries between a

Direct Edge implementation and a HISP; validates message structure

Exchange eHI securely using Edge Protocol

• Gazelle EVS Client • Validates message structure ATNA

• Gazelle XUA simulator • Validates structure of SAML assertions

User security assertions

Value Sets

IHE NA Connectathon • Gazelle Sharing Value Set

simulator • RI to test repositories

and consumers

ONC HIT 2014 Edition and 2015 Edition • Unified Medical

Language System (UMLS) • Requires free license

NIST ONC Health IT Certification Tools http://healthcare.nist.gov/NIST-TOOLS/MU/index.html IHE Test Tools http://wiki.ihe.net/index.php?title=IHE_Test_Tool_Information#Overview Cypress http://demo.projectcypress.org Stella Technology Interoperability Testing Tool (ITT) https://itt.stella-apps.com/itt/login.jsp Continua Plugfest Resources https://cw.continuaalliance.org/wg/members/home/test-tool-download

Quick References: Tools

ConCert by HIMSS™ http://www.himssinnovationcenter.org/concert IHE International Conformity Assessment http://ihe.net/Conformity-Assessment/ Continua PCHA http://www.pchalliance.org/ Stella Technology http://stellatechnology.com/ ONC Health IT http://healthit.gov

Quick References: Orgs

Michelle Knighton, MBA, RHIA Health IT Test Lab Manager, ICSA Labs [email protected] +1 541.224.1141