Presentation 5: Equipping Your Organization for

Success: What to Expect when Purchasing an Interoperable

System

John T Donnelly President, IntePro Solutions, Inc. IHE Board, PCC Domain; IHE USA rep to CAsC Implementation Task Force, NJ HIMSS Board

• Interoperable Systems Explored • The RFI/RFP Process Considerations • Sales / Contracting Implications • Operationalizing the Selected Solution

Agenda

• Understanding the key components of interoperable systems across different kinds of technologies

• Value of selecting solutions that have achieved milestones through conformance testing and certification programs

• Identify tips that will ensure the organizational success during the acquisition, implementation, and maintenance phases

Learning Objectives

Interoperable Systems

Information Systems in Healthcare

Pharmacy

Pathology

Radiation Oncology

Radiology/PACS

Cardiology

Patient Care Devices

Patient Care Documentation

Eye Care

Quality Research & Public

Health

Laboratory

(Healthcare) IT Infrastructure

Emergency Department

Electronic Health Record System

Billing

Physical/Occupational Therapy

Interoperable Systems Legacy

• Conventional HIT Software Products • Pt Reg, EMR’s, RIS, LIS, EDIS, PharmIS, PHIS, etc • PACS/VNA, Interface Engines, HIE Services

• Medical Devices • Pt Monitoring, Pumps, etc

• Diagnostic & Treatment Devices • Imaging, Lab, Anesthesia

• Implantable Devices • Pacemaker, Defibrillator

Interoperable Systems Works-in-Progress

• Home Medical Devices • Pt Monitoring, Weight Scale, …

• “Smart phone” Apps • Pt wellness, Home Care Regimens, …

• “Smart” Meds • Bio-feedback, Treatment Enablers, …

• Precision Medicine Systems • Bio-markers, Personalized Care Protocols, …

“…the body as the data source”

Interoperable Systems IHE Interoperability Guidance

System A System B IHE Domain(s)

HIT SW HIT SW All

Med Device Med Device PCD

Med & Implantable Device HIT SW ITI, PCD

Imaging Equip Imaging Equip RAD, CARD

Imaging Equip HIT SW RAD, CARD

Lab Equip Lab Equip LAB/AP

Lab Equip HIT SW LAB/AP

HIT SW Pharm Disp Equip PHARM

Interoperable Systems IHE Interoperability Guidance (projections)

System A System B IHE Domain(s)

Home Care Device Home Care Hub ITI, PCD

Home Care Device/Hub HIT SW PCD

Smart Phone App HIT SW ITI, PCC, RAD, QRPH, more tbd

“Smart” Meds Smart Phone App ITI, PCC, PHARM, RAD, CARD

Precision Med Syst HIT SW ITI, PCC, LAB/AP

The RFI / RFP Process Considerations

Transport Standards

• Address the format of messages that are exchanged

Content Standards

• Represent health concepts in an encoded, structured way

Vocabulary Standards

• Define the structure and content organization of the electronic message or document

Security Standards

• Define safeguards that protect the privacy and security of health information

Standards Categories

Informing RFI/RFP Content for Interoperability Requirements • Inherently Involving Multiple Vendors Products • Classify as Transport, Content, Vocabulary,

Security/Privacy Related • Review High-level HIT Standards Documentation /

Diagrams for Potential Fit IHE Profile Summaries

A Pragmatic Info Exchange Transport Framework

Quality, Research & Public Health Domain

Form Filler

Form Manager

Form Receiver

Content Creator

Information Source

Content Consumer

Information Recipient

Share Content (CDA)

Retrieve Form

[ITI-34]

VRDRFeed [QRPH-38] BFDRFeed [QRPH-39]

(Message)

Vital Records Form

VRDRFeed [QRPH-38] (VRDR Message)

Share Content (CDA)

Form Receiver

CDA Exporter

Submit Form [ITI-35]

Form Receiver Message Exporter

QRPH: Vital Records Reporting Profiles Basic Process Flow in VRDR and BFDR

Value Proposition • Establish interoperable electronic exchange of VR data

between EHR and VR Systems • More timely data release • Higher quality data for demographic and epidemiologic

surveillance and research • Less costly electronic vital registration systems • Greater integration with other stakeholder electronic systems • Greater standardization of electronic Vital Records data collection

and exchange*

• Support from HL7 (messaging and document standards) and IHE (content profiles) including some international interest

* Source: HL7 EHR-S Vital Records Functional Profile, Release 1 - US Realm Chapter 1: Overview

Leverage IHE Concepts / Experience in the RFI/RFP

• Define Requirements in Terms of Functional “Actors” and “Transactions”

• Determine the Appropriate HIT Transport to be Used • Review IHE Product Registry to Inform the Target List

of Vendors [ http://www.ihe.net/IHE_Product_Registry/ ]

Aligning Interoperability Req to Operational Value

• Transition Conversation from “IT” to “Clinical / Admin Workflow”

• Engage Key Stakeholders and “Champions of Change”

• Understand Current Pain Points and Challenges • Understand Organizational Objectives and

Innovation Targets • Apply HIMSS STEPS™ Value Model

The HIMSS STEPS™ Value Model shows

Ways Interoperability Can Improve The Value of Health IT Interoperability can impact each of the STEPS™ !

- Satisfaction (e.g., Consistent and automatic flow of data between clinical contexts and users) - Treatment/clinical (e.g., Reduce errors and duplicate and wasteful treatment; Doing the Right things right! - Electronic Secure Data (e.g., Consistent application application of well-established security protocols leverages proven, testable eCommerce solutions.) - Patient Engagement and Population Management (e.g., Like travel and banking, it becomes far easier for patients and families to locate complete medical and health data at a finite number of portals; Enables consistent public health data analysis. - Savings ( e.g., Standards-based interoperability lowers the cost for all parties, reduces the learning curve for users, improves patient safety and the costs of errors.

Sales / Contracting Implications

Key Contracting Points for Interoperability Services

IT • Multi-vendor Sales and Technical Partners • Robust Test Environments – Dev and Pre-Prod • Leverage Industry-sponsored Programs for

Conformity Assurance Testing and Certification • Include Conformity to Standard Security Protocols

via Actual Connectivity Tests • Extended Timeframe for Production Onboarding

Clinical / Admin

• Ensure Acceptance Includes End-to-End Operational Workflow Validation

• Validate Deliverables via User-level Conversations with Existing Customers

Conformance Testing and Certification

ONC CEHRT Program ATLs

Drummond Group

ICSA Info Guard National Tech

Systems (NTS) SLI Global

ACBs Drummond

Group ICSA Info Guard

ATLs Kereval ICSA (2016)

ACBs Determined by

Regional Deployment Committee

ATLs ICSA

ACBs ICSA

Sample of ISO Accredited Programs

Commenced 2015 In-Progress for 2016

Impact on Sales/Contracting Schedule

• Required Business Associate Agreements and other Legal Documents

• Multi-product/vendor Testing Scheduling Pilot implementation phases typical

• Detailed SLA and Business Continuity Commitments

Remember…this is typically the beginning of a long-term partnership

Remember…you have the most leverage BEFORE you sign the contract

Operationalizing the Selected Solution

Nuances of Interoperable Systems in Production

• The Interoperability Paradigm is a Healthcare Industry “Works-in-Progress”

• IT Processes for HIT Maintenance More Complicated and Challenging to Schedule

• Continue to Leverage Industry CA/Cert Program Deliverables ISO - non-conformity complaint management procedure and

industry surveillance Standards continue to evolve, e.g. HL7 FHIR

Nuances of Interoperable Systems in Production

• Interoperability and HIT Innovation are “Joined at the Hip”

• Clinician Community Evolving to be Better “Requestors” of HIT and External Resources

• Patient Community Evolving to be Better Participants in HIT Ecosystem

… basically, you’ve jumped on a moving train who’s tracks are just being laid ahead of it !!

Questions?

• Understanding the key components of interoperable systems across different kinds of technologies

Key Take-aways

• Value of selecting solutions that have achieved milestones through conformance testing and certification programs Leveraging external programs improves onboarding efficiency Engage with standards entities to establish testing/cert

priorities

• Identify tips that will ensure the organizational success during the acquisition, implementation, and maintenance phases

Key Take-aways

KPI Pre-requisite = Associate acquired HIT solution to clinical/ administrative workflows

Develop value metrics (per STEPS) early in project lifecycle Establish ongoing “conformance” process for installed HIT

products

John T Donnelly, MBA, MSc, CPHIMS President, IntePro Solutions Inc, and Board Member, IHE International and NJ HIMSS

jtdonnelly@intepro.biz, 908-693-7162 (m)

https://www.linkedin.com/in/john-donnelly-897681

Thank You!