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Advancing Medical Device

Interoperability (MDI)HESY 670 – Introduction to Health Information Systems

Department of Health Systems Administration Brandon Lock

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Agenda

• Key Questions• Overview of ICE/MDI Initiatives• Overview of ICE/MDI Stakeholders• Overview of Regulatory Environment• Key Findings

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Agenda

• Key Questions• Overview of ICE/MDI Initiatives• Overview of ICE/MDI Stakeholders• Overview of Regulatory Environment• Key Findings

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Key Questions:

•What is an Integrated Clinical Environment (ICE)?•What is Medical Device Interoperability (MDI)?•Why do we need ICE/MDI?•What are the Challenges & Barriers for ICE/MDI?

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What is an Integrated Clinical Environment (ICE)?

• Workflow Optimization• Systems Analysis & Engineering• Care Pathways & Clinical Workflow

• Clinical Simulation• Pre-Clinical Testing• Provider Education & Training

• Interoperability• Medical Device Plug-and-Play (MD PnP) Program• Standards Development for Device Integration

• Enabling Technologies• “Smart” Algorithms & Automated Surveillance• Wireless Technology Support (Sensors & Effectors)

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What is Medical Device Interoperability (MDI)?Medical Device Interoperability: The ability for medical devices to communicate with other medical devices; or information systems that ultimately leads to or enables secure, safe, and effective use. (MDICC)Functional Medical Device Interoperability:The ability for clinical medical devices to communicate in a consistent, predictable and reliable way, allowing for the exchange of, and interaction with, data from other medical devices and with patient data sources and repositories, such as electronic health records (EHRs), in order to enhance device and system functionality. (WHI)

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Why Do We Need ICE/MDI?• Healthcare Delivery is High Risk• DHS Critical Infrastructure Sector • FDA Regulated Medical Devices are Mission-

Critical Safety-Systems• Healthcare Delivery is Costly &

Fragmented• Need to Improve Safety, Quality, & Efficiency• Need to Network, Coordinate, & Connect

• Promising Value of HIT• Enterprise-Wide Interoperability• HIT Integration into Clinical Workflow

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What are the Challenges & Barriers for ICE/MDI?• Financial • Lack of Incentive Structuring for Interoperability • Regulatory Burdens for Medical Device

Manufacturers & Purchasers• Connectivity • Lack of Interconnection between Medical Devices &

Clinical Information Systems (CIS)• Lack of Established Standards for Uniform Medical

Device Interoperability• Health Delivery• Limits in Human Factors Engineering (HFE) of

Medical Devices and System/Process Failures• Balancing Customization, Standardization, Clinical

Workflow, & Ease of Provider Delivery

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Igniting an Interoperable Healthcare SystemHCI | DC 2014 Healthcare Innovation Day

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Connecting Health & Care for the Nation A Shared Nationwide Interoperability Roadmap

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Agenda

• Key Questions• Overview of ICE/MDI Initiatives• Overview of ICE/MDI Stakeholders• Overview of Regulatory Environment• Key Findings

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Overview of ICE/MDI Initiatives

• 1998 - The Center for Integration of Medicine & Innovative Technology (CIMIT)• Integrated Clinical Environments (ICE) Initiative • Clinical Systems Innovation (CSI) Program• 2004 - The Medical Device Plug-and-Play (MD

PnP) Interoperability Program

• 2012 – The Medical Device Interoperability Council (MDICC)• 2013 – The Center for Medical

Interoperability (C4MI)

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MD PnP Interoperability Program Projects

• Developing a New Open Standard for a Patient-Centric “Integrated Clinical Environment” (ICE)• Defining a Safe Regulatory Pathway for Patient-

Centric Networked Medical Devices• Creating and Refining Interoperability

Contracting Language• Performing Detailed Workflow & Gap Analysis• Developing a Prototype Healthcare Intranet

(IoT)

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MD PnP – Open ICE• Open Integrated Clinical Environments (ICE) Open-Source Digital Research Platform• Open ICE Equipment Interfaces Translate Proprietary Manufacturer-Specific Interfaces to Common Data Representation and Communication Protocol•Devices are Plug-and-Play using Software Device Adapters (SDAs)

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MD PnP – Prototype Healthcare Intranet• The creation of an eco-system for

interoperability of medical device and clinical information systems to support innovation in patient safety and healthcare quality with an Open ICE Platform.• Interoperability of devices and IT systems

in clinical environments will permit:• Mixed-Vendor Data Transfers• Comprehensive Secure Data Acquisition• Safety-Enhancing Capabilities• Safety Interlocks• Closed-Loop Device Control

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Agenda

• Key Questions• Overview of ICE/MDI Initiatives• Overview of ICE/MDI Stakeholders• Overview of Regulatory Environment• Key Findings

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ICE/MDI Stakeholders• Patients• Health Delivery Organizations (HDOs)• Medical Device Manufacturers• Regulatory Agencies• FDA, FCC, NIST, ONC, HHS, etc.

• Trade Associations• Standards Developing Organizations (SDOs)• Academic Institutions• Teaching Hospitals, Labs, & Universities

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ICE/MDI Stakeholder Development Map

Center for Medical

Interoperability

2013

Health Systems

$

Health Systems

+Universities

+Laboratories

Center for Integration of

Medicine & Innovative Technology

1998

Federal Government Regulatory+

Medical Device Industry+

Standards Development Organizations (SDOs)

+Trade Associations

+Academia/Research

Medical Device Interoperability

Coordinating Council2012

$

The ICE Alliance

SDOs+

Manufacturers+

Healthcare & Clinical

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Agenda

• Key Questions• Overview of ICE/MDI Initiatives• Overview of ICE/MDI Stakeholders• Overview of Regulatory Environment• Key Findings

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Overview of Regulatory Environment

• Operational Regulations• Clinical• Technical• Commercial

• Information Security• Regulatory Compliance• Incentive Programs• Tax & Approval

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Operational Regulatory Environment

ONC2015 Interoperability Standards Advisory

GAO

Draft Shared Interoperability Road

Map (2015)

EHR: Nonfederal Efforts to Help

Achieve Information Interoperability

(2015)

HITECH 2009

ACA 2010 TRUST IT 2015

Impact on ICE/MDI• Standards• Security Protections• Supportive Regulatory Environment

AAP

AHAVendor Impact

Provider Impact

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Agenda

• Key Questions• Overview of ICE/MDI Initiatives• Overview of ICE/MDI Stakeholders• Overview of Regulatory Environment• Key Findings

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Key Findings• Operationalizing the Integrated Clinical Environment (ICE)• Clinical Workflow Optimization• Clinical Simulations & Vendor-Neutral Sandbox Testing• Leveraging Enabling Technologies• Reference Compendium of Medical Device Interface Capabilities & Data

Elements • Building the Environment for Medical Device Interoperability

(MDI)• Develop & Promote Open Standards• Define Safe Regulatory Pathways• Enable Device Integration• Build an Integrated Medical Device Intranet

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Operationalizing the Integrated Clinical Environment (ICE)

• Clinical Workflow Optimization• Clinical Simulations & Vendor-Neutral Sandbox

Testing• Leveraging Enabling Technologies• Reference Compendium of Medical Device

Interface Capabilities & Data Elements

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Building A Bridge for Medical Device Interoperability

Health Delivery

Organizations

(HDOs)Current Environment

Standard Developin

g Organizations (SDOs)

FutureState ofHealth

Delivery

Medical Device

Manufacturers

DeviceIntegrati

on

Safe Regulato

ryPathway

s

ClinicalSimulati

onSandbox

Capabilities

ReferenceCompendi

um

Integrated Clinical

Environment (ICE)Data Logger

“Black Box”Forensic Analysis

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Building an Environment for Medical Device Interoperability (MDI)

• Develop & Promote Open Standards• Define Safe Regulatory

Pathways• Enable HDO Device Integration• Build an Integrated Medical

Device Intranet

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Develop & Promote Open Standards

• Standards Goals for HIT• Interoperability• Portability• Exchangeability

• Types of HIT Standards• Vocabulary & Terminology Standards• Standards for Electronic Data Exchange• Health Record Content & Functional Standards

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Develop & Promote Open Standards• Standards Development for Device Integration• Device-Generated Data• EMR Observational & Procedural Data• Alignment with Local, Regional, & National EMR Initiatives

• Articulation of future clinical states to ensure that proposed technical solutions and standards will yield useful clinical capabilities.• Interoperability among Medical Devices• Interoperability among components of Integrated Medical Device Systems• Interoperability among Medical Devices & EHRs• Interoperability among Medical Devices & Hospital IT/Clinical Information

Systems• Interoperability among Personal Medical Devices & Telehealth Data Hubs

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Define Safe Regulatory Pathways• Define Safe Regulatory Pathways for

Patient-Centric Networked Medical Devices• FDA Draft Guidance & Interoperability Work

Groups• Example: Medical Device Interoperability

Coordination Council (MDICC) Clinical Needs & Clinical Landscape Team (2010)

• Example: Guidance Document to Assist Industry in Conducting Appropriate Human Factors Testing & Identifying Device Feature Optimization Through Total Product Life Cycle (2011)

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Enable HDO Device Integration

• Developing an HIT Safety Administration (HITSA)• Developing Medical Device Interface Data

Sheets (MDIDS)• Developing Open ICE Data Logger System• Forensic Analysis of Safety-Critical Systems• ICE Black Boxes

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Build an Integrated Medical Device Intranet

• The creation of an eco-system for interoperability of medical device and clinical information systems to support innovation in patient safety and healthcare quality with an Open ICE Platform.• Interoperability of devices and IT systems

in clinical environments will permit:• Mixed-Vendor Data Transfers• Comprehensive Secure Data Acquisition• Safety-Enhancing Capabilities• Safety Interlocks• Closed-Loop Device Control

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What Can ICE Platforms Deliver?

• ICE Platforms Can Enable Revolutionary Improvements• Patient Safety• Rich Clinical Data Availability• Innovation through Interoperable Apps,

Sensors, & Actuators • Operations & Logistics• Cybersecurity of Medical Devices & HIT

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What Can MDI Deliver?

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Questions?Contact: Brandon LockEmail: bjl64@georgetown.edu