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RATIONALE AND ARCHITECTURE

PRINCIPLES FOR MEDICAL

APPLICATION PLATFORMS (MAPS)

An Architectural Approach to the Design and Analysis MAPs for Cyber-

Physical Systems

John Hatcliff Andrew King, Insup Lee Alasdair MacDonald Anura Fernando

Kansas State University University of Pennsylvania eHealth Technology UL (Underwriters Laboratories)

Michael Robkin Eugene Vasserman Sandy Weininger Julian M. Goldman

Anakena Solutions Kansas State University US Food and Drug Administration Massachusetts General Hospital

CIMIT MD PnP Program

Presented by Amara Naas

E&CS department, odu

PRESENTATION OUTLINE

• INTRODUCTION

• MEDICAL APPLICATION PLATFORMS (MAPs)

• MAPs CHARACTERISTICS

• SOLUTION GOALS

• INTEGRATED CLINICAL ENVIRONMENT (ICE)

• OPEN-SOURCE PROJECT MDCF

• CONCLUSION

INTRODUCTION

Problems, Solutions, Goal, Motivation

Information Integration in Other Domains

The Need for Solutions

The Obstacles to Progress

INTRODUCTION 1

Even though many medical devices have some kind of

connectivity but still considered as stand-alone units or

system because they have been developed on this base.

INTRODUCTION 1

Problem:

The problem is that medical devices are

functioning as stand-alone units or system

which uses unidirectional flow of data

technique in predetermined manner.

devices are not context aware, they often generate

false alarms.

The algorithms and capabilities of medical devices

that vertically integrated by a single manufacturer

are difficult to update.

INTRODUCTION 1

Solutions:

“smart alarms” are needed which integrate physiological

data from multiple devices and use context awareness to

overcome false alarms.

“technology refresh” but is more difficult and costly

INTRODUCTION 1

Goal

A new medical application platform (MAP) is needed to

provide health information systems (HIS) interoperability,

safety critical network middle-ware, and an execution

environment for clinical applications

INTRODUCTION 1

Motivation

MAPs will offer numerous advantages for

safety and effectiveness in health care delivery

and enabling faster, cheaper, and more

reliable construction of systems. Also setting

up a new vision of integrated medical systems

for Syber Physical System.

INTRODUCTION 2

• Information Integration in Other Domains:

Information integration in other domain such as mobile

communication sys. are developed by following three trends:

INTRODUCTION 2




• Device Interoperability:

INTRODUCTION 2





• Platform Approach:

INTRODUCTION 2





• Platform Approach:

• Embracing a “Systems Perspective”:

INTRODUCTION 3

• The Need for Solutions

Increasing in population raises the healthcare demand and that needs more exchangeable healthcare information.

Reducing the clinicians’ mistakes

Collection of clinical data and tracking of clinical workflows needed for medicine quality enhancements and cost reductions.

Providing the IT infrastructure to integrate devices and information systems and automatically coordinate their actions would led to the notion of MAP desired as “system of systems”

INTRODUCTION 4

• The Obstacles to Progress

Designing and deploying a system of system such

as medical application platform that supports

interoperability and interconnection between

devices of different types and from different

manufacturers in a safe way will face many

obstacles that impeding the progress such as:

INTRODUCTION 4 THE OBSTACLES TO PROGRESS

• Lack of Appropriate Interoperability

Standards:

While there are activities on creating standards

and organizations for health information exchange

such as (HL7 , DICOM , IHE) but there Problem

with these standards:

• Do not address the technical requirements for device

connectivity, safety, and security needed for systems

Engineering.

• IEEE 11073 (Point of Care, POC), or (Personal Health

Devices, PHD) does not support needed real-time, safety,

security, and device control capabilities.


Lack of Appropriate Architectures: Proposed Medical device architectures must facilitate development of component and support building systems with real-time constraints such as

- (Avionics) - networked computing modules , common interfaces ,

and principles of portability across an assembly of common hardware modules.

- The Multiple Independent Levels of Security (MILS) architecture

- define common infrastructure components (including separation Kernel)


Lack of Appropriate Architectures: The goals of such architectures is to facilitate the growth of commodity markets of verified/certified system components, which will in turn enable faster, cheaper, and more reliable construction of systems.


Lack of a Regulatory Pathway:

Most of analogous agencies group their activities as

complete system such as FDA. No pathway now for

obtaining regulatory approval for individual system

components.

“Components-wise” instead of “pair-wise” regulation.


Lack of an Ecosystem:

Medical device ecosystem should provide Well-designed interfaces for common medical devices and

health IT systems

Third-party certification organization that work to ensure trust between system components

Education materials.

Variety of stakeholders including device manufacturers, device integrators, standards organizations, certification organizations, health care delivery organizations, and regulatory authorities share the responsibilities to design the MAP Ecosystem

MEDICAL APPLICATION PLATFORMS (MAPS)

New vision of (MAPs) will overcome all above problems. A MAP is a safety- and security- critical real-time computing platform for: integrating varieties of medical IT systems, devices,

and communication infrastructure for displaying medical related information.

hosting application programs provides information acquisition and updating and device controlling with respect to the patient care system perspective.

Medical Utilities of MAP

Examples of Medical Applications

The clinician’s view of a clinical-based MAP

MEDICAL APPLICATION PLATFORMS (MAPs)


MEDICAL UTILITIES OF MAP

Medical Display and Storage: App can transfer data from one or more devices to patient’s

electronic medical record or displaying gathered data in the room.

Remotely clinical displaying at a nurses station, or a physician’s

smart phone. MAP maintain both Medical Data Display Systems

(MDDS) and real-time alarm management systems as Philips

Emergin system

.



Derived/Smart Alarms: App may implement derived alarms and smart alarm by using more

advanced logic. The decisions of these alarms about a problematic

physiological conditions are based on sophisticated Analysis

including physiological parameters from multiple devices,

monitoring trends/history, and comparison and correlation with data

patterns from broader population.



Clinical decision support:

An app may acquire information from any element in the system to

support clinician decision making, diagnoses, or

guidance/suggestions for treatment.



Safety interlocks:

An app may control one or more devices. E.g lock out potentially

unsafe individual device behaviors or interactions between devices.



Workflow automation:

An app may automatically activating/deactivating devices or setting

device parameters based on a patient’s medical record or other

resources.

Closed-loop control:

An app may use information collected from sensing devices and

possibly a patient’s medical record to control actuators on devices

providing treatment or collecting diagnostic information from

patients.

MEDICAL APPLICATION PLATFORMS (MAPs) Medical Utilities of MAP


EXAMPLES OF MEDICAL APPLICATIONS

CARDIO-PULMONARY BYPASS

- Anesthesiologist forgot to

resume ventilation after

separation

- Alarms from the pulse

oximeter and capnograph

disabled during bypass

- Either the anesthesia machine

or the cardiopulmonary bypass

machine must be connected to

the patient.

Therefore medical device

coordination framework must

be used with a connected

anesthesia machine and bypass

machine to detect this invariant

violation and to raise an

appropriate alarm



Laser Surgery Safety Interlock (trachea cancer)

The potential system error can be reduced by coordination

of the laser and ventilator system. safety interlock and

alarm may used to disable the laser if the oxygen

saturation is greater than a configured level (e.g. 25%) and

an alert is raised if the oxygen level exceeds the maximum

level while laser in use.



X-ray / ventilator Coordination: Doctors must manually turn off the ventilator for a few

seconds while they acquire the X-ray image during surgery.

Accident always happened and patient may die because of

simple accident but these risks can be minimized by

automatically coordinating the actions of the X-ray imaging

device and the ventilator.


THE CLINICIAN’S VIEW OF A CLINICAL-BASED MAP

Figure 1 illustrates the clinician’s view of a clinical-based MAP.

MAPS CHARACTERISTICS MAP systems have different characteristics from

traditional medical devices and from other cyber-physical

systems.

MAPS CHARACTERISTICS Cyber-physical Systems of Systems:

MAP systems are complex systems composed of smaller

systems that are designed, in most cases, to function stand-

alone.

MAPS CHARACTERISTICS Interoperability with Heterogeneous Components:

Individual manufactures pursue interoperability as a business

strategy and to follow device design and interface specification

strategies that facilitate interoperability

MAPS CHARACTERISTICS System Instances are Variable:

an app A running at hospital H1 may utilize one model (a pulse

oximeter from manufacturer M1) for one of its required devices

whereas the same app running at hospital H2 may utilize a different

model (a pulse oximeter from manufacturer M2).

same safety and effectiveness requirements must be satisfied by both

devices of M1 and M2

MAPS CHARACTERISTICS Integration at Runtime After Deployment:

system integrator (clinical engineers or even clinicians) has no full

knowledge of devices to be attached to communication infrastructure

and launching apps that dynamically bind to devices with which they

may have never been tested.

MAPS CHARACTERISTICS Open and Extensible:

No need for knowing Elements or devices in advance where the

infrastructure components can support new apps and devices that

were not known at the time of infrastructure development

MAPs will require adoption of appropriate architecture to avoid the

need of new regulatory clearances.

MAPS CHARACTERISTICS Safety Critical:

MAP systems are safety-critical. Therefore support of various safety regimes are needed such as fail safe, fail operational etc.

Security Critical: If the "open system" is vulnerable to attack then safe

operation is impossible and privacy requirements like HIPAA is necessary for MAPs.

Also the nature of medical operation environment where different clinicians have different roles/permissions and the need to override access controls in emergencies making the development of such a system more complicated and challengeable.

MAPS CHARACTERISTICS Component-Wise Regulation:

A component-wise regulatory paradigm is that a MAP system as a

whole and the app and devices used in it must be regulatory

reviewed and certified separately.

SOLUTION GOALS In order to satisfy the demands such that of the architecture,

platform, Safety, and ecosystem, a complete solution must be

sufficiently constrained and fulfill some of the following

goals/requirements:

SOLUTION GOALS Architecture and Interfacing Goals:

For long-term success and integrity of a project, the

Architecture of MAP should consider the following:

Interoperability Architecture.

Interoperability Points.

Interface Compliance/Compatibility.

Rich Device Interface Language.

SOLUTION GOALS

Platform Goals

In addition to the implementation of a good

interoperable architecture MAP must provide

necessary capabilities as follows so that safe operation

of the system can be achieved.

Direct Support for Static/dynamic Verification of Systems.

Compossibility & Flexibility.

Global Resource Management.

Automatic Trust Establishment.

Automatic Security Services.

SOLUTION GOALS

Safety, Effectiveness and Certification Goals:

Interoperability Demonstration for Component-Wise

Regulation

Third-Party Certification Regime

INTEGRATED CLINICAL

ENVIRONMENT (ICE)

(ICE) development has been led by the CIMIT Medical Device

Plug-and-Play interoperability project and standardized in the

ASTM F2761-2009 standard.

INTEGRATED CLINICAL

ENVIRONMENT (ICE)

MEDICAL DEVICE COORDINATION

FRAMEWORK (MDCF)

MEDICAL DEVICE COORDINATION FRAMEWORK

(MDCF)

CONCLUSION

The concept of a medical application platform have

presented in terms of achieving the cyber-physical

system domain related to application of medical

systems. Also some of the main characteristics of

MAPs and its goals were discussed in order to

develope successful MAP's architecture. Two MPA

framework ICE and MDCF were presented.

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