AAMI Conference presentation - "Tackling Interoperability - What's Being done?"

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Tackling Interoperability

What ´s being done? Efforts, Working together, Impact

AAMI Conference 1-2 June , 2013

Long Beach - CA - USA

Dr. Terenzio Facchinetti

Underwriters Laboratories

2

Digital System / PnP System of Systems

digitization

integration

INTEGRATION driven future Who integrates the best wins !

I N T E R O P E R A B I L I T Y

Improvement of HC Quality – HC Costs Containement – Sustaining HC Industry

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Stand Alone MD

UL and the UL logo are trademarks of UL LLC © 2013


Medical Device engineering is evolving

3 Dr. Terenzio Facchinetti

S A F E T Y


Healthcare is going digital

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S

A

F

E

T

Y

THE

TOMORROW HEALTHCARE

S

E

C

U

R

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T

Y

R E G U L A T O R Y

Improvement of HC Quality – HC Costs Containement – Sustaining HC Industry


INTEROPERABILITY

• The ability of two or more systems or components to

exchange information and to use the information that has

been exchanged (IEEE)

• Being able to accomplish end-user applications using

different types of computer systems, operating systems,

and application software, interconnected by different types

of local and wide area networks (O`Brien & Marakas)

• The capability to communicate, execute programs, or

transfer data among various functional units in a manner

that requires the user to have little or no knowledge of the

unique characteristics of those units (ISO/IEC 2382-01)

• Ability of medical devices, clinical systems, or their

components to communicate in order to safely fulfill an

intended purpose (AAMI-HITI)

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CONTRIBUTING TO SOLUTIONS


AAMI-UL 2800

Underwriters Laboratories Copyrights


PRIORITIES


• Need for standardization

• Align incentives, expectations, roles and responsibilities.

• Drive Patient safety with systems approach to design and

implementation

• Focus on human behavior first

• Improve regulatory clarity

• Streamline clinical workflow to improve return on investment

• Remove barriers with shared continuous learning


INTEROPERABILITY focus

• The technology of interoperability

- Architecture, Interfaces & Infrastructure

- Interoperability technical specification and communication standards

• Safety & safety standards for interoperable scenarios

• Security and Privacy


Level INTEROPERABILITY

0 No Interoperability

1 Technical Interoperability

2 Syntactic Interoperability

3 Semantic Interoperability

4 Pragmatic Interoperability

5 Dynamic Interoperability

6 Conceptual Interoperability

*Turnitsa 2005


Safety Finding The Weakest Links & Emerging Properties

AAMI-UL 2800


SAFETY: freedom from unacceptable risk [ISO 14971: 2007]

SYSTEM

Collection

of parts

behaviour

Safety System Approach

Underwriters Laboratories Copyrights


AAMI-UL 2800 in the “big picture”


Clinical Scenario

Interoperable Scenario

System Safety / Interoperability

Connectivity / Interoperability (HL7, IEEE.

Continua, etc…)

Enabling Technologies (Wi-Fi, Bluetooth, Zigbee, Ethernet,

etc…)

AAMI-UL 2800


THE CLINICAL ENVIRONMENT


ICE Supervisor

Ext.

Interface

NC

Network Controller

Data

Logger

Interface

MD

Interface

MD

APP APP APP

INTERFACE

Adaptation from ASTM 2761-09

AAMI/UL 2800 UPFRONT RECOMMENDATIONS

• Focus on SAFETY

• Avoid duplication of efforts

• Recognize Work and Intellectual efforts

a. Make use of case studies & devices

b. On-going federally funded projects

• Provide Quality of work: „Useful & Usable“

Focus

Trust

Cooperation



BENEFITS of having a MD Interoperability

Safety Standard


MANUFACTURERS

•Safety Std of reference

•Mitigate R&D investments

•Reference for regulatory

•Overall risks mitigation

•Exclude unfair market entry of „cheap but unsafe“ producs

REGULATORY

•Reference of criteria and rules for MD safety review

•Reference and guidance for manufacturers

•Support for product clearance submissions

•Reference for Users and HC providers

PATIENTS, HC PROVIDERS, INSURANCE, MARKET

•Assurance of safety

•Reference for procurement

•Support in selection of quality products

•Risks mitigation

Trust

Security

Safety

THANK YOU

Dr. Terenzio Facchinetti

Underwriters Laboratories

[email protected]

phone +49 162 262 1912

SAFETY Finding The Weakest Link & Emerging Properties

AAMI / UL 2800


mailto:[email protected]

AAMI Conference presentation - "Tackling Interoperability - What's Being done?"

Health & Medicine

Transcript of AAMI Conference presentation - "Tackling Interoperability - What's Being done?"