© 2013 UL LLC All rights reserved. May not be copied or distributed without permission
Tackling Interoperability
What ´s b...
2
Digital System / PnP System of Systems
digitization
integration
INTEGRATION driven future Who integrates the best wins !...
UL and the UL logo are trademarks of UL LLC © 2013
Medical Device engineering is evolving
3Dr. Terenzio Facchinetti
S A F ...
UL and the UL logo are trademarks of UL LLC © 2013
Healthcare is going digital
4
Dr.TerenzioFacchinetti
4
S
A
F
E
T
Y
THE
...
UL and the UL logo are trademarks of UL LLC © 2013
INTEROPERABILITY
• The ability of two or more systems or components to
...
UL and the UL logo are trademarks of UL LLC © 2013
CONTRIBUTING TO SOLUTIONS
6Dr. Terenzio Facchinetti
AAMI-UL 2800
Underw...
UL and the UL logo are trademarks of UL LLC © 2013
PRIORITIES
7Dr. Terenzio Facchinetti
• Need for standardization
• Align...
UL and the UL logo are trademarks of UL LLC © 2013
INTEROPERABILITY focus
• The technology of interoperability
- Architect...
UL and the UL logo are trademarks of UL LLC © 2013
Safety
Finding The Weakest Links & Emerging Properties
AAMI-UL 2800
9Dr...
UL and the UL logo are trademarks of UL LLC © 2013
AAMI-UL 2800 in the “big picture”
10Dr. Terenzio Facchinetti
Clinical
S...
UL and the UL logo are trademarks of UL LLC © 2013
THE CLINICAL ENVIRONMENT
11Dr. Terenzio Facchinetti
ICE Supervisor
Ext....
AAMI/UL 2800
UPFRONT RECOMMENDATIONS
• Focus on SAFETY
• Avoid duplication of efforts
• Recognize Work and Intellectual ef...
UL and the UL logo are trademarks of UL LLC © 2013
BENEFITS of having a MD Interoperability
Safety Standard
13Dr. Terenzio...
THANK YOU
Dr. Terenzio Facchinetti
Underwriters Laboratories
terenzio.facchinetti@ul.com
phone +49 162 262 1912
SAFETY
Fin...
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AAMI Conference presentation - "Tackling Interoperability - What's Being done?"

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Tihs presentation was delivered at the 2013 AAMI Conference in Long Beach, California, USA by Dr. Terenzio Facchinetti of UL LLC. The subject matter of interoperability for medical devices is a very important subject and has implications for Healthcare Quality, Healthcare Costs Containmnet and Sustaining the Healthcare industry.

UL is working with AAMI to develop a series of standards that address interoperability of medical devices.

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

  1. 1. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission 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. 2. 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 TerenzioFacchinetti:adaptedfromShahidN.Shah Stand Alone MD UL and the UL logo are trademarks of UL LLC © 2013
  3. 3. UL and the UL logo are trademarks of UL LLC © 2013 Medical Device engineering is evolving 3Dr. Terenzio Facchinetti S A F E T Y
  4. 4. UL and the UL logo are trademarks of UL LLC © 2013 Healthcare is going digital 4 Dr.TerenzioFacchinetti 4 S A F E T Y THE TOMORROW HEALTHCARE S E C U R I T Y R E G U L A T O R Y Improvement of HC Quality – HC Costs Containement – Sustaining HC Industry
  5. 5. UL and the UL logo are trademarks of UL LLC © 2013 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) 5 Dr.TerenzioFacchinetti
  6. 6. UL and the UL logo are trademarks of UL LLC © 2013 CONTRIBUTING TO SOLUTIONS 6Dr. Terenzio Facchinetti AAMI-UL 2800 Underwriters Laboratories Copyrights
  7. 7. UL and the UL logo are trademarks of UL LLC © 2013 PRIORITIES 7Dr. Terenzio Facchinetti • 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
  8. 8. UL and the UL logo are trademarks of UL LLC © 2013 INTEROPERABILITY focus • The technology of interoperability - Architecture, Interfaces & Infrastructure - Interoperability technical specification and communication standards • Safety & safety standards for interoperable scenarios • Security and Privacy 8Dr. Terenzio Facchinetti 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
  9. 9. UL and the UL logo are trademarks of UL LLC © 2013 Safety Finding The Weakest Links & Emerging Properties AAMI-UL 2800 9Dr. Terenzio Facchinetti SAFETY: freedom from unacceptable risk [ISO 14971: 2007] SYSTEMCollection of parts behaviour Safety System Approach Underwriters Laboratories Copyrights
  10. 10. UL and the UL logo are trademarks of UL LLC © 2013 AAMI-UL 2800 in the “big picture” 10Dr. Terenzio Facchinetti Clinical Scenario Interoperable Scenario System Safety / Interoperability Connectivity / Interoperability (HL7, IEEE. Continua, etc…) Enabling Technologies (Wi-Fi, Bluetooth, Zigbee, Ethernet, etc…) AAMI-UL 2800
  11. 11. UL and the UL logo are trademarks of UL LLC © 2013 THE CLINICAL ENVIRONMENT 11Dr. Terenzio Facchinetti ICE Supervisor Ext. Interface NC Network Controller Data Logger Interface MD Interface MD APP APP APP INTERFACE Adaptation from ASTM 2761-09
  12. 12. 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 UL and the UL logo are trademarks of UL LLC © 2013
  13. 13. UL and the UL logo are trademarks of UL LLC © 2013 BENEFITS of having a MD Interoperability Safety Standard 13Dr. Terenzio Facchinetti 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
  14. 14. THANK YOU Dr. Terenzio Facchinetti Underwriters Laboratories terenzio.facchinetti@ul.com phone +49 162 262 1912 SAFETY Finding The Weakest Link & Emerging Properties AAMI / UL 2800 UL and the UL logo are trademarks of UL LLC © 2013

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