1. Author : Elliot B. Sloane, Ph.D. (ebsloane@ieee.org) American College of Clinical Engineering, President 2000-2001 Villanova University Department of Decision and Information Technologies; Villanova, PA 2005/09/29 Vision, Mission, and Scope: The Patient Care Device (PCD) Domain’s role in healthcare, and within the overall Integrating the Healthcare Enterprise (IHE) program. IHE-PCD

2. American College of Clinical Engineering, Author: Elliot B. Sloane, Ph.D. 2005/09/29 2 IHE-PCD The General IHE Vision: Integrating the Healthcare Enterprise “Providers and vendors working together to deliver interoperable health information systems within and between enterprises and settings”

3. American College of Clinical Engineering, Author: Elliot B. Sloane, Ph.D. 2005/09/29 3 IHE-PCD IHE-PCD Domain Vision Statement - Proposed The IHE Patient Care Devices Domain (IHE PCD) is the nexus for vendors and providers to jointly define and demonstrate unambiguous interoperability specifications, called profiles, which are based on industry standards and which can be brought to market. IHE-PCD profiles: 1. improve patient safety and clinical efficacy, 2. reduce healthcare delivery cost by improving efficiency, reliability, and operational flexibility for healthcare providers, 3. enable innovative patient care capabilities, and 4. expand the international marketplace for patient care device vendors.

4. American College of Clinical Engineering, Author: Elliot B. Sloane, Ph.D. 2005/09/29 4 IHE-PCD IHE-PCD Mission The IHE Patient Care Devices Domain will apply the proven, Use Case driven IHE processes to: 1.Deliver the technical framework for the IHE-PCD domain profiles; 2.Demonstrate IHE-PCD profile implementations via Connectathons; and 3.Publicly demonstrate marketable solutions at Association trade shows.

5. American College of Clinical Engineering, Author: Elliot B. Sloane, Ph.D. 2005/09/29 5 IHE-PCD ISSUES from 29/30 Sept 2005 Meeting Classification scheme may be needed for deployment? –Different verticals may not warrant full IHE interoperability Liaison with other Domains profiles, and integration across verticals (e.g., hemodynamics monitoring) Concerned about defining “interoperability” Scope statement should not dictate standards

6. American College of Clinical Engineering, Author: Elliot B. Sloane, Ph.D. 2005/09/29 6 IHE-PCD IHE-PCD Scope - Original The Patient Care Devices Domain is concerned with regulated patient care devices which do not fall within one of the other IHE clinical specialty based domains such as medical imaging.

7. American College of Clinical Engineering, Author: Elliot B. Sloane, Ph.D. 2005/09/29 7 IHE-PCD Patient Care Devices are unique, e.g., 1.There are many potential clinical verticals within the PCD domain, such as anesthesia, vital signs, dialysis, perioperative, intensive care, and emergency medicine. 2.Within the PCD domain there are equipment types that are used in different contexts, filling roles in one context that may differ from another context. 3.In the arena of interoperability, which cannot be separated from the IHE requirements for connectivity, many of the signals and information from the devices – such as life-critical alarms -- have direct significance to patient safety and well being in real-time, and should be accorded appropriate priority in the system. 4.These signals become part of the information stream that feeds the emerging Electronic Health Record (EHR). 5.Since many of the devices are portable, means of connectivity will of necessity include wireless portions, direct network connections, and Internet links, all with “hacker and virus” risks, too. 6.Device management and maintenance data must be considered, including the fact that device configurations can rapidly change.

8. American College of Clinical Engineering, Author: Elliot B. Sloane, Ph.D. 2005/09/29 8 IHE-PCD IHE-PCD Scope - Revisited The Patient Care Devices Domain is concerned with Use Cases in which at least one actor is a regulated patient care device (or is embedded within another device or Domain?) which does not fall within one of the other IHE clinical specialty based domains such as medical imaging.

9. American College of Clinical Engineering, Author: Elliot B. Sloane, Ph.D. 2005/09/29 9 IHE-PCD Thank You! Questions – Comments? Elliot B. Sloane, Ph.D. ebsloane@ieee.orgebsloane@ieee.org www.homepage.villanova.edu/elliot.sloane www.ACCEnet.org American College of Clinical Engineering (ACCE) Villanova University ACCE President, 2000-2001 HIMSS Strategic Planning Committee IEEE EMBS Board of Directors