CLSI AUTO9 A : 1ED 2006
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
REMOTE ACCESS TO CLINICAL LABORATORY DIAGNOSTIC DEVICES VIA THE INTERNET
28-03-2016
12-01-2013
Abstract
Committee Membership
Foreword
1 Scope
2 Definitions
3 Information Security
3.1 Encryption
3.2 Access Control
3.3 Audit Trail
3.4 Technology Considerations
4 Patient Privacy
4.1 HIPAA (Health Insurance Portability and Accountability
Act of 1996) (U.S. Regulations)
4.2 European Union Privacy Directive 95/46/EC
4.3 Asian Regulation
4.4 Canadian Regulation
5 Protocol for Remote Service
6 Patient Safety
6.1 Electronic Record Integrity
6.2 Operator Safety
7 System Protection/Security
7.1 Healthcare Facility IT Environment - Malicious
Actions (e.g., Virus, Worm) Through Vendor Connection
7.2 Vendor IT Environment
References
Appendix A. Device Operating System (OS) Hardening Examples
Appendix B. Protocol Examples
Summary of Delegate/Consensus Comments and Subcommittee
Responses
The Quality System Approach
Related CLSI/NCCLS Publications
Gives a standard communication protocol for instrument system vendors, device manufacturers, and hospital administrators to allow remote connections to laboratory diagnostic devices.
| DevelopmentNote |
Supersedes NCCLS AUTO9 P. (05/2006)
|
| DocumentType |
Miscellaneous Product
|
| PublisherName |
Clinical Laboratory Standards Institute
|
| Status |
Withdrawn
|
| Supersedes |
| CLSI AUTO11 A : 1ED 2006 | IT SECURITY OF IN VITRO DIAGNOSTIC INSTRUMENTS AND SOFTWARE SYSTEMS |
| CLSI AUTO11 A2 : 2ED 2014 | INFORMATION TECHNOLOGY SECURITY OF IN VITRO DIAGNOSTIC INSTRUMENTS AND SOFTWARE SYSTEMS |
| CLSI AUTO13 A2 : 2ED 2003 | LABORATORY INSTRUMENTS AND DATA MANAGEMENT SYSTEMS: DESIGN OF SOFTWARE USER INTERFACES AND END-USER SOFTWARE SYSTEMS VALIDATION, OPERATION, AND MONITORING |
| CLSI LIS5 A : 1ED 2003 | SPECIFICATION FOR TRANSFERRING CLINICAL OBSERVATIONS BETWEEN INDEPENDENT COMPUTER SYSTEMS |
| CLSI LIS9 A : 1ED 2003 | GUIDE FOR COORDINATION OF CLINICAL LABORATORY SERVICES WITHIN THE ELECTRONIC HEALTH RECORD ENVIRONMENT AND NETWORKED ARCHITECTURES |
| CLSI AUTO3 A : 1ED 2000 | LABORATORY AUTOMATION: COMMUNICATIONS WITH AUTOMATED CLINICAL LABORATORY SYSTEMS, INSTRUMENTS, DEVICES, AND INFORMATION SYSTEMS |
| CLSI LIS1 A : 1ED 2003 | SPECIFICATION FOR LOW-LEVEL PROTOCOL TO TRANSFER MESSAGES BETWEEN CLINICAL LABORATORY INSTRUMENTS AND COMPUTER SYSTEMS |
| CLSI LIS2 A2 : 2ED 2004 | SPECIFICATION FOR TRANSFERRING INFORMATION BETWEEN CLINICAL INSTRUMENTS AND COMPUTER SYSTEMS |
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