CLSI AUTO9 A : 1ED 2006
Withdrawn
REMOTE ACCESS TO CLINICAL LABORATORY DIAGNOSTIC DEVICES VIA THE INTERNET
01-12-2013
03-28-2016
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Withdrawn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 |