Name: CLSI AUTO9 A : 1ED 2006
Brand: CLSI

CLSI AUTO9 A : 1ED 2006

Withdrawn

REMOTE ACCESS TO CLINICAL LABORATORY DIAGNOSTIC DEVICES VIA THE INTERNET

Withdrawn date

28-03-2016

Published date

12-01-2013

Publisher

Clinical Laboratory Standards Institute

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Status	Withdrawn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 AUTO9 P : 1ED 2005

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