Website Index


Home

Directory of 1,000 Healthcare Recruiters  physician recruiters

Health Administration Toolbox 

Calendar of Health Observance Dates

Recommended Reading Lists & Bookstore New!

Job Search Resources  

Career & Interview Resources 

Glossary of Managed Care Terms 

Health Care Companies & Hospitals 

Health & Medical Associations 

Tools for Physician Executives 

Tools for Finance Directors 

Tools for Nursing Managers 

Tools for Personnel Managers 

Tools for Traveling Executives 

Search this Site


About Us

About Pam Pohly Associates

Info for Healthcare Employers 

Info for Job Hunters

Jobs to Apply for  

Our Hot Jobs 

Pam Pohly's Background

Contact Us





 

To search this site, click here

Copyright©, Pam Pohly, All Rights Reserved.  

Return Home

 

You are here > Home > Reading Lists > Information Systems, Medical Records  & Technology Books > Electronic Record Keeping: Achieving & Maintaining Compliance with 21 CFR Part 11 & 45 CFR Parts 160, 162 & 164

Electronic Record Keeping: Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164
David Nettleton, Janet Gough

Hardcover, 384 pages
ISBN 0849321646
Taylor & Francis
January 2004
(click below for the very best currently available price for this important resource)

 

This book is relevant and important. Compliance may be mandatory, but it also makes good business sense. Companies that are compliant will always be poised to move forward. They will also avoid the grief that comes from poor or faulty record keeping and documentation. 

This book gives you the tools you need to keep your organization both compliant and competitive.

The current fast-paced evolution in healthcare information management, and the new regulations that have evolved to address it, have increasingly caused companies to turn to off-the-shelf software for electronic record keeping. Data captured in computerized systems must be as reliable, if not more so, than data on paper. This book provides guidance for selecting, purchasing, installing, validating, and managing commercial off-the-shelf software for data collection and retention.

Covering the recently passed 45 CFR, and the parallel CFR 21 Part 11 and HIPAA regulations 160, 162, and 164, Electronic Record Keeping: Achieving Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 explores how to evaluate, select, implement, and document an e-system that will keep your organization in compliance.

It takes a number of years for industry standards for a new regulation to develop from dialog between companies and the regulating agency. These standards are in place for Part 11, which was passed into law in 1997. The authors review what the regulations mean in terms of industry standards, explain the audit function for facilities that are subject to the newer HIPAA regulations, and present the standards for documentation. Addressing the interface between these regulations and how to be in compliance with them, the book fully covers:

  • audit trails
  • validation
  • documentation
  • training, and
  • how to establish and maintain security and accountability. 

Healthcare providers who must implement electronic record keeping can learn how to best do it by understanding the parallel between the new HIPAA regulations and the industry standards for Part 11. Further, certain FDA-driven activities, such as patient record keeping in clinical trials, now must comply with the new HIPAA regs as well.   

Table of Contents:

Ch. 1 Electronic Record Keeping: The Big Picture 1
Ch. 2 The Regulations: Not Just What They Say, But What They Mean 19
Ch. 3 Going Electronic: What You Need to Know and Do 43
Ch. 4 Documentation and Training 65
Ch. 5 Security, Accountability and Change Management 83
Ch. 6 Auditing Electronic Record Keeping Systems 97
Ch. 7 Moving Forward 113
Ch. 8 Frequently Asked Questions 121
  App. I 139
  App. II 235
  App. III 247
  References 357
  Index 359

(information from the publisher)

You may also be interested in / The Directory of Healthcare Recruiters /

Jump to a List / Health Administration & Leadership / Physician Executive, Medical Staff & Practice Management / Finance, Accounting, Economics, Billing & Reimbursement / Coding for Hospital, Physician & Clinical Services / Law, Malpractice, Ethics, Accreditation & Compliance / Quality Improvement, Outcomes & Customer Service / Risk Management, Security, Error Reduction & Patient Safety / Information Systems, Technology & Medical Records / Clinical Management & Executive Nursing / Behavioral Health, Social Work & Psychiatry Management / Human Resources, Management & Supervision / Directories, Data, Trends & Benchmarks / Software & CD-ROMs / Gift Ideas & Recommended Gifts / Journals, Magazines & Newsletters / Search for Books / Books Index /

Go to / Home Page / Toolbox for Health Administrators / Bookstore