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November 2007
Reflection Paper on Expectations for Electronic Source Documents Used in Clinical Trials (EMEA GCP Inspectors Working Group).






May 2007
Guidance for Industry: Computerized Systems Used in Clinical Investigations.






undated
Risk-Based Approach to 21 CFR Part 11.






May 2005
Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.






November 2006
Leveraging the CDISC Standards to Facilitate the use of Electronic Source within Clinical Trials (Final).






September 2005
Leveraging the CDISC Standards to Facilitate the use of Electronic Source within Clinical Trials (Draft).






August 2003
Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope and Application.






February 2003
Draft Guidance for Industry on 'Part 11, Electronic Records, Electronic Signatures - Scope and Application.






January 2002
General Principles of Software Validation; Final Guidance for Industry and FDA Staff.






November 2000
Legal Considerations in Designing and Implementing Electronic Processes: A Guide for Federal Agencies.






October 2000
Records Management Guidance for Agencies Implementing Electronic Signature Technologies.






September 1999
Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software use in Medical Devices.






April 1999
Guidance for Industry: Computerized Systems Used in Clinical Trials.






March 1997
Electronic Records; Electronic Signatures; Final Rule.







3 March 2010
A study just published examines the leaks of PHI from peer-to-peer file sharing program users in the US and Canada, and compares that to leaks of financial information. The article also examines the ethical issues in collecting personal information from the Internet without consent, and what the considerations should be.




12 February 2010
A new article in Healthcare Information Management and Communications describes the privacy risks to patients from inadvertant and deliberate disclosure of health information. Because the frequency and magnitude of these disclosures is expected to increase, the articles calls for more meaningful patient engagement in developing rules on the collection, use, and dislcosure of health information and the incorporation of the principles of Privacy by Design in the development of new systems.




11 January 2010
In conjunction with the Canadian AI Conference, we are organizing a workshop focusing on the theory, development, and application of intelligent methods for protecting the privacy of personal information when disclosed for secondary purposes. This will be held on May 30th 2010 in Ottawa.




4 December 2009
The presentation slides from the 2009 Electronic Health Information and Privacy conference are now available. This year's theme was the privacy of genetic information, with additional coverage of public health issues.



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This page last modified on:
Wed Mar 3 2010