about IT-driven legal issues and compliance

It is becoming increasingly clear that as a university, that in addition to our pursuit of excellence in learning, research and patient care, we are also becoming compliance driven. So much so that I believe we can no longer enjoy the position that someone else is taking care of this. A couple of years ago, I wrote an editorial discussing the need to bring together the financial and patient care aspects of a patient's hospital record, in order to better address compliance within the health-care setting. Mostly the paper's point has been ignored, but the principles upon which it was derived are fact. Here, I have brought together some links to help me, and others locate resources dealing with a number of compliance-driven issues.

Federal Law, Regulations and Court Decisions

Copyright-related Supreme Court Decisions

Peer-2-Peer provider liability

Copyright Related Links

Trade Secrets and the Public Domain

Publishing the algorithm for playing DVDs has been an interesting case to follow. The motion picture industry limited distribution of the encyption techology to the manufacturers of DVD players and somewhere in the mix - the Linux community was without a tool to play a DVD they had purchased. The decision below is interesting in that it clearly articulates the nature of a Trade Secret and information that becomes available in the public domain. Both the positive aspect of Internet communication (makes access to information avaiable to just about everyone) and the negative aspect (tough to keep a secret) are articulated. A good read.

Here are the PDF files for the recently released (28 Dec 2000) Standards for Privacy of Individually Identifiable Health Information

Social Security Administrations Regulations

Searching the Social Security Administration Sites:

Here are the August 2000 Federal Registry notes for Health Insurance Reform - Standards for Electronic Transactions; Announcement of Designated Standard Maintenance Organizations.

Here are the HIPAA regulations in nice 50 page bite-size chunks

Here are the final (Feb 22, 2003) regulations for parts of HIPAA

Here is the February 2000 Rederal Registry notes for the Family Educational Rights and Privacy Act

FDA Regulations

Here are the Fed Register reports of regulations related to IRBs, Human Subject studies, Electronic Records, GLP etc.

Here are the FDA regulations about e-signatures and a tutorial

Here is a link to the Amer. Bar. Assoc tutorial on electronic signatures: http://www.abanet.org/scitech/ec/isc/dsg-tutorial.html

Misc FDA Regulations

Here is the Section 508 stuff dealing with web page accessibility - priimarily as it relates to the Disabilities Act

  • Add an < alt="describe the image"> tag Section 508 enabling disabled folks to harvest information from your web site.