Originally Published MX January/February 2005

IT IN HEALTHCARE

If a coalition of regulated industry associations has its way, FDA's regulation on electronic records and signatures may soon be a thing of the past.

In September of last year, a group calling itself the Industry Coalition on 21 CFR Part 11 submitted a citizen petition to FDA requesting that the agency "revoke 21 CFR Part 11 in its entirety, and pursue implementation of electronic record and signature systems through the application of Government Paperwork Elimination Act (GPEA) standards and the enforcement of predicate rules."

In its petition, the coalition argues that "the prescriptive approach adopted in Part 11 has failed to adapt to changing technologies and has placed an unnecessary burden on regulated entities."