Paper Covers Rock: In Search of the e-record Model

Abstract

In 1997 the FDA published a set of regulations for the pharmaceutical industry intended to establish controls over the use of computer technology. To briefly re-call this moment in history, the Electronic Records; Electronic Signature (ERES) regulation, 21CFR11 or Part 11, was introduced to provide criteria whereby electronic records (e.g., database information) would be considered ‘equivalent’ to paper records. The underlying motivation was a concern that technology could potentially invalidate the truth claim of an utterance (e.g., ‘this drug is effective’) by ‘scrambling’ the context of the utterance and by potentially falsifying the name (attributability) and the date (auditability). But this regulation was based on a premise, which I will argue, was founded on a metaphysical blind spot derived both from an underestimation of the difficulties inherent in the reconstitution of events (historiography), on the one hand, as well as an overestimation of the nefarious impact of technology, on the other. As a consequence, it is no surprise that the Part 11 narrative fell prey to an onto-theology of the worse kind, and as a consequence never uncovered the true essence of technology.