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2.1.1.2.6 Patient Privacy

The issues of clinical data protection (HIPAA, etc.) were recognized in the first proposal to be a major challenge. The important change over this phase is the introduction of the Analytical Cytometry Standard (ACS) archive format as a proposed standard format for the security container of the test/experiment. This supports a plug-in security model much like the one described below. The analysis engine doesn't need to know about the security procedure. It assumes the ACS container has been authenticated, as have all the contents therein.

FlowDx will use the signature and cryptographic services of data security leader PGP Corporation[4] to implement 21 CFR Part 11 security requirements. PGP's so-called "weak link" license allows FlowDx to make JAVA calls to security services, including electronic signature and dynamic data security using public/private key encryption. These services reside outside the FlowDx software itself, performing custom encryption and authentication functions on demand and at user-specified points in the workflow.

Because user infrastructure will vary widely, FlowDx can be customized to provide security overall, as in the diagram below. Alternatively, individual security elements missing from the user's workflow can be activated independently.

This workflow is automated up to the opening of a flagged ACS for manual inspection and analysis in FlowJo (lower right of figure). Each transition of data from place to place can be encrypted, and each inspection of the process can require an electronic signature. All reports are protected from being overwritten. Dates and incremental file names provide an audit trail through the history of each cytometry run and subsequent analysis. At the user's option, data can be de-identified before entering into the Archive Utility, or as a function of the Archive Utility.

ACS stands for Analytical Cytometry Standard; it is a data/format standard proposed by the Flow Informatics and Computational Cytometry Society [10]. In this implementation, it comprises:

  1. The data files produced by the cytometer
  2. An otherwise empty FlowJo workspace that will read in the contents of the files when opened
  3. A text listing of the contents of the ACS container (the Manifest)
  4. A checksum calculation that uniquely identifies the archive and flags changes