ASTM e2147 Revised For 2018

EHR Standards Rewritten After Being Withdrawn in 2017

When the Congress under the Clinton administration passed the health information portability and privacy act commonly known and referenced as HIPPA there was a recognition that while healthcare would benefit from the creation of electronic medical records that such a development also posed inherent problems. Electronic records are easily modified, deleted, and viewed without detection. In order to assure the integrity of our electronic medical records regulations were promulgated to address these problems.

in 2001 ASTM wrote the first audit trail standard, which was reviewed and replaced unchanged in 2009 and 2013.

Along the way, this audit trail standard was incorporated by reference into HIPAA, so is the standard to which all software users should have been held – but they weren’t because there was inadequate enforcement.

When HITECH came along, the defense bar convinced judges that only access trails were needed, since HITECH focused largely on security issues. That’s when everyone got attuned to audit trails and were happy to get pretty much anything – even a bad, incomplete access trail. No one seemed to realize that hospitals were still supposed to maintain and produce audit trails per ASTM e2147.

In 2017, 4 people on the ASTM electronic records committee rightly said that 2147 was outdated; then, in my humble opinion, wrongly, ASTM “withdrew” the standard with no replacement and with no committee in place to work on a replacement. The “incorporated by reference” part of the standard was never withdrawn, so even though the standard was “withdrawn” by ASTM, it was still part of federal law.

Defense people took full advantage of this confusion and convinced judges that 2147 was no longer in effect.

Within a couple of weeks of the withdrawal of 2147, we started working to revise it. It took a while for ASTM to put up our working status on their website, so defense people continued telling judges that 2147 was dead and gone.

Nursine Jackson and I rewrote the standard then Steve Barnes, Jenn Keel, Roger Leslie, and Jon Lomurro edited our work and made it better. We submitted our work product to ASTM, then additional listmates joined the ASTM electronic medical records committee and pushed our standard through. Our colleagues, Kimberly Kirkland, Steve Lane, Mike Foley, Laura Ozak, Aline Jordan, Jennifer Matyac, Sidney Royer, and David Damick’s [I sure hope I didn’t overlook anyone] joined the ASTM committee and were instrumental in getting this standard passed. We had a total of 48 members on the ASTM committee, including representatives from the software industry, from US academia, but interestingly, also from Singapore and from Rwanda and more places who barely have electricity, let alone opportunity to use electronic records. We had 75% return on the ballots and no negative votes!!!

The next step is to get this new standard incorporated by reference into federal law. The director of ASTM feels that this phase of the process is going to go forward quickly, that is unless some powerful lobbyist blocks the process.  Though  ASTM has published our revised standard, it has as yet not been adopted by reference.  Until then you can cite 45 CFR §170.210(b) and ASTM E2147-01(reapproved 2013),  as the standard to which users of EHR are held.

All articles in this blog are the collaborative effort of attorneys Jerry Meyers, Brendan Lupetin, and Gregory Unatin.

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