Is portable document format (PDF) considered a “machine-readable format” for purposes of the alternative manner condition of the Manner exception?

It depends. The Manner Exception, in particular the last provision of the “alternative manner” (45 CFR 171.301(b)(1)(iii)), does not specify the particular file extensions or outputs that must be supported. Instead, as a last alternative to make electronic health information (EHI) accessible, exchangeable, or useable, this specific provision within the exception requires actors to produce EHI in a “machine-readable format, including the means to interpret the electronic health information, agreed upon with the requestor.” If it is necessary to produce a PDF for the purpose of meeting this provision, the PDF should be an interpretable, machine-readable output. While this may be possible for some PDFs, other PDFs, such as those that include EHI as images, generally might not be an interpretable, machine-readable output.  

One way a PDF could be a machine-readable format would be if it was structured so that the data it conveyed could be consumed by another software program using consistent processing logic, consistent with the National Institute of Standards and Technology’s definition of “machine-readable.” If a data output format is structured so that the EHI it conveys is machine readable, then that output format is a machine-readable format, regardless of the file extension.

Updated:

This FAQ has been updated pursuant to the HTI-1 Final Rule.