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.

Generally, yes, but it may depend on the circumstances.

The scope of EHI^[1] for which the actor must fulfill a request for access, exchange, or use in order to satisfy the Manner Exception is determined by the scope of the request and thus by the requestor. This is true regardless of whether the actor seeks to fulfill the request consistent with the manner requested condition (see 45 CFR 171.301(a)), the alternative manner condition (45 CFR 171.301(b)), or a combination of the conditions.

If the requestor’s request is for access, exchange, or use of a subset of EHI that the actor can fulfill in the manner requested (45 CFR 171.301(a)), then the actor can satisfy the Manner Exception by providing access, exchange, or use of that subset of EHI in that requestor-specified manner so long as the actor’s practice in doing so is otherwise consistent with the Manner Exception (45 CFR 171.301).

By contrast, if the actor cannot reach an agreement with the requestor or is not technically capable of providing all of the requested EHI in a particular requestor-specified manner, then to satisfy the Manner Exception for the request the actor would need to use one or more additional alternative manners specified by the requestor (45 CFR 171.301(b)(1)(i) and (ii)) or agreed to by the requestor (45 CFR 171.301(b)(1)(iii)), working through manners in the priority order identified in the alternative manner condition, until the actor has made all requested EHI available to the requestor.

An actor might have the technical capability to satisfy the Manner Exception for only some of the EHI requested in the manner(s) the requestor specifies. In such instances, the actor may want to consider whether another exception may apply for the remaining EHI not fulfilled through the Manner Exception.

^[1] EHI is defined for purposes of the information blocking regulations in 45 CFR 171.102. On and after October 6, 2022, the scope of EHI for purposes of the information blocking definition (45 CFR 171.103) is EHI as defined in 45 CFR 171.102 (89 FR 1199, 85 FR 70069). 

When an actor believes they can fulfill a request for access, exchange, or use of electronic health information (EHI), they may seek to satisfy the Manner Exception (45 CFR 171.301) to be sure they are not committing information blocking. The Manner Exception states in principle that an actor “must fulfill a request for EHI in any manner requested, unless the actor is technically unable to fulfill the request or cannot reach agreeable terms with the requestor to fulfill the request in the manner requested” (45 CFR 171.301(a)(1), 85 FR 25877). If an actor does not fulfill a request for EHI in any manner requested because the actor is technically unable to fulfill the request or cannot reach agreeable terms with the requestor, the Manner Exception then specifies that an actor must fulfill the request in an alternative manner (45 CFR 171.301(b)).

Under this alternative manner condition of the Manner Exception, the actor must fulfill the request for EHI without unnecessary delay in an alternative manner (45 CFR 171.301(b), 85 FR 25878). The actor must offer alternative manners in a strict priority order, starting with 45 CFR 171.301(b)(1)(i) and only proceeding to the next consecutive paragraph if the actor is technically unable to fulfill the request in the manner identified in the paragraph.

Importantly, a requestor must specify the technology or standards, respectively, of the alternative manners under paragraphs (b)(1)(i) and (ii) or agree to an alternative machine-readable format under paragraph (b)(1(iii). Simply put, if the requestor does not specify technology certified to a standard or standards adopted in part 170 ((b)(1)(i)), or content and transport standards published by certain publishers ((b)(1)(ii)), or agree to an alternative machine-readable format ((b)(1)(iii)), then the actor cannot meet the alternative manner condition of the Manner Exception. An actor is not permitted to presume or dictate the manner in which access, exchange, or use of EHI is fulfilled under the alternative manner condition of the Manner Exception.

If an actor is unable to meet the Manner Exception, the actor may want to consider whether the actor can meet the conditions of another exception. For example, the actor may be able to rely on the Infeasibility Exception. One factor of the infeasible under the circumstances condition of the Infeasibility Exception is “why the actor was unable to provide access, exchange, or use of electronic health information consistent with the Manner Exception.” (45 CFR 171.204(a)(5)(i)(F), 85 FR 25867).