With four exceptions already down, we have four more to go in Gravely Group’s series on the Information Blocking Exceptions under the ONC Final Rule. In this post, Gravely Group discusses the Infeasibility Exception.
The Infeasibility Exception looks at when an Actor’s Practice of not fulfilling a request to access, exchange, or use electronic health information (EHI) will, nonetheless, not be considered information blocking because fulfilling the request is infeasible. ONC created this exception in recognition of the fact that real-world circumstances that are outside of an Actor’s control can arise that will prevent the Actor from being able to respond to particular requests for access, exchange, or use of EHI.
To satisfy the Infeasibility Exception and be protected from information blocking penalties or disincentives, an Actor must meet one of three conditions AND the requirements for providing a written response to the request. These conditions and requirements are unpacked below.
Infeasibility Conditions
- Uncontrollable Events – The Actor cannot fulfill the request for access, exchange, or use of EHI due to events outside the Actor’s control such as a natural or man-made disaster, public health emergency, public safety incident, war, terrorist attack, civil insurrection, strike or other labor unrest, telecommunications or internet service interruption, or act of military, civil, or regulatory authority.
- Segmentation – The Actor is unable to “unambiguously segment” the requested EHI from other EHI that either:
- Cannot be accessed, exchanged, or used under applicable law and/or an individual’s preference; or
- Is permitted to be withheld under the Preventing Harm Exception.
- Infeasible Under the Circumstances – The Actor demonstrates, through a contemporaneous written record, that complying with the request would be infeasible under the circumstances based on the Actor’s consistent and non-discriminatory consideration of the following factors:The type of EHI and the purpose for which the EHI may be neededThe cost to the Actor of complying with requestThe financial and technical resources available to the ActorWhether the Actor’s Practice is non-discriminatory, and the Actor provides the same access, exchange, or use to all with whom it has business relationshipsWhether the Actor owns or has control over a predominant technology, platform, health information exchange, or health information network through which EHI is accessed or exchanged; andWhy the Actor was unable to provide access, exchange, or use consistent with the Content and Manner Exception (up next).
For purposes of evaluating whether fulfilling a request for EHI is infeasible under the circumstances, the Information Blocking Rule also specifies that consideration may NOT be given to whether providing the EHI in the manner requested would have (a) facilitated competition with the Actor or (b) prevented the Actor from charging a fee or resulted in a reduced fee.
Responding to the Request
In addition to satisfying one of the conditions above, the Actor must also provide a written response to the requestor identifying the reason(s) responding with the EHI requested is infeasible. Importantly, to avail oneself of the Infeasibility Exception, the Actor must provide this written response within ten business days of receiving the request.
If an Actor does not respond within 10 business days of receipt of the request, the Actor does not meet the Infeasibility Exception. However, ONC’s commentary within the Final Rule indicated that an Actor’s contemporaneous documentation as to why the Actor was unable to respond within 10 business days might be considered by ONC and OIG in evaluating an Actor’s intent as part of an information blocking investigation.
UP NEXT …The Infeasibility Exception marks the last of the exceptions that involve not fulfilling requests for access, exchange, or use of EHI. Gravely Group’s next post on the eight Information Blocking Exceptions moves us into the first of three exceptions that involve procedures for fulfilling requests to access, exchange, or use EHI. We will kick off this next category of exceptions with the Content and Manner Exception. Content & Manner is a big one, so be sure to check it out!