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The 21st Century Cures Act Information-Blocking Rule

Steven M. Harris, Esq.  |  Issue: April 2021  |  April 17, 2021

Common examples of information blocking include unnecessary delays in the provision of patient test results, policies requiring staff to obtain written consent from a patient before sharing EHI with unaffiliated providers for treatment or interfering with an EHR that would generally enable EHI to be shared with other providers or patients.

A provider must provide a written response within 10 business days for why fulfilling a request is infeasible.

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5. Health IT performance: Reasonable and necessary measures that are limited in scope that may be taken to make health IT temporarily unavailable or to degrade health IT’s performance for an overall benefit will not be considered information blocking. This exception recognizes that to properly secure EHI, health IT must occasionally be improved, which may require taking IT temporarily offline. An actor may take action against a third-party app that negatively impacts their health IT. If IT unavailability is in response to risk of harm or a security risk, the actor must comply only with the preventing harm or security exceptions, as applicable.

3 procedural exceptions

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  1. Content and manner: An actor can limit the content of a response to a request to access, exchange or use EHI, or the manner in which it fulfills a request, subject to certain conditions. The purpose of this exception is to provide flexibility for actors concerning the scope of EHI to be included in the actor’s response and the manner in which the request is fulfilled. If a request is fulfilled in an alternative manner it must comply with a priority order and satisfy the fees and licensing exceptions, as applicable.
  2. Fees: An actor can charge fees, including fees that result in a reasonable profit, for accessing, exchanging or using EHI. Fees should relate to the development of technologies and the provision of services that enhance the technology and interoperability. Notably, this exception does not protect rent-seeking or opportunistic fees, or exclusionary practices that interfere with access, exchange or use of EHI.
  3. Licensing: Under this exception, an actor can license interoperability for EHI to be accessed, exchanged or used. This enables an actor to protect the value of their innovations and earn returns on investments they have made to develop, maintain and improve those innovations. This exception is more likely to be used by health IT entities rather than providers.

Enforcement

A provider’s act of interfering or delaying the release of EHI that does not satisfy an exception will not automatically constitute information blocking, and any suspect practices will be evaluated on a case-by-case, facts-and-circumstances basis to determine whether information blocking has occurred. The Office of the Inspector General will investigate allegations of information blocking to determine whether a violation has occurred.

The HHS is currently engaged in rulemaking to establish enforcement disincentives for providers. Providers should consult with healthcare counsel and compliance officers regarding information blocking practices and exceptions. Improper information blocking conduct can be reported through the ONC’s Information Blocking Portal.

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