ONC clarifies expectations for data sharing with patients

In a series of answers to questions raised by the 21st Century Cures Act, the agency explains how much data organizations must share.

Responses released Monday by a federal agency bring more clarity to long-standing questions surrounding the information blocking of the 21st Century Cures Act.

In a series of answers to frequently asked questions, the Office of the National Coordinator for Health Information Technology put a stake in the ground on what it expects provider organizations to be able to after October 2022, as well as providing guidance on interference, content and manner.

Current rules limit data that must be shared to the U.S. Core Data for Interoperability (USCDI), but ONC said in one of its responses that, after October 6, 2022, the definition of information blocking “will apply to the full scope of EHI” and means electronic protected health information as defined in federal statute. The rules will apply “regardless of whether the group of records are used or maintained by or for a covered entity.”

However, EHI shall not include psychotherapy notes or “information compiled in reasonable anticipation of, or for use in, a civil, criminal or administrative proceeding.”

Electronic health information is not tied to a specific system in which it is maintained, but is “information that is consistent with the definitions of electronic protected health information (ePHI) and the designated record set (DRS) regardless of whether they are maintained by or for an entity covered by the Health Insurance Portability and Accountability Act (HIPAA) Rules,” ONC noted.

ONC’s full answer to this question can be seen here.

One answer by ONC suggests that any fee charged by an organization to print EHI on paper or copy it to a CD or thumb drive could be considered information blocking if it does not meet the fees exception outlined in federal regulations. The agency’s answer to the question of cost surrounding physical production of EHI can be found here.

Additional answers from ONC discuss:

  • What constitutes a progress note, for the purpose of information blocking, when the USCDI is the basis for data access, found here.
  • Whether organizations must “proactively” make electronic health information available through patient portals, application programming interfaces or other health information technology, found here.

Whether a claim of information blocking is predicated on a request for access, exchange or use of EHI – which gets to the point of whether an organization needs to be asked for EHI first, and whether not providing data before requested constitutes information blocking (ONC answers no).

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