March 25, 2021

New ONC Information Blocking FAQ Muddies Previous Clarity on Report Access

On March 19, 2021, the Department of Health and Human Services (HHS) Office of the National Coordinator for Health IT (ONC) updated their Frequently Asked Questions (FAQ) webpage (see Interference subsection) on the information blocking provision from the 21st Century Cures Act (Cures) Section 4004. The new update focused on the ONC’s view of “requests” for electronic health information (EHI), delayed responses and organizational communication policies.

Previously, an ONC FAQ published on Jan. 15, 2021, clarified that providers would not be required to proactively provide EHI to patients or others who have not requested that EHI, though failure to timely respond to a specific request would likely constitute an interference. Taken at face value, the prior FAQ appeared to reasonably address timed release policies in radiology, or temporary holds of unrequested imaging data to enable appropriate care coordination and consultation with referring providers. The Jan. 15 FAQ on proactive access remains online and unchanged.

Despite the prior clarification, the March 19 FAQ counterintuitively indicated that requests for EHI could be inclusive of inconspicuous electronic queries, such as portal logins or queries from third-party applications. This is a significantly different standard for data access requests than is currently defined under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. Moreover, the new FAQ indicated that organizational policies resulting in a delay in responding to such electronic queries —for any period of time — would likely constitute an interference. In practical effect, this clarification would appear to necessitate proactive access to finalized EHI, even when not yet requested by an individual or entity, to avoid delays of any length in responding to unforeseen queries for EHI.

At this writing, a mere two weeks before the April 5 “applicability date,” it is unclear how HHS intends to enforce this controversial clarification. Critically, the Cures Act’s definition of information blocking explicitly requires provider knowledge that the practice in question is both unreasonable as well as a likely interference. If a likely interference is not known by the provider to be unreasonable, it would not meet the statutory definition of information blocking. Whether or not information blocking has occurred in a particular scenario will be determined by case-by-case HHS investigations into the circumstances.

The American College of Radiology® (ACR®) has been working to inform HHS about the unintended consequences and practical compliance concerns with the March 19 FAQ. For additional information, please visit the ACR educational webpage on Information Blocking.

The American College of Radiology provides the above news article only as general information. Readers should not construe this article to provide specific legal advice on their individual practice matters.