HHS Issues Final Rule Implementing Information Blocking Penalties

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The Department of Health and Human Services Office of Inspector General (“HHS-OIG”) recently issued on June 27, 2023 its final rule on information blocking penalties.  The final rule establishes statutory penalties for committing information blocking of up to a $1 million penalty per violation.  According to an HHS website, enforcement assessing penalties began as of September 1, 2023.

To view the text of the final rule pertaining to information blocking, please click here: https://www.federalregister.gov/documents/2023/07/03/2023-13851/grants-contracts-and-other-agreements-fraud-and-abuse-information-blocking-office-of-inspector.

In case you are unfamiliar with the original legislation pertaining to information blocking, this is explained at the HealthIT.gov website: https://www.healthit.gov/topic/information-blocking.   The brief explanation is that information blocking is a prohibited practice by an actor “likely to interfere with the access, exchange, or use of electronic health information (“EHI”), except as required by law or specified in an information blocking exception.” To view an HHS worksheet defining EHI in more detail, please click here: https://www.healthit.gov/sites/default/files/page2/2021-12/Understanding_EHI.pdf

Actors may include health care providers, health information networks or health information exchanges, and health IT developers of certified health IT.  To view an HHS worksheet defining actors, please click here: https://www.healthit.gov/sites/default/files/page2/2020-03/InformationBlockingActors.pdf.

The information blocking legislation defined eight information blocking exceptions:

  • preventing harm;
  • privacy;
  • security;
  • infeasibility;
  • health IT performance;
  • licensing;
  • fees; and
  • content and manner.

To view the HHS worksheet defining these information blocking exceptions in more detail, along with the conditions required to meet the terms of each information blocking exception, please see the attached link: https://www.healthit.gov/sites/default/files/2022-07/InformationBlockingExceptions.pdf.

The information blocking legislation was mandated in 2016 by the 21st Century Cures Act which made information sharing of electronic healthcare information the norm.  To view the full text of the legislation, please click on the link: https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf.

The information blocking legislation is certainly not new legislation, so digital health compliance professionals are likely already familiar with the provisions.  However, given the fact that the enforcement phase of the information blocking legislation has just commenced, digital health companies should take the time to review their current information sharing practices to ensure that they are familiar with the rules relating to information blocking and that they remain in compliance with them.

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Kristie Prinz