Effective September 1, 2023, the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) began enforcing the final rule implementing information blocking penalties under the 21st Century Cures Act. The 21st Century Cures Act empowers HHS to assess civil monetary penalties for information blocking,which is defined as “a practice that interferes with, prevents, or materially discourages access, exchange, or use of electronic health information” except as required by law or covered by an exception defined by the Secretary of HHS.
Although the information blocking rule went into effect on October 6, 2022, the enforcement rule and recent regulatory guidance have clarified that civil monetary penalties will only be assessed for information blocking that occurs after September 1, 2023. Healthcare entities subject to the rule include health IT developers of certified health IT, entities offering certified health IT, health information exchanges, and health information networks. Individual or entity violators of the information blocking rule may be subject to a penalty of up to $1 million per violation.