- July 6, 2023
- Alerts
HHS-OIG Posts Final Rule Implementing Information Blocking Penalties
By:
David M. Traskey
On June 27, 2023, and in response to the 21st Century Cures Act (Cures Act), the U.S. Department of Health and Human Services, Office of the Inspector General (HHS-OIG) posted a final rule that amended its Civil Money Penalty (CMP) regulations to authorize penalties of up to $1 million per violation against (1) health information technology (IT) developers of certified health IT, (2) entities offering certified health IT, (3) health information exchanges, and (4) health information networks that engage in information blocking. Significantly, this final rule does not apply to health care providers. HHS-OIG will begin enforcing the information blocking penalties on September 1, 2023.
Information blocking is “any practice that is likely to interfere with, prevent, materially discourage, or otherwise inhibit the access, exchange or use of Electronic Health Information (EHI)” unless that practice is required by law or specified in an information blocking exception.
This final rule should be read “in tandem” with the information blocking regulations set forth by The Office of the National Coordinator for Health Information Technology (ONC). HHS is establishing separate rules that will outline “disincentives” for health care providers that engage in information blocking, but the timeline for the rollout of these rules is unclear. Although “disincentives” are not specifically covered by this final rule, health IT developers of certified health IT, health information exchanges, and health information networks could be subject to CMPs under this final rule even if they also meet ONC’s definition of a “health care provider.”
HHS-OIG also announced that it will initially prioritize the investigation of cases in which allegations of information blocking (1) resulted in, is causing, or had the potential to cause patient harm; (2) significantly impacted a provider's ability to care for patients; (3) was of long duration; (4) caused financial loss to Federal health care programs, or other government or private entities; or (5) was performed with actual knowledge.
HHS-OIG will not impose penalties on information blocking conduct occurring before September 1, 2023. The procedural rights that currently exist under the Civil Monetary Penalties Law (CMPL) remain unchanged with the addition of this new authority.
Should you have any questions regarding the above, please contact the author or the Garfunkel Wild attorney with whom you regularly work, or contact us at info@garfunkelwild.com.
Information blocking is “any practice that is likely to interfere with, prevent, materially discourage, or otherwise inhibit the access, exchange or use of Electronic Health Information (EHI)” unless that practice is required by law or specified in an information blocking exception.
This final rule should be read “in tandem” with the information blocking regulations set forth by The Office of the National Coordinator for Health Information Technology (ONC). HHS is establishing separate rules that will outline “disincentives” for health care providers that engage in information blocking, but the timeline for the rollout of these rules is unclear. Although “disincentives” are not specifically covered by this final rule, health IT developers of certified health IT, health information exchanges, and health information networks could be subject to CMPs under this final rule even if they also meet ONC’s definition of a “health care provider.”
HHS-OIG also announced that it will initially prioritize the investigation of cases in which allegations of information blocking (1) resulted in, is causing, or had the potential to cause patient harm; (2) significantly impacted a provider's ability to care for patients; (3) was of long duration; (4) caused financial loss to Federal health care programs, or other government or private entities; or (5) was performed with actual knowledge.
HHS-OIG will not impose penalties on information blocking conduct occurring before September 1, 2023. The procedural rights that currently exist under the Civil Monetary Penalties Law (CMPL) remain unchanged with the addition of this new authority.
Should you have any questions regarding the above, please contact the author or the Garfunkel Wild attorney with whom you regularly work, or contact us at info@garfunkelwild.com.