The maximum civil money penalty for violations of the confidentiality provisions of the Patient Safety and Quality Improvement Act of 2005[i] (Patient Safety Act) will rise to $11,000 on November 24, 2009 unless the Department of Health & Human Services (HHS) Office of Civil Rights (OCR) receives comments impacting a new final rule (Final Rule) published on August 25, 2009. You can read the Final Rule here.
The Patient Safety Act created a voluntary program through which health care providers can share information related to patient safety events and concerns with patient safety work product organizations (PSOs) for the purpose of improving patient safety and the quality of care nationwide. The Patient Safety Act provides that PSWP is both privileged and confidential. While participation in the patient safety program is voluntary, a violation of the Patient Safety Act’s confidentiality requirements currently is subject to a civil money penalty (CMP) of up to $10,000.[ii] Under Section § 3.404 of the current HHS Patient Safety Act Regulations,[iii], a person who discloses identifiable PSWP in knowing or reckless violation of the Patient Safety Act is subject to a CMP of not more than $10,000 for each act constituting a violation.
The Federal Civil Penalties Inflation Adjustment Act of 1990 (Inflation Adjustment Act) requires HHS to adjust for inflation the Patient Safety Act’s civil money penalty amount at least once every four years, beginning from the Patient Safety Act’s date of enactment, which was July 29, 2005. Issued along with a proposed rule providing for the same adjustment, the Final Rule provides for the maximum civil money penalty amount for a violation of the confidentiality provisions of the Patient Safety and Quality Improvement Act to increase from $10,000 to $11,000.
The Final Rule and a simultaneously published Proposed Rule allow the public 30 days to comment on the Final Rule and its accompanying proposed rule. If no adverse comments are received, the direct final rule will go into effect 90 days after publication, and the proposed rule with be withdrawn. If, however, adverse comments are received during the comment period, HHS states it will withdraw the direct final rule.
For More Information
We hope that this information is useful to you. If you need assistance with Patient Protection Act or other health care compliance, risk management, transaction or operation concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270‑2402, firstname.lastname@example.org or your other favorite Curran Tomko Tarski LLP Partner. Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health care privacy and data security and related matters.
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If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here or e-mailing this information here.
[i] 42 U.S.C. 299b–21 to 299b–26.
[ii] 42 U.S.C. 299b–22(f).
[iii] 42 CFR part 3.