As reported previously (seehere), the requirements under the HIPAA/HITECH statutes and regulations for public disclosure of security breaches of Protected Health Information (“PHI”) have been bringing direct intervention by attorneys general with respect to enforcement actions regarding such breaches. Last week for the first time, the Office for Civil Rights (“OCR”) of the U.S. Department of Health and Human Services (“HHS”) exacted heavy financial obligations from (i) Cignet Health and its affiliates (“Cignet”) on February 22, 2011, with a $4.3 million civil monetary penalty assessment (“CMP”) for violations of the HIPAA Privacy Rule and (ii) the General Hospital Corporation and Massachusetts General Physicians Organization Inc. (collectively, “Mass General” ) on February 24, 2011, for a settlement that includes a payment to the U.S. government of $1,000,000 by Mass General for potential violations of HIPAA.
This is the first time that the OCR has publicized its activities in enforcement actions involving heavy monetary payments. Until now, as discussed above, the publicized enforcement activity for monetary recoveries from covered entities under HIPAA/HITECH has been by attorneys general in Connecticut, Indiana and Vermont.
The cases of Cignet and Mass General are efforts by the OCR to demonstrate its seriousness in taking action against violations or alleged violations of HIPAA/HITECH. In the OCR press release relating to Cignet (the “Cignet Press Release”), Kathleen Sibelius, Secretary Of HHS stated the following:
Ensuring that Americans’ health information privacy is protected is vital to our health care system and a priority of this Administration. The U.S. Department of Health and Human Services is serious about enforcing individual rights guaranteed by the HIPAA Privacy Rule.
In the OCR press release relating to Mass General (the “Mass General Press Release”), OCR Director Georgina Verdugo was quoted as follows: “We hope the health care industry will take a close look at this agreement and recognize that OCR is serious about HIPAA enforcement. It is a covered entity’s responsibility to protect its patients’ health information.”
The close proximity of the two OCR actions and press releases is noteworthy. According to the Cignet Press Release, the Cignet case involved 41 patients, while, according to the Mass General Press Release, the Mass General case involved 192 patients. Each of these numbers is far fewer than the threshold of 500 affected individuals for listing on the HHS website (the “HHS List”). Some of the 241 incidents reported on the current HHS List involve hundreds of thousands, or even more than one million, affected individuals. It is clear that OCR felt it necessary to make examples of Cignet and Mass General.
The two cases are very different in that the Cignet Health payment involves a CMP imposed by OCR for violations that the OCR found Cignet to have committed, including, according to the Cignet Press Release, the fact that “. . . Cignet failed to cooperate with OCR’s investigations on a continuing daily basis from March 17, 2009, to April 7, 2010, and that the failure to cooperate was due to Cignet’s willful neglect to comply with the Privacy Rule.” Therefore, the heavy CMP on Cignet would appear to based in major part on OCR’s view that Cignet flouted the authority of OCR to investigate alleged HIPAA Privacy violations.
On the other hand, according to the Mass General Press Release, Mass General settled for a $1,000,000 payment and other compliance actions for “potential violations of the HIPAA Privacy Rule.” It is clear that Mass General, while having an incident that affected almost five times as many individuals as that of Cignet, exhibited a spirit of cooperation with OCR and, therefore, settled for less than one-fourth of the CMP imposed on Cignet and was not found by OCR to have committed a violation.
The juxtaposition of the two cases by OCR shows that cooperation may achieve significant benefits for alleged HIPAA violators, while those who fail to cooperate can be severely punished. The importance of these two cases warrant further discussion in future blog entries.