Cignet Proves That It Is Bad To Violate The HIPPA Privacy Rule, But Worse To Ignore HHS

Cignet Health (Cignet), which operates four health centers in Maryland, is a little lighter in the wallet after the U.S. Department of Health and Human Services’ (HHS) Office of Civil Rights (OCR) found that Cignet violated the Privacy Rule of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) - $4.3 million lighter, to be exact.

This penalty marks the first civil money penalty imposed by HHS for violations by a “covered entity” of the HIPAA Privacy Rule. In the past, HHS has primarily worked with covered entities to settle the violations and obtain agreement to changes in practices. The civil monetary penalty imposed upon Cignet is based on the violation categories and increased penalty amounts authorized by Section 13410(d) of the Health Information Technology for Economic and Clinical Health (HITECH) Act, which modified HIPAA.

HHS news release, part of the penalty stems from Cignet’s denying 41 patients their right to access their medical records when requested between September 2008 and October 2009. Under HIPAA, a covered entity must provide access to a patient who requests such access to his or her medical record within 30 days of the request, subject to various exceptions and limited rights to extend such time period. (Numerous state laws include similar obligations that health care providers provide a patient with access to his or her own records, often within shorter time frames than is required by HIPAA.) Thirty-eight separate complaints of such denial of access had been filed with OCR, pursuant to which OCR began its investigation of Cignet. HHS has indicated that $1.3 million of the $4.3 million penalty is attributable to this denial of access to a patient’s records.  

Notably, out of the over 50,000 complaints of alleged HIPAA Privacy Rule violations that OCR has resolved, the denial of a patient’s access to his or her own records has been the third most cited reason for such a complaint every year since 2003, when compliance with the Privacy Rule was first legally required. But every other such complaint of denial of access was informally resolved with OCR. According to various news reports, Cignet never attempted to informally resolve the complaints with OCR.

In Cignet’s case, $3 million of the penalty is attributable to OCR finding that Cignet repeatedly failed to respond to various requests from OCR for more than a year (March 17, 2009 to April 4, 2010), resulting in per-day penalties, up to the maximum permissible penalties per year pursuant to applicable enforcement rules. Under HIPAA, covered entities are required to cooperate with HHS investigations. Even after Cignet finally produced the applicable patient records to HHS (in response to a federal court order), Cignet’s cooperation was limited in that it produced records relating to thousands of patients in addition to the 41 at issue. In various communications from OCR during the course of the investigation and the initial proposal of penalties, Cignet was notified of its rights to offer defenses and mitigating factors, and subsequently, of its rights of appeal. Cignet never exercised any of its rights.

The lesson to be learned from Cignet is that if you violate the HIPAA Privacy Rule, be prepared to pay, but if you fail to cooperate with OCR investigations into such violations, be prepared to pay even more (potentially 200% more). The question remains as to whether or not the extent of this fine is a true example of a new approach to enforcement of HIPAA, or whether Cignet’s ignoring official inquiries, failing to pursue informal resolution and not exercising its rights under HIPAA warranted unusual measures.

Decrypting HHS Guidance on Breach Notification and Security under the HITECH Act: NIST, FIPS, and More

Two months after Congress mandated notification for the breach of unsecured protected health information (PHI), the Secretary of Health and Human Services (HHS) defined what it means to be “unsecured.” As required by Section 13402 of the HITECH Act, H.R. 1, 111th Cong. (1st Sess. 2009) (which was part of the American Recovery and Reinvestment Act of 2009), the Secretary issued guidance and a request for comments on the technologies and methodologies rendering information unusable, unreadable or indecipherable. 74 Fed. Reg. 19006 (Apr. 27, 2009) (to be codified at 45 C.F.R. pts. 160, 164).

As we previously reported, the HITECH Act’s notification requirements for breaches of unsecured PHI apply to entities subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA), their business associates, and non-HIPAA covered vendors of personal health records (PHR). To constitute a breach, the acquisition, use, access or disclosure of the PHI must “compromise[] the security or privacy of such information.” HITECH Act at §13400(1)(A). The newly issued HHS guidance lists technologies and methodologies that secure information, rendering the data unusable, unreadable, or indecipherable. If PHI is secured according to the HHS guidance, unauthorized access to such information will not trigger the HITECH breach notification requirements, although these breaches may still be subject to state law notification requirements.

This HHS guidance also is to be used to render identifiable health information unusable, unreadable, or indecipherable for purposes of the temporary breach notification requirements that apply to vendors of PHRs, the requirements for which are to be administered by the Federal Trade Commission (which in turn issued proposed regulations, on April 16, 2009, addressing consumer notice for breaches of electronic health information by PHRs).

The HHS guidance provides two methods of securing information for the purposes of the HITECH Act: destruction and encryption. Destruction may secure information that was found in either paper format or in electronic media. In order to satisfy the destruction method, the paper or other hard copy media must be shredded or destroyed such that the PHI cannot be read or otherwise reconstructed. Electronic media must be cleared, purged, or destroyed in accordance with the specifications set forth in National Institute of Standards and Technology (NIST) Special Publication 800-88. 74 Fed. Reg. at 19010.

According to the guidance, the effectiveness of encryption depends on the strength of the algorithm and the security of the decryption key or process. PHI is not secure if the decryption key or process has been breached. Encryption only secures PHI if, in accordance with the HIPAA Security Rule, an algorithm “transform[s] data into a form in which there is a low probability of assigning meaning without the use of a confidential process or key.” 45 C.F.R. § 164.304. Accordingly, the HHS guidance only specifies encryption processes that have been tested and approved by NIST. Data at rest, which is filed or stored in a database, should be encrypted according to the processes outlined in NIST Special Publication 800-111, Guide to Storage Encryption Technologies for End User Devices. Encryption processes for data in motion, including that being transmitted or moving through a network, should comply with Federal Information Processing Standards (FIPS) 140-2. Some examples of conforming processes for data in motion are outlined in NIST Special Publications 800-52 (relating to Transport Layer Security (TLS) Implementations); 800-77 (addressing IPsec VPNs); and 800-113 (SSL VPNs), and may include others which are FIPS 140-2 validated.

Since the technologies and methodologies in the guidance are intended to be exhaustive, the Secretary of HHS sought comments regarding additional technologies or methodologies for inclusion in future guidance. HHS also requested comments on various other related issues, including instances when specified technologies and methodologies would fail to secure information, how the federal notice requirements affect existing state law requirements, and whether and how limited data sets (created in accordance with the HIPAA Privacy Rule) could be included in this guidance. This HHS guidance will be closely watched not only as it relates to federal law, but also as to how it informs state law interpretations. Encryption remains undefined under state law, and the HHS guidance provides a potentially important source of interpretation.

This guidance will apply to breaches that occur at least thirty days after publication by HHS of the interim final regulations on breach notification (which have not yet been issued). Any modifications to this guidance based on comments received are expected to be made prior to or concurrent with those regulations.

Proskauer summer associate Katrina McCann contributed to this post.