Lack of Encryption Leads to $3 Million HIPAA Penalty for New York Medical Center

The University of Rochester Medical Center (URMC) has paid a $3 million HIPAA penalty for the failure to encrypt mobile devices and other HIPAA violations.

URMC is one of the largest health systems in New York State with more than 26,000 employees at the Medical Center and various other components of the health system, including Strong Memorial Hospital and the School of Dentistry.

The Department of Health and Human Services’ Office for Civil Rights (OCR) launched an investigation following receipt of two breach reports from UMRC – The loss of an unencrypted flash drive and the theft of an unencrypted laptop computer in 2013 and 2017.

This was not the first time OCR had investigated URMC. An investigation was launched in 2010 following a similar breach involving a lost flash drive. In that instance, OCR provided technical compliance assistance to URMC. The latest investigation uncovered multiple violations of HIPAA Rules, including areas of noncompliance that should have been addressed after receiving technical assistance from OCR in 2010.

Under HIPAA, data encryption is not mandatory. Following a risk analysis, as part of the risk management process, covered entities must assess whether encryption is an appropriate safeguard. An alternative safeguard can be implemented in place of encryption if it provides an equivalent level of protection.

In this case, URMC had assessed risk and determined that the lack of encryption posed a high risk to the confidentiality, integrity, and availability of ePHI, yet failed to implement encryption when it was appropriate and continued to use unencrypted mobile devices that contained ePHI, in violation of 45 C.F.R. § 164.31 2(a)(2)(iv).

OCR’s investigation confirmed that the ePHI of 43 patients was contained on the stolen laptop and as a result of the theft, that information was impermissibly disclosed – 45 C.F.R. §164.502(a). OCR also determined that URMC had failed to conduct a comprehensive, organization-wide risk analysis – 45 C.F.R. § 164.308(a)(1)(ii)(A) – that included all risks to the confidentiality, integrity, and availability of ePHI, and covered ePHI stored on the lost and stolen devices.

Risks had not been sufficiently managed and reduced to a reasonable and acceptable level – 45 C.F.R. §164.308(a)(l)(ii)(B) – and policies and procedures governing the receipt and removal of hardware and electronic media in and out of its facilities had not been implemented – 45 C.F.R. § 164.310(d).

In addition to the $3,000,000 financial penalty, URMC is required to adopt a robust corrective action plan to address all aspects of noncompliance identified by OCR. URMC’s compliance efforts over the next two years will be scrutinized by OCR to ensure continuing compliance.

“Because theft and loss are constant threats, failing to encrypt mobile devices needlessly puts patient health information at risk,” said OCR Director Roger Severino. “When covered entities are warned of their deficiencies, but fail to fix the problem, they will be held fully responsible for their neglect.”

This is the sixth financial penalty of 2019 that OCR has issued to resolve violations of the Health Insurance Portability and Accountability Act and it is the fourth enforcement action to cite a risk analysis failure.

The risk analysis is one of the most important elements of HIPAA compliance and a risk analysis failure is the most common HIPAA violation cited in OCRs enforcement actions.

OCR has released a risk assessment tool to help covered entities and business associates comply with this aspect of HIPAA. Further information on the HHS risk assessment tool is available on this page.

Author: Steve Alder has many years of experience as a journalist, and comes from a background in market research. He is a specialist on legal and regulatory affairs, and has several years of experience writing about HIPAA. Steve holds a B.Sc. from the University of Liverpool.