The HHS Office for Civil Rights released, at the end of last year, findings from audits it conducted in 2016 and 2017 of 166 covered entities and 41 business associates. The report represents the periodic audit that the Department of Health and Human Services must periodically conduct of covered entities and business associates for compliance with the requirements of HIPAA and the HITECH Privacy, Security, and Breach Notification Rules. There are many practical take-aways for businesses from the OCR’s report.
Continue Reading Learning from the Mistakes of Others: OCR Releases Audit Report

An amendment to the CCPA recently passed through the legislature, adding some much needed clarity to HIPAA-regulated entities, research institutions and other life science and medical device companies. CCPA in its current form left open uncertainty for business associates, de-identified information, and information collected in the course of medical research. AB 713 helps clarify certain exemptions and applicability of CCPA to organizations in the health and research space.
Continue Reading CCPA Amendment Adds Needed Clarity for Medical & Research Community

The U.S. Department of Health and Human Services recently published a Notice of Enforcement Discretion that markedly reduced HIPAA-related penalties. According to the Notice, effective immediately, HHS will change how it applies regulations concerning the assessment of Civil Money Penalties under HIPAA. Prior to issuance of the Notice, HHS regulations applied the same $1.5 million cumulative annual CMP limit across all categories of violations (which are based on the level of culpability of the violator). In other words, if a company found itself in violation of HIPAA, the penalties for which it would be responsible could be no more than $1.5 million per year regardless of the category of violation and regardless of the number of violations the company had committed.
Continue Reading HHS Reduces Penalties for HIPAA Violations; Distinguishes Based on Culpability