Posts by Lena Shore

You may recall the Office of Civil Rights (OCR) is required by the HITECH Act of 2009 to conduct random audits of covered entities and business associates. Since that time the audits have been hit or miss—mostly miss.In 2011 and 2012, the OCR conducted Phase I pilot audits. The goal of these audits was to…

The Federal Civil Penalties Inflation Adjustment Act of 2015 requires OSHA to adjust its civil penalties annually for inflation. The adjustments are made by January 15th every year.In 2014, OSHA’s maximum penalties for serious and other-than-serious violations were $7,000 per violation. Ten years later, in 2024, OSHA’s maximum penalties for serious and other-than-serious violations increased from…

Filed under: Articles and Updates Guest Contributor, Jennifer Venturini, RDH, BASDH, CDSO, Graduate According to the Federal Drug Administration (FDA), Instructions for Use (IFU) are required written directions which detail how to prepare, use, handle, store, and dispose of a medical device. Basically, the goal of an IFU is to ensure that the operator has…

Amidst all the recent Supreme Court, OSHA, and CDC updates last week, the 2022 annual adjustments to OSHA civil penalties went into effect January 15th. It’s important to note that serious fines went from $13,653 per violation to $14,502 per violation. The maximum penalty for willful or repeated violations increased from $136,532 per violation to…

In previous blogs, we reported that the Phase II random HIPAA audits were underway. If you weren’t one of those chosen so far, you may be wondering what’s been happening. The Phase II audits began in 2016 and included covered entities as well as business associates. They were intended to start with desk audits and…