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SQA Regulatory Surveillance Summary 4 | Monthly Update 2021

SQA

The new regulation, RDC 478/2021 , repeals economic monitoring and reporting processes previously established under RDC 185/2006, and initially reduces the number of medical device types for which economic monitoring will be required. Due to the COVID-19 pandemic, there was an increase of 39.2% National Research Council.

FDA 52
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What are the Penalties for HIPAA Violations?

HIPAA Journal

The Health Insurance Portability and Accountability Act of 1996 placed a number of requirements on HIPAA-covered entities to safeguard the Protected Health Information (PHI) of patients, and to strictly control when PHI can be divulged, and to whom. 19 settlements were reached to resolve potential violations of the HIPAA Rules.

HIPAA 122