article thumbnail

HIPAA Waiver: How COVID-19 Impacts HIPAA Compliance

Total HIPAA

Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a limited waiver of certain HIPAA sanctions and penalties to ease access of data for providers , public health authorities , and others.². This is intended to give Federal public health authorities and health oversight agencies access to data.

article thumbnail

SQA Regulatory Surveillance Summary 3 | Monthly Update 2021

SQA

726/2004, 09 March 2021. 726/2004 , which essentially means duplicate MAAs for products authorized via the centralized procedure. These missions will allow the Commission to identify, and, if necessary, correct any non-compliance or weaknesses. Under Article 82(1) of Regulation (EC) No.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

SQA Regulatory Surveillance Summary | Monthly Update 2022 – September/October

SQA

China’s Center for Medical Device Evaluation (CMDE) Update Compliance Guidelines and Recommended Paths for Clinical Evaluation Paths for Certain Medical Devices, 25 July 2022. 29 of 2022 , Technical Guidelines for Compliance with the Essential Principles of Medical Device Safety and Performance. CMDE Announcement No.

FDA 40
article thumbnail

SQA Regulatory Surveillance Summary | Monthly Update 2023 – July and August 2023

SQA

In addition, it contains essential recommendations to avoid complications and protect public health. While preparing the patient’s compliance pack, the pharmacy misinterpreted the product to contain 500 mg of Calcium Carbonate when each tablet actually contained 500 mg of elemental Calcium. As a result, the patient received 2.5

FDA 40