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License Verification and Monitoring Critical Amidst Healthcare Labor Shortages

Provider Trust

An increasing trend of nurse strikes and hospital staffing shortages across the country in early 2023 has led many healthcare organizations to turn to travel nurses and staffing agencies to fulfill their workforce needs. However, this solution comes with its share of compliance risks, especially if interstate licenses are involved.

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SQA Regulatory Surveillance Summary 1 | Monthly Update 2021

SQA

SQA Regulatory Surveillance Summary, #1 2021. ANVISA has Published its Annual Management Plan (PGA) for 2021, which Comprises 61 Goals and Actions, 16 December 2020. NMPA Adjusts Classification Catalog and Down-Classifies Some Medical Devices, 19 January 2021. Agência Nacional de Vigilância Sanitária (ANVISA).

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The Corporate Transparency Act: A Reporting Guide for Medical Groups and MSOs

Healthcare Law Blog

Congress passed the Corporate Transparency Act (the “CTA”) in 2021 with the aim of enhancing transparency in entity structures and ownership as well as combating terrorism, money laundering, and other forms of corporate misconduct. non-publicly traded entities), regardless of the degree to which they are already regulated at the state level.

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Florida Continues Pursuit of Improved Patient Safety

Health Law RX

The Florida Legislature previously approved a requirement that hospitals and ambulatory surgical centers (ASCs) conduct patient safety surveys and tasked the Agency for Health Care Administration (AHCA) with implementing a rule specifying the submission process for these surveys. Patient Safety Surveys. Survey Questions.

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How Serious are OIG Exclusions? Key Insights into the Fraud Risk Spectrum

Provider Trust

According to the OIG site on Fraud Risk: OIG applies published criteria to assess future risk and places each party to an FCA settlement into one of five categories on a risk spectrum. OIG uses its exclusion authority differently for parties in each category (as described in the criteria…). So what are the risk categories?

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – January

SQA

Eudralex, Volume 4: GMP Guidelines and Annexes Revision of the EU GMP Guide Annex 11 “Computerized Systems” – Presentation of Concept Paper, 18 November 2022 On 16 November 2022, the European Medicines Agency EMA published a concept paper on the planned revision of Annex 11 “Computerized Systems.”

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – March And April

SQA

MDCG 2023-3 , Questions and Answers on Vigilance Terms and Concepts as Outlined in the Regulation (EU) 2017/745 on Medical Devices, provides additional information on key vigilance terms. The reporting period begins on the day after the awareness date of a serious incident. Although the original awareness date in Section 1.2c

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