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Compliance Policies and Procedures Public Health Emergency

Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations. ... more +
Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations.  In response to many corporate scandals evidencing rampant unethical business practices, many nations, including the United States, began passing strict regulatory frameworks aimed at curbing these abuses. Notable pieces of legislation in this area include the U.S. Foreign Corrupt Practices Act (FCPA), Sarbanes-Oxley (SOX), and the U.K. Bribery Act, to name a few. The foregoing statutes and the severe penalties often associated with them form the basis of many modern institutional compliance programs. less -
Health Care Compliance Association (HCCA)

Emergency preparedness for FQHCs and RHCs, post-pandemic

On May 11, 2023, the U.S. Department of Health and Human Services (HHS) issued a news release on behalf of HHS Secretary Xavier Becerra, announcing the end of the COVID-19 public health emergency (PHE). The duration of the...more

Ankura

COVID-19 Public Health Emergency – Compliance Considerations as We Prepare for the End of the PHE

Ankura on

On January 30, 2023, the Biden Administration announced plans to end the Public Health Emergency (PHE) on May 11, 2023. The PHE was enacted on January 27, 2020, to provide flexibility to healthcare providers and payors...more

McDermott Will & Emery

CNIL Issues Provisional Recommendations for Remote Quality Control of Clinical Trials During the Health Crisis

Given the challenges of conducting clinical trials during the COVID-19 pandemic, many countries — including France — have allowed for some use of remote quality controls. In response to guidelines issued recently by European...more

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