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December 2023 Regulatory Compliance Updates

Verisys

– The best resource for monthly healthcare regulatory compliance updates. Rule 402(2) states that when a multistate licensee changes primary states of residence to another NLC party states, they shall apply for a multistate license in the new residence state within 60 days. 01ER ): Effective as a permanent rule on 11/13/2023.

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What is FACIS and Why is it the Gold Standard

Verisys

Excluded from one means excluded from all, and the fines for non-compliance will likely be in the hundreds of thousands. Our FACIS database of more than 10 million records makes it easy to maintain regulatory compliance by identifying red-flag behaviors and trends for any individual you employ from 5,000+ sources. Credentialing.

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Key Legal Considerations Relating to Ketamine Behavioral Health Platforms

Health Care Law Brief

This means that although ketamine is approved by the FDA for some medical uses, it is not specifically approved to treat depression. In many states, operating a ketamine clinic does not require a specific regulatory facility license. Ketamine is a Schedule III controlled substance. [4] 1] [link]. [2] 2] [link]. [3] 3] [link]. [4]

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Key Legal Issues Facing Telehealth Platforms, as Compliance Concerns Bubble for Platforms Launched During the Public Health Emergency

Health Care Law Brief

For example, New York continues to maintain a professional licensing waiver that enables certain providers, licensed out of state, to render care within the state, for the duration of the declared state of emergency. Provider Licenses. What types of providers will render care via telehealth?

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EU and US Regulatory Challenges Facing AI Health Care Innovator Firms

Bill of Health

Although the cross-sectoral AI legislation that is now introduced by the European Commission’s Digital Strategy aims to be integrated with existing sectoral legislation such as the MDR, the IVDR and the Machinery Directive, it is uncertain how overlapping regulatory compliance requirements for AI-driven medical devices will be managed in practice.

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SQA Regulatory Surveillance Summary | Monthly Update 2022 – July/August

SQA

The counterfeit devices were sold online by a distributor named Healthful Plus without the required license to import, distribute, or sell medical devices in Canada. The packaging of the counterfeit kits resembles authentic (licensed) BTNX Inc. products in color and typeface and uses the BTNX Inc. device identifier “COV-19C25.”

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The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

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