Verisys

DECEMBER 12, 2023

– 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.

Regulatory Compliance 52

Regulatory Compliance Compliance US Department of Health and Human Services Licensing 52

Verisys

NOVEMBER 30, 2022

Maintaining compliance and safeguarding against fraud and abuse in today’s changing healthcare landscape can be challenging. Excluded from one means excluded from all, and the fines for non-compliance will likely be in the hundreds of thousands. License Verification & Monitoring. OIG, SAM DEA, GSA, FDA.

Regulatory Compliance 52

Regulatory Compliance Medicare Medicare Medicaid 52

Health Care Law Brief

JUNE 2, 2022

In addition, the PHE fueled a boom in the number of direct-to-consumer (“DTC”) telehealth platforms, many of which have relied upon COVID-19 regulatory waivers to launch and operate in multiple states across the nation. Provider Licenses. Concerns Proliferate for Telehealth Platforms.

Public Health 52

Public Health Compliance COVID-19 Licensing 52

Health Care Law Brief

OCTOBER 27, 2021

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]

Licensing 40

Licensing Telemedicine COVID-19 FDA 40

Bill of Health

APRIL 4, 2024

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.

FDA 282

FDA Regulatory Compliance Malpractice Health Insurance 282

SQA

OCTOBER 18, 2022

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.”

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 Compliance 40

Drug & Device Law

DECEMBER 29, 2023

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.

FDA 105

FDA US Department of Health and Human Services COVID-19 Informed Consent 105