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

Health Care Law Brief

Therefore, a telehealth platform operating in all 50 states will, for example, need to comport with the laws governing corporate formation, provider licensure, scope of practice, and telehealth encounters in all 50 states. Provider Licenses. What types of providers will render care via telehealth? How is this disclosed to consumers?

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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. Such laws and regulations are largely governed at the state level, and there may be (i) considerable variations among state laws and (ii) frequent updates to such laws. 1] [link]. [2] 2] [link]. [3]

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EU and US Regulatory Challenges Facing AI Health Care Innovator Firms

Bill of Health

On top of that comprehensive rulebook, the European Data Strategy bundle of laws encompasses the EU General Data Protection Regulation (GDPR), the Free Flow of Non-Personal Data Regulation, the Data Governance Act and the Data Act, as part of the EC’s ambition to establish a single unified market for data. Sectoral US Laws In the U.S.,

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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

2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. Further, the plaintiffs’ arguments were based on scientific standards “not utilized by the FDA,” and thus preempted. Polansky v. 3d 239 (Cal.

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