Healthcare & FDA Law Blog

OIG Advisory Opinion Regarding Possible AKS Violations. Part Two.

OIG advisory opinion provides that payments for travel, lodging, and other costs related to a drug infusion treatment should not violate the federal Anti-Kickback Statute

OIG Advisory Opinion Regarding Possible AKS Violations. Part one.

A pharmaceutical company sought an advisory opinion to determine if payment for travel, lodging, and other costs are an inducement that violates the federal Anti-Kickback Statute.

Compliance and Regulatory Issues for Technical Companies and Ventures

Regulatory compliance and business transactional review of digital health companies and practices including telemedicine, medical software, health hardware, and the IoT.

US FDA Sends Warning Letter to Red Pill Medical That Its CBD Dietary Supplements Violate FDA Rules

FDA sends out another warning letter to CBD companies that promote that company products for medical uses and for treating diseases will be in violation of the FD&A Act.

FAQs About HIPAA and the Right of Access Part two

The US Department of Health and Human Services provides questions and answers to the HIPAA Privacy Rule’s Right of Access. These FAQs directly affect healthcare practices

Regulatory Compliance for Cosmetics, Nutrition, and Cannabis Companies – Part 2

Regulatory compliance of cosmetics, diet, and CBD products including FDA misbranding and adulteration, FTC compliance, labeling requirements, and other legal issues.

FDA Warning Letters for Misbranding Cannabinoid Products as Dietary Supplement on the Rise – Bella Rose Labs

FDA issues warning letter to New York manufacturer for CBD claims that indicates its products are new drugs and do not qualify as dietary supplements

FAQs About HIPAA and the Right of Access, Part one

The US Department of Health and Human Services provides questions and answers to the HIPAA Privacy Rule’s Right of Access. These FAQs directly affect healthcare practices.

Healthcare Business and Transaction Issues for Medical Practices

Legal, business, compliance, and practice issues for the formation and day-to-day administrative and medical operations of medical practices and health specialties

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