Healthcare Law

The Food and Drug Administration issued a warning letter to a foreign manufacturer that the substation of methanol for ethanol rendered its produce a new drug, adulterated, and misbranded.

Regulatory compliance review and business review for psychologists, therapists, marriage counselors, health coaches, substance abuse centers, and other practices.

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

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.

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

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

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.

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

Veterinary practices are subject to most of the regulations human medical practices are subject. The rules that govern veterinary practices do differ though because animals are different than people