Healthcare Law

Pharmacies need to ensure their staff complies with HIPAA’s Privacy Rule, Security Rule, and Breach Notification Rule – and implement “best practices” to help ensure compliance.

The FTC’s new healthcare product compliance guidelines explain the broad range the agency has to find that marketers are liable for deceptive advertising

The FDA recently approved the drug, of Leqembi, a treatment of Alzheimer’s disease, through the accelerated approval process.

ChatGPT will help doctors and medical practices keep better records, review medications, track diseases, and monitor patients. Healthcare providers need to understand the legal rules that govern [...]

The FDA has approved Transcranial Magnetic Stimulation (TMS) treatments for depression and obsessive-compulsive disorders. Other treatments may be FDA-approved based on the substantial [...]

Developers and manufacturers of medical devices need to understand 510 (k) approval of medical devices and other FDA compliance issues.

Developers and manufacturers of medical devices need to understand how FDA classifies the devices and the criteria for approval

Managed Service Organizations Can Help Medical Practices Comply with Stark Law, the Anti-Kickback Statute (AKS), and Corporate Practice of Medicine Laws

Developers and manufacturers of stem cell therapies need to understand how to conduct clinical trials in order to process FDA investigational new drug (IND) applications.

A MSO helps separate the medical side of a med spa from the business side of the med spa. A properly drafted MSA helps clarify the roles of the MSO and federal and state compliance issues.