Healthcare & FDA Law Blog

The advantages and risks of using an MSO after your medical practice buys another medical practice or merges with another medical practice.

The US Department of Health and Human Services Office for Civil Rights announced on April 12, 2023 that the Notification of Enforcement Discretion – issued through HIPAA would end on May 11, 2023, when the COVID-19 public health emergency officially ends. HIPAA stands for the Health Insurance Portability and Accountability Act of 1966 (HIPAA). Any [...]

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 ChatGPT use.

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 equivalence test.

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