Healthcare & FDA Law Blog
How MSOs Can Help Medical Practices After a Merger or an Acquisition – Part One
The advantages and risks of using an MSO after your medical practice buys another medical practice or merges with another medical practice.
HIPAA Notification of Enforcement Discretion During COVID-19 Emergency Ends
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 [...]
HIPAA Compliance for Pharmacies Part One: HIPAA Rules and Best Practices
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.
New FTC Healthcare Product Compliance Guidance Aims to Correct “Urban Myths” That Have Circulated about FTC Substantiation Standards
The FTC’s new healthcare product compliance guidelines explain the broad range the agency has to find that marketers are liable for deceptive advertising
FDA Grants Accelerated Approval for a New Alzheimer’s Disease Treatment
The FDA recently approved the drug, of Leqembi, a treatment of Alzheimer’s disease, through the accelerated approval process.
The Possibilities and Legal Risks of ChatGPT for Doctors and Medical Practices
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 Transcranial Magnetic Stimulation Approval Process
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.
Understanding the Medical Device Classification and Approval Process – Part Two
Developers and manufacturers of medical devices need to understand 510 (k) approval of medical devices and other FDA compliance issues.
Understanding the Medical Device Classification and Approval Process – Part One
Developers and manufacturers of medical devices need to understand how FDA classifies the devices and the criteria for approval