FDA Issues Warning Letter to Company that Sells CBD Products Online and Through Social Media

FDA sends warning letter to a company because its website and social media accounts made claims about CBD products that suggest they are drugs or dietary supplements and were misbranded.

New HHS 21st Century Cures Act IT Rule – Part 2

These are two more of the non-fulfillment exceptions to the ONC rule. Another three fulfillment exceptions follow. The exceptions try to balance the ability of the developers and practitioners to [...]

New HHS 21st Century Cures Act IT Rule – Part 1

The Office of the National Coordinator for Health Information Technology (ONC), which is part of the Department of Health and Human Services, approved a final rule which implements certain [...]


New Proposed Rules from the CMS and the OIG-HHS on Stark Law and from the Anti-Kickback Statute

The CMS and HHA are proposing new rules, such as the Patients over Paperwork Initiative, where the focus of Stark and AKS will be on value-based arrangements


How to Resolve Healthcare Legal Roadblocks & Make the Most of Your Healthcare Lawyer

What is it that you want to get out of talking to a healthcare lawyer, an FDA lawyer or really any lawyer?


Judge Confirms FDA Regulation of Stem Cell Industry

A federal judge confirmed that the FDA has the right to regulate for-profit stem-cell therapy treatments. Autologous treatments may require FDA approval as drugs.


Regulatory Compliance for Cosmetics, Nutrition, and Cannabis Companies – Part 1

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


DOJ Penalizes Doctors, Hospitals, & Medical Practices Millions to Settle Allegations of Anti-Kickback Statute Violations

The DOJ reported several new cases in which health care companies and doctors agreed to pay millions to settle claims of healthcare fraud due to AKS and Stark violations.


Compliance Issues For Medical Specialties

Regulatory compliance review and business review for dentists, veterinarians, therapists, and chiropractors


Physician Run and Physician Driven Practices – Part 2

Experienced healthcare lawyers advise doctors, physicians, and medical practices or a full range of regulatory and compliance issues including HIPAA, Stark Law, and the AKS.