Expert Mentor Session Part 3: Intellectual Property and Disclaimers on Business Contracts

This video is Part 3 of a 9-Part Series excerpted from an Expert Mentor Session held by Michael H. Cohen, JD and Dr. Sunny Smith, MD on July 3rd, 2020.

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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

Expert Mentor Session Part 2: Can a Disclaimer Help Protect My Business?

This video is Part 2 of a 9-Part Series excerpted from an Expert Mentor Session held by Michael H. Cohen, JD and Dr. Sunny Smith, MD on July 3rd, 2020.

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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?

September 2020 FDA Warning Letters

FDA and FTC warning letters continue to find violations of the FD&C Act when companies boast their products can cure or treat diseases such as COVID-19.

Expert Mentor Session Part 1: Importance of a Business Contract

This video is Part 1 of a 9-Part Series excerpted from an Expert Mentor Session held by Michael H. Cohen, JD and Dr. Sunny Smith, MD on July 3rd, 2020.

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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.

Do Telemedicine Laws Require a Minimum Number of In-Person Visits?

In today’s video, we discuss what are the minimum number of times per year and that a physician must see a patient, in-person, prior to treating the patient via telehealth?

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FDA Warning Letters Can Cause Cosmetic Companies to Lose Revenue and Face Substantial Fines

FDA might classify your cosmetics product as a new drug if you make disease claims for your cosmetics product. FDA also requires that you substantiate your claims and have safe ingredients