Multistate Coaching Laws & Legal Challenges
In today’s video, we discuss healthcare legal compliance challenges that a healthcare startup might face when it ventures into digital healthcare, and advises its customers on healthcare and [...]
2021 Healthcare Trends
Most 2021 healthcare trends include new technology such as genome editing, mRNA messaging, artificial intelligence, predictive analytics, and advanced EHR systems.
What Happens If You Make Cosmetic, OTC Drug, or Dietary Supplement with Hemp, Cannabis, or THC – Part Two
Healthcare makers, distributors, and sellers must comply with FDA rules and warning letters for their cannabis, hemp, and THC products including foods, OTC drugs, cosmetics, and dietary supplements
Functional Medicine Telemedicine: How Do You Set It Up
Dr. Bob Smith came to our law firm, he was a hospital physician with 15 years’ experience. The hospital let go a lot of its staff, and Dr. Bob decided to open a telemedicine practice focusing on [...]
FDA Reviewing Moderna’s COVID-19 Vaccine
An Advisory Panel for the Food and Drug Administration is reviewing a request by Moderna for its COVID-19 vaccine. Moderna’s vaccine is expected to be distributed in the coming months.
FDA Approves Authorized Use of a COVID-19 Test Product
FDA granted emergency use authorization to Lucira Health Inc. for a COVID-19 self-testing kit. The EUA has numerous conditions that the manufacturer must meet.
FDA Issues Emergency Use Authorization for Pfizer COVID-19 Vaccine
FDA granted an Emergency Use Authorization to a COVID-19 vaccine developed by Pfizer, Inc. Doses of the vaccine have already been administered to health workers
Legal Risk Issues in Regenerative Medicine and Anti-Aging Medicine
As the population ages, health providers and health companies are developing and expanding their regenerative medicine and anti-aging practices. As with all healthcare services and products, [...]
The FDA Provides New Guidance on the “Minimal Manipulation and Homologous Use” of Cell and Tissue Products.
The FDA new guidelines on minimal manipulation include questions and answers. Meeting the minimal manipulation test can save companies a fortune in IND studies and clinical trial tests.
Expert Mentor Session Part 9: When Should You Consider Trademarking?
This video is Part 9 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.
Telehealth – Licensing, mHealth, Online Prescriptions, and Informed Consent
The current status of rules and regulations for telehealth services, mHealth regulations, cross-state licensing, online prescriptions, and informed consent
Telehealth and National Medicaid/Medicare Policies
The current status of rules and regulations for telehealth services including Medicaid and Medicare reimbursement requirement, credentials and privileges, and what services are not considered [...]
Expert Mentor Session Part 8: Forming a Legal Entity
This video is Part 8 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.
3 Ways Marketing Claims Can Destroy Healthcare Companies: FTC, Plaintiff Trolls, & State Regulatory Agencies
Here’s why you need legal review of any information your healthcare company puts out on the Web: advertising claims can not only hurt, they can destroy your healthcare company.
