Healthcare & FDA Law Blog

Mitigate Legal Quagmires While Digital Health Opportunities Expand Your Healthcare Practice and Business by Following These Core Legal Rules

Mitigate Legal Quagmires While Digital Health Opportunities Expand Your Healthcare Practice and Business by Following These Core Legal Rules

California Healthcare Laws and Agencies that Doctors, Health Providers, and Health Companies Should Know Regarding Patient Healthcare Rights

Medical providers and healthcare companies need to know numerous rules that govern the products and services the providers offer. Health providers need to pay special attention to the needs of patients starting with the privacy of patient information.

FTC Warning Letters Target IV Therapy and Vitamin C Therapy Claims for Unsubstantiated COVID-19 Treatments

Federal Trade Commission is sending warning letters after reviewing company websites, social media, and marketing materials for unsubstantiated claims that therapies can prevent, or cure COVID-19.

Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)

The FDA has a new proposal for approving AI and ML software that looks at the total product lifecycle from development to post-market uses and the adaptations the software learns

FTC Sends 45 Warning Letters to Companies Making False Claims that their Products and Treatments Can Prevent or Cure COVID-19

The Federal Trade Commission sent 45 more waring letters to businesses for falsely claiming their supplements, herbs, and other products and therapies could prevent to treat COVID-19

How the California Consumer Privacy Act Affects the Healthcare Industry

The California Consumer Privacy Act Affects the Healthcare Industry goes into effect on January 1, 2020. Failure to comply with the data protection requirements can result in fines and penalties.

Strong Compliance Plans for Small Medical Practices

OIG Compliance guidelines for physicians (MDs, Dos) and small medical practices

The FDA’s Frequently Asked Questions about the Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD) – Part Two

More FDA answers to questions about cannabis-derived CBD drugs, foods, dietary supplements and food products including access to CBD for clinical investigations.

FDA Policy on When Software that Uses Artificial Intelligence and Machine Learning qualifies as a Medical Device

As more artificial intelligence products become available, the FDA is reevaluating its approval criteria. For now, De novo approval and 501(k) are being used along with premarket approval.

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