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June Roundup of FDA and FTC Warning Letters To Healthcare Companies Claiming COVID 19 Treatments and Cures

The Federal Trade Commission (FTC) and Federal Drug Administration (FDA) are continuing to send warning letters to companies that promise treatments and cures for COVID-19

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A Summary of Federal and State Health Laws on the California Health and Human Services Website – Privacy, Breaches, and other Patient Right Issues

Doctors, medical practices, and health businesses in California need to be aware of the relevant federal and state laws that regulate their practice and industry – including those on the CHHS website.

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

Key provisions of the FDA’s proposed regulatory framework of software that uses and adapts to artificial intelligence and machine learning

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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

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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 [...]

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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.

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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

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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

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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.

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Strong Compliance Plans for Small Medical Practices

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