With the ever-growing adaptation of software in all realms of health care, the market for software for medical devices (SaMD)…
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Analysis by Julie Dautermann, Competitive Intelligence Analyst – This update helps automotive suppliers inform their legal and operational decisions to help…
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Homeopathic drugs have an unusual status in the United States. On the one hand, they are incorporated into the Federal…
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As previously discussed here, the IRS published guidance in December 2022 effectively postponing the January 1, 2023 effective date for…
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Technically, it’s “up to $10 million”, but it’s potentially a LOT of money, nevertheless……
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The U.S. Food and Drug Administration (FDA or Agency) on June 23, 2023, released its first draft guidance concerning design…
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Through the vicissitudes of the continuing chaos of subject matter eligibility, Senators Coons and Tillis have been steadfast in attempting…
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AI is already capable of doing all sorts of tasks that, until recently, could only have been done by humans.…
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Continued advancement in artificial intelligence offers great promise to improve health care. But AI feeds on tremendous amounts of data, and…
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The Federal Trade Commission (”FTC”) continues to prove that failing to comply with the Children’s Online Privacy Protection Act (“COPPA”)…
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