On June 28, 2023, Roosevelt University (“RU”) filed a notice of data breach with the Attorney General of Maine after…
Read More →The layperson’s expectation is that products work as designed, safely, and without putting the public at risk. But while that…
Read More →The New York State Office of the Medicaid Inspector General (“OMIG”) recently posted on its website a Compliance Program Self-Assessment…
Read More →With the ever-growing adaptation of software in all realms of health care, the market for software for medical devices (SaMD)…
Read More →Analysis by Julie Dautermann, Competitive Intelligence Analyst – This update helps automotive suppliers inform their legal and operational decisions to help…
Read More →Homeopathic drugs have an unusual status in the United States. On the one hand, they are incorporated into the Federal…
Read More →As previously discussed here, the IRS published guidance in December 2022 effectively postponing the January 1, 2023 effective date for…
Read More →The U.S. Food and Drug Administration (FDA or Agency) on June 23, 2023, released its first draft guidance concerning design…
Read More →Through the vicissitudes of the continuing chaos of subject matter eligibility, Senators Coons and Tillis have been steadfast in attempting…
Read More →AI is already capable of doing all sorts of tasks that, until recently, could only have been done by humans.…
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