Definition FDA Informed Consent 
Bill of Health
JULY 14, 2023
The federal government’s commitment to assuring that participants in human subject research provide fully informed consent dates back to the U.S In 2017, Congress acted again to update the Common Rule and strengthen the provisions related to consent. While the U.S. These warnings echo those of the U.S.
Healthcare Law Today
JANUARY 20, 2022
Food & Drug Administration (FDA) recently issued draft guidance regarding the use of digital health technology (DHT) for the remote acquisition of clinical trial data. The FDA, however, does not regulate all DHT products because the products do not always meet the definition of a medical device, e.g., a general wellness device.
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Healthcare IT Today
JUNE 13, 2024
Data security also remains a pervasive worry, with insufficient reassurance to allay fears of breaches or unauthorized access to sensitive patient information. Enhancing the interpretability of AI models and promoting informed consent empower patients to understand and control how their data is used in AI applications.
Healthcare Law Blog
AUGUST 9, 2023
The bill amends the existing Women’s Right to Know Act with the expansion of the definition of abortion. The information included in this article is current as of August 1, 2023, but it does not address all potential legal issues or jurisdictional differences, and the information presented may no longer be current. [1]
Drug & Device Law
DECEMBER 21, 2023
FDA , 78 F.4th 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. The questionable allegations of that single complaint thus effectively trumped many years of the FDA’s science-based decision-making. The FDA, for one, advised patients to keep using these drugs.
Drug & Device Law
NOVEMBER 28, 2022
While cosmetic talc is not a drug or medical device, the FDA also regulates it (the “C” in the FDCA). While the compensation claims did “not definitively establish” other asbestos exposure, plaintiff “nonetheless made statements. . ., 11-17 (Jan. may well be factually applicable to Dr.
Drug & Device Law
AUGUST 8, 2022
Anyway, this fraudulent “doctor” allegedly “touched them without informed consent” and caused them “emotional distress. Nor could a trade association be liable for common-law negligence in either jurisdiction: “[P]ublication of testing standards and ingredient definitions did not create any legal duty to the general public.”
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