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Healthcare IT Today
AUGUST 9, 2022
Data analytics can be broken down into four distinct categories — diagnostic, descriptive, prescriptive and predictive — all of which analyze both current and historical data to predict certain outcomes as they relate to an individual. Another major ethical concern of AI use surrounds the principle of informed consent.
Healthcare Law Blog
MARCH 17, 2022
The three-component Therapy includes the following: (1) a device to process patient bone marrow (after an extraction procedure); (2) a device to re-inject processed bone marrow into cardiac tissue; and (3) an FDA-approved guide catheter to facilitate placement of processed bone marrow into cardiac issue.
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Health Populi
MAY 30, 2018
This is important because in 2017, one in four new drugs approved by the FDA were designed to treat a small population, falling. into the precision medicine category. Autonomy refers to data subjects’ (patients’) informed consent as a precondition of collecting personal health information agreeing to further uses.
SQA
FEBRUARY 15, 2023
Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.
Drug & Device Law
AUGUST 22, 2022
The plaintiff in Jacob sued the manufacturer of a Class III, FDA premarket-approved medical device. First, the plaintiff’s non-parallel claims were “preempted to the extent” that they would have imposed “alleged labeling or manufacturing requirements that are different from, or in addition to, those imposed by the FDA.” 341 (2001).
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