Health Law Advisor

JULY 5, 2022

Thus, in terms of metrics, medical device companies should not adopt as a goal reducing recalls, as that will lead to behavior that could put users at risk by leaving bad products on the market. In presenting the data, I eliminated one medical specialty, “medical genetics,” because there were so few reported. Background.

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Total HIPAA

SEPTEMBER 11, 2019

PHI is the combination of any health-related information (like a diagnosis or medical record) with a unique personal identifier. Any information that ties medical data to a specific person constitutes PHI and must be protected accordingly. The Privacy Rule (2003). However, this list is not exhaustive. The Security Rule (2005).

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Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 23, 37 (2003) (“the phrase refers to the producer of the tangible goods that are offered for sale, and not to the author of any idea, concept, or communication embodied in those goods”). 2003), review denied (Cal.

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Drug & Device Law

JUNE 1, 2023

Accord Long Beach Memorial Medical Center v. 2003) (a court that “permits [an expert] to testify as an expert without first determining whether he or she has a sufficient basis” is “abdicating its evidentiary gatekeeping responsibilities”) (footnote omitted). Advanced Micro Devices, Inc. , Advanced Micro Devices, Inc.

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Drug & Device Law

JANUARY 30, 2023

The availability of this type of cutting-edge presentations is yet another reason why drug and medical device manufactures would be well served by joining PLAC. For those of you accessing the Blog on mobile devices, this post may be hard to read. So, here are links to both the slide images and the accompanying text.

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FDA Fraud Governance Medicare 72

Drug & Device Law

APRIL 18, 2022

The Wisconsin guest post let us know about a pending decision that – we all hoped – would take that state out of the “no state appellate precedent” category altogether: Wisconsin has recently made it to the red zone, and may soon cross the goal line, with the Wisconsin Court of Appeals’ forthcoming decision in Rennick v. Teleflex Med.

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Drug & Device Law

AUGUST 26, 2022

Atrium Medical Corp. , — F. The court indicated the hernia device at issue, the month when it was implanted, and the month when plaintiffs sued. 2003) (“[C]ourts are to assist the plaintiff by allowing jurisdictional discovery unless the plaintiff’s claim is ‘clearly frivolous.’ ”).” 3d –, 2022 WL 3357485 (E.D. 3d 446 (3d Cir.

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