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FDA Issues a Draft Guidance for Content of Premarket Submissions for Device Software Functions

FDA Law

Over the past 16 years, there have been numerous advances in healthcare technology, particularly with respect to the use of software in and as a medical device. According to the 2005 software guidance document, FDA used Major, Moderate, or Minor Level of Concern to determine the recommended documentation for software.

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Assisted Living Communities: Podcast with Sheryl Zimmerman, Kenny Lam, and Ken Covinsky

GeriPal

We additionally firmly establish that the song How to Save a Life by the Fray was a product of the aughts (2005, to be exact), not the 90’s ): Enjoy! People saw that there were people who needed to have supportive care, didn’t need to have the level of nursing that was provided in nursing homes, and there was money to be made.

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Well-being and Resilience: a Podcast with Jane Thomas, Naomi Saks, Ishwaria Subbiah

GeriPal

I must admit, though, sometimes it just feels off… inauthentic, as if it’s not a genuine desire to improve our lives as health care providers, but rather a metric to check off or a desire to improve productivity and billing by making the plight of workers a little less miserable. I mean, in other work, hard work environments as well.

IT 110
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Negotiation and Dispute Resolution: A Podcast with Lee Lindquist and Alaine Murawski

GeriPal

Dealing with conflict in caring for the seriously ill: “it was just out of the question” JAMA 2005. In social work, it’s called self-determination of the client, meaning at the end of the day, I can provide resources to this older adult or to this caregiver, whoever it may be. Journal of Patient Experience.