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District Court Interprets EKRA

FDA Law Blog

A “health care benefit program” is defined as “any public or private plan or contract, affecting commerce, under which any medical benefit, item, or service is provided to any individual, and includes any individual or entity who is providing a medical benefit, item, or service for which payment may be made under the plan or contract.”

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Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

FDA Law Blog

In addition, manufacturers should identify whether the modifications will apply to all devices in the field (referred to as global adaptations) or will be implemented based on a specific clinical site or individual patients” (referred to as local adaptations).

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District Court Interprets EKRA

FDA Law Blog

A “health care benefit program” is defined as “any public or private plan or contract, affecting commerce, under which any medical benefit, item, or service is provided to any individual, and includes any individual or entity who is providing a medical benefit, item, or service for which payment may be made under the plan or contract.”

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Episode 240: Anti-Racism in Medicine Series – Episode 17 – ‘Just’ Births: Reproductive Justice & Black/Indigenous Maternal Health Equity

The Clinical Problem Solvers

Kozhimannil—the Distinguished McKnight University Professor in the Division of Health Policy and Management at the University of Minnesota and Director of the Rural Health Research Center. She urges us to recognize that maternal mortality changes the life trajectories of individuals and communities. Published January 16, 2019.

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AGS Beers Criteria for Potentially Inappropriate Medication Use: A Podcast with Todd Semla and Mike Steinman

GeriPal

Mike: 2019. Eric: 2019. I feel like geriatricians have a, maybe it’s more of a hate/hate relationship with NSAIDs right now. Ruining the patient doctor relationship because you get into a fight about what anti-coagulants should be on. Eric: Or another good example is like for individuals with dementia.

Medical 97
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PC for Patients with Substance Use Disorder: Janet Ho, Sach Kale, Julie Childers

GeriPal

Why the field is moving away from prescribing methadone to bupenorphine; how to manage patients prescribed methadone for opioid use disorder who then develop serious and painful illness – should we/can we split up the once daily dosing to achieve better pain control? When to consider bupenorphine vs methadone? That’s what we do.

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The importance of social connection: Julianne Holt-Lunstad, Thomas Cudjoe, & Carla Perissinotto

GeriPal

I initially got into it because I was really looking at the psychophysiology of stress, and so how stress affects our health and how relationships were always a component of that. But then recognizing that our relationships impact our health even outside the context of stress. I would say that. Alex: You did get big press.

IT 99