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FDA Updates the Regulatory Definitions of Certain Software Types for Consistency with 21st Century Cures Act Exclusions

FDA Law Blog

Remove non-device software functions intended for storing and retrieving, so that a medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. By McKenzie E. Certain types of clinical decision-support software. Medical Image Storage Device.

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New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law Blog

Since the first issuance of FDA’s guidance Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” in 2016, sponsors submitting premarket submissions to FDA have had the option of using these techniques to evaluate certain biocompatibility endpoints.

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Kaiser Permanente study shows screening efforts cut colorectal cancer deaths in half

Permanente Medicine

From 2012 to 2016, death rates from colorectal cancer among Black people were nearly 40% higher than in whites and double that seen in Asians and Pacific Islanders, according to the American Cancer Society. The electronic health record system automatically prompts care teams to schedule patients for health screenings.

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PC Trials at State of Science: Tom LeBlanc, Kate Courtright, & Corita Grudzen

GeriPal

Kate: So it was an embedded alert in the electronic health record and they just clicked those two answers very quickly. Eric: And that’s similar to the 2016 JAMA paper, right? Did it negate everything from the 2016 trial?Palliative Eric: And how did you do that? Tom: That’s probably true. So what did this one show?

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Palliative care for cancer: Podcast with Jennifer Temel and Areej El-Jawahri

GeriPal

But at that time I was struck by how in that field, there wasn’t a focus or really interest in symptom management and support for patients and their families. They supported patients, they gave them a holding environment, they did symptom management, yada, yada, yada, like all the things we know palliative care clinicians do.

Illness 110
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GeriPal 300th Episode: Ask Me Anything Hot Ones Style

GeriPal

Alex: And, they were talking about how they were so annoyed because they felt like they got called so frequently by companies trying to sell them electronic wheelchairs. Why are all these companies after me trying to get my money and get me an electronic wheelchair? Alex: And, it means pain management. ” Love it.

IT 126
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Storycatching: Podcast with Heather Coats and Thor Ringler

GeriPal

Integration of Person-Centered Narratives Into the Electronic Health Record: Study Protocol. Connection — The Integration of a Person-Centered Narrative Intervention into the Electronic Health Record : An implementation study. So like I said, I got to meet Thor, I believe it was May, 2016. Bennett, C.R., Schilling, L.,