FDA Law Blog

JULY 12, 2022

Mullen — Last month, FDA announced two important steps towards accepting electronic 510(k) submissions. As discussed in an earlier post ( here ), CDRH piloted the eSTAR electronic submission template last year. As discussed in an earlier post ( here ), CDRH piloted the eSTAR electronic submission template last year.

Electronics 52

Electronics Individual Specialization Physicals 52

Annals of Family Medicine

NOVEMBER 20, 2024

Context: Digital Twins (DTs) are innovative tools that blend physical and virtual objects, with potential to transform health care. Study Design: We performed a scoping review searching three electronic databases. Dataset: We systematically searched PubMed, Embase (Ovid), and IEEE Xplore on August 4, 2023.

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Clinic Electronics Screening Physicals 130

Annals of Family Medicine

NOVEMBER 20, 2024

Context: Pre-consultation questionnaires designed to provide rapid assessments of the physical, social, mental and cognitive health of older adults may support effective primary care management and improved patient outcomes for this population.

Primary Care 130

Primary Care Consulting Patient-Centered Electronics 130

Annals of Family Medicine

NOVEMBER 20, 2024

Instrument: Providers randomly received an electronic medical record (EMR)-embedded survey in approximately 10% of telemedicine visits. Population Studied: 87 primary care providers, including family physicians, internists, nurse practitioners, and physician assistants.

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Telemedicine Primary Care Provider Nurse Practitioner 130

Physician's Weekly

JUNE 25, 2025

By 2027, at least 80% of electronic prior authorization requests will be answered in real time, and the process will be easier to do online. Officials are also working to improve access to physical therapy, diagnostic imaging and outpatient surgery. Still, some experts remain skeptical. Talk is cheap,” Gaffney said.

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Insurance Patient-Centered Electronics Physicals 52

Today's Hospitalist

MAY 9, 2025

Focus on hospitalist-specific needs: Ambient systems are increasingly being designed with hospitalists in mind, focusing on such needs as: Capturing detailed physical exam findings: The AI will be able to accurately transcribe and interpret subtle physical exam findings, ensuring comprehensive documentation. Healthcare (Basel).

Patient-Centered 52

Patient-Centered Telemedicine Clinic Electronics 52

Aspiring Minority Doctor

APRIL 18, 2021

There is also the option of electronic health record (EHR) training and support work where you would travel to various hospitals/clinics around the country and train individuals on how to use EMR systems. This would require relocating and I am not aware of how much it pays.

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GP Medical Student Insurance General Practitioner 52

FDA Law Blog

NOVEMBER 9, 2021

Lenz, Senior Medical Device Regulation Expert — FDA introduced electronic copies (eCopies) of 510(k)s in 2013 (see our prior blogs here and here ) as a way to reduce the need for submission of paper copies of 510(k)s to the Agency. This pilot program, which utilized FDA’s eSubmitter electronic submission template, ended in May 2021.

Electronics 40

Electronics Physicals Provider Utilities 40

FDA Law Blog

SEPTEMBER 22, 2024

This process includes requesting an ESG (electronic submission gateway) account, submitting a “test MDR submission”, and sending FDA a copy of the “pass” acknowledgement (AcK3) to the eMDR help desk to request approval for a production account, all of which can take some time before the laboratory is able to submit MDR electronically.

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Manufacturing Electronics Provider Management 64

PEMBlog

AUGUST 30, 2023

System level innovations such as the electronic health platform, including order entry, were intended to improve efficiency but may result in the unintended consequence of making it easier to order a chest radiograph without substantiating the need or in conflict with best clinical practice guidelines.

Asthma 52

Asthma Electronics Utilities Clinical Practice 52

The Motivated MD

OCTOBER 10, 2024

You spend your life dedicated to patient care while still hoping to leave work and have the energy to be mentally and physically present for your families and friends. How should doctors invest their money? You are already a hardworking professional.

Finance 52

Finance Individual Management IT 52

FDA Law Blog

AUGUST 10, 2023

The Secretary’s request shall include a sufficient description of the records requested. Remote review of records in lieu of an inspection is known as a “paper inspection” or, in FDA guidance , a “remote regulatory assessment.”

Manufacturing 52

Manufacturing Electronics IT Physicals 52

CDOCS

MAY 18, 2021

Different techniques are used for exposing the photoresist, and these are through contact exposure, proximity exposure, projection, direct laser imaging, and electron beam.</p> This is typically done with wavelengths less than 400nm (Ultra-violet rays).

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IT Electronics Specialization Physicals 52

FDA Law Blog

SEPTEMBER 17, 2023

CDRH recently announced its acceptance and hosting of in-person meetings, including hybrid options that allow for both physical and virtual participation. Additionally, recent visitors did not have to scan their identification cards through an electronic machine. Our recent experiences indicate that is no longer the practice.

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Screening Transportation Provider Electronics 59

33 Charts

OCTOBER 2, 2021

It’s the physics of physician bandwidth: You can’t add something without taking something away. It’s everything written here about electronic health records. The problem is that doctors work in what I call a zero-sum medical day. Essentially, there are only so many hours in the day to handle new inputs. Happy reading.

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Patients IT Provider Family Doctor 75

FDA Law Blog

MARCH 20, 2022

In recognition that hard copy communications are slower and more cumbersome, FDA recommends that firms use electronic communications, as they lay out the details of the electronic means here , to notify the public about recalls.

Electronics 40

Electronics Manufacturing Provider IT 40

Annals of Family Medicine

NOVEMBER 20, 2024

Instrument Electronic survey to assess sludge encountered in the CRC screening process (0-100 visual analog scale for five sludge types), treatment burden (Treatment Burden Questionnaire), and whether screening was delayed/skipped. Outcome Measures Independent variables: MCC status (none, Physical, Mental, Physical+Mental); sludge score.

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Chronic Condition Screening Physicals Electronics 130

FDA Law Blog

MAY 20, 2021

As the starting point for the audit, the investigators use a physical count conducted by the registrant, usually a biennial inventory taken at least a year prior. The registrant’s employees together with the investigators conduct a closing physical count of the drugs to be audited.

Management 40

Management Consulting Provider Physicals 40

FDA Law Blog

MAY 20, 2021

As the starting point for the audit, the investigators use a physical count conducted by the registrant, usually a biennial inventory taken at least a year prior. The registrant’s employees together with the investigators conduct a closing physical count of the drugs to be audited.

Management 40

Management Consulting Provider Physicals 40

GeriPal

JULY 19, 2024

I heard this beautiful thing the other day, which was to an electronic medical record, I am not a whole person. There’s plenty more to learn, but within the knowledge base that we currently have, we can do a lot of good for people. And this is not about treating dementia as a disease of the brain in isolation from the person.

Screening 120

Screening Primary Care Patient-Centered IT 120

Mesa Family Physician

MARCH 6, 2025

Age-appropriate physical examination that typically covers heart, lung, abdominal, skin, neurological, and musculoskeletal assessments. Health risk assessment considering factors like diet, physical activity, sleep patterns, stress levels, tobacco or alcohol use, and other lifestyle elements that significantly impact your health trajectory.

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Preventative Care Preventive Care Appointment Screening 100

Medical Xpress

JUNE 16, 2025

A 2024 study published in the journal Nature Medicine found that military veterans with brain injuries saw major mental and physical improvements after just one ibogaine session. Some studies suggest it may help people stop using opioids or other drugs, even after just one session. In Brazil, the therapy has helped thousands.

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Mental Health IT Medical Specialization 52

The Clinical Problem Solvers

DECEMBER 20, 2021

difficulty of sending patient messages through the electronic medical record in languages other than English), limited healthcare literacy, and English-only signage on healthcare campuses are just a few of the structurally racist barriers faced by many Asian folks seeking healthcare. Insufficient language services (i.e.,

Community 52

Community Patient-Centered Relationship Healthcare 52

FDA Law Blog

JULY 7, 2024

FDA regulations define a complaint expansively, to include “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.” [2] MDRs must be reported to FDA in electronic format.

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

Medical Xpress

JUNE 16, 2025

This achievement is the result of an interdisciplinary collaboration among researchers in life science, physics, and computer science. Dr. Po-Ting Yeh, the studys first author, explains the challenge: "It is difficult to study the basic physiological functions controlled by the hypothalamus, which lies deep inside the brain.

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Provider Medical Complication Diabetes 109

Georgetown Pediatrics & Family Medicine

FEBRUARY 10, 2023

There are a lot of physical obstacles (pets in the bed, partners snoring…etc), mental obstacles (anxiety, PTSD … etc), health obstacles (waking up to urinate, coughing etc. ), and unhealthy routines (caffeine intake, playing with your phones …etc) that contribute to this issue. The bedroom is recommended only for sleep.

Primary Care Physician 40

Primary Care Physician DO Family Medicine Appointment 40

The Motivated MD

SEPTEMBER 19, 2024

This way, you are always on track to meet your savings goals while limiting the physical and mental effort needed to get there. Do yourself a favor and set your finances up to remove ‘you’ from the equation. Set it and forget it!

Finance 52

Finance Individual Education Healthcare Professional 52

GeriPal

DECEMBER 8, 2022

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. Bennett, C.R., What Mattered Then, Now, and Always: Illness Narratives From Persons of Color.

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Patient-Centered Illness Healthcare IT 116

GeriPal

JULY 28, 2022

And as a resident, I just was drawn, similar to many oncology clinicians and fellows, to just be traumatic and difficult experience of patients with blood cancers during prolonged and intense hospitalizations, where they experience a lot of physical symptoms, emotional trauma related to the diagnoses. Areej: That’s exactly right.

Illness 111

Illness Hospital Patient-Centered Patients 111

GeriPal

JULY 21, 2022

Or somebody who has other physical cognitive problems at any age. This is something we’ve heard from people: that if you just bring it up every year as part of your routine physical, like, “Any concerns about driving?” Or have electronic health record prompts so people remember to ask it?

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IT Families Family Diagnosis 102

GeriPal

DECEMBER 15, 2022

And so mine is here at the University of Colorado system, so a non-VA system, so different electronic health records, we have Epic. And so began the journey of, okay, how can we emulate what they’re doing with a different electronic health record program? ” So lo and behold, that’s how I met Thor. And then came back.

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IT Patient-Centered Healthcare Illness 106

GeriPal

SEPTEMBER 7, 2023

And then the duo, physical and cognitive function, those are the seven that… Alex: Oh, that’s a good way of remembering it. So pretty soon, I hope, we’ll be able to do this all electronically by anyone who wants to. Or electronically, to fill out, right? Drugs has to do with polypharmacy. I like it, John.

Patient-Centered 130

Patient-Centered IT Patients Clinic 130

GeriPal

JUNE 15, 2023

Audio: [electronic voice] Alex Smith has been taken over by an artificial intelligence. I actually like reading books and the physical,” and what the internet 2.0 This is Eric Widera. Eric: I’m not sure if people could hear that, but that’s artificial intelligence – Alex Smith is here.

IT 100

IT Patient-Centered Patients Healthcare 100

GeriPal

FEBRUARY 29, 2024

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? And, they thought, “This is a racket.

IT 127

IT Patient-Centered Illness Education 127

PEMBlog

MARCH 27, 2024

You won’t be able to diagnose them on history and physical alone. Therefore, in the ED, the goal is really to recognize the science and symptoms on history and physical exam that are suggestive of metabolic disease. Now, first off, realize that most IEMs present with very nonspecific clinical features. So get the ABCs, start D10.

Consulting 59

Consulting Individual Families Family 59

GeriPal

JUNE 19, 2025

Gender expression is your physical outward manifestation of how you express your gender identity. So in your electronic health records, I think it’s really important to have that and include a question about pronouns and assigned sex at birth, because that’s the only way for us to really see the individual for who they are.

Individual 82

Individual Community IT Chronic Condition 82

GeriPal

MARCH 28, 2024

Kate: So it was an embedded alert in the electronic health record and they just clicked those two answers very quickly. And that helped them focus on that instead of, say, the blood pressure, the vasopressors or the ventilator settings that day. Eric: And how did you do that? I’m going to go to stem cell transplants.

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Consulting Patient-Centered IT Patients 116