FDA Law Blog

JUNE 10, 2024

In an effort to clarify for industry and alleviate some of the stress associated with these activities, last week the FDA issued a draft guidance aimed at providing recommendations on how to handle inspections under FDA’s Bioresearch Monitoring (BIMO) program. 11-12 of the guidance for a list of these resources).

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Provider Electronics Clinical Practice Management 111

ABIM

MAY 7, 2025

Blueprints provide an outline of what content will appear on an assessment and the relative percentage of the assessment covered by each topic area. During this process, Item-Writers will often provide feedback and societies provide their own perspectives on behalf of their members.

Board-Certified Physicians 52

Board-Certified Physicians Board-Certified Provider Specialization 52

FDA Law Blog

MAY 13, 2024

FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices. However, in our experience, there is a large gap between FDA’s lauding the value of RWE and practice.

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Medical Clinic Patients IT 111

The Clinical Problem Solvers

OCTOBER 18, 2022

Our guests remind us to think critically about our role in the carceral system and in imposing systems of control and punishment within clinical settings. Providing communities with the resources they need to survive, such as educational opportunities, jobs, and quality healthcare, will eliminate the need for incarceration.

Healthcare Professional 52

Healthcare Professional Healthcare Patient-Centered Mental Health 52

FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

Clinic 52

Clinic Medical Provider Patients 52

ABIM

APRIL 24, 2025

Upgrades to the ABIM website and Physician Portal for 2025 designed to make it easier for both physicians and the public to find information. Dr. McDonald explained that the LKA provides MOC points for questions answered correctly, but since ABIM is not an accreditation organization, it does not offer CME credit.

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

PEMBlog

AUGUST 30, 2023

As many as 40% of these children will receive a chest x-ray (CXR) during their ED visit despite clinical guidelines advising most of these tests are low value. Understanding root causes of CXR use in the ED clinical setting is key to mitigating overuse of this test. But it’s just a CXR right?

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Asthma Electronics Utilities Clinical Practice 52

GeriPal

JANUARY 23, 2025

Join us as we dive deeper into these studies and discuss the implications for clinical practice and patient care. And there’s so much work on, you know, you’ve got to take these medicines, you got to prevent this treat, that there isn’t that same sort of clinical momentum towards deprescribing. Alex 15:36 Yeah.

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Specialization IT Patient-Centered Medical 119

GeriPal

JUNE 20, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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IT Patient-Centered Patients Clinic 120

GeriPal

JULY 19, 2024

Joe 03:55 You know, my thoughts are screening is important for a variety of reasons, and certainly Doctor Boris and Soo and Anna, Doctor chodos can provide a lot greater clinical insight than I. There has to be effective support provided behind any type of screening strategy in order for it to truly be effective.

Screening 119

Screening Primary Care Patient-Centered IT 119

GeriPal

JANUARY 12, 2023

Not every hospital or every health system is the same physically or financial incentives or which clinical programs exist and patient demographics. ” And the environment that we worked in, in geriatrics, was more of this sharing information and different groups or calling. What is your clinician to patient ratio?

Hospital 100

Hospital Patient-Centered IT Nurse Practitioner 100

GeriPal

MAY 5, 2022

Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. And he is also a clinical audiologist, which is going to be key for this podcast. I’m guessing not. Transcript.

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IT Screening Hospital Clinic 102

Physician's Practice

JUNE 25, 2025

These videos are 5 to 10 minutes in length and will provide practical ideas and suggestions that have been tested in his practice or used by other physicians that significantly improve the efficiency and productivity of their medical practices. About Neil Baum, M.D. He has written a book, What’s Going on Down There?

Patients 52

Patients Private Practice Management Healthcare 52

GeriPal

JUNE 12, 2025

Eric 00:42 So on this podcast, we’re gonna be talking about what every healthcare provider should know about radiation oncology. I’m sort of seeing them in clinic for consideration of palliative radiation, they have a lot going on. Evie, welcome to GeriPal. Evie 00:41 Thank you. Do you have the song request for Alex?

Patient-Centered 102

Patient-Centered Referral Patients IT 102

FDA Law Blog

SEPTEMBER 10, 2023

Interventional studies are generally clinical investigations under the regulations and thus require an IND under 21 C.F.R. § In all cases, applicable requirements regarding informed consent (21 CFR Part 50) and Institutional Review Board review (21 CFR Part 56) must be met.

Provider 108

Provider Patient-Centered Clinic Clinical Practice 108

ABIM

JUNE 4, 2025

Representatives from the American Association of Clinical Endocrinology (AACE), the Association of Program Directors in Endocrinology, Diabetes and Metabolism (APDEM) and the Endocrine Society joined for a portion of the meeting*.

Diabetes 52

Diabetes Board-Certified Telehealth Government 52

ABIM

JUNE 24, 2025

Upgrades to the ABIM website and Physician Portal for 2025, designed to make it easier for both physicians and the public to find information. Preliminary data show that 90% of respondents are clinically active with the majority in hospital- or system-owned practice (38%), academic faculty practice (32.9%) and private practice (26.8%).

Board-Certified 40

Board-Certified Board-Certified Physicians Government Community 40

GeriPal

FEBRUARY 20, 2025

Summary Transcript CME Summary Trauma is a universal experience, and our approach as health care providers to trauma should be universal as well. With that said, there is so much more that I learned from our guests for this trauma-informed care podcast. Eric 00:15 And we have three guests to help us talk about trauma informed care.

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Patient-Centered IT Screening Individual 66

FDA Law Blog

MARCH 17, 2022

Proposed 2022 CDC Clinical Practice Guideline for Prescribing Opioids, 87 Fed. et al, CDC Clinical Practice Guideline for Prescribing Opioids-United States, 2022, CDC. Proposed 2022 CDC Practice Guideline, 7,839. CDC Clinical Practice Guideline, 10. 7,838 (Feb. 10, 2022); Dowell, Deborah, MD.,

Patient-Centered 75

Patient-Centered Clinical Practice Patients Individual 75

ABIM

JUNE 11, 2025

Upgrades to the ABIM website and Physician Portal for 2025 designed to make it easier for both physicians and the public to find information. ABIM’s website features expansive sections on research related to assessment and clinical outcomes. The group discussed some of Dr. McDonald’s updates in greater detail.

Board-Certified 52

Board-Certified Government Community Education 52

FDA Law Blog

MARCH 6, 2025

population due to differences in demographics, practice of medicine, or standard of care. inpatient hospital, out-patient clinic), date range for the data, and location of the data collection sites (e.g., sampled from completely different clinical sites), and any data cleaning or processing performed on the training or tuning data.

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Manufacturing Management Clinical Practice Clinic 105

GeriPal

JANUARY 18, 2024

In particular, we talk about Katie’s and Jesica’s paper in NEJM titled “ Juggling Two Full-Time Jobs — Methadone Clinic Engagement and Cancer Care ,” which described the difficulty in managing cancer pain and methadone for opioid use disorder. AMA PRA Category 1 credit(s) ™. ABIM MOC credit will be offered to subscribers in November, 2024.

Illness 136

Illness Patient-Centered Screening Clinic 136

ABIM

MAY 30, 2025

Upgrades to the ABIM website and Physician Portal for 2025 designed to make it easier to find information for both physicians and the public. Reddy, MPH, Senior Research Associate for ABIM, reviewed aggregate data gathered so far related to nephrologists, including practice setting, practice size and physician ownership of practices.

Board-Certified 40

Board-Certified Government Internal Medicine Private Practice 40

GeriPal

MARCH 9, 2023

FDA is considering approval, shifting away from Schedule I restrictions, paving the way for use in clinical practice. And some people in studies and just in clinical use have found that to be helpful, including for patients with serious illness. If you put on your clinical hats, what is demoralization to you?

Patient-Centered 91

Patient-Centered Community IT Medical 91

GeriPal

JUNE 27, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Illness 129

Illness IT Diagnosis Patient-Centered 129

FDA Law Blog

NOVEMBER 29, 2022

CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022. Expected clinical benefits should be weighed against risks before beginning therapy. Duration should be individualized based on the specific patient’s clinical circumstances. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R.,

Patients 52

Patients ER Patient-Centered Individual 52

GeriPal

FEBRUARY 27, 2025

Substance use disorder is one of those complex issues in which clinical practice is changing rapidly. Sach Kale set up an outpatient clinic focused on substance use disorder for patients with cancer. Do you need to be an addiction medicine trained physician to start such a clinic (no: Sach is not). What do they do?

Patients 72

Patients Clinic Patient-Centered Illness 72

GeriPal

APRIL 4, 2024

The Cruzan ruling led to a flood of interest in Advance Directives, and eventually to the Patient Self Determination Act, which mandates provision of information about advanced directives to all hospitalized patients. Other states set lower bars, including oral assignment of surrogate decision-makers. AMA PRA Category 1 credit(s) ™.

Family 112

Family Families Patient-Centered IT 112

GeriPal

FEBRUARY 29, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

IT 126

IT Patient-Centered Illness Education 126

GeriPal

MARCH 28, 2024

Ten years ago we would have been hard pressed to find 3 clinical trial abstracts submitted to the annual meeting, much less high quality randomized trials with robust measures, sample sizes, and analytics plans. I’m just stunned even writing that! We’ve come so far as a field. Eric: Nudge it. Kate: Nudge it.

Consulting 115

Consulting Patient-Centered IT Patients 115

GeriPal

MAY 25, 2023

LJ: I’ll take that one that I feel really strongly that we are not assessing the right outcomes in advance care planning, and I think that’s part of the problem, is that we I think we do this in a lot of science and a lot of research in clinical medicine too. Hillary or Sarah. Thoughts on that. Hillary: So those all differ.

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Community IT Patient-Centered Primary Care 95

GeriPal

FEBRUARY 9, 2023

Amber tells the moving story of how these findings led a clinical colleague, her chief, to question and change his behavior. Alex: We are delighted to welcome Amber Barnato, who’s a palliative care physician and health service researcher, and she’s director of the Dartmouth Institute for Health Policy and Clinical Practice.

Patient-Centered 111

Patient-Centered Patients IT Healthcare 111

GeriPal

SEPTEMBER 12, 2024

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 backed into that role.

IT 110

IT Healthcare Healthcare Professional Patient-Centered 110

GeriPal

AUGUST 24, 2023

And the role of the palliative care provider is to figure out, knowing that different things affect different people, is what causes somebody in that particular instance to feel their dignity is being undermined. And the data was saying, “What is really important is the way you, the care provider, experience that person.”

Patient-Centered 98

Patient-Centered Patients IT Illness 98

GeriPal

APRIL 24, 2025

We and our guests have noticed that in our clinical practices, patients and caregivers seem to be asking for such treatments more frequently. It’s just that he was foregoing things that we think would have provided him more benefit. And in addition, my work in palliative care, I also am a clinical ethicist.

Patient-Centered 77

Patient-Centered IT Patients Illness 77

GeriPal

FEBRUARY 16, 2023

Alex: And we’re delighted to welcome back to the GeriPal podcast, Keri Brenner, who is also a psychiatrist and palliative care doctor and clinical associate professor at Stanford. I’m really excited about this because clinically this happened to me, somebody was very angry at something we were talking about. Eric: Yeah.

Patients 109

Patients IT Family Families 109

GeriPal

MARCH 10, 2022

Now when I say variation, I’m not talking about small little clinically questionable variations. The Lived Experience of Providing Feeding Assistance to a Family Member with Dementia. Well, I’m a geriatric nurse practitioner and I provided care to over 800 nursing home residents in 11 different nursing homes. Ruth: Sure.

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Nurse Practitioner Hospital Family Families 60