The Clinical Problem Solvers

DECEMBER 16, 2020

Nwamaka Eneanya and Jennifer Tsai to discuss the limitations and harms of race-based medicine in clinical practice. Our guests explain how we can incorporate race-conscious medicine in clinical settings, medical education, and biomedical/epidemiological research to responsibly recognize and address the harms of racial inequality.

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

Annals of Family Medicine

NOVEMBER 20, 2024

Context: The COVID pandemic disrupted global healthcare, impacting academic medical centers (AMCs) in the United States, necessitating a comprehensive understanding of its effects on healthcare delivery and utilization. Study Design: This retrospective case series analysis utilizes Vizient’s clinical database data. compared to 2.1

Utilities 130

Utilities Healthcare Patient-Centered Illness 130

Today's Hospitalist

MAY 9, 2025

Since the mid-1990s, our capacity for innovation has never stopped as hospitalists navigate a complex landscape of acute illnesses, interprofessional collaborations and the imperative to provide efficient, high-quality care. Yet this expansion has come with a significant administrative burden, particularly that of clinical documentation.

Patient-Centered 52

Patient-Centered Telemedicine Clinic Electronics 52

The Clinical Problem Solvers

APRIL 3, 2023

[link] CPSolvers: Anti-Racism in Medicine Series Episode 20 – Medical Racism and Indigenous Peoples Show Notes by Sudarshan (“Sud”) Krishnamurthy April 4, 2023 Summary: This episode highlights the checkered past of medicine and the advancements in the field that have occurred at the expense of the humanity of Indigenous peoples.

Medical 52

Medical Healthcare Individual Community 52

The Clinical Problem Solvers

MARCH 14, 2025

Dr. Benton mentors clinical and research physicians, fellows, and postdoctoral trainees. Clinically, he cares for youth and families through the Department of Psychiatry & Behavioral Sciences and the new Division of Addiction Medicine at Boston Children’s Hospital.

Mental Health 52

Mental Health Community Patient-Centered Hospital 52

The Clinical Problem Solvers

SEPTEMBER 19, 2024

Michelle Ogunwole, MD, PhD, an internist and social epidemiologist who specializes in the care of women with chronic medical conditions and racial disparities in maternal health outcomes, and Dr. Caroline Sloan, MD, a general internist whose research focuses on how financial considerations are imbued into medical decision-making.

Internal Medicine 52

Internal Medicine Patient-Centered Specialization Community 52

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

FEBRUARY 28, 2022

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ). The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies.

Patients 52

Patients Clinic Medical Patient-Centered 52

FDA Law Blog

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). RWE is “the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.” By Jeffrey N.

Medical 111

Medical Clinic Patients IT 111

The Clinical Problem Solvers

APRIL 24, 2025

Dr. Benton mentors clinical and research physicians, fellows, and postdoctoral trainees. Clinically, he cares for youth and families through the Department of Psychiatry & Behavioral Sciences and the new Division of Addiction Medicine at Boston Children’s Hospital. Child and Adolescent Psychiatric Clinics of North America.

Mental Health 52

Mental Health Community Hospital Appointment 52

FDA Law Blog

SEPTEMBER 30, 2022

This approval decision charts a path for the exercise of appropriate flexibility in regulatory decisions for other rare conditions where there is a serious and/or life-threatening unmet medical need, as is very often the case. Hyman, Phelps & McNamara, P.C.’s This is evidence of FDA’s embrace of patient-focused drug development.

Community 98

Community Provider Patients Specialization 98

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

FDA Law Blog

AUGUST 12, 2021

As a result of this decision, Semglee can now be substituted for Lantus prescriptions without the intervention of a health care provider in accordance with state substitution regulations. Thus, though Semglee is not new to the market, it is for the first time substitutable for Lantus without intervention of a health care provider.

Clinic 98

Clinic Provider IT Patients 98

FDA Law Blog

OCTOBER 2, 2023

The eagerly anticipated guidance, Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence (i.e., Instead, FDA’s determination of whether a single study plus confirmatory evidence could provide substantial evidence is to be “based on relevant science.”

IT 64

IT Clinic Provider Medical 64

FDA Law Blog

OCTOBER 11, 2022

For the past two years, CDER’s Guidance Agenda has included a spot for this eagerly anticipated guidance, tentatively titled ‘Meeting the Substantial Evidence Standard Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence’. Some may confuse this requirement for two studies as a need for replication.

Clinic 61

Clinic Provider IT Patient-Centered 61

PEMBlog

APRIL 22, 2025

While we pride ourselves on providing high-quality care for all children, we must acknowledge that the noisy, fast-paced, and unpredictable environment of the ED can be especially distressing for autistic patients. Discuss options like oral medications, intranasal routes, or the presence of trusted caregivers during procedures.

Families 80

Families Family Patient-Centered Physicals 80

FDA Law Blog

MAY 8, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. In February 2020, FDA granted a de novo classification request (DEN190040) for software intended to assist medical professionals in the acquisition of cardiac ultrasound images and that included a PCCP for future software modifications.

Manufacturing 98

Manufacturing Provider Medical IT 98

FDA Law Blog

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

Medical 64

Medical Electronics Manufacturing Utilities 64

FDA Law Blog

OCTOBER 14, 2021

Rather, FDA seems intent on regulating RAS devices almost as if they were therapeutics responsible for long term clinical outcomes. It is well out of bounds for FDA to regulate them as if they were a determinant of long term clinical outcomes. We support FDA’s general efforts to inform healthcare providers and protect patient safety.

Patient-Centered 52

Patient-Centered Healthcare Manufacturing Provider 52

FDA Law Blog

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

FDA Law Blog

JUNE 29, 2022

The Expedited Programs Guidance describes situations warranting rescission as when emerging data no longer support the BTD, another product gains traditional approval and evidence is not provided that the designated drug may demonstrate substantial approval over the approved product, or when the program is no longer being pursued.

IT 52

IT Clinic Provider Medical 52

PEMBlog

SEPTEMBER 27, 2023

The diagnosis of a virus illness is generally made clinically with a history and clinical exam and does not require confirmatory testing. A negative test can also provide false reassurance. Reasons to not order a comprehensive respiratory viral panel (i.e., for bronchiolitis and 1.5% isolation for SARS-CoV-2).

Patients 52

Patients Illness Hospital Management 52

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. Dr. Baum was the columnist for American Medical News for more than 25 years.

Patients 52

Patients Private Practice Management Healthcare 52

FDA Law Blog

JUNE 23, 2021

I have witnessed it inform whether clinical trial results are clinically meaningful (or not) as well as the selection and even development of primary endpoints. Cavazzoni lays out is the traditional way in which patients have informed drug benefit-risk decision-making: by setting the “clinical context” of the disease.

Patients 52

Patients Patient-Centered Clinic IT 52

FDA Law Blog

JULY 10, 2023

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. By Philip Won & Adrienne R.

Provider 75

Provider IT Engineering Medical 75

FDA Law Blog

JANUARY 6, 2022

In general, EKRA prohibits, knowingly and willfully, soliciting, receiving, paying or offering kickbacks in exchange for referring to, inducing a referral to, or using the services of a recovery home, clinical treatment facility, or laboratory. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 24(b) (emphasis added). 18 U.S.C. § 220(b)(2).

Lab Testing 52

Lab Testing Individual Referral Patient-Centered 52

FDA Law Blog

JANUARY 6, 2022

In general, EKRA prohibits, knowingly and willfully, soliciting, receiving, paying or offering kickbacks in exchange for referring to, inducing a referral to, or using the services of a recovery home, clinical treatment facility, or laboratory. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 24(b) (emphasis added). 18 U.S.C. § 220(b)(2).

Lab Testing 40

Lab Testing Individual Referral Patient-Centered 40

GeriPal

MAY 18, 2023

Summary Transcript Summary Hot off the press is a brand spanking new updated 2023 AGS Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. The Beers Criteria is one of the most frequently cited reference tools in geriatrics, detailing potentially inappropriate medications to prescribe to older people.

Medical 97

Medical IT Patients Clinic 97

Annals of Family Medicine

NOVEMBER 20, 2024

Context: Appropriate use of medication is a key indicator of the quality of care provided in long-term care (LTC). Objective: To determine whether resident-facility language concordance/discordance is associated with the odds of potentially inappropriate prescribing of antipsychotics (PIP-AP) in LTC.

Patients 130

Patients Provider Individual Hospital 130

BMJ

FEBRUARY 8, 2021

7 The same degree of focus has not been paid to misuse of other prescription medications which also have high abuse potential among youth, including medications such as prescription stimulants, tranquilizers, and sedatives. misuse of prescription medications). 2 Opioids contribute a large share of this overdose crisis.

Medical 40

Medical Holistic Care Healthcare Healthcare Professional 40

The Clinical Problem Solvers

FEBRUARY 8, 2023

Between 2007 – 2019, Black individuals experienced a higher death rate for opioid overdose deaths than any other racial or ethnic group. This parallels another process, which is the medicalization of human experiences, especially those relating to childbirth and pregnancy. She then ties this back to Dr.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

The Clinical Problem Solvers

APRIL 5, 2022

Do you have a medical respite center? Dr. Kushel and Mr. Watts remind healthcare providers to speak out about the structural causes of homelessness. This episode was hosted by Sudarshan Krishnamurthy, Jazzmin Williams, and Alec Calac. Calac, Victor A. Lopez-Carmen, MPH, Naomi F. Can you refer your patient there? 3.

Community 52

Community Patient-Centered Emergency Room Medical 52

The Clinical Problem Solvers

DECEMBER 20, 2021

Highlight how structural racism against Asian-Americans surfaces in clinical settings, and describe means of counteracting such structures. provision in only English +/- Spanish), limitations of medical technology (i.e., provision in only English +/- Spanish), limitations of medical technology (i.e., January 19, 2021.

Community 52

Community Patient-Centered Relationship Healthcare 52

FDA Law Blog

JUNE 7, 2021

Subpart H) pathway in 2014, then issued it as final guidance in January 2019. However, the FDA guidance goes on to say in some cases, additional context is needed by specifically inserting a sentence in the indications statement that: no clinical benefit has been established.

Clinic 98

Clinic IT Private Practice Utilities 98

GeriPal

MARCH 9, 2023

FDA is considering approval, shifting away from Schedule I restrictions, paving the way for use in clinical practice. In our prior podcast with Ira Byock on psychedelics in 2019 we talked primarily about the potential of psychedelics. I’m part of a clinical trial that’s housed at the Lundquist Institute down at Harbor-UCLA.

Patient-Centered 91

Patient-Centered Community IT Medical 91

My Green Doctor

MAY 29, 2025

Investing in climate-smart healthcare infrastructure—clinics that can withstand extreme heat, storms, and flooding. At My Green Doctor, we help clinics and health professionals build climate resilience from the ground up. At My Green Doctor, we help clinics and health professionals build climate resilience from the ground up.

Healthcare Professional 52

Healthcare Professional Healthcare Finance Education 52

GeriPal

MARCH 2, 2023

AFP 2019 Gabapentin for chronic neuropathic pain in adults. Eric: Any other interesting tidbits or facts that we should know as providers about gabapentin or Lyrica dosing or pharmacology? It’s not a controlled substance medication. Eric: So I heard gabapentin is the 10th most commonly prescribed medication in the US.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96