The Clinical Problem Solvers

JUNE 26, 2023

[link] CPSolvers: Anti-Racism in Medicine Series Episode 22 – Live from SGIM 2023: Best of Antiracism Research at the Society of General Internal Medicine’s 2023 Annual Meeting Show Notes by Alec J. Describe difficulties and examples of how to measure unconscious race bias in medical practice.

Electronics 52

Electronics Internal Medicine Patient-Centered Healthcare 52

Annals of Family Medicine

NOVEMBER 20, 2024

Study design and analysis: A retrospective matched cohort study using data from more than 70 Dutch general practices collected from 2015 until 2023. Setting or Dataset: The Academic GP Developing Network Database (AHON), containing data from the electronic patient file of more than 460,000 patients was used for analysis.

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Integrated Care News by CFHA

MAY 1, 2025

Traylor and colleagues (2025) show that generative‑AI tools can boost health literacy by translating medical jargon into plain language. Bridging the 17‑Year Research–Practice Gap Implementation scientists estimate that it takes about seventeen years for new evidence to become routine care (Rubin, 2023). References Menchaca, J.

Patient-Centered 130

Patient-Centered Integrated Care Primary Care Healthcare Professional 130

Family Medicine Initiative

APRIL 9, 2024

Demand for new obesity medications like semaglutide (GLP-1 analogs) is high, but availability is low. Yes, one year after stopping the medication, patients regain ½ – ⅔ of their previous weight loss: What are other clinical benefits? So, which patients should get them first? What are the true benefits and side effects?

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Barton Associates

MAY 8, 2025

In this blog, we’re going to outline four key ways temporary medical staff such as locum tenens providers can help healthcare facilities maintain continuity of high-quality patient care in the face of growing shortages. Enter temporary medical staff, such as locum tenens providers. Many healthcare facilities in the U.S.

Medical Staff 52

Medical Staff Medical Patients Healthcare 52

Annals of Family Medicine

NOVEMBER 20, 2024

Context: As academic medical centers purposefully integrate telemedicine visits into primary care, efficacy studies are needed to appropriately guide resource allocation and triage processes. Setting: Providers across six Northern California clinic sites surveyed over an 8-week period (March 21-May 16, 2023).

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Physicians Alliance of Connecticut

MAY 27, 2025

Healthcare administrative assistants manage crucial administrative tasks in medical offices. As a healthcare administrative assistant, your day-to-day tasks may vary depending on the needs of the medical office. Managing accurate, up-to-date electronic health records while protecting patient confidentiality.

Healthcare 52

Healthcare Private Practice Electronics Management 52

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

Physician's Weekly

JUNE 25, 2025

It’s “going to streamline it in some incremental ways only,” Dr. Adam Gaffney , a critical care doctor and assistant professor at Harvard Medical School, told NBC News. Medical professionals will be required to review all denials (though insurers say they already do this).

Insurance 52

Insurance Patient-Centered Electronics Physicals 52

FDA Law Blog

OCTOBER 5, 2022

eSTAR will be mandatory October 1, 2023 for all 510(k) submissions and subsequent supplements and amendments (e.g. eSTAR will be mandatory October 1, 2023 for all 510(k) submissions and subsequent supplements and amendments (e.g. add-to-files). add-to-files). eSTAR submissions are automated (e.g., form construction, auto filling).

Electronics 45

Electronics Medical Screening IT 45

Annals of Family Medicine

NOVEMBER 20, 2024

Population Studied: Individuals identified through electronic medical record (EMR) periodic surveillance with either diagnosed with HCV and either not engaged in treatment or not completed treatment, as well as those needing additional testing (SVR or high-risk re-testing).

Behavioral Health Services 130

Behavioral Health Services Primary Care Patients Healthcare 130

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

Annals of Family Medicine

NOVEMBER 20, 2024

It includes modifications to the EpicTM electronic medical record (EMR) for guidance on treatment alternatives, support for provider-patient communication and goal setting, billing and coding support, and a new visit type called a Weight Prioritized Visit (WPV).

Primary Care 130

Primary Care Management Electronics Provider 130

Annals of Family Medicine

NOVEMBER 20, 2024

to complete an analysis of qualitative data collected from primary care clinician and staff perspectives on the use of anti-obesity medications. Setting or Data Set: Baseline and follow-up semi-structured interviews conducted with clinicians and staff between February 2021 and August 2023 (N=220).

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Primary Care Electronics Provider Management 130

Today's Hospitalist

MAY 9, 2025

But these early systems often struggled with complex medical terminology and the natural flow of conversation. For many of us, the emergence of medical scribes, both in-person and remote, provided a valuable solution, offloading documentation and allowing us to have more focused patient interactions. Dragon Medical One.

Patient-Centered 52

Patient-Centered Telemedicine Clinic Electronics 52

Annals of Family Medicine

NOVEMBER 20, 2024

Study Design and Analysis: Retrospective chart search of the electronic medical records of a specific sub-group of patients at UNMC. Setting: Criteria Time Frame: 2013-01-01 to 2023-12-31. Number of patients who meet inclusion criteria at Family Medicine Clinics: 6,551 Patients. are Not Hispanic or Latino and 87.7%

Internal Medicine 130

Internal Medicine DO Family Medicine Screening 130

FDA Law Blog

JULY 31, 2023

Now, in July 2023, DEA has finally issued its final rule amending its regulations for partial filling of prescriptions for schedule II substances. 46,983 (July 21, 2023). 21 U.S.C. § Partial Filling of Prescriptions for Schedule II Controlled Substances, 85 Fed. 78,282 (Dec. The Final Rule a.

Electronics 98

Electronics Consulting Patients Medical 98

Medical Xpress

FEBRUARY 2, 2023

Analysis of 20 years of electronic health records across the U.S. 8-10, 2023, is a world premier meeting for researchers and clinicians dedicated to the science of stroke and brain health. 8-10, 2023, is a world premier meeting for researchers and clinicians dedicated to the science of stroke and brain health.

Complication 97

Complication Electronics 97

FDA Law Blog

AUGUST 9, 2023

However, electronic prescriptions for controlled substances (“EPCS”), which a practitioner transmits directly to a pharmacy, do not allow the patient such an option. Transfer of Electronic Prescriptions for Schedule II-V Controlled Substances Between Pharmacies for Initial Filling, 88 Fed. 48365, 48369 (July 27, 2023).

Electronics 52

Electronics Patients IT Provider 52

FDA Law Blog

OCTOBER 24, 2023

Mullen — As of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted to FDA using the electronic Submission Template And Resource ( eSTAR ). Currently, eSTAR is voluntary for medical device De Novo submissions, but FDA has initiated the process of requiring De Novos to be submitted using eSTAR.

Medical 52

Medical Electronics Provider Screening 52

Physician's Weekly

JUNE 24, 2025

Robin Wolaner, 71, a retired publisher in Sausalito, California, has been known to badger friends who delay getting recommended shots, sending them relevant medical studies. Some older people are really eager to be vaccinated. “I’m sort of hectoring,” she acknowledged.

Vaccination 52

Vaccination Illness Hospital Patient-Centered 52

FDA Law Blog

DECEMBER 4, 2023

11, 2023 ( DOJ Press Release ). 6, 2023 ( DOJ Press Release ). Pharmacists’ Corresponding Responsibility A controlled substance prescription, to be valid, must be issued for “a legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” Zarzamora Press Release.

Treatment Plan 139

Treatment Plan ER Government Patient-Centered 139

FDA Law Blog

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time.

Electronics 59

Electronics Manufacturing Provider Medical 59

FDA Law Blog

JUNE 21, 2023

Cato — On June 1, CDRH announced that it is seeking public comment on questions regarding how CDRH can facilitate access to medical technologies designed for use outside of traditional clinical settings, particularly in the home. At-home medical technologies include, but are not limited to, monitoring and wearable devices (e.g.,

Medical 45

Medical Patients Healthcare Electronics 45

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

MARCH 14, 2025

Simon is a pediatric addiction medicine psychiatrist at Boston Children’s Hospital; an assistant professor in psychiatry at Harvard Medical School; a recent Commonwealth Fund fellow in health policy at Harvard University; and the medical director of Wayside Youth & Family Support Network.  2023 Apr;21(2):166-7.

Mental Health 52

Mental Health Community Patient-Centered Hospital 52

FDA Law Blog

FEBRUARY 15, 2023

By Véronique Li, Senior Medical Device Regulation Expert & Allyson B. These regulations apply to radiation emitting products, including not just medical devices but all other radiation emitting products as well. The final rule will be effective February 21, 2023. Thus, these regulations apply to a huge variety of products.

Manufacturing 52

Manufacturing Electronics Medical Clinic 52

FDA Law Blog

OCTOBER 18, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — Last week, our blog post advised planning a transition strategy in advance of the news of the termination of the Covid-19 public health emergency. On October 17, 2022, FDA published the list of CDRH proposed guidances for FY 2023 (see here ).

Medical 52

Medical Electronics Complication Clinic 52

FDA Law Blog

JANUARY 5, 2023

In mid-November, FDA collaborated with the MITRE Corporation to publish an update to the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook. Combination products are sharing the digital moment with those classified solely as medical devices. More updates will follow here as trends develop in 2023.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

FDA Law Blog

JUNE 27, 2023

By Véronique Li, Senior Medical Device Regulation Expert & Anne K. On June 12, 2023, FDA issued a public notice to solicit comments on the information collection related to the voluntary submission of allegations of regulatory misconduct to CDRH. Any comments to the public notice must be submitted by August 11, 2023.

Manufacturing 59

Manufacturing Utilities Electronics IT 59

FDA Law Blog

OCTOBER 24, 2022

These data are routinely collected from a variety of sources, such as electronic health records, providing information on health and healthcare in actual patients, rather than in the controlled environment of a clinical trial. This value is potentially even greater for rare diseases, where there are limited sources of data.

Electronics 78

Electronics IT Healthcare Patients 78

FDA Law Blog

MAY 4, 2023

Section 3606(a) of the Food and Drug Omnibus Reform Act (FDORA) directed FDA to “issue or revise draft guidance that includes recommendations to clarify and advance the use of decentralized clinical studies to support the development of drugs and devices,” not later than December 29, 2023. DHTs include monitoring instruments (e.g.,

Clinic 59

Clinic Telehealth Provider Electronics 59

FDA Law Blog

SEPTEMBER 17, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — Over the last three and a half years, meetings with FDA were conducted virtually. 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.

Screening 59

Screening Transportation Provider Electronics 59

FDA Law Blog

FEBRUARY 28, 2023

Lenz, Principal Medical Device Regulation Expert — Since 2005, 510(k) submissions have been formatted according to FDA guidance Format for Traditional and Abbreviated 510(k)s. By Adrienne R. The guidance describes twenty sections to be included in a Traditional or Abbreviated 510(k).

Provider 52

Provider Electronics IT Complication 52

Annals of Family Medicine

NOVEMBER 20, 2024

The Centers for Disease Control and Prevention recommends discussing family planning and preconception counseling at the domestic medical exam (DME), yet there is little guidance on specific counseling needs in this population. Population Studied Inclusion criteria were ages 16-45 with a DME performed between 2018 and 2023.

DO 130

DO Family Medicine Complication Families 130

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

Objective: 1) Demonstrate the feasibility of collecting data from prescription drug monitoring programs (PDMPs) for population health reporting, 2) analyze trends in PDMP and electronic health record patient data relative to CDC guidelines and 3) identify use of patient-centered measures for pain management in primary care.

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Patients Patient-Centered Primary Care Electronics 130