Annals of Family Medicine

NOVEMBER 20, 2024

Reviews were identified through a search of scientific electronic databases: MEDLINE, CINAHL, PsycInfo, AMED, Healthcare Administration Database, ABI/INFORM Collection, Cochrane Database of Systematic Reviews, Epistemonikos, and Scopus. Results: Thirteen reviews published in English from 2010 to 2023 were included.

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Annals of Family Medicine

NOVEMBER 20, 2024

Context: In response to a call initiated by CIHR in 2023, inviting patient, public, and community participation, the Patient Council of the Canadian Primary Care Research Network (CPCRN) responded with a Report on March 25, 2024. Results: The Pan-Canadian Patient Council met electronically to co-analyze and interpret the themes.

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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. Identify strategies to mitigate bias and stigma in the electronic health record as a trainee and medical practitioner.

Electronics 52

Electronics Internal Medicine Patient-Centered Healthcare 52

Annals of Family Medicine

NOVEMBER 20, 2024

Objective: To assess provider perceptions of the clinical effectiveness of telemedicine video visits, immediately post-encounter, compared to in-person visits. Setting: Providers across six Northern California clinic sites surveyed over an 8-week period (March 21-May 16, 2023).

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Physician's Weekly

JUNE 17, 2025

from Massachusetts General Hospital in Boston, and colleagues conducted a retrospective cohort study using electronic health record data from March 1, 2020, to Aug. Vinod Rao, M.D.,

Telehealth 52

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Annals of Family Medicine

NOVEMBER 20, 2024

Context: Weight loss is desired by many patients, but many primary care practices struggle to provide this care. Setting or Data Set: Semi-structured interviews conducted with clinicians and staff between February 2021 and October 2023 (N=220). Outcome Measures: Key themes and adoption groupings.

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Annals of Family Medicine

NOVEMBER 20, 2024

This analysis was part of a larger implementation study called PATHWEIGH, which provides a toolset embedded in the EpicTM electronic health record and other supportive services to help practices provide weight management to their patients. We utilized AI tools in the qualitative software program Atlas.ti

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Physicians Alliance of Connecticut

MAY 27, 2025

Their role improves the patient experience and helps doctors, nurses, and other providers work more efficiently. Scheduling patient appointments and ensuring providers’ schedules are well-organized. Scheduling patient appointments and ensuring providers’ schedules are well-organized.

Healthcare 52

Healthcare Private Practice Electronics Management 52

FDA Law Blog

SEPTEMBER 11, 2023

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. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R.

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Medical Electronics Manufacturing Utilities 64

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.

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Physician's Weekly

JUNE 25, 2025

Insurance companies have promised changes like these before, in 2018 and 2023, but many didn’t follow through, Dr. Mehmet Oz , head of the Centers for Medicare & Medicaid Services (CMS), said. Insurers must provide clearer explanations when care is denied and explain how patients can appeal.

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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. It offers us a path toward reclaiming our time, reducing burnout and ultimately enhancing the care we provide.

Patient-Centered 52

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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

Physician's Weekly

JUNE 24, 2025

Deana Hendrickson, 66, who provides daily care for three young grandsons in Los Angeles, sought an additional MMR shot, though she was vaccinated against measles, mumps, and rubella as a child, in case her immunity to measles had waned. .” “I’m sort of hectoring,” she acknowledged.

Vaccination 52

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The Clinical Problem Solvers

SEPTEMBER 19, 2024

Interconception Care for Primary Care Providers: Consensus Recommendations on Preconception and Postpartum Management of Reproductive-Age Patients With Medical Comorbidities. Clinician Response to Patient Medication Prices Displayed in the Electronic Health Record. References Ogunwole, S. Zakaria, S., Vaught, A. Toth-Manikowski, S.

Internal Medicine 52

Internal Medicine Patient-Centered Specialization Community 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. The development of an electronic submission template for 510(k) submissions is significant in that: eSTAR submissions are not expected to go through the refuse to accept (RTA) process. add-to-files).

Electronics 45

Electronics Medical Screening IT 45

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.

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Electronics Manufacturing Provider Medical 59

FDA Law Blog

DECEMBER 4, 2023

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. 11, 2023 ( DOJ Press Release ). 6, 2023 ( DOJ Press Release ). By Larry K. Complaint ¶ 62. Complaint ¶ 63.

Treatment Plan 139

Treatment Plan ER Government Patient-Centered 139

FDA Law Blog

FEBRUARY 27, 2025

While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3). Meanwhile, Annex 2, which provides guidance on pragmatic and decentralized clinical trials as well as trials incorporating real-world data, is expected to be finalized by ICH later in 2025.

Clinical Practice 88

Clinical Practice Clinic Government Management 88

FDA Law Blog

AUGUST 27, 2023

As industry is well aware, by the terms of the statute, the DSCSA’s interoperability provisions become effective ten years after its 2013 enactment, or on November 27, 2023. Drug manufacturers have had electronic systems in place since 2017. By Karla L.

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Supply Chain Electronics Manufacturing Provider 52

The Clinical Problem Solvers

MARCH 14, 2025

There are a growing number of Child Psychiatric Access Programs, including one in Massachusetts, which provide quick access to psychiatric consultation and facilitates referrals for accessing ongoing behavioral health care. Diversifying your mental health outreach goes hand in hand with diversifying your providers. 2022;31(2):211-221.

Mental Health 52

Mental Health Community Patient-Centered Hospital 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 ). On September 29, 2023, FDA released a draft guidance on Electronic Submission Template for Medical Device De Novo Requests. By Philip Won & Allyson B.

Medical 52

Medical Electronics Provider Screening 52

FDA Law Blog

MAY 13, 2024

RWD can be collected from a wide range of sources, such as electronic health records, registries, administrative claims, pharmacy data, and feedback from wearables and mobile technology. Rather than looking at how RWD/RWE provide meaningful information on safety and effectiveness, reviewers often focus on perceived gaps.

Medical 111

Medical Clinic Patients IT 111

FDA Law Blog

JUNE 27, 2023

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. FDA does not define, however, when information submitted is deemed to be “complete.”

Manufacturing 59

Manufacturing Utilities Electronics IT 59

FDA Law Blog

JUNE 21, 2023

enable individuals to have virtual consultations with healthcare providers through video calls or online platforms), at-home diagnostics (e.g., enable individuals to have virtual consultations with healthcare providers through video calls or online platforms), at-home diagnostics (e.g., telemedicine and telehealth solutions (e.g.,

Medical 45

Medical Patients Healthcare Electronics 45

FDA Law Blog

MAY 4, 2023

In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories. With regard to clinical trial visits and activities, the draft guidance provides examples of the types of approaches that may be possible with a DCT.

Clinic 59

Clinic Telehealth Provider Electronics 59

FDA Law Blog

OCTOBER 7, 2024

27, 2024), the plaintiff H&P challenged an FDA administrative complaint assessing a civil money penalty of $20,678 for H&P sale of an electronic cigarette without FDA authorization. H&P specifically relies on the Supreme Court decision in Jarkesy , as well as the 2023 Supreme Court decision in Axon Enterprise, Inc.

Electronics 59

Electronics IT Government Clinic 59

FDA Law Blog

JANUARY 5, 2023

Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well. By John W.M.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

FDA Law Blog

FEBRUARY 15, 2023

FDA is making these updates in part due to recognition that some of the records and reporting requirements are unnecessary to comply with the Electronic Product Radiation Control (EPRC) program (sections 532, 534(a)(1), and 537(b) of the FD&C Act (21 U.S.C. The final rule will be effective February 21, 2023.

Manufacturing 52

Manufacturing Electronics Medical Clinic 52

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

SEPTEMBER 17, 2023

Once your request for an in-person or hybrid meeting is agreed upon, you are expected to provide a list of in-person and virtual attendees. If FDA is slow in providing that list, it is fine to send a follow-up email requesting a list of FDA attendees in advance of the meeting. Be ready with backup options (e.g.,

Screening 59

Screening Transportation Provider Electronics 59

FDA Law Blog

OCTOBER 18, 2022

On October 17, 2022, FDA published the list of CDRH proposed guidances for FY 2023 (see here ). electronic thermometers, single lumen needles, piston syringes). Also part of FDA’s FY2023 guidance document plan is a retrospective review of guidance documents issued in 1993, 2003, and 2013.

Medical 52

Medical Electronics Complication Clinic 52

FDA Law Blog

FEBRUARY 28, 2023

FDA announced on October 3, 2022 that the voluntary electronic Submission Template And Resource (eSTAR) templates would be required beginning October 1, 2023, as we blogged about here. There are additionally places to provide attachments for test reports and other supporting documents. New Labeling Requirements.

Provider 52

Provider Electronics IT Complication 52

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.

Patients 130

Patients Patient-Centered Primary Care Electronics 130

FDA Law Blog

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. Below, we provide a high-level summary of the Final Guidance, focusing on the legal and regulatory updates from the May 2023 draft guidance.

Manufacturing 105

Manufacturing Provider IT Electronics 105

Medical Xpress

JUNE 16, 2025

DOI: 10.1038/s41467-025-58661-1 Journal information: Nature Communications Provided by National Taiwan University Citation : Rewiring the body clock: Deep brain imaging reveals unexpected complexity in jet lag adjustment (2025, June 16) retrieved 16 June 2025 from [link] This document is subject to copyright. Your feedback is important to us.

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Provider Complication Medical Diabetes 109

Medical Xpress

JUNE 16, 2025

The content is provided for information purposes only. Citation : Texas invests $50M in psychedelic drug research to treat addiction (2025, June 16) retrieved 16 June 2025 from [link] This document is subject to copyright. Your feedback is important to us. However, we do not guarantee individual replies due to the high volume of messages.

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Mental Health IT Medical Specialization 52