Annals of Family Medicine

NOVEMBER 20, 2024

Understanding health information seeking behavior is critical in providing effective interventions and improving quality of life for patients, especially for those facing complex health needs. The data was obtained from the 2022 Health Information National Trends Survey® (HINTS). Objectives. Conclusions.

Patients 130

Patients Family Families Government 130

ABIM

JUNE 20, 2025

ABIM Governance provides a meaningful and rewarding opportunity to join outstanding colleagues in service to the profession and to patients. Read more about how ABIM chooses members of governance. In addition to positions for physicians, these include several openings for patients/caregivers and healthcare team members.

Government 40

Government Board-Certified Internal Medicine Community 40

California Academy of Family Physicians (CAFP)

MAY 14, 2025

Key Health Care Budget Proposals: Proposed Medi-Cal Cuts and Enrollment Changes Medi-Cal, California’s Medicaid program, is typically funded through a partnership between the state and the federal government. To fill that gap, California has chosen to use state-only funds to provide certain Medi-Cal benefits to undocumented Californians.

Healthcare 204

Healthcare Family Physician Management Individual 204

Annals of Family Medicine

NOVEMBER 20, 2024

Context: Adults with complex needs require health and social services from a variety of providers, which can lead to frequent use of services. Outcome Measures: Organizational and governance factors influencing the implementation of ICP, and recommendations to facilitate scale-up. Study Design: A qualitative multiple-case study design.

Integrated Care 130

Integrated Care Primary Care Healthcare Professional Management 130

Physician's Weekly

JUNE 19, 2025

Had she signed up for the government insurance plan when she turned 65, Diamond could have avoided a financially perilous situation that left her unexpectedly responsible for the medical costs she incurred during that time. Some of those providers are now seeking payment from her. “It’s horrifying,” she said.

Insurance 52

Insurance Patient-Centered Government Provider 52

The Physicians Foundation

FEBRUARY 14, 2025

Scorecard with National and State Level Data Reveals Workforce Shortages, Low Primary Care Reimbursement, and Reduced Patient Access to Vital Services February 18, 2025 – As the nation faces a widespread surge in chronic diseases, the third Primary Care Scorecard highlights how systemic disinvestment in U.S. Key findings include: 1.

Primary Care 52

Primary Care Chronic Disease Primary Care Physician Nurse Practitioner 52

Permanente Medicine

APRIL 16, 2025

NWP and TPMG are physician-led, independent Permanente Medical Groups who partner exclusively with Kaiser Foundation Health Plan to provide care for their patients in Oregon, southwest Washington, and Northern California. TPMG comprises nearly 10,000 physicians in 116 specialties, providing care for 4.6

Medical 52

Medical Patient-Centered Community Hospital 52

FDA Law

APRIL 10, 2025

While much of the focus has been on how these cuts may impact application review timelines and industry engagement, see earlier post about the effect on generic drugs, another quieter consequence is emerging a significant slowdown in the availability of information that FDA is required to produce under the Freedom of Information Act (FOIA).

Government 59

Government Provider Community Individual 59

BMJ

AUGUST 20, 2021

doi: 10.1136/fmch-2020-000845 The appetite for and ability to collect accurate digital patient-level data in low-resource settings has fueled numerous massive global health initiatives. As impressive as these large numbers may be, the question that is less often asked is “How much of that big data is actually helping us do better?”

Patient-Centered 40

Patient-Centered Provider Clinic Patients 40

PEMBlog

JUNE 7, 2023

There are protocols in place that assist highly trained Emergency Medical Service providers in assuring that agitated children are safely transported to their destination. Government. NASEMSO: Clinical care and restraint of agitated or combative patients by emergency medical service practitioners. Prehosp Emerg Care.

Transportation 122

Transportation Patient-Centered Management Finance 122

33 Charts

OCTOBER 2, 2021

Medicine is facing a crisis of information. Beyond the increase of biomedical information are rising demands for physician response to portal messaging (MyChart messages) and review of wearable generated data. More recently health professionals have seen a rise in MyChart messages coming in through the Epic patient portal.

Patients 75

Patients IT Provider Family Doctor 75

Permanente Medicine

MAY 20, 2025

Khang Nguyen, MD, chief transformation officer of the Southern California Permanente Medical Group, discusses how AI can increase clinicians’ joy in medicine and improve patient outcomes with Chris Grant, chief operating offer and executive vice president of Kaiser Permanente, The Permanente Federation, and host of the Permanente Medicine Podcast.

Patient-Centered 52

Patient-Centered Patients Medical IT 52

FDA Law

FEBRUARY 27, 2025

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. The guideline expands its focus on data governance and clearly defines the roles and responsibilities of sponsors, investigators, and service providers.

Clinical Practice 88

Clinical Practice Clinic Government Management 88

ABIM

APRIL 24, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Upgrades to the ABIM website and Physician Portal for 2025 designed to make it easier for both physicians and the public to find information. McDonald affirmed as a long-term goal.

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

FDA Law

FEBRUARY 20, 2023

This case was the latest example of government regulators punishing a company that refused to live up to its promises of consumer data protection. That Rule requires data companies to notify consumers and regulators of unauthorized disclosures of consumers’ personal health information. The penalty of $1.5 million is, well, not a lot.

Patient-Centered 105

Patient-Centered Telehealth IT Government 105

FDA Law

NOVEMBER 30, 2022

According to the Realtor, these CIP qualification discrepancies “may lead to contamination” and “…over time [lead to] to adulterated [Gamunex] product and significant risk of patient harm.” These CIP equipment qualification reports were provided to the FDA in support of its PAS and PAI to approve the new facility.

Manufacturing 72

Manufacturing Government Healthcare Management 72

BMJ

JULY 17, 2020

4 This short article draws on lessons learnt from other infectious disease outbreaks, such as HIV and Ebola, to help inform approaches to COVID-19-related stigma within China. 8 For example, prestigious medical schools and hospitals could use official WeChat accounts to share information and news with the general public.

Community 40

Community Individual Physicals Finance 40

FDA Law

JUNE 2, 2025

Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. District Court for the Eastern District of Texass decision vacating the LDT Rule lapsed without the government doing so. By Steven J. Gonzalez & Allyson B.

IT 64

IT Manufacturing Government Clinic 64

FDA Law

MAY 7, 2025

Two recent cases from the Fifth and Seventh Circuits, however, support the legality of these arrangements in the absence of the government proving certain circumstances. Mallory , 988 F.3d 3d 730 (4th Cir. Sorenson follows the Fifth Circuits decision last year in United States v. Marchetti, 96 F.4th Marchetti, 96 F.4th Medicare or Medicaid).

Referral 59

Referral Relationship Government Healthcare 59

FDA Law

OCTOBER 10, 2022

The final guidance therefore may have significant implications for a wide range of stakeholders, including not only software developers but also health care providers, hospitals, patients and payors. FDA gives no rationale for interpreting the apparently broad statutory term “medical information” in such a restrictive manner.

Clinic 52

Clinic Medical Provider Patients 52

FDA Law

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. Specifically, that it allows for fast production of “patient-matched devices” (i.e.,

Medical 98

Medical Manufacturing Healthcare Government 98

The Clinical Problem Solvers

NOVEMBER 22, 2021

Dr. Neuner reminds us of the importance of centering Indigenous Peoples in our research and data because this information helps drive policy and health initiatives that can address barriers to health in the community. Do not exclude Indigenous peoples in your research narratives. If you’re going to, acknowledge your limitations.

Community 52

Community Patient-Centered Medical Student Medical 52

FDA Law

MARCH 6, 2024

More information about the conference can be found here. Charles assists clients across a range of FDA-related regulatory matters by providing timely strategic advice on new drug and biologic development and helping them tackle complex regulatory issues. For complete information on the conference, click here.

Management 59

Management Manufacturing Government Specialization 59

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. Joe, your thoughts?

Screening 119

Screening Primary Care Patient-Centered IT 119

FDA Law

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. Specifically, that it allows for fast production of “patient-matched devices” (i.e.,

Medical 75

Medical Manufacturing Healthcare Government 75

FDA Law

SEPTEMBER 6, 2022

As the new Federal Register notice explains, FDA issued the 2016 Guidance in question and answer format to respond to the most frequently asked questions about charging for investigational drugs provided under an IND for either clinical trials or expanded access for treatment use under 21 CFR section 312.8. Changes from the 2016 Guidance.

Clinic 52

Clinic Manufacturing Patients IT 52

FDA Law

MARCH 1, 2023

The purpose of these two pilot programs was initially to inform development of a FDA rating system to characterize the QMM of a facility. The report recommends using a QMM rating that is shared throughout the market (purchasers, consumers, competing manufacturers) to provide manufacturers committed to QMM with a competitive advantage.

Management 45

Management Manufacturing Supply Chain Provider 45

FDA Law

JUNE 16, 2023

Under Minnesota’s Prescription Drug Price Transparency Act , manufacturers must submit detailed pricing information for any generic prescription drug with a WAC of at least $100 for a 30-day supply or shorter course of treatment for which it increased the WAC by 50% or greater over the previous 12-month period.

Manufacturing 45

Manufacturing Provider Consulting IT 45

FDA Law

SEPTEMBER 29, 2021

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

Manufacturing 52

Manufacturing Government Referral Provider 52

FDA Law

JANUARY 12, 2025

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. By Charles G. Raver & James E. Valentine & Ellis Unger & Frank J.

Clinic 64

Clinic Relationship Provider IT 64

FDA Law

JUNE 27, 2024

Prescribing Red Flags In the Gulf Med decision, DEA emphasized that “[r]ed flags are circumstances surrounding a prescription that cause a pharmacist to take pause, including signs of diversion or the potential for patient harm.” The expert specifically found that: Patient A.R. The expert specifically found that: Patient A.R.

Insurance 52

Insurance Patients Utilities Chronic Condition 52

FDA Law

JULY 24, 2023

Specifically, FDA determined that Avadel’s Lumryz can “break” Jazz’s ODE because it is “clinically superior” based on Lumryz’s “major contribution to patient care,” rendering it not “the same drug” under the Orphan Drug Act.

Clinic 52

Clinic Provider IT Patients 52

FDA Law

NOVEMBER 2, 2023

These standards would be developed outside the Federal government, leveraging the expertise of the private sector. These meetings have a question-and-answer format to provide clarity to sponsors about the particular topics at hand.

Provider 59

Provider Screening IT Government 59

FDA Law

APRIL 14, 2021

Ask and ye shall receive, if yer requests are vocal and repeated, and ye are patient, and willing to accept less than ye ask for. It says that it expects the regulated entity to cooperate in the use of “livestream and/or pre-recorded video to examine facilities, operations, and data and other information.” By Douglas B. Farquhar —.

Manufacturing 40

Manufacturing IT Provider Government 40

FDA Law

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. His job was governed by an employment contract that contained both salary provisions and restrictive covenants.

Lab Testing 52

Lab Testing Referral Individual Patient-Centered 52

FDA Law

MAY 3, 2021

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. Background. 21 U.S.C. §

Management 52

Management Manufacturing Specialization IT 52

FDA Law

MARCH 20, 2022

The Guidance provides detail on a recalling firm’s responsibilities, preparations, and communications and how the Agency can assist a firm with carrying out its recall responsibilities. FDA maintains a database for recalls of FDA-regulated products based on information gathered from press releases and other public notices. “It

Electronics 40

Electronics Manufacturing Provider IT 40