FDA Law

NOVEMBER 27, 2023

According to the government, these companies knew as early as 2012 that their dehumidifiers were defective, in that they could overheat and catch fire. In 2021, DOJ announced that the Gree Companies agreed to plead guilty to one felony count for willfully failing to report consumer product safety information as required by the CPSA.

Government 104

Government Manufacturing Insurance Individual 104

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. As secondary payer, Diamond’s employer policy picked up 20% of what Medicare would have paid.)

Insurance 52

Insurance Patient-Centered Government Provider 52

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

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. ABIM does not contact individual programs with a lower pass rate to initiate changes to the program.

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

BMJ

AUGUST 20, 2021

Donors, government ministries, agencies and academic partners regularly cascade requests for data that multiply and complicate the simple interaction into a complex, and often redundant, set of data requirements for the same singular interaction. Mobile phone penetration has finally exceeded 90% in low- and middle-income countries.

Patient-Centered 40

Patient-Centered Provider Clinic Patients 40

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. And in my experience the exchange of information from the Cures Act Final Rule has added new dialog around test results.

Patients 75

Patients IT Provider Family Doctor 75

The Clinical Problem Solvers

NOVEMBER 22, 2021

Together, these two phenomenal guests help us understand the structural and individual challenges of Indigenous peoples in academic medicine, public health, and beyond. Sophie Neuner, proud member of the Karuk Tribe, and a Research Associate at the Johns Hopkins Center for American Indian Health.

Community 52

Community Patient-Centered Medical Student Medical 52

Permanente Medicine

MAY 20, 2025

Contributing to this challenge is the exponential growth of information, an expanding population of older adults, and office visit documentation. Information is coming at clinicians, whether they be doctors, nurses, pharmacists, faster than ever, and there is a transparency that exists around us.

Patient-Centered 52

Patient-Centered Patients Medical IT 52

FDA Law

FEBRUARY 13, 2025

The guidance encourages sponsors to engage with FDA using the Q-Submission Program prior to submitting a PCCP in order to obtain FDA feedback on if the proposed modification is suitable for inclusion in a PCCP and what information the PCCP will need to include. FDA may request additional information during the review of the PCCP.

Manufacturing 71

Manufacturing Management Specialization Provider 71

FDA Law

FEBRUARY 27, 2023

In a case involving a challenge to a Freedom of Information Request (“FOIA”) submitted to DEA, the DOJ and DEA appear to now argue that DEA is a “component” of the DOJ and not an agency. The arguments in this case also highlight a longstanding frustration with obtaining FOIA information from the DEA. Aims Institute, PLLC, v.

Manufacturing 45

Manufacturing Government Individual IT 45

FDA Law

JUNE 12, 2023

PFI expressed some of its frustration with the current state of regulation of pet food by individual states in its comments on the Center for Veterinary Medicine (CVM) Virtual Public Meeting FDA and the AAFCO Animal Feed Ingredient Definition Process. PFI has noted that it is not feasible to develop and label products for an individual state.

Manufacturing 45

Manufacturing Individual Government Illness 45

FDA Law

JANUARY 6, 2022

A “health care benefit program” is defined as “any public or private plan or contract, affecting commerce, under which any medical benefit, item, or service is provided to any individual, and includes any individual or entity who is providing a medical benefit, item, or service for which payment may be made under the plan or contract.”

Lab Testing 52

Lab Testing Referral Individual Patient-Centered 52

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. The case law on commission-based marketing agentsincluding the Sorensen decisionfollow in a similar vein. Marchetti , 96 F.4th

Referral 59

Referral Relationship Government Healthcare 59

FDA Law

NOVEMBER 6, 2023

The LMG Life Sciences awards are based on case evidence and feedback from clients and peers and selected by the editors to provide attorneys and law firms with information on the legal market and the U.S. They range from individuals and start-up companies with no in-house legal staff to large multinational corporations.

Government 40

Government Provider Medical Management 40

FDA Law

OCTOBER 10, 2022

Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information. Here again, FDA’s novel interpretation of statutory terms effectively narrows the scope of information that a software product can display, analyze, or print and still be considered Non-Device CDS.

Clinic 52

Clinic Medical Provider Patients 52

FDA Law

MARCH 9, 2023

Our firm has a great deal of experience in pleading with the Government not to prosecute clients that have discovered serious misconduct by employees (including management) and disclosed it to the Government voluntarily. It relies on the Department of Justice to do so, either in the form of CPB or in individual U.S.

Government 52

Government Provider IT Management 52

FDA Law

SEPTEMBER 6, 2022

Below we outline the Draft Guidance and highlight the new information in the 2022 Draft Guidance. The 2022 Draft Guidance keeps all the same 20 questions with minimal tweaks to wording and added just three new questions and answers. The new Q & As (Q21, Q22, and Q23) all concern charging in the context of expanded access.

Clinic 52

Clinic Manufacturing Patients IT 52

FDA Law

JANUARY 6, 2022

A “health care benefit program” is defined as “any public or private plan or contract, affecting commerce, under which any medical benefit, item, or service is provided to any individual, and includes any individual or entity who is providing a medical benefit, item, or service for which payment may be made under the plan or contract.”

Lab Testing 40

Lab Testing Referral Individual Patient-Centered 40

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

NOVEMBER 2, 2023

These standards would be developed outside the Federal government, leveraging the expertise of the private sector. In short, Voluntary Consensus Standards (VCS) are intended to be exactly what the name conveys – standards that are adopted by consensus and are not mandatory (not legal or regulatory requirements).

Provider 59

Provider Screening IT Government 59

FDA Law

JUNE 27, 2024

The Government alleged that Coconut Grove violated numerous federal and state controlled substance laws. The regulation requires that pharmacists “ensure that a reasonable effort is made to obtain” this information. 21 U.S.C. § 823(g)(1)(B), (D). at 50,376. “A 21 C.F.R. §§ 1306.04(a), 21 C.F.R. §§ 1306.04(a), a), 1306.06.

Insurance 52

Insurance Patients Utilities Chronic Condition 52

GeriPal

JULY 19, 2024

What should we use to screen individuals? I don’t have access to change the levers of government. And either of those could be given to the patient or an informant. Anna 43:15 I mean, yeah, as I’ve had, I think in general, primary care doesn’t have a lot of information about how to use these things.

Screening 119

Screening Primary Care Patient-Centered IT 119

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. Community Practice in ABIM Governance* Erica N. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations.

Board-Certified 52

Board-Certified Government Community Education 52

Doctors for America

JUNE 30, 2025

That harm will fall disproportionately on the shoulders of already-marginalized groups, including pregnant people, people with disabilities, low-income families and individuals, and communities of color. Click here for more information.

Healthcare 59

Healthcare Community Families Family 59

FDA Law

FEBRUARY 7, 2024

Gilbert — Last week, DEA and DOJ announced a $59 million civil penalty settlement with eBay related to the failure to comply with Controlled Substances Act (CSA) requirements for identifying purchasers, maintaining records, and filing reports of individuals selling/purchasing pill presses and encapsulating machines.

Government 116

Government Electronics Education Individual 116

The Clinical Problem Solvers

OCTOBER 11, 2021

individual bias or bigotry that leads to a failure to sell a home to a person of color) and personal choices ( e.g. Black people prefer to live among other Black people) is referred to as de facto segregation. These gaps are not a product of lifestyle choices, biology or individual behaviors. Richard Rothstein References Rothstein, R.

Government 52

Government Community Education Individual 52

Medical Xpress

JUNE 16, 2025

In a study published in Nature Communications , led by researchers at National Taiwan University (NTU) and National Tsing Hua University (NTHU), scientists used the deepest-ever two-photon calcium imaging in awake mice to directly observe how individual SCN neurons respond to light. The content is provided for information purposes only.

Provider 111

Provider Medical Complication Diabetes 111

The Clinical Problem Solvers

FEBRUARY 14, 2022

[link] CPSolvers: Anti-Racism in Medicine Series Episode 14: Race, Place, and Health: Clinician and Community Perspectives Show Notes by Alec Calac February 15th, 2022 Summary: This episode highlights how racism manifests in the built environment, and how community and individual-level efforts can mitigate these inequities. Be curious.

Community 52

Community Individual Mental Health IT 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. Community Practice in ABIM Governance* Erica N. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations.

Board-Certified 40

Board-Certified Board-Certified Physicians Government Community 40

FDA Law

NOVEMBER 14, 2021

But like James Bond, companies in the crosshairs of a government investigation have No Time to Die, as they answer to shareholders and fight for corporate survival. To receive such consideration, companies cannot limit disclosure to those individuals believed to be only substantially involved in the criminal conduct.

Individual 52

Individual Government Provider IT 52

GeriPal

JUNE 19, 2025

Just today (June 17th) as we record this podcast: Ezra Klein released a wonderful interview with Sarah McBride , the first openly transgender member of congress A judge ruled that cuts to NIH grants focused on minority groups, including transgender people, were illegal and ordered the government to restore funding. And we also need it.

Individual 85

Individual Community IT Chronic Condition 85

FDA Law

NOVEMBER 18, 2021

The tests are very accurate in detecting individuals with a relatively high viral load (symptomatic or not). On the minus side, a rapid antigen test may miss an infected individual with a low viral load (e.g., The sponsor must gather the requested information and cycle through with a brand new EUA filing. A follow up laboratory?run

Screening 98

Screening Manufacturing Healthcare IT 98

Vida Family Medicine

JUNE 29, 2022

A patient must have the autonomy to choose whether in their individual situation, the potential benefits outweigh the potential harms. I felt that I was not able to provide patients with a full discussion of their options to allow them to come to an informed decision, whether due to time constraints or restrictions from administrators.

Family Physician 52

Family Physician Families Family Healthcare Professional 52

FDA Law

MARCH 15, 2023

See Government Accountability Office, “ GAO-06-724 Mammography: Current Nationwide Capacity Is Adequate, but Access Problems May Exist in Certain Locations ” (July 2006). One key update to the regulation will require that facilities provide information to patients regarding the density of their breasts.

Healthcare 59

Healthcare Diagnosis Provider Individual 59

FDA Law

OCTOBER 17, 2023

Non-Addictive Medical Products to Treat Pain or Addiction The SUPPORT Act ( Public Law 115-271 ) mandated that FDA issue a guidance document to provide information on how the Agency can apply section 515B of the FD&C Act to non-addictive medical products intended to treat pain or addiction. Emphasis added.)

Medical 53

Medical Diagnosis Healthcare Clinic 53

GeriPal

MARCH 6, 2025

We discuss the principles of harm reduction, social determinants of health, and trauma informed care. link] PEACH Good Wishes Program A program that provides meaningful gifts for unhoused individuals who are terminally ill. What we hear is that it is more trauma informed in many contexts to have people first language.

Healthcare 100

Healthcare IT Community Illness 100

GeriPal

JANUARY 20, 2023

There have been multiple subsequent government reports on nursing home care, most recently was about eight, nine years ago from the OIG. Part of it’s what Mike was saying, it’s accountability as a country, as a nation and as the government. Those are evidence-based or evidence-informed tools that have been in practice.

Finance 95

Finance Board-Certified IT Provider 95