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. Therefore, the events surrounding this particular Warning Letter preceded the LDT decision. By Steven J.

IT 64

IT Manufacturing Government Clinic 64

PEMBlog

MAY 31, 2023

When we think of managing agitated patients we think of medicines – but that shouldn’t be our first option. Government. Qualitative study of patient experiences and care observations during agitation events in the emergency department: implications for systems-based practice. 2022 May 11;12(5):e059876. doi: 10.1016/j.psc.2017.05.002.

Management 89

Management Patient-Centered Transportation Finance 89

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 IT Medical 52

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. It permanently bans the company from trafficking-in patient data on several fronts. It’s also the first enforcement action under the 14-year-old FTC Health Breach Notification Rule.

Patient-Centered 105

Patient-Centered Telehealth IT Government 105

FDA Law

JANUARY 5, 2023

To date, regulatory enforcement litigation focused on actual or imminent patient harm has taken a backseat to cybersecurity as FDA continues to update and implement its oversight framework. But a compromised device is a threat to patient safety, so that timeline that could change in the event of an adverse event that imperils consumer health.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

FDA Law

JANUARY 18, 2022

Specifically, that it allows for fast production of “patient-matched devices” (i.e., devices that are fitted specifically to a patient’s anatomy), and anatomical models for surgical planning. complaint handling and adverse event reporting processes) and staff trained in the maintenance of equipment.

Medical 98

Medical Manufacturing Healthcare Government 98

Family Physicians of St. Joseph

MARCH 14, 2018

From the Detroit News If there’s any more argument to be made about getting third-party insurers — whether government or private insurance — out of most routine health care, here’s one. That is, Savage does not work with third-party payers — government or private insurance, period. And it’s a true story.

Insurance 52

Insurance Medical Primary Care Government 52

FDA Law

JANUARY 18, 2022

Specifically, that it allows for fast production of “patient-matched devices” (i.e., devices that are fitted specifically to a patient’s anatomy), and anatomical models for surgical planning. complaint handling and adverse event reporting processes) and staff trained in the maintenance of equipment.

Medical 75

Medical Manufacturing Healthcare Government 75

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. Avadel has intervened as a Defendant, and neither FDA nor Avadel has yet to respond to the Complaint.

Clinic 52

Clinic Provider IT Patients 52

FDA Law

JANUARY 12, 2025

Whether a surrogate or intermediate clinical endpoint (ICE), the endpoint to support accelerated approval is one that can be assessed more rapidly than the ultimate clinical benefit; this is what enables earlier patient access than would be possible while generating the evidence to support a traditional approval, which is typically infeasible.

Clinic 64

Clinic Relationship Provider IT 64

GeriPal

SEPTEMBER 5, 2024

And Bill Andereck is still haunted by the decision he made to have the police break down the door to rescue his patient who attempted suicide in the 1980s, as detailed in this essay in the Cambridge Quarterly of HealthCare Ethics. The patient case. So in some ways, it was an iatrogenic event. Alex 03:33 Yeah.

Patients 98

Patients IT Patient-Centered Hospital 98

FDA Law

DECEMBER 21, 2023

Additionally, there will be smaller touches that often go overlooked like podium branding, event signage, publication cover art and more. But FDLI is also thinking beyond logos and websites—2024 will be filled with events to mark FDLI’s 75th anniversary.

Finance 59

Finance Government Medical IT 59

GeriPal

OCTOBER 20, 2022

And, who within ASPE guides aging policy and connects policy to every day health challenges experienced by patients and clinicians? For the policy buffs and policy newbies out there, we hope this podcast is an essential primer to government in action. difficile that patients are exposed to and antibiotic resistance.

Complication 52

Complication Patient-Centered IT Patients 52

GeriPal

JUNE 26, 2025

Those disruptive events or shocks often portend a major decline in function from which people with dementia never fully recover. Today we talk about disruptive events, or health and wealth shocks. And the government can do something about that?!? Alex 03:41 Okay, so today we’re going to talk about disruptive events.

Illness 93

Illness Hospital IT Patient-Centered 93

GeriPal

MARCH 6, 2025

And this is really traumatic event for his street family and the street community that he knew. And I wonder if that is key in patients, people who are experiencing homelessness as well. Government is not the 51st state. He had overdosed due to a combination of alcohol and street drugs. Or as we said in the podcast, abandonment.

Healthcare 100

Healthcare IT Community Illness 100

GeriPal

MARCH 16, 2023

Rosanne: I think I was motivated by the number of times patients asked me to get rid of their pot-bellies, quite honestly. So I felt like over all these years I have learned so much from my patients and from the science, that it should be out there in one place where people can easily access it and help themselves. Eric: Yeah.

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IT Healthcare Professional Healthcare Transportation 105

GeriPal

DECEMBER 7, 2023

And so any additional stressor such as heat or an extreme weather event or having to move from your home because of a climate related disaster can really tax an older adult whose window of resilience is more limited. And that’s a good thing to share with an older patient or client that making decisions about your activity.

Healthcare 129

Healthcare IT Education Community 129

GeriPal

JULY 6, 2023

I think to some extent, the county doesn’t necessarily know what they don’t know about geriatrics, just like I don’t necessarily know what I don’t know about the county and local government and national government and state government. Is it the patient? Eric: Wait, county 911? Either, or?

Community 89

Community Nurse Practitioner Provider IT 89

Physician's Weekly

JUNE 12, 2025

Centers for Disease Control and Prevention (CDC) database that includes vaccine safety information from millions of patients, according to multiple sources. Children’s Health Defense, an anti-vaccine nonprofit Kennedy once led, is holding an online event this week to mark what it calls the “autism cover-up.” More information The U.S.

Vaccination 52

Vaccination Patient-Centered Government Diagnosis 52

GeriPal

APRIL 20, 2023

Today we talk with Margot Kushel about how we got here, including: That sense of powerlessness as a clinician when you “fix up” a patient in the hospital, only to discharge them to the street knowing things will fall apart. It was in the mid-nineties, and about half of the patients that we cared for in the inpatient service were homeless.

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Mental Health IT Community Individual 123

Physician's Weekly

JUNE 26, 2025

He directed the patients to seek local help. While it’s possible that Nath’s patients suffered covid vaccine injuries, Marks said, their symptoms were so varied it was hard to characterize a possible syndrome. His clinical study was ending. But, Dressen said, there wasn’t any. Kennedy Jr. forced him out in May.

Vaccination 52

Vaccination Patient-Centered Government IT 52

FDA Law

FEBRUARY 20, 2025

Given the numerous changes in policy by the Trump administration, there had been much speculation that the government would now take a different position on this Biden-era rule. Interestingly, counsel focused his arguments exclusively on parrying legal attacks, rather than arguing why the rule was necessary to protect patients.

Patient-Centered 102

Patient-Centered Consulting Government Clinic 102

FDA Law

JANUARY 9, 2024

The government would require at least another 30 days to examine the shipment at the U.S. For example, the Canadian government reiterated its commitment to safeguard Canada’s domestic drug supply and has issued regulations to prohibit bulk exports to the United States that will cause or worsen drug shortages in Canada.

Supply Chain 59

Supply Chain Manufacturing Chronic Condition Government 59