My Green Doctor

MAY 3, 2025

In This Issue : Why Renewable Energy Belongs in Every Clinic Medical Waste: One Model for Improvement OnTrack with your Sustainability Goals? Our Consulting Services offer customized strategies for group practices, health systems, and medical societies ready to accelerate their impact and lead the way in climate-smart care.

Healthcare 52

Healthcare Healthcare Professional Consulting Management 52

FDA Law

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

FDA Law

OCTOBER 2, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Gail H. If a sponsor is able to provide a detailed description of multiple changes with appropriate performance evaluation methods for each, we hope the Agency will be willing to consider them under a single PCCP.

Medical 59

Medical Specialization Manufacturing IT 59

FDA Law

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. Combination products are sharing the digital moment with those classified solely as medical devices. By John W.M.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

FDA Law

FEBRUARY 22, 2023

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec.

Manufacturing 64

Manufacturing Engineering Medical IT 64

FDA Law

JUNE 22, 2023

Most recently, Jeff Shuren, CDRH Director, gave a speech at the 2023 Food and Drug Law Institute (FDLI) annual conference in which he identified facilitating “availability of and access to existing and novel home-use medical technologies” as a strategic priority for 2022-2023 to advance health equity. seeking treatment).

Manufacturing 59

Manufacturing Clinic IT Transportation 59

FDA Law

MAY 3, 2021

Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. DEA seeks to prevent, detect and eliminate the diversion of controlled pharmaceuticals while ensuring their availability for legitimate medical, scientific and industrial purposes. On Commerce, Manufacturing and Trade of the H. Background.

Management 52

Management Manufacturing Specialization IT 52

FDA Law

MARCH 31, 2024

House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Subcommittee Chair Brett Guthrie (R-KY), in announcing the hearing, made their views clear: “FDA has proposed a rule that relies upon dubious and misguided legal, economic, and public health arguments and has provided limited opportunities for stakeholders to offer input.

Patients 64

Patients Medical Provider Manufacturing 64

FDA Law

APRIL 11, 2022

Medtronic Warning Letter) provides an important reminder from FDA as to the correct estimation of risk associated with malfunctions. As background, Medtronic manufactures the MiniMed 600 series insulin infusion pumps. For instance, some products could remain in boxes in hospital inventory for an extended period.

Medical 40

Medical Management Manufacturing Patients 40

FDA Law

OCTOBER 10, 2022

The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions. The CDS Guidance interprets the Cures Act’s definition of “medical software” that is excluded from the statutory “device” definition, as it relates to CDS software.

Clinic 52

Clinic Medical Provider Patients 52

FDA Law

JULY 5, 2023

Outsourcing facilities are not exempt from FDA’s cGMP for drug manufacturers (as lightly tweaked via cGMP Guidance for outsourcing facilities ) or adverse event reporting requirements , and are subject to regular inspection by FDA. Section II at 2. Draft Guidance III.B.2(e) Draft Guidance III.B.2(d)

Supply Chain 52

Supply Chain Manufacturing Physicals Healthcare 52

FDA Law

MAY 3, 2021

Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. DEA seeks to prevent, detect and eliminate the diversion of controlled pharmaceuticals while ensuring their availability for legitimate medical, scientific and industrial purposes. On Commerce, Manufacturing and Trade of the H. Background.

Management 40

Management Manufacturing Specialization IT 40

GeriPal

MAY 5, 2022

COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. So this is a podcast going at the geriatricians and palliative care providers. Including more hospital utilization or healthcare utilization, maybe cognitive impairment issues. My own work focuses on hospitalization and health utilization over time.

IT 102

IT Screening Hospital Clinic 102

Annals of Family Medicine

NOVEMBER 20, 2024

Context: The ExPAND Mifepristone (ExPAND) learning collaborative is a year-long program focused on growing the pool of abortion providers by integrating medication abortion into primary care. Objectives: 1) Participating clinics begin to provide mifepristone for early pregnancy loss (EPL) and/or abortion care.

Primary Care 130

Primary Care Clinic Referral Provider 130

FDA Law

MARCH 6, 2025

Lenz, Principal Medical Device Regulation Expert & Lisa M. For non-AI-enabled devices, the early feasibility research may not directly affect the development process, i.e., the final, finished device can be fully developed, transferred to a controlled manufacturing environment, and tested under a design controls process.

Manufacturing 105

Manufacturing Management Clinical Practice Clinic 105

FDA Law

SEPTEMBER 28, 2022

Valley Hospital, Inc. 25, 2022), [link] , considered whether a provider’s use of a medical device that is the subject of an FDA safety communication constitutes per se evidence of wanton disregard, which would warrant punitive damages. The New Jersey Punitive Damages Act (PDA) provides that “punitive damages may be awarded.

Provider 59

Provider Hospital Patients Manufacturing 59

Alabama Academy of Family Physicians

FEBRUARY 19, 2025

Running from February 4 to May 15, this session promises to bring substantial changes to medical consent laws, Medicaid coverage, rural hospital funding, taxation on essential goods, and the transparency of healthcare costs. Here’s a brief overview of the key pieces of legislation that AAFP is diligently monitoring.

Insurance 130

Insurance Management Hospital Vaccination 130

FDA Law

OCTOBER 17, 2023

Compared to the previous version, the new guidance document highlights that the Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or healthcare disparities and to certain non-addictive medical products to treat pain or addiction. By Philip Won & Lisa M.

Medical 53

Medical Diagnosis Healthcare Clinic 53

FDA Law

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. MRAP would provide oversight of an accreditation body which would conduct assessments—paid for by the manufacturer—based on criteria developed by the MRAP. In Section I.A,

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

GeriPal

MARCH 2, 2023

Eric: And we have Tasce Bongiovanni, who is an acute care trauma surgeon at UCSF and the San Francisco General Hospital. Eric: Any other interesting tidbits or facts that we should know as providers about gabapentin or Lyrica dosing or pharmacology? It’s not a controlled substance medication. Nisha: Thank you so much.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

FDA Law

JANUARY 18, 2024

FDA found that marijuana continued to have a high potential for abuse, lacked accepted safety for use under medical supervision and had no currently accepted medical use in treatment in the United States. Schedule I drugs have a high potential for abuse and no currently accepted medical use in treatment in the U.S. 21 U.S.C. §

Medical 69

Medical Physicals IT Healthcare Professional 69

GeriPal

MAY 8, 2025

Vincent’s Hospital in Melbourne, Australia. Alex 06:03 Is psilocybin that’s used for medicinal purposes in your studies, for example, is that manufactured or is it derived directly from mushrooms? So medication adjustments. James, welcome to the GeriPal Podcast. James 00:32 Good afternoon. Im b leary eyed.

Illness 107

Illness IT Patient-Centered Patients 107

GeriPal

MARCH 24, 2022

And I don’t think necessarily, that appointment needs to be a medicalized process. And I would say too, as a primary care provider, it really doesn’t take that long to ask people about a surrogate decision maker. So every transition into the hospital, every transition out of the hospital. Who are they?

Illness 72

Illness IT Healthcare Patient-Centered 72

GeriPal

DECEMBER 7, 2023

And so we do see hospital admissions for heat exposure and certainly cardiovascular and respiratory problems related to air pollution with climate change and also cognitive problems. What do we do to very concretely provide heat shelters and cool shelters? I mean, many people in their mid to older years are on certain medications.

Healthcare 129

Healthcare IT Education Community 129

Alabama Academy of Family Physicians

FEBRUARY 20, 2025

By Wes Stubblefield, MD, MPH, FAAP ADPH Medical Officer H5N1 influenza, or “bird flu,” is a type of influenza that was first discovered in the 1950s. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed. For the public, cautious monitoring is recommended.

Patient-Centered 130

Patient-Centered Provider Manufacturing Screening 130

FDA Law

MAY 21, 2024

The 2016 reviews concluded that marijuana continued to meet schedule I criteria for having a high potential for abuse, no currently accepted medical use in treatment in the U.S., and lacked accepted safety for use under medical supervision. 21 U.S.C. § 21 U.S.C. § Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed.

Physicals 69

Physicals Medical Clinic Emergency Room 69

GeriPal

OCTOBER 31, 2024

Alex 00:23 And we’re delighted to welcome Peter Chin-Hong, who is an infectious disease physician and medical educator, professor at UCSF and associate dean for regional campuses. But it feels the same in that I was on call a lot over the summer, and I took care of a lot of people behind those hospital walls. Eric 19:21 So, Q.

Vaccination 127

Vaccination IT Patient-Centered Patients 127

FDA Law

NOVEMBER 8, 2022

By Véronique Li, Senior Medical Device Regulation Expert — At the latest MedTech conference held in Boston, MA from October 24-26, we heard from FDA officials and industry representatives on a range of topics. Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF).

Medical 59

Medical Manufacturing Patient-Centered Provider 59

Physicians News Digest

APRIL 2, 2025

By Julie Appleby Tim Winard knew he needed to buy health insurance when he left his management job in manufacturing to launch his own business. We were so nervous about not being on a company-provided plan,” Winard said. Early last year, he had the colonoscopy at a hospital in Elmhurst, Illinois, not far from his home in Addison.

Insurance 52

Insurance Screening Hospital Patient-Centered 52