C&M Health Law

FEBRUARY 1, 2022

Food & Drug Administration (FDA) published a notice in the Federal Register announcing the availability of a final guidance for industry and FDA staff entitled “Principles of Premarket Pathways for Combination Products”. The final guidance is available on the FDA’s website. On January 31, 2022, the U.S.

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FDA Licensing Public Health 52

Health Law Advisor

SEPTEMBER 12, 2023

The HHS recommendation is predicated, via the FDA, on a scientific and medical evaluation of marijuana, using a statutorily required eight-factor analysis. In addition, only certain components of FDA’s eight-factor analysis bind the DEA. This effectively allows the DEA to adopt a different outcome than the FDA.

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Health Care Law Brief

JUNE 2, 2022

The onset of the COVID-19 public health emergency (“PHE”) led to a surge in the use of telehealth by health care providers. Provider Licenses. Are all providers licensed or otherwise authorized to render care via telehealth to patients located in a given state?

Public Health 52

Public Health Compliance COVID-19 Licensing 52

Healthcare IT News - Telehealth

MAY 6, 2020

The quickly evolving COVID-19 public health emergency has warranted the growing use of telehealth and non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and possible exposure to the virus. iRhythm Technologies.

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HIT Consultant

MAY 9, 2022

The legislation mandated healthcare providers to modernize their internal recordkeeping, allowing for the swifter dissemination of medical information to support public health efforts and better medical care. Software matters: A snapshot of the digital transformation at a large health system.

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FDA COVID-19 Public Health Compliance 98

Bill of Health

APRIL 8, 2025

Food and Drug Administration (FDA) is responsible for the oversight of medical devices and products. FDA has various premarket pathways for medical devices depending on the classification of the technology. However, FDAs current framework was designed for traditional medical devices, which are static. Most recently, on Jan.

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Licensing FDA Electronic Medical Records Informed Consent 234

Hall Render

JUNE 5, 2024

In April 2024, the Food and Drug Administration (“FDA”) issued a Final Rule amending the definition of in vitro diagnostics products (“IVDs”) found in 21 C.F.R. This phaseout is scheduled to occur over four years, starting from the publication date of the Final Rule on May 6, 2024.

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FDA Compliance Regulatory Compliance Licensing 40

Healthcare Law Blog

OCTOBER 25, 2023

Effective January 1, 2022, an individual in Oregon who acts as a pharmaceutical representative for more than 15 days during the calendar year must have, and renew annually, a license from the Department of Consumer and Business Services (“DCBS”). ix] Nevada.

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Licensing Compliance FDA Public Health 52

AIHC

FEBRUARY 2, 2022

COVID-19) for discharges occurring on or after April 1, 2020, through the duration of the COVID-19 public health emergency period. • Encounter for screening for other viral diseases (asymptomatic) Z11.52 Encounter for screening for COVID-19, asymptomatic Z20.822 Contact with and (suspected) exposure to COVID-19 Z86.16

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COVID-19 Vaccine COVID-19 Medicare Medicare 52

AIHC

JUNE 6, 2023

Algorithms perform relatively well on knowledge-based tests despite the lack of domain-specific training; ChatGPT achieved ~ 66% and ~ 72% on Basic Life Support and Advanced Cardiovascular Life Support tests, respectively, and performed at or near the passing threshold on the United States Medical Licensing Exam.

Compliance 59

Compliance Medical Billing HIPAA Due Diligence 59

Bill of Health

NOVEMBER 23, 2024

Marijuana is still classified as a Schedule I controlled substance , which means it is illegal to possess, sell or distribute, although the FDA has approved several purified medications containing marijuana derived compounds. Under Amendment 3 , only licensed medical dispensaries would have been allowed to grow and sell marijuana.

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Public Health Licensing Fraud FDA 100

Bill of Health

APRIL 14, 2022

Food and Drug Administration (FDA) has not approved any genetically modified or pure animal organs for xenotransplantation in humans. For the surgery to go forward in Bennett’s case, the team had to submit a request to the FDA seeking to use the pig heart in the emergency procedure (so-called “compassionate use” ). Categorization.

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AIHC

JUNE 6, 2023

Algorithms perform relatively well on knowledge-based tests despite the lack of domain-specific training; ChatGPT achieved ~ 66% and ~ 72% on Basic Life Support and Advanced Cardiovascular Life Support tests, respectively, and performed at or near the passing threshold on the United States Medical Licensing Exam.

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Compliance Medical Billing HIPAA Due Diligence 52

Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

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FDA Licensing Hospitals Medicaid 98

Bill of Health

OCTOBER 31, 2024

by Alice Bryk Silveira The alarming rise in diabetes and obesity rates in the United States has placed significant strain on health care systems and poses a serious public health threat. Despite international momentum and calls from public health experts, the United States remains behind. Since 2009, the U.S.

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Healthcare IT Today

MAY 3, 2023

The excitement has been largely fueled by the renowned public health benefits of, and the seductive commercial opportunity for, a seamless hypertension management solution that is virtually invisible – part of what people are already wearing, such as smartwatches, earbuds, smart rings, and apparel.

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Healthcare IT News - Telehealth

MAY 30, 2023

The COVID-19 public health emergency came to an end on May 11. This also happens to coincide with the World Health Organization declaring an end to the COVID-19 global health emergency. What does the end of the public health emergency mean for the future of the healthcare industry?

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Telemedicine COVID-19 Governance Medicare 216

SQA

SEPTEMBER 2, 2022

Ma rketing authorization holders (MAHs) can now register their Industry Single Point of Contact (i-SPOC) who will inform EMA about the supply and availability of critical medicines identified in the context of a ‘public health emergency’ or a ‘major event’. United States Food and Drug Administration (FDA) – Regulations and Guidances.

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SQA

DECEMBER 10, 2021

Pilot Program: EMA-FDA Parallel Scientific Advice for Hybrid/Complex Generic Products – General Principles, 15 September 2021. The agencies conduct PSA meetings under the auspices of the confidentiality arrangement between the European Commission, the EMA, and the FDA. European Medicines Agency (EMA). The EMA and the U.S.

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FDA Compliance Public Health Hospitals 52

SQA

AUGUST 1, 2024

These variations are required to be assessed by the authorities based on their impact on public health and the medicine’s characteristics. CDSCO is looking to adopt the use of this guidance for premarket license applications and post-approval change applications. Kappin Ltd.

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FDA Licensing Compliance World Health 40

SQA

FEBRUARY 15, 2023

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. A concerted and collaborative effort is essential to address this threat to global health, economies, and security effectively.

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US Department of Health and Human Services FDA COVID-19 World Health 40

Healthcare IT Today

JANUARY 6, 2023

An end to the Public Health Emergency (PHE) is likely to be announced and end mid-January followed by a grace period of approximately 5 months. And with the Public Health Emergency (PHE) set to expire in January, stakeholders are urgently calling upon Congress to pass the Advancing Telehealth Beyond COVID-19 Act of 2021.

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US Department of Health and Human Services Doctors Telemedicine Public Health 101

Kaiser Health News

APRIL 6, 2022

Other graduates interviewed for this article talked about using the moving skills or commercial driving licenses they gained to obtain full-time jobs. In North Carolina, there are 62 licensed long-term residential treatment facilities, according to the SAMHSA treatment locator , and fewer than half accept patients who take these medications.

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SQA

DECEMBER 16, 2022

It will also facilitate cross-border circulation of these critical health therapies as well as cross-border cooperation between public health authorities. United States Food and Drug Administration (FDA) – Regulations and guidance. Computer Software Assurance for Production and Quality System Software, 13 September 2022.

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FDA Compliance COVID-19 Licensing 40

SQA

MAY 24, 2023

The deadline for reporting serious incidents not constituting serious public health threats, deaths, or unanticipated serious deteriorations in state of health was reduced to 15 calendar days. The name and address of manufacturers provided by the company on its establishment license application were not accurate.

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FDA Licensing Governance Compliance 40

SQA

MAY 24, 2023

The deadline for reporting serious incidents not constituting serious public health threats, deaths, or unanticipated serious deteriorations in state of health was reduced to 15 calendar days. The name and address of manufacturers provided by the company on its establishment license application were not accurate.

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SQA

OCTOBER 18, 2023

In addition, it contains essential recommendations to avoid complications and protect public health. The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products.

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FDA Compliance Licensing World Health 40

SQA

OCTOBER 18, 2023

In addition, it contains essential recommendations to avoid complications and protect public health. At the same time, the EU has recognized the US FDA as an equivalent authority to carry out these inspections. CGMP compliance is the floor and FDA is looking for companies to exceed those standards.

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FDA Compliance Licensing World Health 40

Bill of Health

JUNE 1, 2023

Food and Drug Administration (FDA) announced that it is lifting its highly contested blood deferral policy for men who have sex with men (MSM, i.e., gay and bisexual men), colloquially known as the blood ban. This fits a paradigm I describe in recent work , the demedicalization of preventive health care.

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Health Law Advisor

MARCH 1, 2023

In the era of abortion regulation and the wind-down of the COVID-19 public health emergency (“PHE”), new legislation in states such as Utah may be a sign of what is to come for online and telehealth prescribing. The bill currently awaits Governor Spencer Cox’s signature and would take effect sixty (60) days after its signing. [1]

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Telemedicine COVID-19 Fraud Licensing 52

Healthcare IT Today

JUNE 13, 2023

They also plan to offer APIs to labs and public health organizations, delivering test results securely through an app along with advice about how to handle the risk. Also, ixlayer utilizes only FDA-approved sample collection devices following best practice standards, everything in HIPAA compliant environment.

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COVID-19 Nurses FDA Licensing 114

SQA

FEBRUARY 26, 2024

This edition is aligned with the latest regulatory guidelines, including EU Annex 1 (revised 2022), EU Annex 15, the FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practices, and the FDA Draft Guidance for Industry: Current Good Manufacturing Practice for Medical Gases.

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FDA Compliance COVID-19 Public Health 52

SQA

MARCH 25, 2021

United States Food and Drug Administration (FDA) – Regulations and Guidances for Biologics and the Bioresearch Monitoring Program (BIMO). Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency, January 2021.

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SQA

OCTOBER 18, 2024

NPMA Issues Draft Guidelines for Inspection of Medical Device Clinical Trial Sites, 14 June 2024 China NMPA has released a new guideline that aims to enhance the management of clinical trial institutions for medical devices, ensuring compliance with regulatory standards and safeguarding public health.

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FDA Compliance Public Health World Health 52

SQA

FEBRUARY 26, 2024

This edition is aligned with the latest regulatory guidelines, including EU Annex 1 (revised 2022), EU Annex 15, the FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practices, and the FDA Draft Guidance for Industry: Current Good Manufacturing Practice for Medical Gases.

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FDA Compliance COVID-19 Public Health 40

SQA

OCTOBER 18, 2024

NPMA Issues Draft Guidelines for Inspection of Medical Device Clinical Trial Sites, 14 June 2024 China NMPA has released a new guideline that aims to enhance the management of clinical trial institutions for medical devices, ensuring compliance with regulatory standards and safeguarding public health.

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FDA Compliance Public Health Governance 40

Innovaare Compliance

OCTOBER 6, 2022

Adult vaccine recommended by ACIP is a covered Part D drug when licensed by the US Food and Drug Administration (FDA) under the Public Health Service Act for use by adult populations and administered in accordance with recommendations of ACIP.

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Medicare Medicare Compliance Public Health 52