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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FDA Licensing Public Health 111

Healthcare IT News - Telehealth

AUGUST 6, 2024

UpScriptHealth also works with other medical device companies to increase access – for example, it powers telehealth consultations for Spark Biomedical's Sparrow Ascent, the only FDA-cleared, drug-free, non-addictive, non-invasive, wearable treatment technology for the relief of opioid withdrawal symptoms.

Telemedicine 112

Telemedicine FDA HIPAA Licensing 112

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.

FDA 115

FDA Public Health Licensing Telemedicine 115

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 IT News - Telehealth

DECEMBER 1, 2021

What's less certain, however, is what that utilization will look like in the future, particularly as the end of the public health emergency looms. What is driving all this, of course, is the regulatory changes during this public health emergency. First of all, we should think about the public health emergency.

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COVID-19 Public Health Doctors Governance 172

Healthcare IT News - Telehealth

FEBRUARY 5, 2024

Despite the end of the public health emergency, individuals and informed political leaders will continue to work with pharmacies to continue access to vital care for individuals in need of medication for mental health because mental health is part of overall health. Your third prediction concerns medication.

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COVID-19 Public Health Licensing Telemedicine 150

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

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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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 193

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 112

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

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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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.

Public Health 100

Public Health FDA Governance Licensing 100

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.

Medicare 52

Medicare Medicare Compliance Public Health 52

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 130

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.

FDA 40

FDA Compliance COVID-19 Licensing 40

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

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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COVID-19 FDA Hospitals Elder Care 191

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 59

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 52

Compliance Medical Billing HIPAA Due Diligence 52

Hall Render

MAY 20, 2022

AHA asks HHS to continue the public health emergency until conditions stabilize. Considerations for Social Determinants of Health Screening Design. COVID-19 public health emergency set to be extended. Covid-19 remains a public health emergency in US, administration says. Million COBRE Grant Extension.

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Bill of Health

SEPTEMBER 28, 2023

Public Health Service and the National Institutes of Health (NIH) incorporated a fair pricing condition as part of cooperative research and development agreements (CRADAs) between federal laboratories and private manufacturers. In 1989, the U.S.

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COVID-19 COVID-19 Vaccine Pharmaceutical Industry Governance 208

Healthcare Law Blog

AUGUST 25, 2022

Drugs eligible for negotiation must be FDA-approved for at least 7 years and marketed in conformance with the Federal Food, Drug, and Cosmetic Act. Negotiation-Eligible Drugs. Drugs bundled as part of an item or service that are not separately payable under Medicare Part B are excluded from such calculation.

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Medicare Medicare Medicaid Medicaid 52

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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FDA Public Health Licensing 228

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

Bill of Health

JANUARY 16, 2024

The judge did so by suspending an FDA rule that required in-person ordering, prescribing, and dispensing of the pill by a provider. We hear providers struggle with new legal risks: “I can’t keep providing services if I get [my license] taken away.”

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COVID-19 FDA Licensing Doctors 113

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.

FDA 40

FDA Licensing Governance Compliance 40

AIHC

AUGUST 2, 2022

Two vaccines may be used for the prevention of Monkeypox virus infection: JYNNEOS (also known as Imvamune or Imvanex), licensed (or approved) by the U.S.

US Department of Health and Human Services 98

US Department of Health and Human Services FDA Licensing Compliance 98

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

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

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

Hall Render

FEBRUARY 18, 2022

Lawmakers call on Biden to end public health emergency. License wait times reach crisis levels for healthcare workers. Meet new FDA chief Dr. Robert Califf: 5 things to know. 5 recent hospital, health system COO moves. of Public Health website. 8 recent hospital, health system executive resignations.

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Hall Render

MARCH 25, 2022

FDA to revive facility visits. Dr. Lorna Breen Health Care Provider Protection Act becomes law. Here are the top health systems by patient reviews. Moderna wants the FDA to authorize its COVID-19 vaccine for kids under 6. Sensitive health data of 50 million Americans hacked or breached last year: analysis.

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COVID-19 US Department of Health and Human Services Nursing Homes Nurses 40

Hall Render

MARCH 31, 2023

County-owned buildings facing potential earthquake risk Gilead drops option to buy cancer therapeutics company Health and Life Organization Inc. What happens if it disappears? buys industrial property in Rancho Cordova for $5.12

US Department of Health and Human Services 40

US Department of Health and Human Services Nursing Homes COVID-19 Nurses 40

Hall Render

SEPTEMBER 20, 2024

Vincent, Indianapolis Colts announce new partnership Franciscan Health launches 24/7 ambulance to help patients in rural counties Lilly to make $1.8B Mary’s Hospital helps high-risk babies Reasons behind 3 recent CON denials St.

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US Department of Health and Human Services Nurses Hospitals Nursing Homes 40

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