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’. ISPE Good Practice Guide: Critical Utilities GMP Compliance.

FDA 91

FDA COVID-19 Nursing Homes Compliance 91

Bill of Health

FEBRUARY 27, 2024

There is a common and problematic misconception that colonization was an isolated historical event and that the present is somehow divorced from its precedent. To explore how colonization drives health inequities, we have to acknowledge the causal relationship between what is past and what is present and think critically about colonization.

Governance 120

Governance FDA World Health Health Outcomes 120

Bill of Health

MARCH 27, 2023

Bard The White House is preparing to shut down their COVID Task Force this May, in conjunction with ending the public health emergency — the latest in a series of astounding and shortsighted decisions that put individual Americans at as great a risk from serious harm as a result of catching COVID-19 as at any stage in the pandemic.

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COVID-19 Public Health Governance COVID-19 Vaccine 332

Bill of Health

APRIL 14, 2023

By Jennifer Bard Recent events, including the discovery that Justice Thomas has been accepting luxury vacations from and selling real estate to a billionaire, and the Fifth Circuit’s finding in Alliance for Hippocratic Medicine v.

Governance 176

Governance FDA COVID-19 Public Health 176

SQA

FEBRUARY 26, 2024

The Agency has worked to combat the irregular practice of using cosmetics as injectables since last year, when the first serious adverse events involving this type of product occurred. The reported irregularities and the manufacturing conditions of the products, that is, compliance with Good Manufacturing Practices, were verified on the spot.

FDA 52

FDA Compliance COVID-19 Public Health 52

Health Law Advisor

AUGUST 1, 2023

Both Colleen and Brad have decades of experience in FDA regulation, but we have different impressions on that topic, so we decided to inform the debate with a systematic look at the data. To tie the MDR data with the recall data, we are using K numbers, the numbers that FDA assigns during the course of a 510(k) review.

FDA 52

FDA 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.

COVID-19 52

COVID-19 FDA Public Health Licensing 52

Health Populi

JUNE 24, 2021

The third chart details some of these points: On the macroeconomic side of the forecast, we see increasing private consumption, higher inflation, less public sector support (e.g., PPP in the US), and in emerging markets, currency weakness.

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COVID-19 COVID-19 Vaccine FDA Public Health 108

Health Populi

AUGUST 12, 2021

. “During the chaos and confusion, threat actors launched cyberattacks,” Ordr observed in the wake of the public health crisis. In this Rise of the Medical Machines, the major risks for health care organizations were that, 68% of health care deployments had more than 10 FDA recalls.

COVID-19 174

COVID-19 FDA Public Health Hospitals 174

Bill of Health

NOVEMBER 18, 2022

The book explains that despite these events, DEG adulteration continues due to regulatory failures. India has had at least five major cases of DEG poisoning in the past. Most recently, in 2020, 11 children in India died of DEG poisoning. This is only one example of the deep rot within the system.

Governance 317

Governance Bioethics FDA Public Health 317

Exeed Regulatory Compliance

MARCH 5, 2020

Travel is being restricted, large scale public events are likely to be cancelled, and schools and businesses may be closed to contain the spread of the virus. Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency. There is now an FDA policy released on 29 Feb.

US Department of Health and Human Services 52

US Department of Health and Human Services FDA Public Health COVID-19 52

Exeed Regulatory Compliance

JULY 31, 2020

It is a public health emergency of massive scale that has affected nearly all aspects of our life. In a major crisis like this, it is good to know that the FDA has a special authority to quickly allow marketing of medical products that can help diagnose, mitigate or treat this highly infectious disease.

FDA 52

FDA COVID-19 US Department of Health and Human Services Public Health 52

SQA

AUGUST 2, 2021

Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) and the United States Food and Drug Administration (FDA) released a series of policy recommendations to address the vulnerabilities in United States pharmaceutical supply chains. b) and 320.31(d)(3)).

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FDA COVID-19 Pharmaceutical Industry Hospitals 83

Healthcare IT Today

MAY 20, 2023

Health Gorilla and LexisNexis Risk Solutions are working to make SDoH data actionable , John found out in an interview with Avery Haller (Health Gorilla) and Diana Zuskov (LexisNexis). Read more… Hearing From Our Health IT Friend on Capitol Hill. Read more… How Were the Spring Health IT Conferences ?

Ransomware 93

Ransomware Telemedicine Public Health FDA 93

Bill of Health

MAY 24, 2022

But I think that the availability of medication abortion and possible steps involving FDA preemption will put more pressure on states to considering consider punishing patients. If the draft opinion becomes law, how might it affect medication abortion?

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FDA Public Health 157

SQA

AUGUST 8, 2023

Experience with large-scale events such as Hurricane Maria and the COVID-19 pandemic, and more recent geopolitical events, have cast a wider lens on global supply chain and distribution vulnerabilities. The model provides expanded guidance that reflects new insight and best practices that have emerged in the past several years.

FDA 40

FDA Compliance COVID-19 World Health 40

AIHC

JANUARY 28, 2022

The policies in this IPPS and LTCH PPS final rule build on key priorities to close health care equity gaps and support greater access to life-saving diagnostics and therapies during the COVID-19 public health emergency (PHE) and beyond. billion in FY 2021, or 2.7 billion in FY 2021, or 2.7 percent.

Medicare 52

Medicare Medicare Hospitals Payment Systems 52

Health Populi

JANUARY 31, 2018

Omron is submitting the HeartGuide watch for FDA review this year and once cleared, the device will be the first blood pressure monitor that accurately reads BP right from the wrist. Omron seeks to jump that hurdle through FDA clearance. Here is Omron’s blog written for #CES2018 on Going for Zero.

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FDA Doctors Public Health Medicare 81

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. PCPC’s current priority is to work with the FDA to effectively implement the Modernization of Cosmetics Regulation Act of 2022.

FDA 40

FDA Licensing Governance Compliance 40

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.

FDA 52

FDA Compliance Public Health Hospitals 52

HIPAA Journal

DECEMBER 8, 2022

The FDA should also make it clear that security updates are required, not optional. CHIME/AEHIS also suggest a broadening of the types of technology eligible for donation under Stark and Antikickback policies, and prohibit donor recipients from taking legal action against their donor in the event of a cyber incident. Patient privacy.

HIPAA 104

HIPAA FDA Governance Hospitals 104

SQA

OCTOBER 18, 2022

The UK sees the plans as an opportunity to introduce new regulations after Brexit in order to strengthen the public health sector. Policymakers, regulators, and legislators should not make any decisions that impact consumers’ access to FDA-approved sunscreen UV filters until the scientific community reaches an informed consensus.

US Department of Health and Human Services 40

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

Health Populi

JANUARY 7, 2019

This week’s heart-and-food tech announcements at #CES2019 coincide with an FDA recall on a popular drug prescribed to treat hypertension (high blood pressure). Using food and tech as medicine can help people avoid going on medications like statins and others for heart health. Eating a healthy diet. Limiting alcohol consumption.

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FDA Patient Advocacy Medicare Medicare 67

SQA

OCTOBER 18, 2023

The measure, adopted through Resolution – RE 2910/2023 , was made after the Agency was informed by the Sanitary Surveillance of Goiás about the occurrence of serious adverse events associated with the incorrect use of the products. To be injectable, the product must be registered with the Agency as a medicine or health product.

FDA 40

FDA Compliance Licensing World Health 40

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

AUGUST 2, 2022

Food and Drug Administration (FDA) for the prevention of Monkeypox virus infection, and ACAM2000, licensed (or approved) by FDA for use against smallpox and made available for use against monkeypox under an Expanded Access Investigational New Drug application. game meat, creams, lotions, powders, etc.)

US Department of Health and Human Services 98

US Department of Health and Human Services FDA Licensing Compliance 98

HIT Consultant

OCTOBER 14, 2021

Some recent events have underscored the need for clean, semantically interoperable data. COVID was a wakeup call: state public health departments were unable to process test results quickly because of lack of a standard way for labs to report test results, slowing the pandemic response. via a mobile app.

COVID-19 98

COVID-19 FDA Medicare Medicare 98

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.

US Department of Health and Human Services 40

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

Kaiser Health News

FEBRUARY 9, 2023

The FDA is at the center of the abortion pill case, which challenges its approval of the drug decades ago and could set a precedent for legal challenges to the approval of other drugs. They rebuffed calls from activists to declare a public health emergency for abortion. Rovner: Sarah, is the FDA worried about this case?

US Department of Health and Human Services 52

US Department of Health and Human Services Medicare Medicare FDA 52

AIHC

JUNE 6, 2023

The best thing you can do is have reliable cybersecurity protection, and ensure you will find out ASAP in the event of being affected. Compromised personal data can have serious consequences, including identity theft, financial fraud, and job losses in addition to OCR HIPAA fines and costs associated with breach notifications.

Compliance 59

Compliance Medical Billing HIPAA Due Diligence 59

Healthcare Law Blog

JANUARY 9, 2024

On the healthcare services side, NVIDIA mentioned GI Genius, which has an FDA approved AI-assisted endoscopy device that provides real-time identification and decision support to the provider conducting the endoscopy. Somatus is looking to use AI to generate automated prediction of cost model events.

Medicare 59

Medicare Medicare Hospitals Doctors 59

AIHC

JUNE 6, 2023

The best thing you can do is have reliable cybersecurity protection, and ensure you will find out ASAP in the event of being affected. Compromised personal data can have serious consequences, including identity theft, financial fraud, and job losses in addition to OCR HIPAA fines and costs associated with breach notifications.

Compliance 52

Compliance Medical Billing HIPAA Due Diligence 52

Health Law Advisor

MARCH 7, 2023

Should the final rules limit the issuance of prescriptions of controlled medications to the FDA-approved indications contained in the FDA-approved labeling for those medications? DEA has specifically requested feedback on whether it should limit telemedicine prescribing to only the drug’s FDA-approved indications. 1301.28.

Telemedicine 52

Telemedicine COVID-19 FDA Compliance 52

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 102

FDA Public Health Licensing Telemedicine 102

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. 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 Nurses COVID-19 40

Hall Render

APRIL 15, 2022

FDA clarifies cybersecurity recommendations for device makers in new guidance. HHS reveals strategy on social determinants of health. HHS extends COVID-19 public health emergency for another 90 days. Prices are soaring — but not for health care. Social Determinants of Health Worsened Specialty Care Access.

COVID-19 40

COVID-19 Nursing Homes Nurses Hospitals 40

Hall Render

JANUARY 5, 2024

rehab facility files $6M expansion proposal Largest health care system in Massachusetts now offering hospital level treatment at home Flooding at a Boston hospital has disrupted IVF services for 200 patients. See how patients rated each hospital.

COVID-19 40

COVID-19 Nursing Homes Nurses Hospitals 40