Kaiser Health News

OCTOBER 7, 2024

senators have pressed the FDA to take steps to eliminate pulse oximetry’s racial bias, which has caused delays in treatment and worse health outcomes, and more recently has raised concern about the reliability of hospital AI tools that draw on reams of data from the devices. . The FDA’s response was modest.

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Healthcare Law Blog

JANUARY 12, 2022

On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to relaxed enforcement policies during the COVID-19 pandemic. Guidance Overview.

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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. Part 820 ).

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HIT Consultant

JUNE 10, 2022

In April, FDA Commissioner Dr. Robert Califf laid out areas of challenge and opportunity when it comes to improving health outcomes, restoring public trust in science, and making the most of our ongoing investments in data analytics and clinical research. Wang, Chief Medical Officer of COTA, Inc.

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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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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.

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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.

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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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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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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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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.

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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.

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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.

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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.

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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.

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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 ?

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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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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.

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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.

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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.

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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.

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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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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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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.

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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.

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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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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.

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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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Healthcare Law Today

JANUARY 25, 2023

Under MoCRA, cosmetic companies will be subject to facility registration and product listing requirements, good manufacturing practices (GMPs), serious adverse event reporting and recordkeeping, and safety substantiation. distribution must register with the FDA no later than one year after the enactment of MoCRA, which is December 29, 2023.

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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.

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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.

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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.

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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.

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Bill of Health

OCTOBER 16, 2024

by Rupa Palanki In May 2024, a bipartisan group of female senators introduced the Advancing Menopause Care and Mid-Life Women’s Health Act. If enacted, it would be the most comprehensive federal effort to improve health care related to menopause. FDA Reconsideration of the Boxed Warning on Low-Dose Estrogen The U.S.

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HIPAA Journal

APRIL 5, 2023

To authorized public health authorities to prevent or control disease, injury, or disability. To the Federal Drug Administration to report adverse events and track FDA-regulated products. To Business Associates for the purposes stipulated in a Business Associate Agreement.

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SQA

JANUARY 25, 2021

The Metformin HCl Extended-Release Tablets, USP 500 mg have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as published in the FDA Guidance Document issued in September 2020. has not received any reports of adverse events related to this recall. Nostrum Laboratories, Inc.

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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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