Hall Render

JUNE 21, 2024

Food and Drug Administration (“FDA”) issued a Final Guidance titled “Remanufacturing of Medical Devices,” clarifying the definition of “remanufacturing” for reusable medical devices in need of maintenance or repair (“Final Guidance”). In May 2024, the U.S. Below are some highlights from the Final Guidance.

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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 recommend the FDA and OCR better align their guidance and enforcement activities, specifically to ensure that medical device manufacturers are meeting their obligations as HIPAA business associates. Patient privacy.

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HIT Consultant

OCTOBER 16, 2023

While Ozempic was initially developed to manage Type 2 diabetes, its emerging potential for weight loss is captivating medical professionals and the public alike. How Ozempic Works: The Basics Ozempic is a weekly injection containing the active ingredient semaglutide, FDA-approved in 2017 for adults with Type 2 diabetes.

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Health Populi

FEBRUARY 4, 2019

Consumers point to some organizations that they perceive may be working against their better health: these include fast food manufacturers, the entertainment industry, food processors (“Big Food”), the media, government agencies, and health insurance companies. Health care delivery in the U.S.

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Healthcare IT Today

FEBRUARY 15, 2024

With more than 700 US FDA-approved AI applications, healthcare providers grapple with navigating the complex landscape of niche AI solutions. CARPL is also creating an impact in the public health space by working with the Government of India to enable large-scale Tuberculosis Screening Programmes in the most remote regions of the country.

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Health Populi

AUGUST 3, 2018

A new poll jointly conducted by Politico and the Harvard Chan School of Public Health bolsters my read on the latter issue – prescription drug pricing, which has become a mass popular culture union. There may be no other issue on voters’ collective minds for the 2018 mid-term election that so unites American voters.

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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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NY Health Law

JULY 9, 2019

More than 70% of CBD extracts sold online, for instance, were mislabeled regarding potency, according to a Penn Medicine study in 2017. The FDA is struggling to determine how to regulate CBD. The FDA is also gathering data from the public through the use of a docket that is open for comment until July 16, 2019.

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HIT Consultant

JULY 15, 2024

Innovalve’s Pioneering Mitral Valve Technology Founded in 2017 at ARC Innovation, Innovalve has been at the forefront of developing a minimally invasive approach to mitral valve replacement. The technology has already received FDA approval for initial human trials, with over 40 successful surgeries performed to date. .

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AIHC

JANUARY 28, 2022

For FY 2021, CMS will use a single year of data on uncompensated care costs from Worksheet S-10 of hospitals’ FY 2017 cost reports to distribute these funds, in part because CMS has conducted audits of this data. This is to allow eligible antimicrobial products to begin receiving the new technology add-on payment sooner. percent.

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Bill of Health

APRIL 24, 2023

Yet Dmitry Karshtedt held otherwise at the ASLME Health Law Professor’s Conference in Atlanta, GA in 2017. My latest article, Public Health Product Hops (forthcoming 2023, American University Law Review, available on SSRN ), represented my long-form attempt to reconcile our differing opinions on product hopping.

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Healthcare Law Blog

OCTOBER 25, 2023

Effective July 1, 2017, the Chicago Municipal Code requires that an individual who markets or promotes pharmaceuticals to HCPs within the City of Chicago for more than 15 calendar days during the year must have a license from the City of Chicago’s Department of Business Affairs and Consumer Protection. vi] See Connecticut Public Act No.

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Health Populi

JANUARY 31, 2018

That hasn’t yet been available to those of us who quantify our steps, weight, sleep, food intake, and other health metrics. In 2017, Hugh Langley wrote in Wareable that, “blood pressure is wearable tech’s next challenge.” Omron seeks to jump that hurdle through FDA clearance.

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Health Populi

JANUARY 2, 2020

Healthcare is getting serious at #CES2020, blurring into the medical and FDA regulated turf which Omron pioneered last year launching its 80+-patented blood pressure watch, the HeartGuide. Digital Swiss Army knives for health: devices do more. Your car as a third space for health.

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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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Healthcare It News

OCTOBER 13, 2021

"In 2017, gene therapy was used to cure a teenage boy of sickle cell disease," he said. "That same year, FDA approved smart pills. "COVID-19 showed the world what's wrong: Not enough focus on public health, prevention and equity. They alert users if they've already taken their medication.

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SQA

AUGUST 8, 2023

Personal Care Products Council (PCPC) PCPC MoCRA Toolkit, May 2023 Enacted in December 2022, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents years of efforts by the Personal Care Products Council, the FDA, Congress, and other stakeholders to modernize the U.S. cosmetic regulatory framework.

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SQA

AUGUST 8, 2023

Personal Care Products Council (PCPC) PCPC MoCRA Toolkit, May 2023 Enacted in December 2022, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents years of efforts by the Personal Care Products Council, the FDA, Congress, and other stakeholders to modernize the U.S. cosmetic regulatory framework.

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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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American Medical Compliance

MAY 13, 2024

The Opioid Epidemic As of October 16, 2017, the US government officially declared the opioid epidemic a public health emergency. For dental healthcare providers, this public health emergency signifies a critical need to be vigilant and proactive in opioid prescribing practices.

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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. In addition, the ISPE Guide outlines the authority of State Boards of Pharmacy and their coordination of oversight with the FDA. Science and safety are at our core.

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Bill of Health

AUGUST 29, 2022

5] Stephanie Anne Deutsch & Kristine Fortin, Physical Health Problems and Barriers to Optimal Health Care Among Children in Foster Care , 45 Current Problems in Pediatric and Adolescent Health Care 286, 286 (2015); Council on Foster Care et al., 3] Bell, supra note 99 at 26. [4]

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Kaiser Health News

APRIL 6, 2022

In presentations, they often share a 2017 study — conducted by an independent research institute at TROSA’s request — which found TROSA saves the state nearly $7.5 About 30% of its funding comes from government grants and contracts. million annually in criminal justice and emergency care costs.

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SQA

DECEMBER 16, 2022

The EC presented a first draft for public comment to the revision of Annex 1 in 2017. More than 6,000 comments led, quite unusually, to a second draft for renewed public comment in 2020. United States Food and Drug Administration (FDA) – Regulations and guidance.

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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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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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SQA

MAY 24, 2023

MDCG 2023-3 ,Questions and Answers on Vigilance Terms and Concepts as Outlined in the Regulation (EU) 2017/745 on Medical Devices, provides additional information on key vigilance terms. PCPCs current priority is to work with the FDA to effectively implement the Modernization of Cosmetics Regulation Act of 2022.

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SQA

MAY 24, 2023

MDCG 2023-3 , Questions and Answers on Vigilance Terms and Concepts as Outlined in the Regulation (EU) 2017/745 on Medical Devices, provides additional information on key vigilance terms. 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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Bill of Health

NOVEMBER 13, 2023

In fact, the majority of Americans do not hold strong trust in our health agencies like FDA and CDC. In my forthcoming article, I argue that our cancer regulatory regimes inadequately protect the public. The Privatization of Cancer Privatization is the transfer of public power to private hands. In 2017, 72% of U.S.

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Healthcare IT News - Telehealth

DECEMBER 16, 2020

The virtual trial, to be sure, is not a new concept: One team of researchers counted more than 1,100 trials listed on ClinicalTrials.gov employing connected digital products for remote data collection in both 2017 and 2018, the organization observed. ” The FDA is hinting that some of these changes could be here to stay.

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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

AUGUST 2, 2021

ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process. ISO 22316:2017, Security and resilience – Organizational resilience – Principles and attributes. United States FDA – Guidances for Devices. b) and 320.31(d)(3)).

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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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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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SQA

JUNE 3, 2024

73-2: Application of Medical Device Regulation Annex 1 Requirements for Staked Needle Syringes, February 2024 The European Union regulation (EU) 2017/745 on medical devices, referred to as MDR, introduced new requirements for manufacturers of medical devices. Technical Report No.

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Bill of Health

MARCH 5, 2025

Food and Drug Administrations (FDA) new proposed rule on a front-of-package nutrition label, called a Nutrition Info box. From 1941 to the 1970s, FDA recommended food labels be used only for food products designed for special diets to treat physical and pathological conditions. This is the driving motivation behind the U.S.

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Health Populi

SEPTEMBER 19, 2018

In 2017, 69% of commercially insured patients did not fill a new Rx if there was a $250 out-of-pocket cost. The bottom line for health consumers: prescription abandonment rises as patient out-of-pocket costs at the pharmacy increase. They’ll begin to apply to the FDA in early 2019 to make and sell the generic drugs.

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