HIT Consultant

FEBRUARY 6, 2023

For example, only 3% of the 2,728 US digital health deals since 2011 have focused on women’s health. At- Home Hospital and Remote Patient Monitoring Moving healthcare out of traditional settings (like the hospital) and into people’s everyday lives is the future of healthcare.

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HIT Consultant

MARCH 24, 2022

Founded in 2011 by a physician and engineers from MIT and Harvard, Podimetrics developed the SmartMat — the only easy-to-use, an at-home mat that a patient steps on for 20 seconds per day. The FDA-cleared and HIPAA-compliant SmartMat are remotely monitored by Podimetrics’ in-house nurse support team.

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Nurses FDA HIPAA Hospitals 97

Healthcare Law Blog

JANUARY 20, 2023

The Food and Drug Administration (the “FDA”) has approved a modification to the Mifepristone Risk Evaluation and Mitigation Strategy (“REMS”) Program, increasing the accessibility of mifepristone for patients with a prescription. [1] Supreme Court held in Dobbs v. Jackson Women’s Health Organization that the U.S.

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FDA Hospitals 52

CMS.gov

APRIL 15, 2019

While we support and promote the private sector’s critical role in our health care system, CMS’ duty to monitor the safety of the nation’s hospitals, nursing homes, and other providers, is a unique governmental task which lies at the core of government’s role in health care. We’re also improving quality of life for nursing home residents.

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Nursing Homes Nurses Compliance Medicare 51

SQA

JUNE 3, 2024

Novartis Pharmaceuticals UK Limited has a direct-to-pharmacy supply chain agreement based on the specialist use of the product and know the exact hospitals who have been supplied with the impacted batch. FDA has prepared a draft document entitled Food and Drug Administrations Draft Report and Plan on Best Practices for Guidance.

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FDA COVID-19 Licensing Nurses 40

Hall Render

MARCH 16, 2022

The measure includes funding for health care-related agencies, such as HHS, CMS, HRSA and the FDA, as well as several health care policy riders and provisions that address issues like 340B and telehealth waivers. On Tuesday, March 15, 2022, President Biden signed into law the Consolidated Appropriations Act of 2022 ( H.R.

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COVID-19 Medicare Medicare FDA 40

C&M Health Law

JANUARY 25, 2023

Starting in 2023, the Administration will promulgate regulations to implement the Act’s provisions and to issue reports to Congress as required by statute, including on telehealth utilization, the Acute Hospital Care At Home program, pandemic preparedness efforts, and clinical trials reform, among others.

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Medicaid Medicaid Medicare Medicare 104

HIPAA Journal

APRIL 8, 2025

When the software reaches end of life, medical devices need to be replaced; however, cash-strapped hospitals lack the funding to replace their legacy devices, and the devices continue to be used for years, despite the cybersecurity risks. Fu also voiced concerns about the staff cuts at the FDA.

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FDA HIPAA Governance Hospitals 50

Drug & Device Law

JANUARY 15, 2024

We have discussed how exclusion of FDA compliance in pelvic mesh cases, based on a false equivalence between preemption and evidentiary admissibility, has hampered the defense in that litigation. In state court, Creazzo remains binding precedent. Central Medical Health Services, Inc. , 2d 521 (Pa. 3d 1245 (N.J.

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Compliance FDA Governance State Policy 52

Drug & Device Law

OCTOBER 23, 2023

312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted. 604, 624-25 (2011) (FDCA preemption case). Elizabeth’s Hospital of Chicago, Inc. , Back in 2008, the United States Supreme Court held, in Riegel v. Medtronic, Inc. , Partnership v.

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FDA Governance Nurses Hospitals 59

Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. Are manufacturers liable only for failing to employ an alternative design that the FDA has approved for distribution. . .

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FDA Licensing Hospitals Governance 59

Drug & Device Law

DECEMBER 12, 2022

223, 231-33 (2011), holding that the Vaccine Act preempted all design defect claims asserted by claimants who rejected Vaccine Act awards and sought to litigate their claims instead. The Supreme Court did its part in Bruesewitz v. Wyeth LLC , 562 U.S. Now comes DeCostanzo v. 300aa-22(b)(1). 300aa-22(c).

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FDA Public Health Fraud Hospitals 115

Drug & Device Law

JANUARY 13, 2022

. § 360k(a) because those claims were based on an alleged failure to report adverse events to the FDA and the plaintiff had not shown that Massachusetts recognizes a duty to submit such reports. Earlier this week, the First Circuit side-stepped the question of whether Massachusetts recognizes a duty to submit adverse-event reports to the FDA.

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