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Category: Regulatory


Regulatory

Nursing home fines drop as Trump administration heeds industry complaints

March 15, 2019

Via: The Medical News

The Trump administration’s decision to alter the way it punishes nursing homes has resulted in lower fines against many facilities found to have endangered or injured residents. The average fine dropped to $28,405 under the current administration, down from $41,260 […]


Regulatory

California Jury Awards $29 Million to Woman Who Says She Got Cancer from Johnson & Johnson Baby Powder

March 14, 2019

Via: Time Health

A woman who claims asbestos in Johnson & Johnson products caused her deadly cancer was awarded $29.4 million by a California jury on Wednesday, Reuters reports. A jury in a California Superior Court in Oakland determined that defective Baby Powder […]


Regulatory

The FDA Revealed How It’s Planning to Restrict E-Cigarette Sales to Teens

March 13, 2019

Via: Time Health

In one of his last acts as head of the Food and Drug Administration (FDA), outgoing Commissioner Dr. Scott Gottlieb released new plans for restricting the sale of certain flavored e-cigarettes, in an effort to combat teen vaping. The draft […]


Regulatory

The Economic Implications Behind The Cannabis Legalization Debate

March 11, 2019

Via: Forbes

After decades of prohibition, some countries are starting to consider legalizing cannabis as a way to tackle the increase in consumption and take benefits from it. The fact is that cannabis is the most used illegal drug in the world, […]


Opinions, Regulatory

AI in med tech: how should it be regulated?

March 11, 2019

Via: medicaldevice-network.com

“Our approach to regulating these novel, swiftly evolving products must foster, not inhibit, innovation,” wrote Gottlieb, as the FDA announced plans to evolve its policies to advance development and oversight of innovative digital health tools. Consumers and clinicians are increasingly […]


EHR & EMR, Regulatory

Lawmakers voice concerns about VA’s plans for Cerner EHR

March 7, 2019

Via: Health Data Management

Members of Congress are growing increasingly concerned about Department of Veterans Affairs plans to implement the same Cerner electronic health record system as the Department of Defense. Senior VA officials incurred the wrath of a House appropriations subcommittee on Wednesday, […]


Regulatory

FDA Announces Crackdown on Walgreens, 14 Other National Retailers Selling E-Cigarettes to Kids

March 5, 2019

Via: Time Health

The Food and Drug Administration (FDA) on Monday announced a renewed effort to hold retailers accountable for selling e-cigarettes to kids and teenagers, as part of its ongoing campaign against youth vaping. E-cigarettes are not legally available to anyone younger […]


Regulatory

Prescription Drug Pricing Hearing: Is The Senate Probing In The Wrong Place?

March 4, 2019

Via: Forbes

The media has constructed a straw man of sorts when repeating the mantra of the “relentless rise of prescription drug prices.” That growth has not been so relentless in recent years. This is due in large part to the increased […]


Regulatory

FDA warns against use of surgical robots for cancer surgeries

March 4, 2019

Via: medicaldevice-network.com

Robotically assisted surgical devices can be used to perform different surgical procedures through small incisions. This approach is known to reduce pain, blood loss, scarring, infection and boost recovery time post-surgery compared to procedures that do not leverage surgical robots. […]


Regulatory

Medicare trims payments to 800 hospitals, citing patient safety incidents

March 1, 2019

Via: The Medical News

Eight hundred hospitals will be paid less by Medicare this year because of high rates of infections and patient injuries, federal records show. The number is the highest since the federal government five years ago launched the Hospital Acquired Conditions […]


EHR & EMR, Regulatory

FDA post-market drug surveillance system to tap EHR data

March 1, 2019

Via: Health Data Management

Sentinel, which monitors FDA-approved drugs through active surveillance, is being enhanced to capture clinical data to better detect potential new safety problems. “We’ll be working to link claims data in Sentinel to electronic health records, to improve our ability to […]


Innovation, Medical Devices, Regulatory

FDA issues draft guidance for brain-computer interface devices

February 25, 2019

Via: medicaldevice-network.com

BCI devices are often used to regulate limb prosthesis. The direct control feature of these implants is expected to enable significantly more mobility and independence for patients. The regulatory agency added that the devices possess the potential to help people […]


Regulatory

FDA’s new proposed rule would update regulatory requirements for sunscreen products in the U.S

February 22, 2019

Via: The Medical News

The U.S. Food and Drug Administration today issued a proposed rule that would update regulatory requirements for most sunscreen products in the United States. This significant action is aimed at bringing nonprescription, over-the-counter (OTC) sunscreens that are marketed without FDA-approved […]


Regulatory

Medicare At 50 Act Targets Early Retirees

February 14, 2019

Via: Forbes

The latest proposed expansion of Medicare benefits could be a welcome health insurance option to early retirees who leave employment or have been forced out of their jobs before the age of 65. Democratic U.S. Senators unveiled the latest version […]


Regulatory

Proposed rules on electronic health information met with early industry approval

February 12, 2019

Via: Health Data Management

Monday’s release of proposed rules by the Department of Health and Human Services designed to improve healthcare IT interoperability have generated positive reactions from stakeholder groups. The College of Healthcare Information Management Executives issued a statement that it supports policies […]