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Category: Regulatory


Regulatory

FDA restricts most flavored e-cig sales to curb ‘astonishing’ teen vaping surge, pursues menthol ban

November 15, 2018

Via: CNBC

The Food and Drug Administration will restrict sales of most flavored e-cigarettes to age-restricted stores and pursue bans on menthol cigarettes and flavored cigarettes as it tries to control what Commissioner Scott Gottlieb describes as an “astonishing” surge in teen […]


Regulatory

Provider groups urge Congress to pass maternal health bill this year

November 15, 2018

Via: Health Data Management

A coalition of more than 80 organizations wants Congress to pass a maternal health bill by the end of 2018. The groups, which include the American Hospital Association and American Medical Association, support legislation passed by the Senate health committee […]


Regulatory

NHS to offer better access to glucose monitors for diabetes patients

November 14, 2018

Via: medicaldevice-network.com

The move comes after a recent investigation revealed that patients in some parts of the country are missing out on glucose monitoring devices. Abbott’s Freestyle Libre is the only glucose monitoring system available in the UK. The wearable device sends […]


Regulatory

Short-Term Insurance Plans Offer a Much-Needed Escape from Obamacare

November 13, 2018

Via: Forbes

Several patient advocacy groups recently sued the Trump administration to overturn an August 2018 rule that expands access to short-term health insurance plans. They argue that short-term plans, which they deride as “junk insurance,” violate the Affordable Care Act. The […]


Regulatory

Montana’s legislature could decide Medicaid expansion’s fate

November 9, 2018

Via: The Medical News

A ballot initiative that would have continued funding Montana’s Medicaid expansion beyond June 2019 has failed. But advocates say they’ll continue to push for money to keep the expansion going after that financial sunset. “We now turn our attention to […]


Regulatory

Congress seeks better data sharing to trim maternal mortality

November 5, 2018

Via: Health Data Management

Lawmakers are trying address a deficiency of data when it comes to understanding an alarming spike in U.S. maternal mortality by enabling states to participate in nationwide information sharing. The U.S. maternal mortality rate has more than doubled between 1987 […]


Regulatory

FDA approves Medacta’s two new kinematic alignment options for knee replacement surgery

November 1, 2018

Via: The Medical News

Medacta International, the privately held, family-owned global leader in the design of innovative joint replacement and spinal surgery products, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for the GMK® Sphere – Kinematic Alignment […]


Regulatory

Final rule to pay home health agencies for remote patient monitoring

November 1, 2018

Via: Health Data Management

A final rule from the Centers for Medicare and Medicaid Services will allow home health agencies to be reimbursed for remote patient monitoring. On Wednesday, CMS took the action as part of a broader package of changes to the Home […]


Regulatory

FDA clears Abbott’s assays for influenza and Streptococcus

October 26, 2018

Via: medicaldevice-network.com

The new Influenza A & B 2 assay has been designed for the molecular identification and differentiation of the influenza A and B virus strains within 13 minutes. Abbott said the assay can display positive results in five minutes. Abbott […]


Opinions, Regulatory

Medicaid enrollment falls for first time in more than a decade as economy boosts income for poor Americans

October 25, 2018

Via: CNBC

The booming U.S. economy appears to be reducing dependence on federal health insurance for the poor. Medicaid enrollment fell for the first time since 2007, declining by about 0.6 percent in fiscal year 2018, and states don’t expect to see […]


Regulatory

Trump signs tech-boosting opioid legislation into law

October 25, 2018

Via: Health Data Management

President Trump on Wednesday signed into law opioid legislation that expands use of telehealth and aims to improve prescription drug monitoring programs. The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act boosts several […]


Regulatory

Drugmakers will soon talk about price in ads — but not as explicitly as Trump administration wants

October 15, 2018

Via: CNBC

Major drugmakers will soon include price information in television advertisements, conceding to the Trump administration but not as far as the administration may have hoped. Starting April 15, 2019, members of the Pharmaceutical Research and Manufacturers of America trade group […]


Regulatory

The New ISO 45001 Standard Will Improve Occupational Health And Safety

October 15, 2018

Via: Aberdeen Essentials

The adoption of the ISO 45001 standard is a watershed moment for operational health & safety (OH&S). With the new standard now published, it provides organizations a structure around which they can work to prevent workplace injuries, illnesses, and fatalities. […]


Regulatory

Opioid Lawyers Say Settlement May Hinge On Forcing Plaintiffs Into Class Action

September 27, 2018

Via: Forbes

A settlement binding all potential plaintiffs may be the only practical way of ending nearly 2,000 lawsuits against manufacturers, distributors and retailers of addictive opioid painkillers, said plaintiff lawyers attending a conference on opioid litigation this week. Some 1,200 lawsuits […]


EHR & EMR, Regulatory

VA gearing up to deploy Cerner EHR at initial site in Pacific Northwest

September 27, 2018

Via: Health Data Management

Veterans Integrated Service Network 20 in the Pacific Northwest will serve as the first initial operating capability site to deploy and test the VA’s new Cerner electronic health record system. The planned acquisition calls for aligning the deployment of the […]