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Category: Regulatory


Regulatory

FDA unveils action plan to improve medical device safety

April 18, 2018

Via: medicaldevice-network.com

The US Food and Drug Administration (FDA) has unveiled a new action plan to ensure the safety of medical devices and patient protection while also driving innovation. Titled ‘Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health’, the proposal […]


Regulatory

FDA bans some pure caffeine powders and liquids that pack a potentially lethal punch

April 13, 2018

Via: CNBC

Some pure caffeine products are now unlawful, according to the Food and Drug Administration. The agency said the ban focuses on liquids and powders containing pure or highly concentrated caffeine, which are often sold in large tubs containing thousands of […]


Regulatory

Health Insurers Tout Strides In Preventive Care Amid Attacks On Medicaid

April 9, 2018

Via: Forbes

The health insurance industry Monday launched a detailed report insurers say shows successes health plans are making to increase preventive care and access to treatments after low income Americans are enrolled in a Medicaid health plan. The study is a […]


EHR & EMR, Regulatory

State Department issues Request for Information on new EHR

April 4, 2018

Via: Health Data Management

The U.S. State Department has issued a request for information for a new electronic health records system, following a failed 2015 EHR implementation with the U.S. Coast Guard. The purpose of the State Department’s RFI is to conduct market research […]


Regulatory

FDA grants accelerated approval to leukemia drug for patients with MRD-positive ALL

March 30, 2018

Via: The Medical News

The U.S. Food and Drug Administration granted accelerated approval to Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). MRD refers to the presence […]


Regulatory

Starbucks coffee in California must have a cancer warning, judge rules

March 30, 2018

Via: CNBC

Scientists haven’t rendered a verdict on whether coffee is good or bad for you but a California judge has. He says coffee sellers in the state should have to post cancer warnings. The culprit is a chemical produced in the […]


Regulatory

Senate, House pass omnibus bill boosting funding for HIT-enabled medical research

March 23, 2018

Via: Health Data Management

The Senate and House have passed an omnibus spending bill funding the federal government through the end of September that includes $37 billion for the National Institutes of Health—an increase of $3 billion above the fiscal year 2017 enacted level—including […]


Regulatory

Brace For 10% Obamacare Rate Hikes After Congress Snubs ACA Stabilization

March 22, 2018

Via: Forbes

With Congress leaving out money to stabilize individual coverage under the Affordable Care Act from its $1.3 trillion spending bill, health insurance companies were quick to predict future rate hikes of at least 10% — and that’s not just for […]


Opinions, Regulatory

Opioid plan offers hope that docs may get real-time prescription info

March 21, 2018

Via: Health Data Management

The new Trump administration program to fight the opioid crisis is suggesting a constructive data-based approach to monitoring problematic prescriptions through its proposal for a national prescription drug monitoring network, says the head of Health IT Now, an industry coalition. […]


Regulatory

FDA considering restricting menthol and other flavors from tobacco products

March 20, 2018

Via: CNBC

The Food and Drug Administration is taking the first step toward implementing a rule about the role flavors, including menthol, play in attracting users to certain tobacco products. The agency is publishing an advanced notice of proposed rule-making seeking public […]


Regulatory

Trump opioid plan calls for interoperable exchange of prescription data

March 20, 2018

Via: Health Data Management

President Trump on Monday announced a wide-ranging policy initiative aimed at confronting the forces of supply and demand that are fueling the country’s opioid epidemic, including cutting nationwide opioid prescription fills by one-third within three years. In an effort to […]


Regulatory

FDA chief worries about a new generation of kids getting hooked on nicotine through vaping

March 16, 2018

Via: CNBC

Access to e-cigarettes by kids is a “big concern” for the Food and Drug Administration, and the agency plans to take steps soon to better address the vaping problem. Make no mistake, e-cigarettes contain nicotine, FDA Commissioner Dr. Scott Gottlieb […]


Regulatory

FDA moves forward on nicotine regulation in cigarettes

March 15, 2018

Via: CNBC

The Food and Drug Administration is taking the first steps toward implementing a rule about the maximum level of nicotine in combustible cigarettes, after an announcement of its plans last summer that rocked stocks of tobacco companies. The agency is […]


Regulatory

7 Things To Know About Experimental Drugs & The ‘Right To Try’ Act

March 13, 2018

Via: Forbes

On Tuesday, the House of Representatives plans to vote on its version of the ‘Right To Try’ Act. Like previous iterations, the newest draft of the bill aims at allowing terminally ill patients the right to try experimental treatment options. […]


Regulatory

VA launches platform for developers to build apps for vets

March 9, 2018

Via: Health Data Management

The Department of Veterans Affairs has launched a beta version of its cloud-based application programming interface management platform that will provide commercial software developers with access to tools for building mobile and web apps on a standard set of APIs. […]