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Category: Regulatory


EHR & EMR, Regulatory

VA, Congress create panels to oversee Cerner EHR implementation

July 16, 2018

Via: Health Data Management

With the recent award to Cerner of a $10 billion electronic health record modernization contract by the Department of Veterans Affairs, both the VA and Congress are taking steps to ensure that the implementation of the EHR system receives sufficient […]


Regulatory

FDA approves Medtronic’s less-invasive approach to implant LVAD

July 13, 2018

Via: medicaldevice-network.com

Medtronic has received US Food and Drug Administration (FDA) approval for the less-invasive implantation procedure of the left ventricular assist device (LVAD) called HeartWare HVAD System intended for advanced, refractory heart failure patients. The new approach involves implant of the […]


EHR & EMR, Regulatory

FDA looks to leverage EHR data to better evaluate medical products

July 11, 2018

Via: Health Data Management

The Food and Drug Administration wants to take advantage of the real-world data available from electronic health records to more fully evaluate medical products in the post-market setting, according to FDA Commissioner Scott Gottlieb, MD. The agency is seeking $100 […]


Regulatory

U.S. freezes payments to ACA insurers with sicker patients

July 9, 2018

Via: Health Data Management

(Bloomberg)—Affordable Care Act insurers are facing a fresh round of uncertainty that could drive up premiums or push companies to stop offering coverage through the law, after the Trump administration’s latest move to cut off subsidies meant to help stabilize […]


Regulatory

Walgreens Completes Investment In Chinese Pharmacy Chain

July 6, 2018

Via: Forbes

Walgreens Boots Alliance now has a 40% stake in Sinopharm Holding Guoda Drugstores Co. Ltd., which has a franchise of retail pharmacies across China. The $416 million investment in Sinopharm Guoda will help provided a needed boost to Walgreens international […]


Regulatory

Medical cannabis for epilepsy approved in FDA first

June 28, 2018

Via: Medical News Today

In the context of an ever-louder international debate on whether patients with severe forms of epilepsy should be allowed to use medical cannabis to manage their condition, the Food and Drug Administration have just officially approved one such drug. Recently, […]


EHR & EMR, Regulatory

VA efforts to implement Cerner EHR face close scrutiny from Congress

June 27, 2018

Via: Health Data Management

As the Department of Veterans Affairs looks to implement a new Cerner electronic health record system replacing the agency’s legacy EHR, members of Congress are letting the VA know they are committed to seeing the project through. “$15.8 billion dollars […]


Innovation, Med Tech, Regulatory

FDA clears AI technology that evaluates echocardiograms

June 26, 2018

Via: Health Data Management

A medical technology company specializing in applying artificial intelligence to cardiovascular imaging has received clearance from the Food and Drug Administration for its fully automated video clip selection and calculation of left ventricular ejection fraction. The software from San Francisco-based […]


Innovation, Medical Devices, Regulatory

FDA approves continuous glucose monitoring system

June 25, 2018

Via: Health Data Management

The Food and Drug Administration has given clearance to the first continuous glucose monitoring system with a fully implantable sensor that can be used by adult users with diabetes to regularly measure their blood sugar levels for as long as […]


Regulatory

In Opioid Battle, Cigna Launches New Front To Stop Overdoses

June 21, 2018

Via: Forbes

Health insurer Cigna is intensifying its value-based approach to addiction medicine by adding a focus to reduce opioid overdoses where the epidemic has hit certain communities hard. Cigna, which is working through the regulatory process to buy the pharmacy benefit […]


Regulatory

Federal clinical guidance database to shut down because of funding cuts

June 21, 2018

Via: Health Data Management

A reduction in federal funding for the Agency for Healthcare Research and Quality, which is charged with improving the safety and quality of the nation’s healthcare system, has resulted in defunding of the National Guideline Clearinghouse, a public database of […]


Regulatory

Cigarettes Have to Be Labeled ‘Deadly’ Now. Here’s Why

June 18, 2018

Via: Time Health

A new rule requiring tobacco companies to describe their products as “deadly” and “addictive” on their websites went into effect Monday — and more regulations are coming. Tobacco companies including Altria, R.J. Reynolds Tobacco, Lorillard, and Philip Morris USA were […]


Regulatory

Fed up with rising costs, big US firms dig into health care

June 11, 2018

Via: CNBC

At its Silicon Valley headquarters, network gear maker Cisco Systems is going to unusual lengths to take control of the relentless increase in its U.S. health-care costs. The company is among a handful of large American employers who are getting […]


Regulatory

Trump administration will no longer defend the Affordable Care Act in court

June 8, 2018

Via: CNBC

The Trump administration declared that it will no longer defend the Affordable Care Act from a challenge filed by 20 states in a brief filed Thursday night because it agrees that the law’s individual mandate is unconstitutional and that key […]


Regulatory

FCC chairman calls for boost in Rural Health Care Program cap

June 7, 2018

Via: Health Data Management

Federal Communications Commission Chairman Ajit Pai has sent a draft order to FCC colleagues increasing the annual funding cap by $171 million for the Rural Health Care Program, which provides telecommunications and broadband services to rural communities supporting telemedicine. Pai’s […]