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Category: Regulatory


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 […]


Regulatory

White House: Trump’s drug pricing plan will make rest of the world pay its fair share

June 6, 2018

Via: CNBC

Drug affordability is rightly a top concern for Americans. President Trump recently launched an unprecedented effort to fix this problem with a proposal to tackle excessively high drug prices while still preserving incentives for medical innovation, which ensures better future […]


Regulatory

White House announces still more leadership changes at VA

May 31, 2018

Via: Health Data Management

Palace intrigue in the White House regarding the leadership of the Department of Veterans Affairs continued on Wednesday with the Trump administration’s announcement that Peter O’Rourke has been named acting VA secretary. O’Rourke, who previously served as the VA’s chief […]


Regulatory

FDA issues industry challenge to combat opioid epidemic

May 31, 2018

Via: Health Data Management

The Food and Drug Administration on Wednesday launched a challenge to industry to develop medical devices, including digital health technologies and diagnostic tests, in an effort to combat the nationwide opioid epidemic by targeting the problems of pain, addiction, and […]


Innovation, Medical Devices, Regulatory

FDA to assess impact of medical device definition under Cures Act

May 30, 2018

Via: Health Data Management

The Food and Drug Administration is seeking stakeholder feedback on the benefits and risks to health associated with the software functions excluded from the medical device definition by the 21st Century Cures Act. Section 3060 of the Cures Act compels […]


Regulatory

Doctors call on health authorities for permission to provide stroke patients with life-saving treatment

May 25, 2018

Via: The Medical News

Heart doctors from the European Society of Cardiology (ESC) Council on Stroke are calling on national health authorities for permission to provide stroke patients with mechanical thrombectomy, a life-saving treatment for acute ischaemic stroke, in regions where there is a […]


Regulatory

Senate passes bill to broaden VA information sharing with providers

May 24, 2018

Via: Health Data Management

The U.S. Senate on Wednesday passed legislation by a vote of 92 to 5 that would significantly broaden information sharing between the Department of Veterans Affairs and non-VA healthcare providers. The bipartisan VA Maintaining Internal Systems and Strengthening Integrated Outside […]


Regulatory

The FDA Is Warning People to Steer Clear of Sunscreen Pills

May 23, 2018

Via: Time Health

Sunscreen comes in many forms, from lotions to sprays to creams — but the Food and Drug Administration (FDA) is warning consumers to steer clear of one formula in particular: so-called sunscreen pills. The agency on Tuesday announced that it […]


Regulatory

Drugmakers blamed for blocking generics have milked prices and cost U.S. billions

May 23, 2018

Via: The Medical News

Makers of brand-name drugs called out by the Trump administration for potentially stalling generic competition have hiked their prices by double-digit percentages since 2012 and cost Medicare and Medicaid nearly $12 billion in 2016, a Kaiser Health News analysis has […]


Regulatory

Investors have shrugged off Trump drug price plan, but it is still early days

May 21, 2018

Via: CNBC

The biopharma and drug supply chain sectors outperformed the market last week, even as Trump administration officials pressed the president’s blueprint to lower drug prices, with tough rhetoric for drugmakers and public shaming of pharmaceutical firms for supposedly blocking competition. […]


Opinions, Regulatory

Vermont legislators pass a drug importation law. So what?

May 18, 2018

Via: The Medical News

This week, Vermont passed a first-in-the-nation law that would facilitate the state’s importation of prescription drugs wholesale from Canada. It represents the state’s effort to tackle head-on the issue of constantly climbing drug prices. Other states, including Louisiana and Utah, […]


Regulatory

Lawmakers accuse VA of ‘malign neglect’ regarding EHR modernization efforts

May 17, 2018

Via: Health Data Management

Members of the U.S. Senate and House of Representatives are turning up the heat on the Department of Veterans Affairs for what lawmakers describe as “malign neglect” regarding the VA’s electronic health record modernization efforts. Five senators and six members […]


Regulatory

VA telehealth rule allows providers to treat patients across state lines

May 14, 2018

Via: Health Data Management

The Department of Veterans Affairs has finalized a rule allowing telehealth providers to administer care to veterans across state lines and outside of a federal facility. Previously, VA physicians could only waive state licensing requirements and provide telehealth treatment across […]


Regulatory

To lower drug costs at home, Trump wants higher prices abroad

May 10, 2018

Via: CNBC

WASHINGTON — President Trump, poised on Friday to unveil his strategy to lower prescription drug prices, has an idea that may not be so popular abroad: Bring down costs at home by forcing higher prices in foreign countries that use […]