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Recent Headlines

House panel debates greater FDA role in regulating health apps

The safety, effectiveness and data security of mobile healthcare applications were examined by a U.S. House subcommittee in a July 13 hearing, with lawmakers alternating between excitement over their potential and concern that consumers’ data isn’t being protected.

21st Century Cures Act won’t get Senate vote before long recess

It’s been more than a year since the House passed the 21st Century Cures Act, which aims to speed up regulatory approval for medical devices and drugs, but the Senate’s chief advocate for the legislation said it’ll be at least another seven weeks before its put up for a vote.

HHS issues new guidance on ransomware attacks

HHS’ Office of Civil Rights (OCR) has released its much-anticipated guidance on how healthcare organizations can better understand and respond to ransomware attacks, including defining such incidents as breaches that require affected individuals to be notified under HIPAA in most circumstances.

Is it time for healthcare to have a digital code of ethics?

Entering the digital age has changed a lot of fundamental things in healthcare. Records are computerized, telehealth is booming and your phone can even detect an array of diseases. As the healthcare industry evolves into a more technologically savvy place, a code of ethics may be needed for the digital space.

FDA-approved stomach-draining device may face lawsuit

The Food and Drug Administration has approved several new weight loss interventions in the past year, but one in particular seems to be raising eyebrows among physicians.

Nearly 600 U.S. clinics could be selling unregulated stem cell treatments

The risks of “stem cell tourism” might be overplayed, according to a new paper published June 30 in the journal Cell Stem Cell. But only because the real risks of unregulated stem cells might actually be within the U.S.

 
Biden rallies participants to double cancer progress in 'moonshot' kick-off

Vice President Joe Biden led a major step toward completing his “moonshot” task of curing cancer June 29, when he spoke at the first Cancer Moonshot Summit.

 
FDA approves test for quicker detection of hospital ‘superbugs’

The Food and Drug Administration (FDA) has given a thumbs up to a test hospitals can use to identify certain types of antibiotic-resistant infections more quickly.

Study reveals differing standards for approval of American, European medical devices

Medical devices play a vital role in patient care, but how they are approved and regulated are vastly different in the United States compared to the European Union.

Health IT groups want more time to prepare for MACRA

Electronic health record (EHR) vendors and the clinicians they serve need more than a few months to adapt to the Medicare Access and CHIP Reauthorization Act, according to numerous comments submitted to CMS by health IT groups.

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