Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies. 

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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.

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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.

Around the web

U.S. health systems are increasingly leveraging digital health to conduct their operations, but how health systems are using digital health in their strategies can vary widely.

When human counselors are unavailable to provide work-based wellness coaching, robots can substitute—as long as the workers are comfortable with emerging technologies and the machines aren’t overly humanlike.

A vendor that supplies EHR software to public health agencies is partnering with a health-tech startup in the cloud-communications space to equip state and local governments for managing their response to the COVID-19 crisis.