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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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.

Patients unhappy with UnitedHealth’s limits on insulin pumps

A new deal between UnitedHealthcare and device maker Medtronic means fewer options for UnitedHealth customers who need insulin pumps to treat Type 1 diabetes.

CDC failed to disclose lab mishaps to Congress

The Centers for Disease Control and Prevention (CDC) told Congress it left out 34 incident reports involving lab mistakes from information it provided to a congressional investigation in 2014, according to USA Today.

IT group wants interoperability standards for drug monitoring

As the House and Senate work in a conference committee on anti-opioid abuse legislation, a coalition called Health IT Now has asked lawmakers to lay out more specific standards on how different states’ prescription drug monitoring programs (PDMPs) will be interoperable. 

Study claims high drug prices lead to more long-term savings

A study released by Frank R. Lichtenberg of the Montreal Economic Institute said while the price of prescription drugs remains high, the implementation of medical innovation leads to more savings in the long run.

AMIA asks for new approach on ONC interoperability standards

Measuring interoperability as required by the Medicare Access and CHIP Reauthorization Act (MACRA) calls for a “patient-centric” and flexible strategy, wrote the American Medical Informatics Association (AMIA).

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FDA approves first implant to treat opioid dependence

The Food and Drug Administration has approved the first buprenorphine implant, Probuphine, to treat addiction to both prescription and illegal opioids.

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These health systems have the biggest digital health portfolios

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.

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Toylike robot pleases counseling clients where humanoid counterpart struggles to connect

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.

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Medsender, Patagonia Health team up to aid public health efforts against COVID-19

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.