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. 

New FDA draft guidance seeks to clarify UDI forms

A new draft guidance from the U.S. Food and Drug Administration (FDA) seeks to clarify how Unique Device Identifiers (UDIs) are included on medical devices.

Stolen laptop costs the University of Mississippi Medical Center $2.75 million

The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services has reached a settlement of $2.75 million with the University of Mississippi Medical Center in Jackson concerning the matter of a missing laptop.

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HHS report leaves it to Congress to fill privacy gaps on health data

A report on privacy and security concerns surrounding new technology that collects health data, such as wearable fitness trackers, admitted regulations like HIPAA haven’t kept pace with new developments.

FBI gives suggestions on how to prevent healthcare hackers

In recent news, healthcare hackers such as “TheDarkOverlord” have been stealing private patient records and parading their spoils around the internet. He claims to be selling these private documents on the black market is ransom is not paid by the healthcare providers he initially stole the information from. This activity has caught the interest of the FBI, reports Information Management. 

Joint Commission keeping clinician texting ban in place until September

After reversing a five-year-old ban on healthcare organizations sending orders in May, the Joint Commission has changed plans again, announcing in its June newsletter the previous ban won’t be lifted until September.

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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.

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.

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