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. 

Technology companies have a better view of your health than you might think

It’s a grudgingly accepted fact of life among many that specific personal data and more general meta data about nearly everyone is stored online, possibly accessible to people, corporations and governments willing to look for it. 

August 1, 2016

FDA taking hands-off policy towards ‘low-risk’ health apps, devices

Fitness trackers and mobile apps that focus on “general wellness” won’t be regulated by the Food and Drug Administration (FDA), according to new guidance released by the agency, while warning that more invasive technologies still fall under its purview.

August 1, 2016

New FDA draft guidance seeks to clarify UDI forms

A new draft guidance from the U.S. Food and Drug Administration (FDA) seeks to clarify how Unique Device Identifiers (UDIs) are included on medical devices.

July 25, 2016

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.

July 25, 2016

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.

July 20, 2016

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. 

July 19, 2016

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.

July 19, 2016
U.S. Congress

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.

July 14, 2016

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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