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Category: Regulatory


Regulatory

Hospitals charged employers and insurers 254% more than Medicare in 2022: study

May 14, 2024

Via: Healthcare Dive

Since 2021, health systems and insurers have been required to post pricing information for their 300 most common procedures as the government pushes to make healthcare prices more transparent. However, researchers have accused hospitals and insurers of failing to fully […]


Regulatory

Ensuring Food Safety in Healthcare

May 7, 2024

Via: HitConsultant

Food safety is of paramount importance for all industries. Ensuring the preparation, handling, and storage of food meets certain health and safety standards is critical for businesses involved in the production of food, its distribution and service, not only to […]


Regulatory

California Floats Extending Health Insurance Subsidies to All Adult Immigrants

May 3, 2024

Via: Kaiser Health News

Marisol Pantoja Toribio found a lump in her breast in early January. Uninsured and living in California without legal status and without her family, the usually happy-go-lucky 43-year-old quickly realized how limited her options were. “I said, ‘What am I […]


Regulatory

HHS finalizes reproductive health data protections

April 23, 2024

Via: Healthcare Dive

The Biden administration finalized a rule Monday that bars providers, health plans and other entities covered by HIPAA from disclosing protected health information that could be used to investigate abortions. The regulation from the HHS’ Office for Civil Rights, first […]


Innovation, Medical Devices, Regulatory

Cochlear secures FDA clearance for Osia System for children aged five

April 22, 2024

Via: Medical Device Network

Cochlear, an implantable hearing solutions developer, has received clearance from the US Food and Drug Administration (FDA) to expand the use of its Osia System to children as young as five years old. This decision lowers the eligible age from […]


Regulatory

Lumicell secures FDA approval for imaging platform

April 19, 2024

Via: Medical Device Network

Lumicell has received approval for its new drug application (NDA) for LUMISIGHT optical imaging agent and premarket approval (PMA) application for Lumicell direct visualisation system (DVS) from the US Food and Drug Administration (FDA). The LUMISIGHT optical imaging agent and […]


Regulatory

2023 in Review: The Rise of Healthcare Data Privacy Regulations

April 12, 2024

Via: Health IT Answers

As consumer data privacy evolves, 2023 was the year healthcare came into focus. Many state and federal changes governing data privacy legislation went into effect. These new laws and amendments aimed to strengthen user privacy rights and hold organizations accountable […]


Innovation, Med Tech, Regulatory

Beacon obtains FDA clearance for SleepStageML software

March 28, 2024

Via: Medical Device Network

Beacon Biosignals has secured the US Food and Drug Administration’s (FDA) 510(k) clearance for SleepStageML, a machine learning software designed to enhance sleep analysis. This development expands the company’s analytical capabilities, extending from at-home sleep monitoring to include in-lab polysomnography, […]


Regulatory

Brightside Health Secures $33M to Expand Access to Mental Healthcare

March 26, 2024

Via: HitConsultant

Addressing a Growing Need With one in five adults in the United States struggling with mental health conditions, Brightside Health is well-positioned to address this critical need. Brightside Health offers a range of teletherapy services, including their award-winning Crisis Care […]


Regulatory

UnitedHealth under antitrust investigation by DOJ: reports

February 28, 2024

Via: Healthcare Dive

UnitedHealth is under investigation by the Department of Justice over antitrust concerns, according to reporting by the Examiner News and the Wall Street Journal. Over the past few weeks, investigators have been inquiring about UnitedHealth’s effect on competition in sectors […]


Regulatory

Washington state bill seeks to regulate hospital mergers, care access

February 14, 2024

Via: Healthcare Dive

Software engineer Alexander Surkov recently proposed a new addition to the Chromium source code, the layout engine on which many modern browsers are based. The programmer aims to implement the Web Monetization specifications, providing Chrome and many other free browsers […]


Regulatory

FDA approves Edwards’ EVOQUE for tricuspid regurgitation

February 5, 2024

Via: Medical Device Network

Edwards Lifesciences has received approval from the US Food and Drug Administration (FDA) for its EVOQUE tricuspid valve replacement system, a transcatheter therapy, for treating TR. The system has been designed for patients with symptomatic severe TR who have not […]


Regulatory

Senators reintroduce bill to boost telemental healthcare

January 25, 2024

Via: Healthcare Dive

The Telemental Health Care Access Act comes as a number of Medicare telehealth flexibilities that first went into effect during the COVID-19 pandemic are set to expire at the end of the year without congressional action. Lawmakers have previously shown […]


Regulatory

Providers push back on info blocking penalties

January 8, 2024

Via: Healthcare Dive

The HHS released the proposed information blocking penalties for providers in the fall, years after rules went into effect that banned preventing the exchange of health data. Regulators also finalized penalties for health IT developers over the summer, allowing the […]


Regulatory

Mask mandates return to health facilities amid soaring COVID, flu cases

January 4, 2024

Via: Healthcare Dive

The New York City health commissioner reinstated an indoor mask mandate Jan. 3 for public hospitals, health centers and long-term care facilities amid a rise in COVID-19, flu and respiratory virus cases, according to ABC 7 NY. Health Commissioner Dr. […]


Regulatory

Biden administration urges 9 states to curb high child Medicaid, CHIP disenrollments

December 19, 2023

Via: Healthcare Dive

State Medicaid programs began reassessing eligibility for the safety-net insurance program this spring after a long period of continuous enrollment during the COVID-19 pandemic. Continuous enrollment provisions caused rolls to swell to nearly 94 million people before unwinding began in […]


Regulatory

Senate subcommittee signals support for permanent telehealth flexibilities

November 15, 2023

Via: Healthcare Dive

Lawmakers showed bipartisan support for making pandemic-era telehealth flexibilities permanent in Medicare during a Senate subcommittee hearing on Tuesday. But witnesses noted Congress shouldn’t wait to address the temporary accommodations — some of which expire at the end of next […]


Regulatory

New California Law Offers Fresh Protection From Steep Ambulance Bills

November 7, 2023

Via: Kaiser Health News

Last year, Jennifer Reisz’s college-age daughter, Megan, was kicked in the chest multiple times by the family’s horse. Megan fell to the ground, unable to move or speak. Though she was alone, her Apple Watch detected her distress and called […]


Regulatory

White House orders HHS to collect reports on healthcare AI safety

November 1, 2023

Via: Healthcare Dive

Regulatory scrutiny of AI has increased over the past year. The European Union is developing the AI Act, legislation that it claims will be the first comprehensive AI law, and the FDA is drafting guidance on AI-enabled device software functions. […]


Regulatory

US issues executive order for AI regulation in healthcare

October 31, 2023

Via: Medical Device Network

Apresidential executive order aimed at establishing a new set of guidelines and intended regulations for Artificial Intelligence (AI) has been issued by the United States government. The Joe Biden administration on 30 October released what it describes as a new […]