April 23, 2024
Via: Healthcare DiveThe 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
April 22, 2024
Via: Medical Device NetworkCochlear, 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 […]
April 19, 2024
Via: Medical Device NetworkLumicell 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 […]
April 12, 2024
Via: Health IT AnswersAs 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
March 28, 2024
Via: Medical Device NetworkBeacon 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, […]
March 26, 2024
Via: HitConsultantAddressing 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 […]
February 28, 2024
Via: Healthcare DiveUnitedHealth 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 […]
February 14, 2024
Via: Healthcare DiveSoftware 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 […]
February 5, 2024
Via: Medical Device NetworkEdwards 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 […]
January 25, 2024
Via: Healthcare DiveThe 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 […]
January 8, 2024
Via: Healthcare DiveThe 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 […]
January 4, 2024
Via: Healthcare DiveThe 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. […]
December 19, 2023
Via: Healthcare DiveState 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 […]
November 15, 2023
Via: Healthcare DiveLawmakers 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 […]
November 7, 2023
Via: Kaiser Health NewsLast 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 […]
November 1, 2023
Via: Healthcare DiveRegulatory 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. […]
October 31, 2023
Via: Medical Device NetworkApresidential 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 […]
October 3, 2023
Via: Medical Device NetworkLaboratory Developed Tests (LDT) are set to be regulated as medical devices under new rules proposed by the US Food and Drug Administration. The proposed rule seeks to amend the FDA’s regulations to make explicit that In Vitro Diagnostic Products […]
September 27, 2023
Via: Healthcare DiveThe COVID-19 pandemic highlighted the struggles of front-line healthcare workers including long-standing issues like staffing shortages and burnout. Hospitals still struggle with staffing, with over 80% of healthcare executives labeling recruitment a significant business risk in a survey conducted by […]
September 21, 2023
Via: Kaiser Health NewsThe Biden administration announced a major initiative to protect Americans from medical debt on Thursday, outlining plans to develop federal rules barring unpaid medical bills from affecting patients’ credit scores. The regulations, if enacted, would potentially help tens of millions […]