Dot Compliance

FEBRUARY 15, 2024

On January 31st, 2024, almost a year after the Food and Drug Administration (FDA) published its proposed rule for the harmonization of quality system regulation (QSR) and ISO 13485, it has issued its final rule. director of the FDA’s Center for Devices and Radiological Health. What Is QMSR?

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FDA Compliance 52

Hall Render

OCTOBER 18, 2024

Food and Drug Administration (“FDA”) issued two compliance policies that outlined its strategy for enforcing the drug distribution security requirements established by the Drug Supply Chain Security Act (“DSCSA”), which were set to take effect on November 27, 2023.

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HIT Consultant

JUNE 30, 2022

The market saw a recovery in 2021 and is projected to further increase through to 2026 as cardiac patient management further develops. Apple – Apple first gained FDA approval in September 2018 for its app for the detection of atrial fibrillation (AF) or sinus rhythm using the Apple Watch Series 4 onward.

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COVID-19 FDA Telemedicine Hospitals 97

HIT Consultant

FEBRUARY 14, 2023

billion by 2026, with Long-Term ECG and, to a lesser extent, Mobile Cardiac Telemetry (MCT), being the principal engines of growth. In July 2022, iRhythm and Verily obtained FDA approval for their jointly developed Zio Watch and Zeus System, for identifying and monitoring Afib, incorporating iRhythm’s continuous PPG, AI-based algorithm.

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Healthcare IT Today

JUNE 7, 2023

DSI and Predictive Models ONC is clearly attempting to leverage its certification program to help the Food and Drug Administration (FDA) increase transparency related to decision alerts, but this seems to be an inefficient and burdensome application of the certification lever.

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FDA Compliance Regulatory Compliance Medicaid 97

Hall Render

JUNE 5, 2024

In April 2024, the Food and Drug Administration (“FDA”) issued a Final Rule amending the definition of in vitro diagnostics products (“IVDs”) found in 21 C.F.R. Stage 3: Effective May 6, 2027 Three years after the Final Rule’s publication, the FDA will enforce all remaining quality system requirements (under 21 C.F.R.

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FDA Compliance Regulatory Compliance Licensing 40

HIPAA Journal

APRIL 24, 2023

The use of IoMT devices is growing at an extraordinary rate, with the number of devices used by smart hospitals expected to double from 2021 levels to 7 million IoMT devices by 2026. Food and Drug Administration (FDA) to take action.

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Electronic Medical Records FDA HIPAA Nurses 55

Innovaare Compliance

JANUARY 15, 2024

CMS will implement negotiated pricing based on maximum fair price (MFP) in 2026 on ten (10) selected drugs. 6] A compound drug not approved by the FDA under a New Drug Application or Biological License Application does not meet the definition of an applicable drug and will not be eligible for Part D.

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Medicare Medicare Compliance FDA 52

Healthcare IT Today

AUGUST 26, 2022

billion by 2026. These include HL7 workgroups, Clinical Interoperability Modeling Initiative (CIMI), and the Cancer-Interoperability project supported by the ONC, FDA, CDC, NCI, NIH and RSNA. PenRad is at the front lines of care as demand surges. PenRad provides software, and leadership towards standardization. About Intelerad.

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COVID-19 Patient Satisfaction Health Outcomes FDA 52

Healthcare IT Today

MAY 5, 2023

billion by 2026 , driven in part by direct-to-consumer testing for health risks such as breast cancer and physician orders for prenatal testing, tumor molecular profiling and sequencing to diagnose rare disease. Such scenarios demand vigilance from health plans and new approaches to preventing inappropriate billing before it starts.

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Fraud Medicare Medicare Overpayment 67

HIT Consultant

DECEMBER 8, 2021

between now and 2026. In fact, in January 2021, the FDA released an Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan, a clear indication of the technology’s explosive growth and legitimacy within healthcare. Zeynep Icten, Ph.D., Director of Data Science Solutions at Panalgo.

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FDA Medicaid Medicaid Health Outcomes 52

HIT Consultant

DECEMBER 5, 2024

The Cure for AI Maladies Gartner predicts that 50% of governments globally will enforce responsible AI policies by 2026. Food and Drug Administration (FDA) regulates AI-based medical devices under its software as a medical device (SaMD) category. Regulatory Guidance Oversight by the U.S.

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FDA Governance Health Insurance HIPAA 105

Bill of Health

MARCH 25, 2025

The FDA also required cigarette companies to warn consumers of the addictive nature and potential harms of their products. 2026) is a student fellow with Petrie-Flom Center. The federal government has a point of reference for regulating the advertisement of addictive products: tobacco. Part 1 of this 2-part series is here.

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Governance FDA Public Health 147

Healthcare IT Today

APRIL 13, 2025

Telepsychiatry provider Legion Health adopted QbCheck , FDA-cleared ADHD testing technology from Qbtech. Company News The AMA has approved Category 3 CPT codes for AI-assisted perivascular fat analysis , effective January 1, 2026, for technology available from Caristo Diagnostics. Sales Lungscreen Australia adopted Annalise.ai

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FDA Payment Systems Compliance 76

Health Populi

APRIL 1, 2025

On the supply side of health care and especially public-sector health care services and public health systems and information, I publish this post on a day when major cuts to the CDC, the FDA, and other health agencies are announced. consumers.

Public Health 62

Public Health Electronic Medical Records Regulatory Compliance FDA 62

SQA

FEBRUARY 15, 2023

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. Finalization of the document is planned for 2026. Health Canada Health Canada Inspection of Applied Chemistry Labs Ltd.,

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US Department of Health and Human Services FDA COVID-19 World Health 40

CMS.gov

OCTOBER 2, 2018

economy, and by 2026 the CMS Office of the Actuary projects that one in every five dollars spent in America will be spent on healthcare. This means that patients may experience unnecessary gaps between FDA approval of a technology and Medicare paying for the technology. Administrator, Centers for Medicare & Medicaid Services.

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Medicare Medicare Payment Systems FDA 44

SQA

MAY 24, 2023

As in the past, the PCPC stands ready to collaborate with the FDA and other stakeholders to ensure any reorganization enables the beauty and personal care industry to continue to provide innovative, safe, and effective products while maintaining consumer trust. The PCPC looks forward to working with FDA Chief Scientist Namandj Bumpus, Ph.D.,

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FDA Licensing Governance Compliance 40

SQA

MAY 24, 2023

As in the past, the PCPC stands ready to collaborate with the FDA and other stakeholders to ensure any reorganization enables the beauty and personal care industry to continue to provide innovative, safe, and effective products while maintaining consumer trust. The PCPC looks forward to working with FDA Chief Scientist Namandjé Bumpus, Ph.D.,

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FDA Licensing Governance Compliance 40

Dot Compliance

FEBRUARY 1, 2022

Analysts report that the global life science analytics market (descriptive analytics, predictive analytics, prescriptive analytics) is expected to double in value by 2026 ($47B up from $23B in 2020), driven by the “increased prevalence of chronic diseases, technological advancements and rising demand for improved data standardization.”

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COVID-19 Vaccine FDA Pharmaceutical Industry COVID-19 52

Bill of Health

OCTOBER 16, 2024

FDA Reconsideration of the Boxed Warning on Low-Dose Estrogen The U.S. Food & Drug Administration (FDA) should reconsider the boxed warning currently required for low-dose estrogen, which is a key treatment for menopause symptoms. 2026), whose research interests include innovative medical technologies and chronic disease policy.

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US Department of Health and Human Services FDA Public Health Doctors 100

Healthcare Law Blog

AUGUST 25, 2022

The first list of up to 10 Part D negotiation-eligible drugs will be published in 2026, the earliest “price applicability date” at which the Program takes effect. The drug publication date for 2026 will be chosen by September 1, 2023. Negotiation-Eligible Drugs. Insulin Products.

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Medicare Medicare Medicaid Medicaid 52

Healthcare Law Blog

NOVEMBER 13, 2023

However, as all FDA-licensed biosimilar biological products must be very similar to and would have no clinically meaningful difference from the reference product with respect to safety and efficacy, CMS is comfortable with proposing this formulary change.

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Medicare Medicare Medicaid Medicaid 59

C&M Health Law

JANUARY 25, 2023

HHS is directed to submit to Congressional committees the result of findings in an interim report in October 2024 and a final report in August 2026. Section 3604 of the Act requires FDA to issue a report on an annual basis, beginning two years after the Act’s enactment, that summarizes its diversity action plans.

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Hall Render

JULY 26, 2024

Murphy signs new medical debt protections into law Some N.J. in workforce training NORTH CAROLINA Atrium Health Pineville earns spinal surgery certification by The Joint Commission Atrium Health Wake Forest Baptist opens 20,000 SF, $3.5M Here’s how it’s helped Wisconsin’s mental health crisis.

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US Department of Health and Human Services Nursing Homes Nurses COVID-19 40

Hall Render

JULY 26, 2024

Murphy signs new medical debt protections into law Some N.J. in workforce training NORTH CAROLINA Atrium Health Pineville earns spinal surgery certification by The Joint Commission Atrium Health Wake Forest Baptist opens 20,000 SF, $3.5M Here’s how it’s helped Wisconsin’s mental health crisis.

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US Department of Health and Human Services Nursing Homes Nurses COVID-19 40

Hall Render

FEBRUARY 2, 2024

Inman College of Nursing FDA clears Collierville startup CircumFix’s medical device for surgery, marketing FTC opposes Novant Health’s $320M hospital deal with Community Health Systems HCA CFO to retire HCA nets $5.2B

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Nursing Homes US Department of Health and Human Services Nurses Hospitals 40

Hall Render

SEPTEMBER 20, 2024

See details Mississippi State Medical Association names new president A Decade of Dedication: Enhancing Perinatal Outcomes in Mississippi Mississippi program aims to connect jailed people to mental health services MISSOURI 3 health systems see workforce gains in partnerships Ascension posts $1.8B

US Department of Health and Human Services 40

US Department of Health and Human Services Nurses Hospitals Nursing Homes 40

Hall Render

MAY 10, 2024

Million CALIFORNIA California hospital dismisses CEO California physician pleads guilty to $2.5M million expansion ‘Very, very unusual.’ Health Policy Commission still missing key document in Steward sale to Optum Local obesity drug developer lands deal worth up to $600M with Novo Nordisk Mass.

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Nursing Homes Nurses Hospitals Medicaid 40

Hall Render

DECEMBER 1, 2023

to Recruit, Train Primary Care Students UAMS Gets $17.5M

Nursing Homes 40

Nursing Homes Nurses COVID-19 Ransomware 40

Hall Render

JUNE 3, 2022

Colorado hospital first to implant FDA approved stent. Maryland Department of Health releases the 2022-2026 State Plan to Address Alzheimer’s Disease and Related Dementias. Bakersfield Rehabilitation Hospital Opens in Bakersfield, California. Alameda Health System data breach potentially affects 90,000 patients. MASSACHUSETTS.

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COVID-19 Nursing Homes US Department of Health and Human Services Nurses 40

Hall Render

JANUARY 17, 2025

OrthoIndy to merge with Evansville, Fort Wayne practices St.

Nursing Homes 40

Nursing Homes Nurses Hospitals Medicaid 40

Hall Render

AUGUST 16, 2024

Mount Sinai To Serve As Official Hospital And Medical Services Provider Of The US Open For 12th Year Hospital for Special Surgery names new CIO New York restricts use of meningitis antibiotic over resistance concerns NewYork-Presbyterian pushes back on 2 legal wins for union Governor Hochul Announces $27.5

US Department of Health and Human Services 40

US Department of Health and Human Services Nursing Homes Hospitals Nurses 40

Hall Render

AUGUST 16, 2024

Mount Sinai To Serve As Official Hospital And Medical Services Provider Of The US Open For 12th Year Hospital for Special Surgery names new CIO New York restricts use of meningitis antibiotic over resistance concerns NewYork-Presbyterian pushes back on 2 legal wins for union Governor Hochul Announces $27.5

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US Department of Health and Human Services Nursing Homes Hospitals Nurses 40

Hall Render

MARCH 3, 2023

What does it mean for you?

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Nursing Homes COVID-19 Nurses Hospitals 40

Hall Render

MARCH 21, 2025

operating income, 2.3% margin in 2024 Construction of $45M medical office complex in Arizona underway Scottsdale neuroscience company among two Flinn Foundation entrepreneurship winners UHS of Tucson Acquires 76,770 SF Behavioral Health Hospital in Arizona for $19.1M

Nursing Homes 40

Nursing Homes US Department of Health and Human Services Nurses Hospitals 40

Hall Render

APRIL 18, 2025

Operating Loss for 2024 CHI St. professionals from federal healthcare investigations bluebird bio’s board opts for sale to U.S. health care system needs to be more focused amid federal policy uncertainty SEC filing of the week: Ocean Biomedical’s loss narrows to $9.4M

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