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.,

US Department of Health and Human Services 40

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

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.

Fraud 62

Fraud Medicare Medicare Overpayments 62

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.

FDA 52

FDA Health Outcomes Medicaid Medicaid 52

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.

Medicare 44

Medicare Medicare Payment Systems FDA 44

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.

FDA 97

FDA Hospitals 97

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.”

FDA 52

FDA COVID-19 Vaccine Pharmaceutical Industry COVID-19 52

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.,

FDA 40

FDA Licensing Governance Compliance 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.

Nursing Homes 40

Nursing Homes Nurses Hospitals Medicaid 40

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.

Medicare 52

Medicare Medicare Medicaid Medicaid 52

Hall Render

DECEMBER 1, 2023

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

Nursing Homes 40

Nursing Homes Nurses Ransomware 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

Nursing Homes 40

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

Hall Render

MARCH 3, 2023

What does it mean for you?

Nursing Homes 40

Nursing Homes COVID-19 Nurses Hospitals 40

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.

Medicare 59

Medicare Medicare Medicaid Medicaid 59

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.

COVID-19 40

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

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.

Medicaid 104

Medicaid Medicaid Medicare Medicare 104