Healthcare IT News - Telehealth

DECEMBER 1, 2021

What's less certain, however, is what that utilization will look like in the future, particularly as the end of the public health emergency looms. What is driving all this, of course, is the regulatory changes during this public health emergency. First of all, we should think about the public health emergency.

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SQA

MARCH 25, 2021

United States Food and Drug Administration (FDA) – Regulations and Guidances for Biologics and the Bioresearch Monitoring Program (BIMO). Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency, January 2021.

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Healthcare IT News - Telehealth

MAY 30, 2023

The COVID-19 public health emergency came to an end on May 11. This also happens to coincide with the World Health Organization declaring an end to the COVID-19 global health emergency. What does the end of the public health emergency mean for the future of the healthcare industry?

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Bill of Health

JANUARY 16, 2024

The judge did so by suspending an FDA rule that required in-person ordering, prescribing, and dispensing of the pill by a provider. We hear providers struggle with new legal risks: “I can’t keep providing services if I get [my license] taken away.”

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Healthcare IT Today

JUNE 13, 2023

They also plan to offer APIs to labs and public health organizations, delivering test results securely through an app along with advice about how to handle the risk. Also, ixlayer utilizes only FDA-approved sample collection devices following best practice standards, everything in HIPAA compliant environment.

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HIT Consultant

MAY 9, 2022

The legislation mandated healthcare providers to modernize their internal recordkeeping, allowing for the swifter dissemination of medical information to support public health efforts and better medical care. Software matters: A snapshot of the digital transformation at a large health system.

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Innovaare Compliance

OCTOBER 6, 2022

Adult vaccine recommended by ACIP is a covered Part D drug when licensed by the US Food and Drug Administration (FDA) under the Public Health Service Act for use by adult populations and administered in accordance with recommendations of ACIP.

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Healthcare IT Today

JANUARY 6, 2023

An end to the Public Health Emergency (PHE) is likely to be announced and end mid-January followed by a grace period of approximately 5 months. And with the Public Health Emergency (PHE) set to expire in January, stakeholders are urgently calling upon Congress to pass the Advancing Telehealth Beyond COVID-19 Act of 2021.

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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. A concerted and collaborative effort is essential to address this threat to global health, economies, and security effectively.

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Bill of Health

APRIL 4, 2024

It provides several rules for sharing information and exceptions keyed directly to the realities of the health care setting, such as permitting information sharing for treatment, payment, or health care operations, some public health situations, and if certain identifiers have been stripped from the data set.

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AIHC

JUNE 6, 2023

Algorithms perform relatively well on knowledge-based tests despite the lack of domain-specific training; ChatGPT achieved ~ 66% and ~ 72% on Basic Life Support and Advanced Cardiovascular Life Support tests, respectively, and performed at or near the passing threshold on the United States Medical Licensing Exam.

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Health Law Advisor

MARCH 1, 2023

In the era of abortion regulation and the wind-down of the COVID-19 public health emergency (“PHE”), new legislation in states such as Utah may be a sign of what is to come for online and telehealth prescribing. The bill currently awaits Governor Spencer Cox’s signature and would take effect sixty (60) days after its signing. [1]

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C&M Health Law

FEBRUARY 1, 2022

Food & Drug Administration (FDA) published a notice in the Federal Register announcing the availability of a final guidance for industry and FDA staff entitled “Principles of Premarket Pathways for Combination Products”. The final guidance is available on the FDA’s website. On January 31, 2022, the U.S.

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AIHC

JUNE 6, 2023

Algorithms perform relatively well on knowledge-based tests despite the lack of domain-specific training; ChatGPT achieved ~ 66% and ~ 72% on Basic Life Support and Advanced Cardiovascular Life Support tests, respectively, and performed at or near the passing threshold on the United States Medical Licensing Exam.

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Compliance Medical Billing HIPAA Due Diligence 52

Healthcare IT Today

MAY 3, 2023

The excitement has been largely fueled by the renowned public health benefits of, and the seductive commercial opportunity for, a seamless hypertension management solution that is virtually invisible – part of what people are already wearing, such as smartwatches, earbuds, smart rings, and apparel.

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Hall Render

FEBRUARY 23, 2024

CT’s Medicaid reimbursement rates lower than peer states: report Better safety training, reporting, escorts for CT home health care workers focus of new legislation D.C. biotech pins hopes on 3 drug approvals as battles with FDA continue Luxury senior living facility coming to D.C.

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Hall Render

MAY 20, 2022

AHA asks HHS to continue the public health emergency until conditions stabilize. Considerations for Social Determinants of Health Screening Design. COVID-19 public health emergency set to be extended. Covid-19 remains a public health emergency in US, administration says. Million COBRE Grant Extension.

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Hall Render

SEPTEMBER 1, 2023

ALABAMA American Family Care opens new health care center in Northeast Birmingham doctors secure $13.9M operating margin, $1B net gain halfway through its first year Illinois public health officials warn of “rising COVID-19 activity” St. Warner, Kaine announce nearly $1.4M

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SQA

MAY 24, 2023

The deadline for reporting serious incidents not constituting serious public health threats, deaths, or unanticipated serious deteriorations in state of health was reduced to 15 calendar days. The name and address of manufacturers provided by the company on its establishment license application were not accurate.

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Bill of Health

SEPTEMBER 28, 2023

Public Health Service and the National Institutes of Health (NIH) incorporated a fair pricing condition as part of cooperative research and development agreements (CRADAs) between federal laboratories and private manufacturers. In 1989, the U.S.

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SQA

SEPTEMBER 2, 2022

Ma rketing authorization holders (MAHs) can now register their Industry Single Point of Contact (i-SPOC) who will inform EMA about the supply and availability of critical medicines identified in the context of a ‘public health emergency’ or a ‘major event’. United States Food and Drug Administration (FDA) – Regulations and Guidances.

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SQA

DECEMBER 16, 2022

It will also facilitate cross-border circulation of these critical health therapies as well as cross-border cooperation between public health authorities. United States Food and Drug Administration (FDA) – Regulations and guidance. Computer Software Assurance for Production and Quality System Software, 13 September 2022.

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SQA

OCTOBER 18, 2023

In addition, it contains essential recommendations to avoid complications and protect public health. The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products.

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Healthcare Law Blog

OCTOBER 25, 2023

Effective January 1, 2022, an individual in Oregon who acts as a pharmaceutical representative for more than 15 days during the calendar year must have, and renew annually, a license from the Department of Consumer and Business Services (“DCBS”). ix] Nevada.

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SQA

DECEMBER 10, 2021

Pilot Program: EMA-FDA Parallel Scientific Advice for Hybrid/Complex Generic Products – General Principles, 15 September 2021. The agencies conduct PSA meetings under the auspices of the confidentiality arrangement between the European Commission, the EMA, and the FDA. European Medicines Agency (EMA). The EMA and the U.S.

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FDA Compliance Public Health Hospitals 52

Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

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Bill of Health

JUNE 1, 2023

Food and Drug Administration (FDA) announced that it is lifting its highly contested blood deferral policy for men who have sex with men (MSM, i.e., gay and bisexual men), colloquially known as the blood ban. This fits a paradigm I describe in recent work , the demedicalization of preventive health care.

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Healthcare IT News - Telehealth

MAY 6, 2020

The quickly evolving COVID-19 public health emergency has warranted the growing use of telehealth and non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and possible exposure to the virus. iRhythm Technologies.

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Hall Render

MARCH 31, 2023

County-owned buildings facing potential earthquake risk Gilead drops option to buy cancer therapeutics company Health and Life Organization Inc. What happens if it disappears? buys industrial property in Rancho Cordova for $5.12

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

Hall Render

APRIL 15, 2022

FDA clarifies cybersecurity recommendations for device makers in new guidance. HHS reveals strategy on social determinants of health. HHS extends COVID-19 public health emergency for another 90 days. Prices are soaring — but not for health care. Social Determinants of Health Worsened Specialty Care Access.

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Hall Render

MAY 19, 2023

Supplemental Grant for Rural Health Programs UAMS to Study Affordable Care Act’s Impact on Breast Cancer Treatment Arkansas Children’s Hospital Auxiliary Donates $1.4 Supplemental Grant for Rural Health Programs UAMS to Study Affordable Care Act’s Impact on Breast Cancer Treatment Arkansas Children’s Hospital Auxiliary Donates $1.4

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Hall Render

FEBRUARY 18, 2022

Lawmakers call on Biden to end public health emergency. License wait times reach crisis levels for healthcare workers. Meet new FDA chief Dr. Robert Califf: 5 things to know. 5 recent hospital, health system COO moves. of Public Health website. 8 recent hospital, health system executive resignations.

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Hall Render

DECEMBER 1, 2023

1 Mass General Brigham to build AI products with Australian health tech company Mass General Brigham hospital workers to receive average 21% raises Mass General Brigham to integrate triage AI across system Mass General Brigham sued over infection control lapse Nurse practitioner pleads guilty to $7.8M

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AIHC

FEBRUARY 2, 2022

COVID-19) for discharges occurring on or after April 1, 2020, through the duration of the COVID-19 public health emergency period. • Encounter for screening for other viral diseases (asymptomatic) Z11.52 Encounter for screening for COVID-19, asymptomatic Z20.822 Contact with and (suspected) exposure to COVID-19 Z86.16

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Hall Render

MARCH 25, 2022

FDA to revive facility visits. Dr. Lorna Breen Health Care Provider Protection Act becomes law. Here are the top health systems by patient reviews. Moderna wants the FDA to authorize its COVID-19 vaccine for kids under 6. Sensitive health data of 50 million Americans hacked or breached last year: analysis.

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SQA

OCTOBER 18, 2022

Health Canada is warning consumers about counterfeit BTNX Rapid Response COVID-19 antigen rapid test kits (25-pack boxes) found in Ontario. The counterfeit devices were sold online by a distributor named Healthful Plus without the required license to import, distribute, or sell medical devices in Canada.

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

Hall Render

MARCH 3, 2023

million for youth mental health care KENTUCKY Pike County nursing home officials release statement following loss of Medicare agreement Three Humana executives drop $11.2M

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