Healthcare Law Blog

MAY 31, 2022

Medical devices are regulated by the Food and Drug Administration (“FDA”) and many of the applications and technologies used to deliver or access healthcare in the metaverse may be classified as a medical device. [3] How healthcare providers are licensed in the metaverse is also an open question. Medical Device Regulations. 1, 2021).

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Healthcare Law Today

JANUARY 20, 2022

However, health care providers, employers, and individuals have lacked clarity on if and how federal requirements might apply to such tests, including the Clinical Laboratory Improvement Amendments (CLIA), which govern most laboratory testing and the operations of clinical laboratories.

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COVID-19 FDA Licensing Medicaid 52

Healthcare IT News - Telehealth

FEBRUARY 5, 2024

Patients with mental health issues frequently must wait many months before getting seen by a licensed clinician who can prescribe psychotropic medication. You contend telepsychiatry will continue to grow because it enables access to mental healthcare – which is a big challenge today.

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Health Care Law Brief

JUNE 2, 2022

Therefore, a telehealth platform operating in all 50 states will, for example, need to comport with the laws governing corporate formation, provider licensure, scope of practice, and telehealth encounters in all 50 states. Provider Licenses. What types of providers will render care via telehealth? How is this disclosed to consumers?

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Public Health Compliance COVID-19 Licensing 52

Healthcare IT News - Telehealth

DECEMBER 1, 2021

As more and more wearable devices are becoming common in the technology, they have even started to get some FDA approvals as well. Whether it's government payers or the commercial payers, they have started to cover more and more of these initiatives. But one priority to address is the licensing-based requirement.

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SQA

JUNE 10, 2021

Backgrounder – Government of Canada Investments in Biomanufacturing, Development of COVID-19 Vaccines and Therapeutics, and Research, 18 May 2021. The Government of Canada’s number one priority is to protect the health of Canadians. FDA plant inspection and pay $50 million in fines and forfeiture.

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FDA COVID-19 COVID-19 Vaccine Compliance 52

Verisys

JANUARY 18, 2022

Primary source verification must be done to confirm a provider’s education, professional license and certifications, medical training, work history, references, and more. Provider information should be continuously monitored for any changes to exclusion or license status. Food and Drug Administration (FDA).

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Licensing Medicaid Medicaid Governance 52

Health Care Law Brief

OCTOBER 27, 2021

This means that although ketamine is approved by the FDA for some medical uses, it is not specifically approved to treat depression. Such laws and regulations are largely governed at the state level, and there may be (i) considerable variations among state laws and (ii) frequent updates to such laws. 1] [link]. [2] 2] [link]. [3]

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Licensing Telemedicine COVID-19 FDA 40

Healthcare IT Today

JULY 25, 2022

They purchase the technical solutions such as algorithms and software licenses with no R&D or engineering capabilities on staff. RPM devices work as medical devices which are governed by the FDA and related departments. Principle 2: Evaluate the regulation competence of the suppliers.

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FDA Licensing Governance Telemedicine 88

Pharmacy Law Blog

MARCH 13, 2018

The federal judge refused the dismissal on the grounds that the government had sufficiently backed its allegations against both the company and its owner. The government had also adequately backed its allegations that RS knew it had been overpaid but had made no attempt to refund the difference to Tricare, according to the judge.

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Fraud Governance Licensing FDA 52

Bill of Health

SEPTEMBER 29, 2022

In the July 29, 2022 notice, the USPTO set forth its views on the “duty of disclosure” and “duty of reasonable inquiry,” emphasizing the importance of consistency between statements made to the USPTO, the FDA, and other governmental agencies. Background Context. Practical Implications.

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FDA Governance Fraud Licensing 130

Redox

OCTOBER 12, 2023

The FDA has approved more than 500 AI and machine learning models for medical use—most of which are in radiology. In 2022, the FDA announced that some types of risk-scoring tools were to be regulated as medical devices. They should also factor in ongoing licensing fees as well as expenses for data processing, storage, and management.

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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 59

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

Bill of Health

APRIL 4, 2024

On top of that comprehensive rulebook, the European Data Strategy bundle of laws encompasses the EU General Data Protection Regulation (GDPR), the Free Flow of Non-Personal Data Regulation, the Data Governance Act and the Data Act, as part of the EC’s ambition to establish a single unified market for data. The sectorialism of the U.S.

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FDA Regulatory Compliance Malpractice Health Insurance 286

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. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

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

Jane Sarashon

JULY 29, 2022

The red-boxed items here identify the three largest chasms between experience vs. expectations: for information about providers (say, their ethnicity, gender, and licenses), and abilities to schedule an appointment online or a telehealth encounter. government would have saved $2.6 billion in 2018.

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Health Law Advisor

MARCH 1, 2023

On February 14, 2023, the Utah Senate passed a bill that would repeal the State’s “Online Prescribing, Dispensing, and Facilitation Licensing Act” (“Online Prescribing Act”). States and the federal government have been taking sides on the ability of pharmacies to dispense mail-order medications used for abortion. 1] [link]. [2]

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Telemedicine COVID-19 Fraud Licensing 52

Healthcare IT Today

JANUARY 19, 2024

With the majority of AI tools lacking the necessary FDA clearance for use in healthcare settings, health systems will need to properly evaluate their AI investments to prioritize legitimized solutions that will ensure patient safety and legal compliance.”

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Hospitals Governance FDA Licensing 99

Healthcare IT Today

DECEMBER 29, 2023

Sara Shanti, a partner specializing in health care technology at law firm Sheppard Mullin , says that the Executive Order and recent FDA guidance “start to provide real direction on how to navigate patient risk. Liability and Licensing Are clinicians facing the risk of lawsuits if they heed the advice of AI engines?

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Department of Veterans Affairs FDA Doctors Licensing 110

Bill of Health

SEPTEMBER 28, 2023

Such a provision could prevent the public from paying twice for publicly-funded medical products—first through their taxes subsidizing government funded research and development, and second to procure the product in an inflated U.S. pharmaceutical market. Moreover, the NASDAQ Biotechnology Index increased by 374% from 1995 to 2000.

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SQA

MAY 24, 2023

The company did not have a written procedure in place for the provision of information related to serious risk of injury to health, contrary to what was committed to on it establishment license application. The name and address of manufacturers provided by the company on its establishment license application were not accurate.

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FDA Licensing Governance Compliance 40

Hall Render

FEBRUARY 23, 2024

biotech pins hopes on 3 drug approvals as battles with FDA continue Luxury senior living facility coming to D.C. 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.

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Healthcare IT Today

JANUARY 6, 2023

The Leidos-Milken partnership in spring 2021 launched a collaborative initiative aimed at bringing together leaders in the private, government, academic, and nonprofit sectors to address the national opioid epidemic and mental health crisis. Wayne Johnson, Vice President of Special Operations at Sunwave Health.

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Healthcare Law Blog

DECEMBER 11, 2023

Of particular note is a newly unveiled framework for deciding whether the Government may exercise “march-in” rights and take a pharmaceutical company’s drug patents developed with federal funds and share them with other companies.

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Governance FDA Licensing 52

Healthcare Law Today

DECEMBER 19, 2022

health care sector continues to grow at a rapid rate, and there is a recent government push for health care technologies, which have been identified as essential to U.S. FDA Regulatory Considerations for the U.S. The session is titled, “U.S. Health Care Arrangements: Legal, Regulatory, and Business Considerations.”

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Telemedicine FDA Licensing Governance 64

Hall Render

MAY 10, 2024

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. ranks second nationwide in hospital patient safety, with 7 Central Va.

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Nursing Homes Nurses Hospitals Medicaid 40

SQA

OCTOBER 18, 2023

The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products. At the same time, the EU has recognized the US FDA as an equivalent authority to carry out these inspections.

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FDA Compliance Licensing World Health 40

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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FDA Licensing Hospitals Medicaid 98

Hall Render

MARCH 3, 2023

Clair Health partners with Duquesne University College of Osteopathic Medicine UPMC sees lower operating income in 2022 as economic headwinds persist UPMC settles lawsuit with federal government for $8.5

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Hall Render

MARCH 31, 2023

What happens if it disappears? Cooper signs bipartisan Medicaid expansion into law Greensboro medical office building sold for $1.65

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

Hall Render

SEPTEMBER 15, 2023

billion clawback in Northern District of Texas Fort Worth The Hospital at Westlake Medical Center files for Chapter 11 bankruptcy protection 11 best hospitals in Texas for orthopedic surgery Johns Hopkins physician leader to join UT Southwestern Medical City Fort Worth’s New CEO and Texas Health Stephenville’s $12.5

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

Hall Render

OCTOBER 6, 2023

government grant for maternal health care Alabama slides to 50th on nursing home and long-term care report card Ascension sells Alabama hospital Ascension St. medical school to revamp philanthropic efforts Sage Health opening 3 central Md.

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

Hall Render

OCTOBER 6, 2023

government grant for maternal health care Alabama slides to 50th on nursing home and long-term care report card Ascension sells Alabama hospital Ascension St. medical school to revamp philanthropic efforts Sage Health opening 3 central Md.

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

Hall Render

DECEMBER 22, 2023

health care spending hits $4.5

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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 for Dental Health OakLeaf Medical Network reaches out to HSHS WYOMING Gov.

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

SQA

OCTOBER 18, 2022

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. The packaging of the counterfeit kits resembles authentic (licensed) BTNX Inc. products in color and typeface and uses the BTNX Inc. device identifier “COV-19C25.”

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