Health Care Law Brief

JUNE 2, 2022

The onset of the COVID-19 public health emergency (“PHE”) led to a surge in the use of telehealth by health care providers. Variety of Risks Present in Telehealth Arrangements. The severity and type of risk present in a telehealth business will vary—by jurisdiction, by provider type, by service offering, and by payor mix.

Public Health 52

Public Health Compliance COVID-19 Licensing 52

Bill of Health

FEBRUARY 27, 2024

There is a common and problematic misconception that colonization was an isolated historical event and that the present is somehow divorced from its precedent. To explore how colonization drives health inequities, we have to acknowledge the causal relationship between what is past and what is present and think critically about colonization.

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Healthcare IT Today

APRIL 28, 2023

The following is a guest article by Chris Anello, Director of Digital Platforms at iTech AG The COVID-19 pandemic pushed healthcare organizations to the edge and exposed both challenges and opportunities related to public health data. This is one area where CX can come in.

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COVID-19 Governance Public Health FDA 107

Bill of Health

NOVEMBER 3, 2023

PROM responses can be used for purposes of clinical care, research, quality improvement, Food and Drug Administration (FDA) approval of drugs and devices, and even insurance reimbursement. Medical malpractice could occur for two reasons.

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Malpractice Bioethics HIPAA FDA 284

Bill of Health

APRIL 13, 2022

In fact, a recent FDA regulatory forum toxicology expert review article has suggested that a medication’s 5HT 2B binding affinity (Ki) was considered a better predictor of VHD risk than measures of functional activity such as EC50.

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Health Populi

JUNE 24, 2021

In the larger public and population health context, on the patient side, we can expect the burden of disease beyond COVID to increase due to postponed care and treatment backlogs. This has been found to be the case in the U.S., for example, for heart disease and cardiovascular complications as well as for cancers.

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COVID-19 COVID-19 Vaccine FDA Public Health 108

Exeed Regulatory Compliance

OCTOBER 26, 2020

A double-blinded, placebo-controlled, randomized clinical trial provides support for FDA approval of Remdesivir for treating COVID-19. COVID-19 continues to cause damage to both the public health and the economy at large. FDA is requiring additional post-market studies. There is some good news on the horizon. CONTACT US.

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Healthcare IT News - Telehealth

JULY 16, 2020

Mifepristone, in combination with misoprostol, is FDA-approved for abortions up to ten weeks' gestation. Given the potentially sensitive nature of reproductive health in particular, Yeh said telemedicine can present unique challenges. Colleen McNicholas, the chief medical officer at Planned Parenthood of the St.

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Health Populi

AUGUST 12, 2021

In health care, outdated operating systems present some of the greatest risks: 15% of medical devices and 32% of medical imaging tools run on outdated operating systems. “During the chaos and confusion, threat actors launched cyberattacks,” Ordr observed in the wake of the public health crisis.

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SQA

MARCH 25, 2021

The concepts presented in PDA Technical Report No. United States Food and Drug Administration (FDA) – Regulations and Guidances for Biologics and the Bioresearch Monitoring Program (BIMO). Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing SARS-CoV-2 Virus Variants, 22 February 2021.

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AIHC

JUNE 14, 2023

The question remains, how will the use of AI be regulated for health care use? The Federal Drug Administration & AI The Food & Drug Administration (FDA) released a discussion paper in 2019 and then an action plan on January 21, 2021 regarding Artificial Intelligence and Machine Learning, or AI/ML.

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FDA HIPAA Compliance Regulatory Compliance 45

SQA

FEBRUARY 15, 2023

Eudralex, Volume 4: GMP Guidelines and Annexes Revision of the EU GMP Guide Annex 11 “Computerized Systems” – Presentation of Concept Paper, 18 November 2022 On 16 November 2022, the European Medicines Agency EMA published a concept paper on the planned revision of Annex 11 “Computerized Systems.”

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Healthcare Law Blog

JANUARY 9, 2024

The most jam packed, standing room only session of the day was NVIDIA Corporation, presenting for its fifth year. On the healthcare services side, NVIDIA mentioned GI Genius, which has an FDA approved AI-assisted endoscopy device that provides real-time identification and decision support to the provider conducting the endoscopy.

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Medicare Medicare Hospitals Doctors 59

Bill of Health

JUNE 1, 2022

Food and Drug Administration (FDA) Commissioner Robert M. The FDA has always known that COVID-19 presents severe risks to children, both on initial infection and in the damage it leaves behind. It also means ignoring those who seek to minimize or downplay the threat. Let the truth be the rebuttal to their misstatements.

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Bill of Health

NOVEMBER 15, 2023

health care system, but that are especially present for behavioral health needs like substance use, and are exacerbated by other challenges related to stigma, lack of employment, and fragmented or nonexistent care coordination. This reality reflects structural, policy, and legal misalignments common to the entire U.S.

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Governance Public Health Telemedicine Medicaid 167

Health Law Advisor

MARCH 7, 2023

Should the final rules limit the issuance of prescriptions of controlled medications to the FDA-approved indications contained in the FDA-approved labeling for those medications? DEA has specifically requested feedback on whether it should limit telemedicine prescribing to only the drug’s FDA-approved indications.

Telemedicine 52

Telemedicine COVID-19 FDA Compliance 52

Healthcare It News

DECEMBER 30, 2022

One example is partnering with Healthy Together, which uses the agency's API to provide veterans with secure mobile access to their health records. FDA authorizes at-home COVID-19 tests from Amazon, Roche, Siemens. And it will help public health officials improve public health policy and lower overall costs.

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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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Telemedicine COVID-19 Fraud Licensing 52

HIPAA Journal

APRIL 5, 2023

Of those 300,000 complaints, more than 200,000 have been rejected because “the complaint did not present an eligible case for enforcement”. To authorized public health authorities to prevent or control disease, injury, or disability. To the Federal Drug Administration to report adverse events and track FDA-regulated products.

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HIPAA Hospitals Compliance Medical Personnel 72

Bill of Health

APRIL 14, 2023

FDA that federal courts have the power to modify the conditions under which the FDA can approve a drug, may seem separate. By that I mean, it is one thing to criticize the process of seeking out opposing viewpoints, but quite another to criticize the weight that the experts at the FDA gave them in making a final decision.

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Governance FDA COVID-19 Public Health 176

SQA

MAY 24, 2023

ANVISA Warns of New Cases of Botulinum Toxin Counterfeiting, 05 April 2023 ANVISA alerts health professionals and the population to the fact that new cases of adulteration/falsification of the drug Botox® 100U (botulinum toxin A), Batch Number C6835C3 have been identified.

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FDA Licensing Governance Compliance 40

Bill of Health

MARCH 27, 2023

Bard The White House is preparing to shut down their COVID Task Force this May, in conjunction with ending the public health emergency — the latest in a series of astounding and shortsighted decisions that put individual Americans at as great a risk from serious harm as a result of catching COVID-19 as at any stage in the pandemic.

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SQA

DECEMBER 16, 2022

The EC presented a first draft for public comment to the revision of Annex 1 in 2017. More than 6,000 comments led, quite unusually, to a second draft for renewed public comment in 2020. United States Food and Drug Administration (FDA) – Regulations and guidance.

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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

AUGUST 8, 2023

The main innovations presented in the new standard are: Increased scope of the standard, with the inclusion of anatomopathological and toxicology laboratories, among others. PCPC has long supported providing the FDA with the resources it needs to advance modern federal regulatory oversight of cosmetics and personal care products.

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FDA Compliance COVID-19 World Health 40

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

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. about how they use sunscreen products.

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FDA Compliance Licensing World Health 40

AIHC

JANUARY 28, 2022

For more information on filing compliance cost reports, attend the Medicare Cost Report Camp in March 2022 presented by KraftCPAs and sponsored by the American Institute of Healthcare Compliance. This is to allow eligible antimicrobial products to begin receiving the new technology add-on payment sooner. billion in FY 2021, or 2.7 percent.

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Medicare Medicare Hospitals Payment Systems 52

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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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

MAY 13, 2022

FDA limits J&J COVID-19 vaccine due to rare blood clot risk. Now Durango’s public health agency is sounding the alarm. Oscar Health To Exit Colorado, Arkansas. Kansas Grantmakers in Health award $25,000 in grants in memory of former Kansas Health Foundation CEO Steve Coen. HHS awards $16.3M

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Health Populi

JANUARY 18, 2021

CES 2021 featured some obvious quick-pivoting products that had the pandemic written all over them, with sessions invariably speaking to the way the public health crisis impacted companies and strategic plans. During the pandemic, inpatient hospital beds have been in short supply in various communities across the U.S.,

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US Department of Health and Human Services COVID-19 Electronic Medical Records Hospitals 73

Jane Sarashon

DECEMBER 19, 2022

Heart health has become mainstream in digital health at CES, with wrist-tracking bands embedded various aspects of heart tracking, ear buds growing heart monitoring capabilities, and FDA-cleared blood pressure readings from the wrist from OMRON and Withings.

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COVID-19 FDA Public Health Telemedicine 52

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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Nursing Homes Nurses Ransomware COVID-19 40

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

Hall Render

FEBRUARY 18, 2022

Lawmakers call on Biden to end public health emergency. Meet new FDA chief Dr. Robert Califf: 5 things to know. Lack of ICU doctors presents challenges for healthcare in Idaho. 5 recent hospital, health system COO moves. of Public Health website. Outpatient push being felt in architecture industry.

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SQA

AUGUST 2, 2021

It also presents information on some innovative methods for package integrity testing using existing technologies, including the potential impact of cryogenic conditions. Led by the FDA and ASPR, the White House report and its recommendations ( report PDF ) have been accepted by President Biden. b) and 320.31(d)(3)).

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