Bill of Health

JULY 14, 2023

Public Health Service’s (USPHS) Syphilis Study at Tuskegee , whose revelation to the public sparked today’s legal schema for regulating and protecting the research it funds (the “Common Rule”), as well as research done in anticipation of receiving FDA approval for marketing a new product. While the U.S.

Informed Consent 130

Informed Consent FDA Public Health World Health 130

Hall Render

SEPTEMBER 8, 2023

The Final Guidance provides recommendations on how to enhance consumer comprehension of promotional materials by making the language and presentation of quantitative information more accessible and consumer-friendly across various media formats. 57 out of 100) or percentages (57%). 57 out of 100) or percentages (57%).

FDA 40

FDA Public Health 40

Hall Render

JANUARY 30, 2025

This guidance finalizes FDAs revised draft issued in October 2023 , which updated and replaced the 2014 and 2009 draft guidance documents. A statement disclosing FDA-approved use(s) of the medical product, including any limitations of use specified in the FDA-required labeling. Before the U.S.

FDA 52

FDA State Policy Public Health Compliance 52

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.

COVID-19 174

COVID-19 FDA Public Health Hospitals 174

Dot Compliance

FEBRUARY 5, 2025

Initial Review Verify completeness: Ensure that all required sections are present and filled out accurately. Compliance Assessment Check against regulations: Ensure the BMR complies with relevant regulatory requirements, such as FDA, GMP, or ISO standards. Identify deviations: Look for any discrepancies, errors, or nonconformances.

Compliance 59

Compliance Pharmaceutical Industry Regulatory Compliance FDA 59

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.

COVID-19 216

COVID-19 FDA Hospitals Elder Care 216

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.

Governance 124

Governance FDA World Health Health Outcomes 124

HIT Consultant

SEPTEMBER 30, 2024

Vicky Britton, Associate Principal of Social Media Intelligence The vast amount of data available to patients and consumers—from web sources, social media, wearables, and AI chatbots—has democratized health information on an unprecedented scale. This shift presents unique opportunities and challenges for the healthcare industry.

Public Health 98

Public Health FDA 98

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

Healthcare IT Today

FEBRUARY 15, 2024

With more than 700 US FDA-approved AI applications, healthcare providers grapple with navigating the complex landscape of niche AI solutions. CARPL is also creating an impact in the public health space by working with the Government of India to enable large-scale Tuberculosis Screening Programmes in the most remote regions of the country.

FDA 116

FDA Governance Hospitals Health Outcomes 116

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.

Medicare 40

Medicare Medicare Hospitals Payment Systems 40

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.

FDA 45

FDA HIPAA Compliance Regulatory Compliance 45

Bill of Health

APRIL 24, 2023

Yet Dmitry Karshtedt held otherwise at the ASLME Health Law Professor’s Conference in Atlanta, GA in 2017. On a panel together, we each presented on topics relating to product hopping, but from very different perspectives. But perhaps other forms of public health benefit would outweigh these harms?

Public Health 317

Public Health FDA Bioethics Governance 317

HIT Consultant

JANUARY 22, 2025

Although this combination of drugs has been approved by the FDA, it still has its own set of side effects (rash, diarrhea, nausea, fever, and more) that are commonly temporary and can be managed. The drugs, namely Opdivo (nivolumab) and Yervoy (ipilimumab), served an anti-tumor reaction which caused the tumors to shrink and disappear.

FDA 52

FDA Doctors Public Health 52

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

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.

HIPAA 70

HIPAA Hospitals Medical Personnel Compliance 70

Bill of Health

JANUARY 23, 2025

As a flurry of social media posts floods my feed, I have noticed public health officials plea for residents to remain indoors, minimizing the risk of breathing unhealthy air. About the author Jessica Samuels is a third-year dual degree law and public health student (J.D./MPH Further, Senate Bill No.

Public Health 130

Public Health Governance FDA 130

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.

FDA 98

FDA Licensing Hospitals Medicaid 98

Bill of Health

MARCH 25, 2025

Researchers at the University of Bristol found that some form of gambling advertisement was present for up to 38 percent of NHL and NBA broadcasts. The FDA also required cigarette companies to warn consumers of the addictive nature and potential harms of their products. Related Articles Addiction Marching Toward Gambling Madness (Pt.

Governance 147

Governance FDA Public Health 147

Bill of Health

OCTOBER 31, 2024

by Alice Bryk Silveira The alarming rise in diabetes and obesity rates in the United States has placed significant strain on health care systems and poses a serious public health threat. Despite international momentum and calls from public health experts, the United States remains behind. Since 2009, the U.S.

Public Health 100

Public Health FDA Governance Licensing 100

Bill of Health

OCTOBER 30, 2024

New research has also led the surgeon general to announce a mental health crisis among young people. Holding TikTok liable could lead to major changes in social media algorithms, reducing mental health harm. Jessica Samuels is a third-year dual degree law and public health student (J.D./MPH

FDA 100

FDA Health Outcomes Public Health Governance 100

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.

FDA 354

FDA Public Health 354

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.

Governance 173

Governance Public Health Telemedicine COVID-19 173

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.

FDA 91

FDA COVID-19 Nursing Homes Public Health 91

HIT Consultant

FEBRUARY 1, 2024

The challenges of pharma influencing also present avenues for influencers to bridge the communication gap between brands and consumers. Their role extends beyond simple promotion—influencing public opinions, driving awareness, and ultimately facilitating a positive impact on public health.

Pharmaceutical Industry 111

Pharmaceutical Industry FDA Public Health Regulatory Compliance 111

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.

FDA 52

FDA Compliance Public Health Hospitals 52

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.

COVID-19 212

COVID-19 Telemedicine FDA Public Health 212

HIT Consultant

MARCH 19, 2023

However, few health systems, medical practices, or providers are prepared for the extraordinary public interest in a treatment for Alzheimer’s disease – especially not one targeting mild cognitive impairment (MCI) and early dementia due to Alzheimer’s disease – that is likely headed their way soon. billion marketing the medication.

US Department of Health and Human Services 98

US Department of Health and Human Services Hospitals COVID-19 FDA 98

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.,

US Department of Health and Human Services 77

US Department of Health and Human Services COVID-19 Electronic Medical Records Hospitals 77

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.

COVID-19 124

COVID-19 Governance Public Health FDA 124

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.”

US Department of Health and Human Services 40

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

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.

FDA 40

FDA Compliance COVID-19 World Health 40

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.

FDA 40

FDA Compliance COVID-19 World Health 40

SQA

AUGUST 1, 2024

For this, documents are required to be presented that demonstrate that the products intended for the Brazilian market have the same characteristics of production, indications, and intended use approved by the recognized regulatory authority. Science and safety are at our core.

FDA 40

FDA Licensing Compliance World Health 40

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.

FDA 40

FDA Compliance COVID-19 Licensing 40

Kaiser Health News

APRIL 6, 2022

In presentations, they often share a 2017 study — conducted by an independent research institute at TROSA’s request — which found TROSA saves the state nearly $7.5 About 30% of its funding comes from government grants and contracts. million annually in criminal justice and emergency care costs.

Licensing 93

Licensing Public Health FDA Doctors 93

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.

FDA 40

FDA Compliance Licensing World Health 40