Bill of Health

MARCH 4, 2024

Stigler argued that the government’s main “resource” is the “power to coerce,” and therefore a rational interest group would seek to convince the government to use its coercive power for the group’s own benefit. But the most pertinent lobbying is currently working to shape the FDA’s guidelines for psychedelic therapy.

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FDA Governance 135

Bill of Health

NOVEMBER 30, 2022

Food and Drug Administration (FDA) is now top of mind for lawyers, scholars, policymakers, and the public. healthcare system, representing just one example of “healthcare federalism” — the division of power between the federal and state governments in the regulation of health care. After Dobbs , U.S.

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FDA Bioethics Public Health Governance 176

Health Law Advisor

MARCH 3, 2023

Food and Drug Administration (“FDA”) announced a much-anticipated draft guidance regarding the naming and labeling of plant-based milk alternatives. [1] The dairy industry has lobbied both federal and state governments to restrict the use of “milk” to only fluid “obtained by the complete milking of one or more healthy cows.” [2]

FDA 52

FDA Governance 52

Health Law Advisor

MARCH 1, 2023

To provide more value to readers, I’ve started submitting FOIA requests for unpublished data to produce additional insights into how FDA works. And what better first topic than data on FDA responses to FOIA requests. FDA has been releasing data on its FOIA process, specifically its FOIA logs , for a few years. We were wrong.

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FDA Governance 52

Florida Health Care Law Firm

MAY 5, 2022

The FDA does not regulate essential oils, just like it doesn’t regulate herbs or supplements. That means that there is no FDA approval for any essential oil. But if they say that their product is FDA-approved to do something specific, that is incorrect and they are open to fines and could be shut down.

FDA 52

FDA Compliance Governance 52

Fierce Healthcare

MARCH 26, 2024

Supreme Court justices are concerned that their ruling on unprecedented cases challenging the availability of mail-order abortion medication, and the federal agency that regulates it, could have co | A hotly watched case brought by physicians who object to providing abortion care "seems like a prime example of turning what could be a small lawsuit (..)

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FDA Governance 62

Hall Render

FEBRUARY 7, 2023

Food and Drug Administration (“FDA”) released an updated Mifepristone Risk Evaluation and Mitigation Strategy (the “Mifepristone REMS Program”), which reverses the requirement that the drug be dispensed directly to a patient by certified prescriber in a clinic or a medical office (the “in-person dispensing requirement”).

FDA 40

FDA COVID-19 Public Health Governance 40

Bill of Health

JUNE 26, 2023

have debated whether the government should produce drugs and biologics. Ultimately, the industry was successful in keeping the government away from biologics manufacturing by agreeing to abide by government regulations. Once approved by the FDA, CalRx insulin will be made available at $30 to all Californians who need it.

Pharmaceutical Industry 190

Pharmaceutical Industry Governance FDA Public Health 190

Bill of Health

APRIL 7, 2023

By Aparajita Lath Two articles published last month in the BMJ analyze the public investment and financing of mRNA COVID-19 vaccines, highlighting the extensive government funding that has supported the development of mRNA technology from 1985 to 2022. government. government substantially de-risking the vaccine development process.

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COVID-19 Vaccine COVID-19 Governance Public Health 144

Bill of Health

JANUARY 26, 2024

Besides grants for “psychedelic” research, the FDA just released draft guidance on considerations for psychedelic clinical investigations with an ambiguous definition of what is considered to be a “psychedelic.” When we discuss FDA clinical trials , we’re talking big money , so clarity matters here. cocaine ?).

FDA 191

FDA Governance Health Insurance 191

Bill of Health

NOVEMBER 18, 2022

In fact, before publishing the book, the authors petitioned the government, highlighting glaring regulatory issues, but the government turned a blind eye. The book relies on primary sources of information — mainly government reports, judicial decisions, and government data.

Governance 317

Governance Bioethics FDA Public Health 317

Bill of Health

DECEMBER 26, 2023

Here, the DoJ found that Massachusetts General Hospital discriminated under the ADA by denying a patient, Bryan, the opportunity to be listed on the lung transplant waiting list because he was taking Suboxone, an FDA-approved treatment for opioid use disorder. Bryan ultimately obtained a transplant at the University of Pennsylvania.

ADA 157

ADA FDA Governance Hospitals 157

Healthcare Law Today

JANUARY 11, 2023

The government alleged that, between April 2014 and April 2019, Jet Medical introduced devices into interstate commerce that were misbranded under the Federal Food, Drug and Cosmetic Act (FDCA) because Jet Medical did not obtain approval or clearance from the U.S. Food and Drug Administration (FDA) prior to distribution.

FDA 59

FDA Governance Medicare Medicare 59

Bill of Health

JUNE 1, 2022

Over the past two years, the Supreme Court has shown unprecedented hostility to efforts by both state and federal government to stop the spread of what every day turns out to be an even more deadly pandemic. These decisions are devastating, and likely signal a continued attack on government authority , but they are not a reason to give up.

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COVID-19 Governance FDA COVID-19 Vaccine 293

Mobi Health News

JANUARY 2, 2019

Ongoing FDA submissions and other HHS services are safe, but new regulatory filings will have to be put on hold.

Governance 77

Governance FDA 77

HIPAA Journal

MARCH 15, 2023

Technologies include FDA-regulated devices, non-FDA-regulated devices, laboratory equipment, building and facilities technology, and a host of other technologies. Many different technologies are used that similarly become more vulnerable as they age, and continue to be used after end-of-life has been reached and support is withdrawn.

FDA 90

FDA Governance HIPAA Public Health 90

Bill of Health

APRIL 8, 2022

The Food and Drug Administration has authorized studies of psychedelics , including on a “breakthrough therapy” designation, but these drugs may not be handled by persons without a Drug Enforcement Administration license and outside an FDA approved setting. They may do well to follow suit with respect to psychedelics.

Licensing 293

Licensing FDA Governance 293

Bill of Health

MARCH 25, 2022

Experts’ Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care. A New Way to Contain Unaffordable Medication Costs – Exercising the Government’s Existing Rights. A full posting of abstracts/summaries of these articles may be found on our? 2022 Feb 24. PMID: 35201276.

FDA 205

FDA COVID-19 Medicaid Medicaid 205

HIT Consultant

NOVEMBER 6, 2023

While the program won’t be implemented until the end of 2024 at the earliest and, as currently proposed, will cover only consumer-grade IoT devices, the government taking an active stance in establishing IoT security standards is significant. This is why such government initiatives are so welcome.

Governance 111

Governance Ransomware FDA Hospitals 111

Healthcare IT Today

DECEMBER 20, 2023

However, what makes QHINs different in my view is that it’s what many of the health data sharing networks were trying to accomplish without regulatory and government backing. QHINs now have that government and regulatory backing which makes a big difference. Of course, the proof is really in the pudding.

Governance 76

Governance FDA Doctors 76

Dot Compliance

FEBRUARY 22, 2022

FDA regulations govern what you can claim about your product and whether you can even sell it at all. For companies that manufacture drugs, biotechnology, and related products, demonstrating the safety and effectiveness of your goods to the FDA’s satisfaction has to be a top priority.

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FDA Compliance Governance Public Health 98

HIT Consultant

APRIL 12, 2023

With this acquisition, the consolidated Oxutrx_Spectrum company now has seven (7) process lines, including ISO Optics Lab capabilities, serving medical, commercial and government entities.

FDA 98

FDA Governance Compliance 98

HIPAA Journal

JUNE 17, 2022

Food and Drug Administration (FDA) to review and update its guidelines on medical device cybersecurity more frequently to ensure devices are protected from potential hacking and cyberattacks. A bipartisan bill – The Strengthening Cybersecurity for Medical Devices Act – has been introduced which calls for the U.S.

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FDA HIPAA Governance 101

Mobi Health News

OCTOBER 1, 2018

Scott Gottlieb detailed his agency’s ongoing cybersecurity efforts, which include the signing of two “significant memoranda of understanding” and discussions to facilitate collaboration across government agencies.

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FDA Governance 81

Healthcare Law Today

DECEMBER 15, 2022

These actions are exemplary of the federal government’s shift in its approach to the therapeutic value of psychedelic substances. Breakthrough Therapies Act. On November 17, 2022, U.S. Senators Cory Booker (D-N.J.) Senators Cory Booker (D-N.J.)

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FDA Governance 105

HIT Consultant

APRIL 1, 2024

While prevention efforts have seen progress, the effectiveness of government initiatives like Million Hearts and the WISEWOMAN program has been inhibited by a lack of funding. There are distinct roles individuals, government, and the private sector can assume to reduce heart disease. But now is the time to reverse those setbacks.

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COVID-19 Governance Public Health FDA 98

Healthcare It News

NOVEMBER 16, 2023

Companies are expanding their reach with artificial intelligence through acquisitions, investments and government approvals on a near-daily basis. " FDA clears Lunit breast cancer screening algorithm Lunit, a provider of AI-powered solutions for cancer diagnostics and therapeutics, announced Tuesday that the U.S.

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FDA Hospitals Doctors Governance 224

Bill of Health

JULY 14, 2023

The federal government’s commitment to assuring that participants in human subject research provide fully informed consent dates back to the U.S This commitment to research participants has been re-affirmed consistently since the laws were originally passed in the late 1970s. While the U.S.

Informed Consent 130

Informed Consent FDA Public Health World Health 130

Healthcare IT News - Telehealth

MAY 30, 2023

This change is yet another signal that the country is working to move past the pandemic, which falls in line with recent moves by the federal government to move the pandemic to a more controlled phase. Cozen O’Connor is a research and consulting firm with practices in litigation, business law and government relations.

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Telemedicine COVID-19 Governance Medicare 181

Healthcare IT Today

APRIL 28, 2023

But when it comes to putting the data in front of citizens, healthcare decision makers, government employees, and other key stakeholders, customer experience becomes a major part of the equation. Platform governance—an approach that establishes rules, practices, and standards—can create a hierarchy to manage cross organizational demands.

COVID-19 107

COVID-19 Governance Public Health FDA 107

Hall Render

OCTOBER 18, 2022

Defendant pharmaceutical manufacturers applied for and received approval from the FDA to manufacture Gamunex at a facility converted for that purpose. FDA regulations require current Good Manufacturing Practices [cGMP] to be met or the drug shall be deemed adulterated and prohibited from sale. United States ex rel. at *1 & fn.

FDA 40

FDA Governance Fraud Compliance 40

Healthcare IT News - Telehealth

JANUARY 19, 2021

Jarrett noted that this could be a good opportunity for the government to intervene. "FDA does not regulate telemedicine," she reminded co-panelists. But "if there's one thing FDA has really learned … it's that everybody has to be doing their part."

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Telemedicine Ransomware FDA COVID-19 217

HIT Consultant

MARCH 19, 2023

The US government spent an estimated $350 million on advertising around the COVID-19 pandemic and COVID vaccine public health campaigns with the combined expenses from the Department of Health and Human Services and the Department of Education totaling $520 million. billion marketing the medication. billion marketing the medication.

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

Hall Render

JUNE 29, 2023

Food and Drug Administration (“FDA”) released draft guidance (“Draft Guidance”) updating Good Clinical Practices (“GCPs”) recommendations for interventional clinical trials involving human subjects. Data Governance The Draft Guidance also strengthens the existing focus on data governance from both a sponsor and investigator perspective.

FDA 40

FDA Governance COVID-19 40

Healthcare It News

FEBRUARY 1, 2022

Lastly, artificial intelligence (AI) gains significance and undergoes stronger scrutiny procedures in the US with more than a hundred new AI and machine learning (ML) based device approvals by the FDA. Enterprise Taxonomy: Operations Strategic Planning Digital Health Emerging Technologies Business Organizational Governance Technology.

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COVID-19 FDA Health Insurance Doctors 212

Healthcare It News

FEBRUARY 1, 2022

Lastly, artificial intelligence (AI) gains significance and undergoes stronger scrutiny procedures in the US with more than a hundred new AI and machine learning (ML) based device approvals by the FDA. Enterprise Taxonomy: Operations Strategic Planning Digital Health Emerging Technologies Business Organizational Governance Technology.

COVID-19 202

COVID-19 FDA Health Insurance Doctors 202

Bill of Health

SEPTEMBER 22, 2022

She has previously published articles on synthetic biology regulation and governance, end stage renal disease payment reform, and comparative analyses of learning disorder policy. Sanjay’s research interests include pharmaceutical competition, FDA regulatory reform, and health care coverage.

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Bioethics FDA Governance 130