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Food and Drug Administration (“FDA”) announced a much-anticipated draft guidance regarding the naming and labeling of plant-based milk alternatives.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]

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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To provide more value to readers, I’ve started submitting FOIA requests for unpublished data to produce additional insights into how FDA works.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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HIT Consultant

SEPTEMBER 12, 2021

And that’s just what we can see has been “posted” on the FDA site through June 25, 2021. The FDA has noted that recalled medical devices caused almost 100,000 deaths between 2008 and 2021 — but before and after this time period ? I was once in a hospital operating room, scanning cement that was about to be used in surgery.

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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. As long as they don’t market essential oils as if they are medicine or a cure for any issue, they can otherwise say what they like about the products.

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Bill of Health

JANUARY 26, 2024

It is time to talk about why we include (and exclude) particular drugs from this category. When we discuss FDA clinical trials , we’re talking big money , so clarity matters here. program in the 1990s, they were still teaching us about “hallucinogens,” not “psychedelics.” Insurance coverage codes will also be a big issue here.

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Bill of Health

JUNE 26, 2023

have debated whether the government should produce drugs and biologics. This prompted discussions about preventing recurrences, either through governmental regulation of biologics manufacturers or governmental manufacture of the biologics themselves. At the turn of the 20 th century, the unregulated U.S. Now, the tide is turning.

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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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Healthcare IT Today

DECEMBER 20, 2023

Plus, we also ask them all to share something that people don’t understand about QHINs. No doubt there was a palpable excitement about the QHINs being announced and what that’s going to facilitate when it comes to a national interoperability network. Of course, the proof is really in the pudding.

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Governance FDA Doctors 76

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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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.

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Licensing FDA Governance 293

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.

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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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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.

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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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HIT Consultant

APRIL 1, 2024

Several years ago, the CDC recognized that the rate of hypertension control in Minnesota was about 70%, far higher than the national average. 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.

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Bill of Health

JULY 14, 2023

Bard Until more is known about how to mitigate the threat of AI-fueled persuasion in human subject research, a ban on its use is the only reasonable way to keep the promise that we, as a country, made to those harmed while participating in research. By Jennifer S.

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HIT Consultant

MARCH 19, 2023

– Are your family or friends concerned about your memory or your thinking? Up to 80% of MCI is due to Alzheimer’s disease, which can now be treated. – If you think you may have MCI, you should speak to your physician about if anti-amyloid antibody therapy may be right for you. billion marketing the medication.

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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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Healthcare IT Today

OCTOBER 29, 2023

Additionally, two-thirds of patients said they prefer text or email reminders about their bills, while demand for contactless payments has doubled in two years. Point-to-point encryption vendor Bluefin is integrating with CORE payment products for government and healthcare customers.

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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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Healthcare IT News - Telehealth

JANUARY 19, 2021

"At the end of the day, 'adequate security' is not enough when you think about what we're trying to accomplish," said Logan. Jarrett noted that this could be a good opportunity for the government to intervene. "FDA does not regulate telemedicine," she reminded co-panelists.

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Healthcare It News

FEBRUARY 1, 2022

In contrast, however, according to the authors, women take a predominant role in health decisions and have about one-third higher health expenditures. Enterprise Taxonomy: Operations Strategic Planning Digital Health Emerging Technologies Business Organizational Governance Technology.

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Healthcare It News

FEBRUARY 1, 2022

In contrast, however, according to the authors, women take a predominant role in health decisions and have about one-third higher health expenditures. Enterprise Taxonomy: Operations Strategic Planning Digital Health Emerging Technologies Business Organizational Governance Technology.

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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.

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HIPAA Journal

DECEMBER 8, 2022

Warner says the white paper is a starting point to open up a discussion about changes that can be implemented to improve cybersecurity in the sector, rather than a blueprint for change. However, they need support from the federal government as the field continues to face targets from sophisticated cyber adversaries and nation-states.”.

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Healthcare IT Today

NOVEMBER 9, 2023

The issue takes on new urgency since evidence has emerged about the manipulation of voters and exploitation of children. I talked to Kyle Zebley, senior vice president of public policy at the ATA, about the organization’s determination to enter these policy areas. HIPAA was last revised in 2013.

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Healthcare IT News - Telehealth

DECEMBER 1, 2021

In terms of when the pandemic started, if you think about the numbers in December 2019 or January 2020, one-tenth of about 1% of the total appointments were telehealth related. During the pandemic, somewhere around in the second quarter of 2020, this number actually even went up to about 25% of the appointments.

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Health Populi

JUNE 5, 2022

The good news about prescription drugs, in the context of medical spending in the U.S., But there’s bad news about prescription drugs in the context of medical spending in America. Today, the three largest PBMs, processing about 4 in 5 retail prescription claims, are embedded in large health insurance companies.

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Health Law Advisor

SEPTEMBER 6, 2022

A private equity client asked us recently to assess a rumor that FDA was on the warpath in enforcing the 510(k) requirement on medical devices from a particular region. Such a government initiative would significantly deter investments in the companies doing the importing. To be sure, FDA can have multiple reasons for refusing entry.

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Bill of Health

SEPTEMBER 12, 2023

By James René Jolin and Susannah Baruch On July 13, 2023, the United States Food and Drug Administration (FDA) approved Opill (norgestrel) as the first daily oral contraceptive available for non-prescription use in the U.S. James René Jolin (JRJ): This recent move by the FDA is one without precedent.

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Bill of Health

FEBRUARY 27, 2024

Carr As a researcher studying the psychedelic experiences of people of color in hopes of driving equitable psychedelic health care, I’m concerned about the ways in which Black, Brown, and Indigenous contributions have been excluded in the development of the psychedelic field and investigation of novel psychedelic therapies. By Tegan M.

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HIT Consultant

DECEMBER 14, 2021

They are focused on expanding the number of providers who can prescribe the treatment (it requires a special waiver from the federal government) and training more clinicians to provide support needed for the treatment to be successful. government agencies to develop OUD treatment protocols for decades.

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American Medical Compliance

MAY 13, 2024

The Opioid Epidemic As of October 16, 2017, the US government officially declared the opioid epidemic a public health emergency. This includes educating patients about the risks of opioid use, prescribing the lowest effective dose for the shortest duration, and considering non-opioid pain management alternatives.

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MedTrainer

JANUARY 12, 2024

Healthcare compliance is the process of following the laws, regulations, and ethical standards that govern the healthcare industry. Food and Drug Administration (FDA): The FDA regulates compliance in pharmaceuticals, medical devices, and biotechnology products. What is Healthcare Compliance?

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Healthcare IT Today

JULY 29, 2019

For the 16th episode of the Healthcare IT Podcast, we’re talking about whether we’re “buying” or “selling” various healthcare regulations. EHRs Should be Regulated by the FDA Here's a look at the healthcare regulation assertions discussed on this episode: * The US Needs a National Patient ID.

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Exeed Regulatory Compliance

MARCH 21, 2020

Industry is rapidly developing novel coronavirus diagnostic tests for emergency use authorization by the FDA. According to a recent Science Magazine article , South Korea tested more than 270,000 people, which amounts to about 5200 tests per million! More than 250,000 cases of infection and over 10,000 deaths have been reported.

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Verisys

DECEMBER 1, 2022

A check of government exclusion lists is essential because many healthcare groups receive financing from federal sources. FDA Disbarment. Learn more about how Verisys can assist your HCOs in meeting all government and regulatory standards. FACIS Level 3 background screening of federal sources. SAM ( including SDN ).

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