Healthcare IT Today

NOVEMBER 4, 2024

(Originally posted on his LinkedIn) There’s a secondary AI land grab happening in health care to commercialize “governance” of AI software. You might be surprised who’s staking out positions in the nascent Health AI Governance market: 1. The promo video is set to an anthemic score and b-roll footage is so mid.

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Fierce Healthcare

JULY 8, 2024

Two high-ranking government officials have abdicated their roles on the board of the Coalition for Health AI, the organization and HHS confirmed.

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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.

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HIT Consultant

DECEMBER 3, 2024

Even when manufacturers can develop patches, they may face delays due to FDA regulations that require rigorous testing and approval before updates can be distributed. The Need for FDA Patch Approval Reform The regulatory framework around medical devices creates another major challenge in addressing these vulnerabilities.

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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.

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Bill of Health

NOVEMBER 15, 2023

drug policy using a whole-of-government (W-G) approach to assess where these misalignments are occurring among different agencies at the same level of government (referred to as horizontal W-G), and across different levels of government (referred to as vertical W-G).

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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.

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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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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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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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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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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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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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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 ?).

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Healthcare IT News - Telehealth

JANUARY 22, 2021

For reimbursement by the CMS, a device must be an FDA-listed device. However, an FDA approval ensures a medical device is safe and effective for its intended use. FDA classifies medical devices into three classes based on risk to human life. Dr. Joyoti Goswami is a Principal Consultant at Damo Consulting.

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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 Law Blog

AUGUST 3, 2022

is a reminder that the government will use the FCA to target medical device manufacturers for off-label use of medical devices, even where healthcare providers have decided the use is safe and effective. The FDA even required warnings on the probes’ packaging, “restricted for single person use only,” and “[d]o not re-use.”.

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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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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.

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Dot Compliance

NOVEMBER 2, 2022

Prior to the COVID-19 pandemic, during fiscal year (FY) 2019 (October 1, 2018, through September 30, 2019), the FDA conducted 7,266 GMP inspections of registered drug, device and biologics establishments. Compliance Dashboard, Inspections, FDA, accessed October 3, 2022, [link] cd/inspections.htm ). In its February 2022 report, the U.S.

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Mobi Health News

MARCH 13, 2018

A recently released analysis report from the Deloitte Center for Government Insights that examines the US’s current and proposed software as a medical device (SaMD) regulatory landscape, and includes suggestions on how the FDA’s pre-certification pilot program and other initiatives could better serve this fast-moving industry.

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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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Bill of Health

DECEMBER 6, 2024

The EU AI Act , proposed EU AI Liability Directive , and laws under the European Strategy for Data , such as the Data Governance Act , may also play roles. US Legal Requirements for Quantum-Powered Medical Devices In the United States, some quantum-powered medical devices may be governed under the existing FDA regulatory framework.

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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

DECEMBER 5, 2024

But with that promise comes the responsibility of understanding and applying governance, ethical, and reliability principles. The Cure for AI Maladies Gartner predicts that 50% of governments globally will enforce responsible AI policies by 2026. Regulatory Guidance Oversight by the U.S.

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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.

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Healthcare It News

MARCH 18, 2022

Companies like Pear Therapeutics, Limbix, Applied VR and Click Therapeutics are treating people with clinically validated and FDA-approved (or pending) digital interventions. Fortunately, government, investors and startups are working together to close some of these care gaps.

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McGuire Wood

OCTOBER 12, 2023

Food and Drug Administration (FDA) released updated guidance regarding cybersecurity safety requirements for medical devices. To strengthen the QSR metrics, the FDA recommends implementing a secure product development framework (SPDF) to address cybersecurity risks. 27, 2023, the U.S.

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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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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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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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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

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.

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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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Healthcare IT Today

JUNE 27, 2023

Food and Drug Administration (FDA) has recognized the problem and issued multiple guidance documents over the years—as recently as this March —to ensure the cybersecurity of medical devices. Although none of the FDA recommendations are legally enforceable, device manufacturers no longer have a choice but to comply.

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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. 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.

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HIT Consultant

JULY 18, 2024

What You Should Know: – AliveCor , the global leader in AI-powered cardiology, today announced that the American Medical Association (AMA) has granted new Category III Current Procedural Terminology (CPT) codes that are applicable to the company’s Kardia™ 12L ECG System, which received FDA clearance in June 2024.

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