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.

FDA 52

FDA COVID-19 Compliance Governance 52

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.

FDA 52

FDA Governance Compliance 52

Bill of Health

APRIL 24, 2023

Regulatory and patent exclusivity periods govern the timing of generic entry, and because market share and revenue is often quickly lost upon market entry of generic drugs, extending market exclusivity for any duration can be extremely profitable. My talk was titled “Legal Approaches to Ensuring Timely Generic Drug Availability.”

Public Health 317

Public Health FDA Bioethics Governance 317

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Food and Drug Administration (“FDA”) announced a much-anticipated draft guidance regarding the naming and labeling of plant-based milk alternatives.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To provide more value to readers, I’ve started submitting FOIA requests for unpublished data to produce additional insights into how FDA works.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.

FDA 52

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

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).

Governance 173

Governance Public Health Telemedicine COVID-19 173

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.

FDA 140

FDA Governance 140

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 195

Pharmaceutical Industry Governance FDA Public Health 195

Bill of Health

APRIL 4, 2024

On top of that comprehensive rulebook, the European Data Strategy bundle of laws encompasses the EU General Data Protection Regulation (GDPR), the Free Flow of Non-Personal Data Regulation, the Data Governance Act and the Data Act, as part of the EC’s ambition to establish a single unified market for data. The sectorialism of the U.S.

FDA 288

FDA Malpractice Regulatory Compliance Health Insurance 288

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.

COVID-19 Vaccine 147

COVID-19 Vaccine COVID-19 Governance Public Health 147

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 101

FDA Governance Public Health HIPAA 101

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 321

Governance Bioethics FDA Public Health 321

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 78

Governance FDA 78

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.

COVID-19 299

COVID-19 Governance FDA COVID-19 Vaccine 299

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

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 208

FDA COVID-19 Medicaid Medicaid 208

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.

FDA 108

FDA HIPAA Governance 108

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 162

ADA FDA Governance Hospitals 162

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 193

FDA Governance Health Insurance 193

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.

FDA 98

FDA Compliance Governance Public Health 98

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 83

Governance FDA Doctors 83

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.

FDA 85

FDA Governance 85

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

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

Hall Render

MAY 28, 2024

With a deep understanding of the complexities of this field, Jemalyn works with health systems, hospitals, large physician practice groups and other health care organizations to navigate a broad range of strategic and operational issues including fraud and abuse, FDA compliance and corporate governance.

Fraud 40

Fraud FDA Compliance Governance 40

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.

FDA 114

FDA Medicaid Medicaid Medicare 114

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.)

FDA 105

FDA Governance 105

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.

FDA 252

FDA Doctors Hospitals Governance 252

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-19 124

COVID-19 Governance Public Health FDA 124

HIT Consultant

NOVEMBER 13, 2024

He also highlights the importance of considering factors such as drug development pipelines, FDA approval processes, financial health, and potential litigation when making this crucial decision. How can life science companies assess the market receptiveness to their potential IPO, especially considering the biotech/pharma sector?

Due Diligence 94

Due Diligence Governance FDA Compliance 94

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.

Telemedicine 190

Telemedicine COVID-19 Governance Medicare 190

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.

Ransomware 114

Ransomware FDA Governance Hospitals 114

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."

Telemedicine 218

Telemedicine Ransomware FDA COVID-19 218

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

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-19 218

COVID-19 FDA Health Insurance Doctors 218