Healthcare IT Today

JANUARY 16, 2025

Food and Drug Administration (FDA) clearance. The healthcare industry and biomedical device fields often prioritized keeping devices as static as possible to support clinical quality testing and FDA clearance requirements once manufactured. Is Paying off Tech Debt Worth It? As an example, a health system with an annual revenue of $2.5

Ransomware 52

Ransomware FDA Governance Compliance 52

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 But ethics review boards, often called IRBs are already required to pre-approve all materials used to advertise studies, as well as those presented directly to potential participants.

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Physician Credentialing Company

OCTOBER 31, 2024

Medical history Physical examination Diagnostic procedures Therapeutic and preventive interventions Follow-up and outcomes Patient safety Category 3: Codes in this category are named temporary codes because they remain in this section till their FDA approval and evidence of their wide use by providers.

Medical Billing 52

Medical Billing Compliance Doctors Medicare 52

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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Ransomware FDA Governance Hospitals 114

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Food and Drug Administration (“FDA”) announced a much-anticipated draft guidance regarding the naming and labeling of plant-based milk alternatives.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

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.

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Governance FDA World Health Health Outcomes 124

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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Healthcare Law Blog

MAY 31, 2022

These advancements, present challenges and raise novel questions as to how the current healthcare and life sciences legal regime would apply to the metaverse. In response to the growth of the metaverse and digital health generally, the FDA has been working to expand its guidance in the area. Data Privacy and Security. Healthcare Laws.

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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.

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FDA Governance Hospitals Health Outcomes 116

Healthcare Law Today

DECEMBER 19, 2022

health care sector continues to grow at a rapid rate, and there is a recent government push for health care technologies, which have been identified as essential to U.S. market presents a tremendous opportunity for Israel-based health care companies, though the complexities and challenges of U.S. ” The U.S.

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Telemedicine FDA Licensing Governance 64

Healthcare IT Today

JULY 25, 2022

RPM devices work as medical devices which are governed by the FDA and related departments. Second, FDA cleared status should be well checked, not only the 510K, but also new issues with RPM devices, like whether cybersecurity principles and rules are fully performed, and all the security risks were tested by protocols, API and SDK.

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FDA Licensing Governance Telemedicine 98

YouCompli

DECEMBER 3, 2024

From there, look at the regulations that govern your organization and see what applies so you include it. If you are in clinical research, this means looking at the FDA requirements, ICH-GCP Guidelines, and other applicable regulations.

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Nurses FDA Medicare Medicare 52

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.

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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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Health Care Law Brief

JUNE 2, 2022

Therefore, a telehealth platform operating in all 50 states will, for example, need to comport with the laws governing corporate formation, provider licensure, scope of practice, and telehealth encounters in all 50 states. Variety of Risks Present in Telehealth Arrangements. Does the platform treat certain data as consumer data?

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Public Health Compliance COVID-19 Licensing 52

Healthcare Law Blog

MARCH 17, 2022

Section 1128A(a)(5) of the Act), the Proposed Arrangement nevertheless presented a minimal risk of fraud and abuse under the law on the facts presented. The Therapy is available only for clinical use under an FDA-approved, Category B Investigational Device Exemption (“IDE”) ( see 42 CFR 405.211(b)-(c) ).

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US Department of Health and Human Services Informed Consent Medicare Medicare 52

AIHC

JUNE 14, 2023

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. One of the ways that OCR carries out this responsibility is to investigate complaints.

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FDA HIPAA Compliance Regulatory Compliance 45

MedTrainer

JULY 13, 2023

Laws Are Behind the Technology Governing bodies are racing to keep up with the AI evolution, but very few have released policies to help guide compliance professionals. For example, when a human incorrectly codes an item, it happens one time. Berkeley Research Group’s Thomas F.

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Compliance Compliance Officers FDA Governance 52

Healthcare IT Today

MAY 5, 2023

The surge in genetic testing claims comes with a rise in fraud, waste and abuse across government and commercial payers. However, due to its nonspecific nature, this code can be abused by bad actors to request payment for services not covered, not performed or not FDA-approved. Common schemes include: Code stacking.

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Fraud Medicare Medicare Overpayments 67

HIPAA Journal

JUNE 27, 2022

Government entities are exempt. The ADPPA also has provisions for “sensitive covered data,” which is defined as “any information that describes or reveals the past, present, or future physical health, mental health, disability, diagnosis, or healthcare treatment of an individual.”

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HIPAA FDA Health Insurance Governance 55

Healthcare IT Today

JANUARY 3, 2024

This will present multiple challenges — increased difficulty in determining who to trust during incident response as well as determining when to deliver sensitive diagnosis and treatment plans when not face-to-face with patients. According to the ISC2 Cybersecurity Workforce Study, 2023, the U.S.

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US Department of Health and Human Services Ransomware Hospitals HIPAA 102

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 the Federal Drug Administration to report adverse events and track FDA-regulated products. The complaint was withdrawn, or submitted after the 180-day limit.

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HIPAA Hospitals Medical Personnel Compliance 68

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

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. In Norway and parts of Australia, the government offers pre-commitment schemes, which allow users to register spending caps for themselves before placing bets. Daily betting limits.

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Governance FDA Public Health 147

Bill of Health

JANUARY 23, 2025

The federal government has also allowed the proliferation of hundreds of different flame retardants contained in household products due to historically lax regulations under the Toxic Substances Control Act. Her research interests include genetics, environmental health sciences, novel biotechnologies, and the FDA regulatory process.

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Public Health Governance FDA 130

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. Could Congress or the FDA have incentivized the manufacturer to initiate the switch much sooner?

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Public Health FDA Bioethics Governance 317

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.

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FDA Licensing Hospitals Medicaid 98

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 298

Healthcare IT News - Telehealth

JANUARY 19, 2021

Experts have repeatedly predicted that telehealth would present a major challenge for healthcare cybersecurity in the coming year. 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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Telemedicine Ransomware FDA COVID-19 218

Bill of Health

OCTOBER 30, 2024

The lawsuits, arising from the desire to hold platforms accountable for exploiting children’s susceptibility to rewarding stimuli during development, present a novel theory of liability based solely on an algorithm’s ability to cause addiction rather than adverse mental health outcomes.

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FDA Health Outcomes Public Health Governance 100

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

OCTOBER 31, 2024

government has discussed the potential adoption of a uniform FOP label, with Congress directing the Centers for Disease Control and Prevention and Institute of Medicine (IOM) to produce recommendations on the topic. Food and Drug Administration (FDA) is expected to propose new rulemaking on front-of-package labeling in 2024.

Public Health 100

Public Health FDA Governance Licensing 100

Health Law Advisor

APRIL 26, 2023

FDA have called into question the U.S. Food and Drug Administration’s (“FDA’s”) scientific review process to approve new drug applications. The Texas District Court ruling had the effect of suspending the FDA’s approval of mifepristone. During the past several turbulent weeks for the U.S. While the U.S.

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FDA Hospitals Governance Compliance 97

Natalia Mazina

SEPTEMBER 20, 2021

The associations reminded the public that (1) ivermectin is not approved by the FDA for human use to prevent or treat Covid-19 and (2) Clinical trials and observational studies to evaluate the use of ivermectin to prevent and treat COVID-19 in humans have yielded insufficient evidence to recommend its use.

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COVID-19 FDA Informed Consent Doctors 85

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.

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COVID-19 Telemedicine FDA Public Health 212

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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COVID-19 Governance Public Health FDA 124

Bill of Health

SEPTEMBER 24, 2024

Whereas pregnant people in Idaho should be able to receive emergency abortion care at present, those in Texas cannot. The Fifth Circuit held in a separate case that EMTALA does not authorize the federal government to compel healthcare providers to perform abortions, even in emergency situations. Liacouras Professor of Law.

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