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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MedTrainer

JANUARY 12, 2024

Healthcare compliance is serious business for regulators. In this blog post, we’ll outline who regulates healthcare compliance, how rules are enforced, and why organizations need a robust compliance platform to stay in the good graces of regulators. What is Healthcare Compliance? Who Regulates Healthcare Compliance?

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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 ).

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Healthcare Law Today

JANUARY 20, 2022

Food & Drug Administration (FDA) previously issued emergency use authorizations (EUA) and adopted emergency policies in response to the COVID-19 public health emergency (PHE) to facilitate the availability of key medical devices such as in vitro diagnostic tests, personal protective equipment, and ventilators.

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HIT Consultant

APRIL 5, 2023

What You Should Know: Dot Compliance , a leading provider of eQMS compliance solutions for the life sciences sector, has introduced an industry-first, ready-to-use AI-Based electronic Quality Management System for life sciences, powered by an embedded generative and predictive artificial intelligence.

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Dot Compliance

NOVEMBER 2, 2022

The FDA sends an FDA Form 483 Observation, also known as a “inspectional observation” or “Form 483” to draw attention to any potential legal infractions discovered during a routine inspection. These are issued after a 483 FDA inspection. Without FDA notification, companies may get this paper in the mail.

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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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MedTrainer

JULY 13, 2023

As the VP of Compliance at MedTrainer, I’m not only intrigued by the potential of this technology, but also by the new questions and concerns related to AI and healthcare compliance. These are some of the most common concerns around AI and healthcare compliance.

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Compliancy Group

AUGUST 14, 2023

Regulatory compliance in the healthcare industry plays a crucial role in patient safety, maintaining quality standards, and preventing fraud and abuse. Rated #1 on G2 “Compliancy Group makes a highly complex process easy to understand.” Learn More × Rated #1 on G2 for Healthcare Compliance Find Out More! Please Wait.

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Verisys

DECEMBER 12, 2023

– The best resource for monthly healthcare regulatory compliance updates. 23 ): Effective on 1/14/2024, this amended rule has been updated to comply with specific requirement of §34-23-32 and the FDA Drug Supply Chain Security Act. The post December 2023 Regulatory Compliance Updates appeared first on Verisys.

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Sharps Compliance

MAY 11, 2022

Continue reading FDA Considers New Approach to Improve Safe Disposal of Prescription Opioid Analgesics at Sharps Compliance Blog. Nonmedical use of prescription opioids commonly leads to the use of illegal drugs like heroin and illegally manufactured fentanyl and fentanyl analogues.

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HIPAA Journal

DECEMBER 8, 2022

The tool will point developers to resources where they can find out more information about their compliance obligations, along with best practices to help them deliver a safe and accurate service while ensuring the privacy and security of the health information of app users. The updated version can be found here.

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MedTrainer

JUNE 29, 2023

Compliance isn’t a concept with a lot of grey area — you’re either compliant with regulations or you’re not! Unfortunately, this yes or no perspective often leads to the misconception that compliance tracking is easy. And, in fact, there are times when tracking compliance can be as difficult as meeting the compliance standard itself!

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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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HIPAA Journal

DECEMBER 26, 2022

Generally, HIPAA compliance for nurses is considered to mean adhering to policies and procedures developed by an organization’s HIPAA Privacy Officer and applying the best practices of security awareness training provided by an organization’s HIPAA Security Officer. Why HIPAA Compliance for Nurses can be a Problem.

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Hall Render

SEPTEMBER 15, 2023

In June 2023, the Food and Drug Administration (“FDA”) released Draft Guidance outlining its current view of the psychedelic research landscape. While the FDA does not define psychedelics, it indicated that the shorthand term “psychedelic” includes “classic psychedelics,” which are typically understood to be 5-HT2 agonists (e.g.,

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Health Law Advisor

JANUARY 4, 2022

It is common for FDA and others to show a map of the United States with the states color-coded by intensity to showcase the total number of inspections done in that state. Indeed, FDA includes such a map in its newly released dashboard for FDA inspections. Some years FDA may conduct many inspections; other years not so many.

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Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

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Hall Render

SEPTEMBER 14, 2023

Food and Drug Administration (“FDA”) released draft guidance regarding the conduct of decentralized clinical trials (“DCTs”) for drugs, biological products and devices. This draft guidance expands on previous FDA recommendations released in the midst of the COVID-19 pandemic.

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Health Law Advisor

MAY 20, 2022

Since the passage of the Medical Device Amendments of 1976, FDA has regulated in vitro diagnostic (IVD) tests as medical devices, subject to a full suite of FDA requirements. FDA’s approach changed in 2014 when it issued draft guidance describing a plan to phase out FDA enforcement discretion and regulate LDTs.

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HIT Consultant

NOVEMBER 24, 2022

First, let’s examine the new regulatory framework the FDA established. 4 And compliance decrease over time. . By allowing retail sales of affordable hearing aids, the FDA regulations go a long way in helping consumers address this challenge yet could result in risk to health plans. – What new opportunities will arise?

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Hall Render

OCTOBER 5, 2023

Food and Drug Administration (“FDA”) finalized “ Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. On August 15, 2023, the U.S. study sponsor, regulatory agencies, etc.)

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Hall Render

NOVEMBER 30, 2023

On September 29, 2023, the Food and Drug Administration (“FDA”) announced the issuance of a Notice of Proposed Rulemaking (the “Proposed Rule”) to expand the FDA’s regulatory scope over in vitro diagnostics products (“IVDs”) to specifically address Laboratory Developed Tests (“LDTs”). Part 820 ), unless they fall under an exemption.

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C&M Health Law

OCTOBER 10, 2022

On September 28, 2022, the Food and Drug Administration (FDA) issued Clinical Decision Support Software final guidance. The FDA interprets each of the four non-device criteria in detail and shares multiple examples for clarification. Thus, they are within the definition of device according to the FDA. Criterion 1.

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MedTrainer

JUNE 5, 2023

After years in limbo, USP <800> compliance will be required, effective November 1, 2023. It’s the first USP standard that’s enforceable by State Boards of Pharmacy, OSHA, and the FDA. What’s Needed for USP <800> Compliance?

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Healthcare Law Blog

JANUARY 12, 2022

On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to relaxed enforcement policies during the COVID-19 pandemic. Guidance Overview. I distribute products under an EUA, what do I do now?

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Dot Compliance

MAY 23, 2022

Dot Compliance continues to offer 14-days of free access to its quality and compliance solutions to ensure fast and cost effective QMS adoption. In the life science industry, many companies are recognizing that compliance is not hindered when leveraging pre-configured software technology to accelerate digitization.

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Dot Compliance

MAY 20, 2022

Dot Compliance continues to offer 14-days of free access to its quality and compliance solutions to ensure fast and cost effective QMS adoption. In the life science industry, many companies are recognizing that compliance is not hindered when leveraging pre-configured software technology to accelerate digitization.

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Exeed Regulatory Compliance

MARCH 22, 2020

A new FDA guidance provides much-needed relief during a pandemic. FDA has just revised its relatively less known 2012 guidance entitled “Post-market Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic” to clarify that the guidance is applicable to any pandemic, not just an influenza pandemic.

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AIHC

JUNE 6, 2023

AI Use in Healthcare Research & Quality As posted in the American Institute of Healthcare Compliance (AIHC) June monthly newsletter, the Agency for Healthcare Research & Quality (AHRQ) grantee is testing AI for use to improve breast cancer screening accuracy and efficiency.

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Health Law Advisor

FEBRUARY 1, 2023

Introduction Let’s say FDA proposed a guidance document that would change the definition of “low cholesterol” for health claims. Now let’s say that when FDA finalized the guidance, instead of addressing that topic, FDA banned Beluga caviar. Not to spill the beans, but if you think that, you’d be wrong.

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HIT Consultant

MAY 2, 2024

Advancing Diabetes Management: POGO Automatic Blood Glucose Monitoring System POGO Automatic, the pioneering and sole FDA-cleared automatic blood glucose monitoring (ABGM) system available, revolutionizes diabetes management. POGO Automatic features an all-in-one design that integrates testing supplies into a 10-test cartridge.

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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”).

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The Digital Health Corner

AUGUST 7, 2017

The FDA recently announced its Digital Health Innovation Action Plan. Digital health differs significantly from drugs and traditional medical devices around which the FDA has developed its structure and policies over decades. The FDA will have new digital health experts. This plan was both important and necessary.

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Health Law Advisor

JULY 11, 2023

Word Embeddings If you’re one of my three regular readers, you might remember that I’ve already introduced word embeddings I trained on FDA records. In February 2023, I wrote a post on using NLP to assess FDA’s compliance with notice and comment in guidance development. [1] Instead, I’m going to look for bias in other topics.

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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. What is the process for FDA drug approval?

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AIHC

JUNE 6, 2023

AI Use in Healthcare Research & Quality As posted in the American Institute of Healthcare Compliance (AIHC) June monthly newsletter, the Agency for Healthcare Research & Quality (AHRQ) grantee is testing AI for use to improve breast cancer screening accuracy and efficiency.

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