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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FDA Governance Compliance 52

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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Regulatory Compliance Compliance US Department of Health and Human Services Licensing 52

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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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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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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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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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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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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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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Compliance FDA 52

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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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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HIT Consultant

APRIL 12, 2024

What You Should Know: – Philips Respironics , a subsidiary of Royal Philips, has finalized a consent decree with the US Department of Justice (DOJ) and Food and Drug Administration (FDA) to address issues raised during a 2021 inspection of a Philips facility in Pennsylvania.

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American Medical Compliance

OCTOBER 17, 2023

Get Certified American Medical Compliance (AMC) is a leader in the industry for compliance, Billing and HR solutions. To become certified, please visit us at: American Medical Compliance (AMC). Buy Course Today The post ISO 22000 Standard for Food Safety Management appeared first on American Medical Compliance.

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FDA Compliance Regulations Compliance 52

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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Compliance Medical Billing HIPAA Due Diligence 52

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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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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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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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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FDA HIPAA Compliance 60

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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FDA HIPAA Compliance 60

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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FDA HIPAA Compliance 60

Hall Render

JULY 29, 2022

Food and Drug Administration (“FDA”) issued guidance (“Guidance”) regarding the “Importation of Prescription Drugs” final rule (the “Final Rule”), which became effective November 30, 2020. SIPs are reviewed and authorized by the FDA and managed by States or Indian Tribes (“SIP Sponsors”). In May 2022, the U.S. Brief Discussion.

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Exeed Regulatory Compliance

APRIL 2, 2020

A new FDA guidance offers helpful recommendations for design and premarket submission. One way to understand how FDA is thinking about regulating these devices is to review recently cleared devices. One such example is the Control-IQ technology , a software product recently classified by the FDA as a Class II medical device.

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HIT Consultant

MARCH 14, 2024

Nasdaq Delisting Better Therapeutics previously disclosed the potential delisting of its stock from the Nasdaq Stock Market due to non-compliance with listing standards. The Company developed a proprietary platform for the development of FDA-regulated, software-based solutions for T2D, heart disease and other conditions.

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Hall Render

JANUARY 11, 2023

The Tool is a result of collaborative efforts between the FTC, HHS Office for Civil Rights (“OCR”), HHS Office of the National Coordinator for Health Information Technology (“ONC”) and the Food and Drug Administration (“FDA”). Regulatory Landscape. Hall Render blog posts and articles are intended for informational purposes only.

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Healthcare IT Today

FEBRUARY 12, 2024

As the developer of the world’s first FDA-cleared online visual acuity test, Visibly is committed to growing convenient access to quality vision care nationwide. Visibly , a leading healthcare technology company, is thrilled to announce the merger of Visibly and EyecareLive.

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