Dot Compliance

JANUARY 14, 2025

Regulatory Compliance: eQMS can help organizations meet industry-specific regulations, such as ISO 9001, FDA 21 CFR Part 11, and others. Download our white paper, How to Choose the Right eQMS , to learn how. Automated workflows and built-in compliance features ensure that businesses stay up-to-date with the latest requirements.

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HIT Consultant

JUNE 8, 2022

TytoCare’s FDA-cleared hand-held examination kit enables users to perform comprehensive physical exams of the heart, skin, ears, throat, abdomen, and lungs and measure heart rate and body temperature, vital examinations for diagnosing and treating many acute and chronic conditions.

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Electronic Medical Records FDA Hospitals 98

HIPAA Journal

SEPTEMBER 27, 2022

The Cybersecurity and Infrastructure Security Agency (CISA) and the Food and Drug Administration (FDA) have issued a warning about a recently discovered vulnerability that affects certain Medtronic insulin pumps. The FDA says it is unaware of any cases where the vulnerability has been exploited.

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Healthcare IT Today

JANUARY 5, 2024

The app-based digital therapeutics are the only FDA-authorized app-based treatments for SUD and OUD, respectively. Additionally, the company acquired reSET-A, a digital therapeutic for alcohol use disorder that received FDA breakthrough device designation, supporting the company’s expansion into alcohol addiction treatment and prevention.

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Dot Compliance

JANUARY 29, 2025

Improved Compliance and Risk Management Regulatory compliance: eQMS solutions help organizations meet industry-specific regulations, such as FDA, ISO 9001 , and GMP, by providing built-in compliance features. Download our white paper, How to Choose an eQMS , for more.

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Dot Compliance

APRIL 11, 2025

This may include FDA regulations for medical devices or pharmaceutical products, EMA regulations for products sold in the European Union, or ISO standards for general quality management. Download the white paper for an in-depth look into how to choose an eQMS. Looking for even more information?

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HIT Consultant

OCTOBER 7, 2021

Biocare Cardiac and Biocare Telemed are fully compatible with Google Wear OS, Android, and iOS and can be downloaded via the App Store or the Play Store. This new application is designed to be used as part of Biotricity’s complete cardiac solution.

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Healthcare IT News - Telehealth

MAY 6, 2020

It also equips providers with Eko’s FDA-cleared AI to assist in remote screening for AFib, heart murmurs, tachycardia and bradycardia. In addition, the company is awaiting FDA approval for an onboard ECG feature for spot detection of atrial fibrillation. iRhythm Technologies.

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Health Law Advisor

NOVEMBER 1, 2022

The motivation for this month’s post was my frustration with the techniques for searching the FDA’s 510(k) database. Here I’m not talking about just using the search feature that FDA provides online. You can search that database using the so-called AccessGUDID through an FDA link that takes you to the NIH where the database is stored.

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YouCompli

DECEMBER 3, 2024

If you are in clinical research, this means looking at the FDA requirements, ICH-GCP Guidelines, and other applicable regulations. This way you can demonstrate that your employees are training for the key concepts that they need to do their job. Andrea has taught first grade in Willoughby, Ohio for 25 years.

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HIT Consultant

MAY 12, 2022

Notable transactions in the consumer and member tech category include: Pear Therapeutics , software-based medicine provider, made its mark in 2017 as its tool became the first digital therapeutic approved by the FDA with claims to improve clinical outcomes.

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The Digital Health Corner

NOVEMBER 29, 2023

The FDA has created the Digital Health Center of Excellence to assist. Importantly, it is critical for end users, including patients to be involved in the development process. Clinical tools require studies with outcome data. It is what patients and clinicians expect.

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HIT Consultant

APRIL 4, 2022

TytoCare’s FDA-cleared handheld examination kit enables users to perform comprehensive physical exams of the heart, skin, ears, throat, abdomen, and lungs, and measure heart rate and body temperature, which are key for treating many acute and chronic conditions.

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Electronic Medical Records FDA HIPAA 52

HIT Consultant

APRIL 10, 2024

It therefore comes as little surprise to learn that 53% of all digital health apps are uninstalled within 30 days of download. Take Pear Therapeutics , for example, which recently went bankrupt, although its reset substance use disorder program was the first ever digital therapeutic tool to receive FDA clearance.

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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. The FDA’s recent activities in the region were well within their historical norms. To be sure, FDA can have multiple reasons for refusing entry. Background.

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HIT Consultant

SEPTEMBER 12, 2023

Ninety-one percent of employers cited million-dollar treatments approved by the FDA, and 89% pointed to specialty drug spending as a top threat. These apps introduce the need to download, register, research, and essentially do their physician’s job – making prescribing decisions!

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Doctors FDA Health Insurance 118

Dot Compliance

MAY 3, 2024

Food and Drug Administration (FDA) and the European Medicines Agency (EMA) set standards encompassing every stage of pharmaceutical operations, including R&D, manufacturing, labeling, distribution, and post-market surveillance. The FDA ensures that drug manufacturing processes align with these CGMP objectives.

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Health Populi

FEBRUARY 21, 2023

The second graphic titled “ready to start your health journey” kicks off the downloading of the app and creating an account, and ends with a $10 off grocery coupon. Once upon a time in digital health, it was Fitbit, Nike, Garmin, and Apple who were populating the app stores with health tracking apps.

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Medical Device Industry Medicare Medicare FDA 62

HealthIT Answers

AUGUST 18, 2023

By Meredith Calloway - Take a scroll through your smartphone’s app store, and you’ll find a wide array of applications on everything from fitness and nutrition tracking to fitness coaching and physiological monitoring available for download. The post Health Policy and Evidence on What Make Medical Apps appeared first on Health IT Answers.

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Natalia Mazina

JUNE 26, 2023

counterfeit, unapproved, or potentially dangerous)) Notification (trading partners must notify FDA if they suspect that the product is illegitimate). If you need new policies and procedures addressing this upcoming change, our RxPolicy platform has templates available for download. [1] 1] Visit FDA’s website for more information. [2]

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Dot Compliance

FEBRUARY 23, 2024

For instance, a user could query a generative AI model trained on FDA life sciences regulations about AI use in drug development, and the model would provide a summary based on its training data. Choose an eQMS provider with proven life sciences industry expertise and a platform preconfigured to industry standards like FDA, ISO, and GxP.

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FDA Regulatory Compliance Compliance 52

Dot Compliance

MAY 3, 2022

fully validated and pre-configured with best practices that meet FDA, ISO and GxP regulations. A QMS with FDA 21 CFR part 11 compliant e-signatures, approval workflow and revision control supports compliance with the agency’s electronic record keeping requirements. MES, SQM, PLM, etc.), Align Stakeholders.

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FDA Compliance Regulatory Compliance 52

Dot Compliance

MAY 3, 2022

fully validated and pre-configured with best practices that meet FDA, ISO and GxP regulations. A QMS with FDA 21 CFR part 11 compliant e-signatures, approval workflow and revision control supports compliance with the agency’s electronic record keeping requirements. MES, SQM, PLM, etc.), Align stakeholders. Define impacts.

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FDA Compliance Regulatory Compliance 52

MedTrainer

JANUARY 12, 2024

Food and Drug Administration (FDA): The FDA regulates compliance in pharmaceuticals, medical devices, and biotechnology products. Download this free cheat sheet for healthcare inspections. Office of Inspector General (OIG): This independent agency within the U.S.

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Dot Compliance

SEPTEMBER 11, 2022

FDA 21 CFR Part 11 is a rule that specifies how businesses that are subject to FDA regulation, such as those in the medical device, pharmaceutical, and other industries, should manage their electronic records and electronic signatures. Additionally, any system utilized to provide data to the FDA must comply with Part 11.

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Dot Compliance

APRIL 5, 2023

For instance, generative AI algorithms trained on FDA regulations and the company’s SOPs can alert a quality professional to a potential deviation and propose steps to take for resolution and reporting.

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Dot Compliance

JANUARY 7, 2025

Enhance compliance: Ensure compliance with FDA regulations, including CGMP and 21 CFR Part 11 , through automated compliance checks and audit trails. Strengthen regulatory compliance: Ensure compliance with FDA regulations, such as Quality System Regulation (QSR).

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Medical Device Industry Regulatory Compliance Compliance FDA 59

Redox

MARCH 11, 2020

Next-generation health trackers are more trustworthy than the consumer health bands that popped up a decade ago, with a growing number receiving FDA clearances. Download Now. Supporting day-to-day clinical decisions. What functionality will the next generation of Medical Devices require? appeared first on Redox.

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Doctors FDA Hospitals 52

SQA

JULY 19, 2023

We are also very excited to announce that we have a new and improved Source Inspection tablet application, available for both Apple and Android download. Come see us at our next event! This application serves as a tool to perform all critical actions for clients, suppliers, and associates.

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Dot Compliance

OCTOBER 11, 2024

Regulatory Compliance Adherence to regulatory requirements, such as those outlined by the FDA’s 21 CFR Part 820, is mandatory for pharmaceutical manufacturers. Download our white paper , “A Step-b-Step Guide to Choosing an eQMS,” to learn more about CAPA and other key capabilities you need in your solution.

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Pharmaceutical Industry Regulatory Compliance Compliance FDA 52

Dot Compliance

OCTOBER 11, 2024

Regulatory Compliance Adherence to regulatory requirements, such as those outlined by the FDA’s 21 CFR Part 820, is mandatory for pharmaceutical manufacturers. Download our white paper , “A Step-b-Step Guide to Choosing an eQMS,” to learn more about CAPA and other key capabilities you need in your solution.

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Pharmaceutical Industry Regulatory Compliance Compliance FDA 52

SQA

JULY 19, 2023

We are also very excited to announce that we have a new and improved Source Inspection tablet application, available for both Apple and Android download. Come see us at our next event! This application serves as a tool to perform all critical actions for clients, suppliers, and associates.

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FDA 40

Bill of Health

OCTOBER 30, 2024

They urge that TikTok is dangerous beyond what a child would think when downloading an app because it encourages unhealthy and addictive engagement. Her research interests include genetics, environmental health sciences, novel biotechnologies, and the FDA regulatory process. Will the Lawsuits be Successful?

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HIT Consultant

JANUARY 3, 2023

Pending FDA Clearance, the launch of the Valencell fingertip device will further the company’s vision of bringing life-changing digital health solutions to consumers and is a strategic evolution for the company. Users will also have the ability to view trends over time, track the frequency of their measurements, and download and share data.

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Healthcare IT News - Telehealth

NOVEMBER 7, 2022

Bioflux-AI combines an FDA-approved, high-precision, small mobile cardiac telemetry device with AI-driven algorithms specifically trained for the prediction of stroke in stage 4 and stage 5 chronic kidney disease patients. Upon completion of the patient's study, the device was returned, and the data was downloaded and sent for analysis.

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MedTrainer

FEBRUARY 19, 2024

When healthcare professionals and organizations report equipment malfunctions to the correct authorities, the FDA may recall these items based on increased reports. Incident reporting has led to several FDA recalls in the past, with some including breast implants, insulin pumps, and defibrillators. Contact us to learn more.

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Nurses Compliance FDA COVID-19 52

SQA

MAY 24, 2023

As in the past, the PCPC stands ready to collaborate with the FDA and other stakeholders to ensure any reorganization enables the beauty and personal care industry to continue to provide innovative, safe, and effective products while maintaining consumer trust. The PCPC looks forward to working with FDA Chief Scientist Namandj Bumpus, Ph.D.,

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