Electronic Health Reporter

APRIL 8, 2020

There are several regulatory compliance requirements that healthcare organizations must follow. The article Regulatory Compliance For Healthcare Organizations appeared first on electronichealthreporter.com. Editorial HIPAA HITECH Jordan MacAvoy Medicaid and Medicare compliance Reciprocity LabsThis article is copyrighted strictly for Electronic Health Reporter. Illegal copying is prohibited. By Jordan MacAvoy, vice president of marketing, Reciprocity Labs.

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Regulatory Compliance Compliance Health Insurance Medicaid 111

HealthIT Answers

JUNE 22, 2022

By Matt Fisher - Concerns about the scope of compliance with a growing host of regulations in healthcare are mounting. The post Encouraging Regulatory Compliance appeared first on Health IT Answers.

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Regulatory Compliance Compliance HIPAA 52

Electronic Health Reporter

JULY 9, 2021

The article Healthcare IT Services and Their Role In 2021 Regulatory Compliance appeared first on electronichealthreporter.com. This article is copyrighted strictly for Electronic Health Reporter. Illegal copying is prohibited.

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Regulatory Compliance Compliance 160

HIPAA Journal

NOVEMBER 29, 2022

HIPAA Journal is conducting interviews with healthcare professionals and service providers to find out more about their compliance journeys, how the HIPAA Rules have affected their working lives, and the successes and challenges they have faced with HIPAA compliance.

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Regulatory Compliance Compliance HIPAA Ransomware 56

PowerDMS Compliance

NOVEMBER 23, 2021

Compliance Management

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Regulatory Compliance Compliance 52

YouCompli

NOVEMBER 30, 2022

The same tool nurses use to communicate about health emergencies – can help you secure investment in your compliance department. . Over the past few years, I’ve helped many of our clients demonstrate the value of investing in compliance with an?SBAR. How to use the SBAR Framework.

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

MedTrainer

APRIL 5, 2021

Document Management Solutions for Regulatory Compliance. Document Management Solutions for Regulatory Compliance. In some ways, burned-out administrators can be even more costly to healthcare providers because their lack of time leads to mistakes that can violate regulatory laws, leading to lawsuits from patients as well as fines from the government. The old saying “time is money” might not be strictly true for healthcare, but it’s not too far off the mark.

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Regulatory Compliance Compliance Records Management Doctors 40

Exeed Regulatory Compliance

OCTOBER 12, 2020

Risk Management Regulatory ComplianceRisk analysis is a requirement of ISO 14971:2019. It needs to begin with a clear understanding of the intended use and foreseeable misuse.

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Regulatory Compliance Compliance 52

Exeed Regulatory Compliance

MARCH 9, 2020

In this blog, we provide an update on recent FDA activities to understand the agency’s evolving regulatory approach. Regulatory ComplianceCybersecurity of medical devices is a rapidly evolving area of concern. Here is an update on recent FDA activities.

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FDA Regulatory Compliance Compliance 52

Exeed Regulatory Compliance

OCTOBER 5, 2020

Experts from Medical Safety, Engineering, Manufacturing, Quality, Regulatory and Supply Chain should be included. Regulatory Compliance Product QualityISO 14971:2019 requires medical device manufacturers to perform a risk analysis.

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Regulatory Compliance Compliance 52

Exeed Regulatory Compliance

MARCH 22, 2020

Timely MDR reporting is a challenging regulatory requirement for the industry. Compliance to MDR reporting requirements is a common area of deficiency for the industry. Regulatory ComplianceA new FDA guidance provides much-needed relief during a pandemic.

Nursing Homes 52

Nursing Homes FDA Nurses Regulatory Compliance 52

Exeed Regulatory Compliance

APRIL 2, 2020

Market for interconnected medical devices is projected to grow but the regulatory pathway is still evolving. One challenge confronting the industry is that the regulatory pathway for these inter-connected devices is far from clear. Regulatory Compliance

Medical Device Industry 52

Medical Device Industry FDA Regulatory Compliance Doctors 52

HealthIT Answers

SEPTEMBER 21, 2022

Health IT Security and Compliance Carium healthcare regulatory compliance Matthew Fisher Patients privacyBy Matt Fisher - In healthcare, many layers always exist around seemingly each and every issue.

Informed Consent 52

Informed Consent Regulatory Compliance Compliance 52

Healthcare IT Today

JANUARY 14, 2021

Ambulatory Analytics/Big Data Clinical EMR-EHR Health IT Company Healthcare IT IT Regulations Alley Anne Latz Clinical Advocacy Digital Health Doctor Healthcare Data Science Healthcare Product Development Healthcare Regulatory Compliance

Doctors 105

Doctors Regulatory Compliance Compliance 105

HealthIT Answers

AUGUST 28, 2022

Virtual Care Carium health equity healthcare regulatory compliance Matthew FisherBy Matt Fisher - The integration of virtual care into the delivery of healthcare is opening new doors for access and patient interactions. While that statement is true, it may not be universally true.

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Regulatory Compliance Compliance 52

Healthcare IT Today

NOVEMBER 16, 2020

Ambulatory C-Suite Leadership EMR-EHR Health IT Company Healthcare IT IT Regulations Corporate Integrity Agreement eClinicalWorks EHR Certification EHR Patient Safety Healthcare Regulatory Compliance HHS Office of Inspector General US Department of Justice

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Compliance Regulatory Compliance 96

HealthIT Answers

JUNE 16, 2022

Health IT Security and Compliance Carium healthcare regulatory compliance HIPAA Matthew Fisher privacyBy Matt Fisher - Privacy is an important topic of discussion, consideration, deliberation, or any other word that can be used to say it is front and center.

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Regulatory Compliance Compliance HIPAA 52

Dot Compliance

NOVEMBER 2, 2022

There are repercussions if there is no response within 15 days, and this sit well in terms of quality and compliance. How Dot Compliance QMS can help manage FDA 483s and Warning Letters. Leveraging technology is the best way to manage regulatory issues and stay compliant.

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FDA Regulatory Compliance Compliance 52

Dot Compliance

FEBRUARY 22, 2022

Compliance with this regulation ensures that you’re following the correct path to approval and not skipping any of the required actions. Staying in compliance with all relevant sections of the regulation is the safest and surest path to getting FDA approval. Regulatory Complianc

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FDA Regulatory Compliance Governance Public Health 83

Healthcare IT Today

MAY 19, 2021

Ambulatory Clinical EMR-EHR Health IT Company Healthcare IT Hospital - Health System IT Regulations 21st Century Cures Act Health Data Sharing Healthcare Information Blocking Healthcare Interoperability Healthcare Regulatory Compliance Information Blocking KLAS

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Regulatory Compliance Compliance Hospitals 63

Dot Compliance

SEPTEMBER 11, 2022

There is undoubtedly no shortage of rules that directly affect the pharmaceutical sector in today’s regulatory environment, particularly given that pharmaceutical goods are supplied abroad. ISO 9001 with Dot Compliance.

Pharmaceutical Industry 52

Pharmaceutical Industry FDA Regulatory Compliance Compliance 52

Dot Compliance

SEPTEMBER 11, 2022

Computer Systems That Require Compliance to 21 CFR Part 11. Compliance with 21 CFR Part 11 is required for any computer systems used to store quality-critical data or to make decisions regarding quality. However, the standard for digital compliance is very high.

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FDA Regulatory Compliance Compliance 52

Dot Compliance

AUGUST 25, 2022

It requires focused organizational effort, careful planning, and a complete comprehension of the tasks necessary for compliance. The senior management of a company is responsible for providing the tools required to guarantee ISO 13485 compliance.

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Regulatory Compliance Compliance 52

Dot Compliance

JUNE 16, 2022

Maintaining compliance with safety and quality standards is a significant issue in medical device manufacturing. Millions of dollars are lost by manufacturers every year due to regulatory non-compliance issues and related lawsuits.

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FDA Regulatory Compliance Medical Device Industry Governance 52

Dot Compliance

MARCH 22, 2022

The post FDA’s Quality Metrics Reporting Update March 2022 appeared first on Dot Compliance. Regulatory CompliancePharmaceutical and Biologics manufacturers are required to report on quality metrics to stay compliant with FDA.

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FDA Regulatory Compliance Compliance 52

Dot Compliance

JUNE 23, 2022

It’s not strictly mandatory for a laboratory to obtain ISO 17025 accreditation, and not every lab that stays in compliance with the standard seeks out accreditation. However, accreditation may be a de facto requirement for many customers, suppliers, and regulatory agencies.

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Regulatory Compliance Compliance 52

Florida Health Care Law Firm

FEBRUARY 17, 2022

If you have already completed the requirements necessary to clear your status and renew your medical license, it may be just a matter of documenting your compliance to move forward. Healthcare Law Healthcare Regulatory Compliance

Licensing 52

Licensing Regulatory Compliance Compliance 52

Dot Compliance

APRIL 12, 2022

Then we will provide general guidelines for producing labels that will benefit your customers and meet regulatory obligations. Manufacturers who are unsure of their labeling requirements should refer to the guidelines provided by their regulatory agency.

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FDA Regulatory Compliance Compliance 52

Florida Health Care Law Firm

FEBRUARY 22, 2022

John Telehealth Law Healthcare Regulatory Compliance DME Licensure Florida Telemarketing Act Telemarketing Law telehealth DMEPOS Anti Kickback Statute False Claims Act Medicare fraud Telehealth DME LawBy: Susan St.

Telemedicine 52

Telemedicine Regulatory Compliance Medicaid Medicaid 52

Exeed Regulatory Compliance

NOVEMBER 11, 2020

In Exeed’s Latest Webinar, Dr. Naveen Agarwal Discusses Risk Management, Benefit-Risk Assessments, and Other Submitted Questions About ISO 14971 We’re happy to share the recording of the most recent session of our webinar series, Sharing Knowledge, Solving Problems.

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Regulatory Compliance Compliance 52

Dot Compliance

MARCH 25, 2022

Because ISO 14971 covers a wide range of medical devices, it’s likely most manufacturers will need to apply additional device-specific standards to sufficiently mitigate risk and meet local regulatory requirements. Medical Device Manufacturing Regulatory Compliance Risk Management

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Regulatory Compliance Compliance 52

Exeed Regulatory Compliance

OCTOBER 26, 2020

A double-blinded, placebo-controlled, randomized clinical trial provides support for FDA approval of Remdesivir for treating COVID-19. COVID-19 continues to cause damage to both the public health and the economy at large.

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Regulatory Compliance Compliance FDA COVID-19 52

Exeed Regulatory Compliance

SEPTEMBER 29, 2020

46:52 - Is there a requirement to have separate FMEAs for the process, design, etc from regulatory point of view?

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Regulatory Compliance Compliance 52

Dot Compliance

JANUARY 20, 2022

As a result, pharmaceutical companies of all sizes need quality management systems built to address a slew of unique challenges and regulatory oversight. The product is manufactured and delivered in a way that meets all applicable regulatory requirements.

Pharmaceutical Industry 52

Pharmaceutical Industry Regulatory Compliance Public Health Compliance 52

Exeed Regulatory Compliance

AUGUST 26, 2020

Factors: The policy needs to consider stakeholder concerns, regulatory requirements, international standards and state of the art in guiding the criteria for risk acceptability. ISO 14971:2019 requires top management to establish a risk management policy.

Regulatory Compliance 52

Regulatory Compliance Compliance 52

Exeed Regulatory Compliance

AUGUST 3, 2020

Regulatory News Industry NewsMany individuals infected with SARS-CoV-2 coronavirus do not show any symptoms. Now there is a test for diagnosing COVID-19 in asymptomatic individuals.

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Regulatory Compliance Compliance FDA COVID-19 52

Exeed Regulatory Compliance

JULY 31, 2020

This authority allows the FDA to permit the use of medical products without having to go through the rigorous, often time-consuming, pre-market regulatory review process. Regulatory News

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Regulatory Compliance Compliance US Department of Health and Human Services COVID-19 52

Exeed Regulatory Compliance

JULY 20, 2020

Regulatory News Industry NewsAntibody tests are a powerful tool to help fight COVID-19. Here is a quick overview of how they work and their accuracy. The COVID-19 pandemic has hit us hard. Months into this global health crisis, we are still struggling to get it under control.

Regulatory Compliance 52

Regulatory Compliance Compliance FDA Public Health 52

Exeed Regulatory Compliance

JULY 10, 2020

A clear description of both these parts is required to understand the applicable regulatory requirements outlined by the FDA. Industry News Regulatory NewsThe FDA’s updated policies are striving to make sure PPE is both available and regulated for safe use.

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Regulatory Compliance Compliance Medical Device Industry FDA 52

Exeed Regulatory Compliance

JULY 6, 2020

Regulatory News Industry NewsThere is a lot of controversy over the use of face masks during the current Covid-19 pandemic. Let us understand how they help and how FDA plans to regulate them.

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Regulatory Compliance Compliance Medical Device Industry FDA 52

Dot Compliance

JANUARY 14, 2022

From global volatility, intellectual property theft, to strict and evolving regulatory requirements, risks permeate nearly every facet of this sector, posing a constant threat to growth and success, and that’s why risk Assessment framework . Regulatory Compliance Risk Management

FDA 52

FDA Regulatory Compliance Governance Compliance 52

Exeed Regulatory Compliance

APRIL 6, 2020

Shortages of N95 masks are forcing desperate measures. Decontamination of masks for multiple uses is a viable, low-risk-option under these extreme circumstances.

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Regulatory Compliance Compliance FDA Public Health 52

Exeed Regulatory Compliance

MARCH 21, 2020

Industry is rapidly developing novel coronavirus diagnostic tests for emergency use authorization by the FDA. At the time of writing this blog, the novel coronavirus is rampant in over 150 countries across the world. More than 250,000 cases of infection and over 10,000 deaths have been reported.

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Regulatory Compliance Compliance FDA Governance 52