Regulatory Compliance For Healthcare Organizations

Electronic Health Reporter

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.

Encouraging Regulatory Compliance

HealthIT Answers

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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 Healthcare IT Services and Their Role In 2021 Regulatory Compliance

Electronic Health Reporter

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.

Interview: John Jessop, Sr. Director, HIPAA Security & Regulatory Compliance, PPFA

HIPAA Journal

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.

How regulatory compliance differs between industries

PowerDMS Compliance

Compliance Management

Show the benefits of investing in your healthcare regulatory compliance program

YouCompli

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.

Document Management Solutions for Regulatory Compliance

MedTrainer

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.

Begin Your Risk Analysis with Intended Use and Foreseeable Misuse

Exeed Regulatory Compliance

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.

Regulatory Update on Medical Device Cybersecurity

Exeed Regulatory Compliance

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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ISO 14971 Basics – Using a PHA for Risk Analysis

Exeed Regulatory Compliance

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.

FDA Guidance Provides Relief for MDR Reporting During a Pandemic

Exeed Regulatory Compliance

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.

FDA Guidance Shows a Regulatory Path Forward for Interoperable Devices

Exeed Regulatory Compliance

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

Long Trail for Extra Tissue Samples

HealthIT Answers

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.

The Role of The Digital Health Doctor Continues To Expand

Healthcare IT Today

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

Equity in Virtual Care

HealthIT Answers

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.

Feds Demand Additional Compliance Efforts from eClinicalWorks (eCW)

Healthcare IT Today

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

What is Privacy?

HealthIT Answers

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.

Steps to Consider When Dealing With 483 FDA and Warning Letters

Dot Compliance

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.

FDA 52

21 CFR Part 314 Checklist (with XLS Download)

Dot Compliance

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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Providers Prepared For Information Blocking Rules, But Aren’t Sure They’ll Boost Interoperability

Healthcare IT Today

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

The Ultimate Guide to ISO 9001

Dot Compliance

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.

The Ultimate Guide to 21 CFR Part 11 QMS

Dot Compliance

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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The Essential Guide to ISO 13485 for Medical Device

Dot Compliance

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.

A Step-by-step guide to Medical Device Quality System Management

Dot Compliance

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’s Quality Metrics Reporting Update March 2022

Dot Compliance

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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ISO 17025 Checklist (with XLS Download)

Dot Compliance

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.

Florida Medical License Renewal

Florida Health Care Law Firm

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

A Guide to Medical Device Labeling Requirements

Dot Compliance

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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DME Scheme of Greed Knows No Bounds

Florida Health Care Law Firm

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.

Sharing Knowledge, Solving Problems: Risk Analysis, Benefit-Risk, & More

Exeed Regulatory Compliance

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.

The Essential Guide to ISO 14971

Dot Compliance

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

COVID-19 Treatments: Remdesivir Antiviral Drug

Exeed Regulatory Compliance

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.

Introducing Exeed’s New Webinar Series: Sharing Knowledge, Solving Problems

Exeed Regulatory Compliance

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

QMS and the ICH Q10 Pharmaceutical Quality System

Dot Compliance

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.

5 Elements of a Risk Management Policy

Exeed Regulatory Compliance

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.

FDA Authorizes a COVID-19 Diagnostic Test for Asymptomatic Individuals

Exeed Regulatory Compliance

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.

5 Key Facts to Know About FDA’s Emergency Use Authorization Process

Exeed Regulatory Compliance

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

COVID-19 Testing – Understanding Antibody Tests

Exeed Regulatory Compliance

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.

FDA Guidance for Face Shields and Respirators During the Covid-19 Pandemic

Exeed Regulatory Compliance

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.

FDA Guidance for Face Masks During Covid-19 Pandemic

Exeed Regulatory Compliance

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.

5 Necessary Steps for Building a Risk Assessment Framework

Dot Compliance

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

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Understanding the Risk of Using Reprocessed N95 Masks During Covid-19 Pandemic

Exeed Regulatory Compliance

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

How MedTech is Rising to Help Combat the Coronavirus Pandemic

Exeed Regulatory Compliance

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.