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All Blog Posts (1,379)

How to Email and Text in the World of HIPAA

One errant email or text message can cost you tens of thousands of dollars in HIPAA fines and penalties and it doesn't matter who you're communicating with: patients, staff, providers or with insurance carriers.

A violation is a violation. And if you think it couldn't happen to you, think again. Text and email HIPAA violations are not always caused by what you might think. For example, you may think you are safe as long as you don't text patients - you're wrong.…

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Added by Roger Steven on December 10, 2018 at 8:45am — No Comments

What are the FDA's Process Validation requirements?

Process Validation (PV), according to the FDA, is collecting and assessing data right from the design stage till the production stage. PV is set out for all the stages of production for a product in the FDA-regulated industries. The core purpose of PV is to establish scientific proof that any process being employed has the capability of delivering quality products consistently.

The FDA’s process validation requirements are set out in its general principles of Process Validation.…

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Added by John Robinson on December 10, 2018 at 7:03am — No Comments

You will get Great Results from your Data with Excel PowerPivot and PowerQuery

If you work with data, you’re likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources. Luckily there are two Microsoft tools- PowerPivot and PowerQuery-that solve ALL of these issues, right inside Excel.

In today’s world, there is tons of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful…

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Added by Adam Fleming on December 5, 2018 at 7:05am — No Comments

What Compliance officers need to know about HIPAA Security?

How practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2019.



The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information regarding the do's and don'ts with HIPAA - I want to add clarity for compliance officers and what you guys…

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Added by Roger Steven on December 3, 2018 at 7:36am — No Comments

Will smart devices be the smartphones of the medical device industry?

This is how the current-day situation of administering medical care runs: in the event of a medical need, the patient or someone attached to her is expected to sense the difficulty and call up the medical center to which the patient is attached. Help arrives after this is done. The medical practitioner may come over and attend to the patient at her location if the situation permits. Or else, the ambulance has to be called. All this has to done during what is called the Golden Hour: the most…

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Added by John Robinson on November 29, 2018 at 6:19am — No Comments

A Process Approach to Quality Management Systems

ISO 13485:2016 describes a process approach to Quality Management Systems for Medical Devices.  This 6 -hour virtual seminar will help you to understand the process approach and develop an effective Quality Management System (QMS) for Medical Device Companies.  A well-structured QMS meets the requirements of the Quality System Regulations and is both effective and efficient.  The regulations require that manufacturers “establish and maintain a quality system that is appropriate for the…

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Added by John Robinson on November 26, 2018 at 7:38am — No Comments

Dramatic changes expected into medical device regulations

A slew of updates to existing medical device and diagnostics (MD & D) regulations is on the cards. Medical device and diagnostics is a field that keeps changing every now and then. But what is different this time is that the industry is up against a series of updates, not just from one regulatory agency, but from a multitude of agencies and standards: FDA, EMA, ISO 13485 and ISO 11607, the last of which is about packaging for terminally sterilized medical devices.

Nature of…

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Added by Joseph Wilcox on November 22, 2018 at 6:37am — No Comments

How to Reduce Stress in the Work Place

Workplace health and well being is a rising public health concern. Poor employee health can be costly to the organization (e.g. absenteeism, poor productivity, reduced attention and workplace safety).

Chronic stress has been shown to impinge decision-making, reduce concentration, immune system responses, and job satisfaction, cause psychological distress (e.g. depression and anxiety) and coronary heart disease, and negatively impact client rapport and personal…

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Added by Roger Steven on November 21, 2018 at 7:18am — No Comments

FDA Scrutiny of Promotion and Advertising Practices

If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are…

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Added by John Robinson on November 20, 2018 at 7:38am — No Comments

Applied Statistics for FDA Process Validation

 

In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage through commercial production.." The guidance further delineates the 'process design stage through commercial production' into three distinct stages of the product lifecycle:

Stage 1: Process Design: The commercial manufacturing process is defined during this…

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Added by John Robinson on November 19, 2018 at 7:34am — No Comments

How to Turn Your Cyber Incident Response (Plans from Blah) into Fantastic?

Let us face it. A cyber incident could happen to any organization that has a computer system that is connected to the Net. Well, the next question is, does such an organization exist? Almost no organization in today’s world, no matter of what size and which part of the world it could be in, can function without a cyber system. So, this means that simply any organization is vulnerable to a cyberattack and every organization should have a cyber…

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Added by Adam Fleming on November 16, 2018 at 7:02am — No Comments

Facts that Everyone Should [Know About] Fda Regulation

The Food and Drug Administration (FDA) is the US’ regulatory agency for a variety of products that concern the health of their consumers. The FDA regulates everything concerning food, medicine, medical devices, veterinary products and cosmetics, as well as products that emit radiation. In addition to directly regulating all these through its set of regulations, the FDA also encourages innovation in the products and processes of products in these…

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Added by Adam Fleming on November 2, 2018 at 6:30am — No Comments

The [Ultimate Guide] To Medical Device Inspection

A medical device inspection. Ah! Is there a more dreaded exercise for a medical device manufacturer? If I were given a choice between taking up the world’s toughest rated examination and facing a medical device inspection, I would gladly opt for the former. A medical device inspection should rank right there ahead of the most difficult examination or task.

Alright. We knew this fact all along. So, why should I intimidate you by casting such aspersions on a medical device inspection?…

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Added by Adam Fleming on October 30, 2018 at 6:29am — No Comments

Why HIPAA compliance is becoming more challenging

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a US legislation that was enacted under the HITECH Act under Bill Clinton’s presidency with the intention of offering safeguards for medical information through its data privacy and security provisions. The Act consists of five sections. Also called titles, they are these:

  • HIPAA Health Insurance Reform
  • HIPAA Administrative Simplification
  • HIPAA…
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Added by Roger Steven on October 25, 2018 at 8:36am — No Comments

The Truth About Global Trade and Logistics In a [Few] Little Words

Trade and logistics, despite its relatively recent development, has gone on to become a global one. It is one of the many industries that have benefited in immeasurable ways by the growth of technology and globalization. It is no exaggeration to say that trade and logistics has exploded following these developments.

First, a basic understanding of the two:…

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Added by Adam Fleming on October 15, 2018 at 6:04am — No Comments

Understanding how healthcare IT works

Information Technology (IT), which has traversed and influenced almost every area known to the human mind, has made a solid impact on healthcare. The healthcare industry in the US is the world’s largest, with some estimates putting its size at $ three trillion. Information Technology is an extremely useful and enabling tool in an industry of such proportions. Healthcare IT is now being considered a specialized branch of IT.

The role of IT in healthcare

IT works in innumerable ways in… Continue

Added by Roger Steven on October 11, 2018 at 9:16am — No Comments

Want an Easy Fix for Your Excel Spreadsheet [Techniques?] Read This!

Microsoft Excel is a wonder package, and in saying this, I am not exaggerating or taking sides with Mr. Gates’s developers. They have created a program that is so versatile and so tailor-made for just so many industries that you would wonder from where they got the idea to do this. I reckon they must have worked extensively with the industry closely in understanding its needs and implemented all the details with devilish diligence.…

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Added by Adam Fleming on October 10, 2018 at 3:13am — No Comments

Here’s why you should attend clinical compliance trainings

Wondering if you should attend clinical compliance trainings? The following paragraphs will explain to you the criticality of clinical compliance trainings. We hope this article will help you understand why you should attend clinical compliance trainings.

First, let us…

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Added by Adam Fleming on October 8, 2018 at 5:43am — No Comments

This is How SOX Compliance will Look like in the [Future]

Formally known as the “Public Company Accounting Reform and Investor Protection Act” in the US Senate and as the “Corporate and Auditing Accountability and Responsibility Act” in the House of Representatives, Sarbanes Oxley (SOX) is a landmark legislation that the American Congress passed in 2002. Named for the sponsors of this Bill, senators Paul Sarbanes and Mike Oxley, it was passed in the wake of the financial scandals of huge American…

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Added by Adam Fleming on October 5, 2018 at 3:18am — No Comments

You Will Never Believe These (Bizarre) Truth Behind Food And Beverages

The food and beverages industry, a global one, is an interesting bag of surprising and often contradicting facts. The food and beverages industry is a really global one, meaning there is almost no place on this planet that this industry does not cover. You are as likely to find a food joint in Mongolia as you are in Mozambique. The reason is simple: we can live without many things, but not without food. Any surprise that this industry is a giant,…

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Added by Adam Fleming on October 1, 2018 at 5:39am — No Comments

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