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The Roles and Responsibilities of a HIPAA Privacy & Security Officer

The HIPAA regulations are numerous, complicated, often vague, and affect every person working in a healthcare facility. Compliance with HIPAA will require a unique individual to lead the charge - an individual whose education, background, experience, and demonstrated skill sets offer the opportunity for that person to succeed in achieving the goals of that position.

This is a new position to most healthcare facilities. So understanding who this person should be, what is required of…

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Added by John Robinson on February 28, 2020 at 6:20am — No Comments

Secure Messaging - 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. Many…

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Added by John Robinson on February 27, 2020 at 4:43am — No Comments

A Radical new Approach to Optimizing Revenue cycle Operations

Revenue Cycle operations has been measure the same way for generations.  With the consistent pressure to do more with less and continue to drive strong operating revenue performance, organizations are being forced to evaluate new ways to streamline work.…

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Added by John Robinson on February 26, 2020 at 4:05am — No Comments

Payroll Virtual Boot Camp: Wage & Hour

Knowledge of these five areas of wage and hour law is critical for payroll professionals:

  • Paying exempt employees
  • Calculating gross wages under the FLSA
  • Deducting from an employee’s wages
  • The nuts and bolts of physically paying employees, and
  • Changing payroll frequencies.

A marathon, six-hour training session on April 8 from GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory…

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Added by John Robinson on February 25, 2020 at 4:48am — No Comments

Knowledge of employment laws is absolutely crucial for organizations

As the new presidential administration settles in in the US, employment law could be an area in which to expect tremendous changes. While what the new president’s open and vocal support for protection of the domestic workforce will mean to employment laws may take some to fully unfold and unravel; a look at the evolution of the important employment laws and the changes taking place into them of late should serve as some kind of indication of what is to come.…

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Added by John Robinson on February 24, 2020 at 3:51am — No Comments

Do human factors matter in medical devices?

The FDA has placed significant emphasis on the role of Human Factors in the approval of devices used for medical purposes. There are several current guidance documents and new proposed Draft Guidance documents. This seminar will compare these Guidance documents

Is there a relationship between medical devices and human factors? This is a question that is seriously worth exploring. According to the ANSI/AAMI HE75:2009 document, human factors is an endeavor for…

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Added by John Robinson on February 21, 2020 at 3:55am — No Comments

Controlling Human Error in the Manufacturing Floor

All the technological advancements in the automation processes of many industries notwithstanding, human labor continues to be a core part of manufacturing. This means that manufacturing is highly prone to human error. This is natural, because human error is inseparable from the human presence. Wherever there is human involvement, the potential for human error accompanies it, because, as the old saying goes, to err is human. With all the meticulousness that humans are capable of, the scope…

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Added by John Robinson on February 20, 2020 at 2:09am — No Comments

Tougher Import Rules for FDA Imports in 2020

Those who import FDA regulated products to the US need to be very meticulous in planning their activity. If they get any of these aspects wrong-registration, product compliance, record and data submission-their product can be detained.

Likewise, the requirements set out by the U.S. Customs and Border Protection (CBP) must be completely precise, failing which an importer’s item could get aborted before it enters US shores. While it is common for importers to make certain kinds of…

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Added by John Robinson on February 19, 2020 at 1:59am — No Comments

Project Management for Non-Project Managers

Project management is one of the skills even those whose domain of expertise it is not, are expected to know in detail. Project management is a very useful supplementary skill to have for non-project managers simply because every work in most organizations gets done as projects. When project managers or others who work on project management are unable to deliver-whatever be the reason for it-others are expected to fit into their shoes and deliver. This substitution can make the…

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Added by John Robinson on February 18, 2020 at 4:14am — No Comments

Good Laboratory Practices (GLPs) Comparing and Contrasting GMP

Good Laboratory Practice (GLP) differs from Good Manufacturing Practice (GMP) in a fundamental way. GLP deals with preclinical development, while GMP has to do with manufacturing. That is, while GLP concerns itself with study, GMP is all about the method, i.e., the process.

GLP are a set of regulations for conducting nonclinical laboratory studies, and are not a set of guidelines. GLP is covered under 21 CFR Part 58, and regulate nonclinical laboratory studies that support or intend…

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Added by John Robinson on February 13, 2020 at 4:33am — No Comments

Good Laboratory Practices (GLPs) Comparing and Contrasting GMP

Good Laboratory Practice (GLP) differs from Good Manufacturing Practice (GMP) in a fundamental way. GLP deals with preclinical development, while GMP has to do with manufacturing. That is, while GLP concerns itself with study, GMP is all about the method, i.e., the process.

GLP are a set of regulations for conducting nonclinical laboratory studies, and are not a set of guidelines. GLP is covered under 21 CFR Part 58, and regulate nonclinical laboratory studies that support or intend…

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Added by John Robinson on February 13, 2020 at 4:33am — No Comments

Email, Texting & HIPAA-TCPA Compliance - Electronic Message Rules & Myths

Regular (unencrypted) Email and Text Messaging are effective engagement and communication tools that patients like and have the right to use.

A simple 3 step HIPAA safeguard fully protects Covered Entities from violating both HIPAA and the TCPA (Telephone Consumer Protection Act) and stymies expensive TCPA class actions. Unfortunately few take advantage of the 3 step safeguard. And the Internet is awash with mis-information that can get Covered Entities into serious…

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Added by John Robinson on February 12, 2020 at 5:17am — No Comments

Dealing with OCD in the Office

 

If you have a colleague who gets down to hairsplitting detail at every work she undertakes, to the extent that she takes half a day to complete a task that can be done in half an hour, you have a person with OCD in your midst. Obsessive Compulsive Disorder is a psychological condition in which the person with it is too obsessed with perfection. This penchant for perfection in everything they do can be painstaking for others who interact with them, but for those with…

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Added by John Robinson on March 7, 2019 at 6:54am — No Comments

Implementing an Effective Succession Plan

Fortune 500 companies and small family businesses alike share a business need - insuring that they have the talent necessary to effectively lead their organizations in the future. One of the most significant contributions a leader can make is insuring his/her business'continuity and sustainability - by having employees who are willing and capable of filling each key position with a plan for doing so when the need arises.

Succession Planning is a:

  • Deliberate, systematic…
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Added by John Robinson on March 5, 2019 at 6:59am — No Comments

How to interpret and use more than just a standard tool-box

How to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows:

  • ISO standards and FDA/MDD regulations regarding the use of statistics.
  • Basic vocabulary and concepts, including distributions such as binomial, hypergeometric, and Normal, and transformations into Normality.
  • Statistical…
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Added by John Robinson on January 23, 2019 at 5:51am — No Comments

eCTD Submissions of IND-NDA to the US FDA, EU and Canada

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies.  Reformatting for multiple submissions is substantially limited.  The CTD has improved the regulatory review processes and enabled implementation of good review…

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Added by John Robinson on January 18, 2019 at 5:16am — No Comments

Effective Technical Writing in the Life Sciences

Technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.

After setting the stage for this content, we delve into the writing process beginning with the audience and how the…

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Added by John Robinson on January 9, 2019 at 6:44am — No Comments

How the FDA interprets advertising and promotion in principle and in fact

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 January 7, 2019 at 7:28am — No Comments

6-Hour Virtual Seminar on FDA's Software Monsters

The complexity and vulnerability of software is expanding exponentially, so fast that Congress removed some device software from FDA’s jurisdiction.  The remaining software regulated by FDA presents a degree of a risk to health that creates a public health concern.  Part of that risk involves the intentional activity that can conflict, intrude or destroy software.  The problems are taking center stage in the “healthcare software” dialogue.  What issues can compromise or defeat the…

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Added by John Robinson on January 2, 2019 at 5:58am — No Comments

Nutrition Facts labels of pure maple syrup and honey

FDA Commissioner, Scott Gottlieb, has announced a major overhaul of the FDA’s update to the Nutrition Facts label on products. This overhaul, the first in nearly twenty years, is aimed at empowering consumers by furnishing information on Nutrition Facts labels pure maple syrup and honey that ensures greater accuracy and is more science-based. With this, the FDA wants to help consumers make more informed and healthier choices.

This update to the Nutrition Facts label has incorporated…

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Added by John Robinson on December 14, 2018 at 5:48am — No Comments

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