MedTech I.Q.

The Cutting Edge of Medical Technology Content, Community & Collaboration

All Blog Posts (1,655)

Understand the False Claims Act to be a better whistleblower

Whistleblowing is a very important area of the healthcare industry. When exercised properly and with integrity, it helps expose major frauds and saves the industry from many malpractices. There have been instances of whistleblowers bringing many companies into the legal net and helping save frauds.

A whistleblower act, or what is called or qui tam action, can offer huge financial rewards to those who are retaliated against for exposing financial fraud that their company…

Continue

Added by Roger Steven on September 20, 2016 at 6:35am — No Comments

Exploring the FDA’s guidance on financial disclosure by clinical investigators

Transparency and integrity of the financial interests of clinical investigators is a matter of utmost importance to the healthcare industry in the US. The financial interests of the investigators are directly associated with the results, thinks the FDA. It believes that “financial interests and arrangements of clinical…

Continue

Added by Adam Fleming on September 20, 2016 at 6:22am — No Comments

Physician Leases need to be structured under the new 2016 Stark Rules

Stark Law, more formally referred to as The Physician Anti-Referral Law (known as Stark II), is a prominent law concerning physician referrals. Healthcare providers that file claims require compliance with the Stark rules. Failure to comply can invite an enforcement action. The fundamental aim of this law is the elimination of malpractices in the healthcare sector. Implemented in stages known as Stark II and Stark III; the Stark Laws consider particular actions on the part of the…

Continue

Added by Roger Steven on September 19, 2016 at 6:39am — No Comments

Designing your retail store for the old and new generations

The demographic profile of the nation has a direct and very important bearing on the productivity of an organization. There is a common perception that the Baby Boomers are on their way out and are making way for Gen X. While this is true to on the surface, in the sense that Gen X is the next phase of the workforce; the Baby Boomers are certainly not done yet.

The key to getting more out of the American workforce is to analyze how one generation…

Continue

Added by Adam Fleming on September 19, 2016 at 5:57am — No Comments

Understanding the final regulations for the new HIPAA Breach Notification Rule

The final regulations for the new HIPAA Breach Notification Rule place a far greater burden on Covered Entities and Business Associates than earlier. It is not enough for them to just notify individuals whose Protected Health Information (PHI) have been affected. For them to determine if a breach occurred, they must follow and document a very specific process. Their work does not end here. If no Breach occurred, then documentary evidence to this effect must be compiled and kept for…

Continue

Added by Roger Steven on September 16, 2016 at 6:55am — No Comments

The right way of choosing sample sizes based on valid statistical rationale

Performing at least some verification testings or validation studies of design-outputs and/or manufacturing processes is essential for almost all manufacturing and development companies. Yet, it is sometimes difficult to explain the rationale that goes into the selection of the sample sizes used in such efforts.

Removing this doubt and showing participants a way out of this quandary will be the content of a webinar that Compliance4All, a leading…

Continue

Added by Adam Fleming on September 16, 2016 at 6:29am — No Comments

Article on Understanding the NI 43-101

The NI (short for National Instrument) 43-101 is a Canadian national instrument used for the Standards of Disclosure for Mineral Projects within the country. This is a codified set of rules and regulations used to report and exhibit information relating to mineral properties owned by, or explored by companies that report these findings on the nation’s stock exchanges.

The NI 43-101 came into existence in the wake of the notorious Bre-X scandal. It…

Continue

Added by Adam Fleming on September 15, 2016 at 6:37am — No Comments

The Conditions of Participation for Discharge Planning set for change

The Centers for Medicare and Medicaid Services (CMS) has proposed major changes into the Conditions of Participation for Discharge Planning. These changes will have a profound effect on case management departments, which are now required to put in place a plan of action that addresses the new requirements that will affect their departments. Among the changes that will be made are out-patient discharge planning assessments, 7 days a week/24 hours a day discharge planning, and care…

Continue

Added by Roger Steven on September 13, 2016 at 8:41am — No Comments

Getting their documentation right is very important for medical device manufacturers

Documentation is at the heart of medical devices. If a medical device manufacturer cannot convincingly establish documentation of the manufacturing process; the medical device is bound to have regulatory approval hurdles. Every medical device manufacturer has to both establish and maintain all of these: documents, procedures and records, all of which must be under a state of control.

So, what should the documentation establish and prove?…

Continue

Added by Adam Fleming on September 13, 2016 at 6:52am — No Comments

Good documentation lies at the heart of GxP environments

Good Documentation Practice (GDP) constitutes the backbone of any GxP environment. Not only is GDP a sound business practice; it is also an FDA requirement. This being the case, it is absolutely essential for FDA-regulated organizations to get their GDP right. An organization that does not get its GDP right risks facing a number of consequences.

Today’s regulatory requirements are stricter than ever before. In this environment of very rigid regulatory environment;…

Continue

Added by Adam Fleming on September 6, 2016 at 7:57am — No Comments

Risk analysis is the soul of HIPAA implementation

The criticality of risk analysis to HIPAA implementation can be understood from the fact that inability to carry out this activity is the principal reason for which The United States Department of Health and Human Services (DHHS or just HHS) levies civil money penalties on Business Associates and Covered Entities.

This means that Covered Entities and…

Continue

Added by Roger Steven on September 2, 2016 at 6:56am — No Comments

Vaccines and immunotherapeutics on the rise

With the advent of globalization, the profile and nature of spread of many infectious diseases have changed. Earlier, many infectious diseases were limited to certain specific geographical regions. But this has changed with the emergence of the globetrotter. Additional factors such as globalization of trade and commerce and global warming have contributed significantly to propelling and motivating people to travel more and more all over the world. This trend has brought about a…

Continue

Added by Roger Steven on September 2, 2016 at 6:37am — No Comments

Microbial monitoring becomes successful when myths about the topic are removed

Although unfortunate; it is true that those who work in water systems design them keeping obsolete concepts in mind. Why this happens is that the water systems organization is reluctant to be open-minded enough to update its water systems from time to time. The result is that the water systems get built on a shaky foundation, making them fundamentally weak.

Myths are the backbone of water systems failures

An additional problem faced by most microbial monitoring…

Continue

Added by Adam Fleming on September 2, 2016 at 6:12am — No Comments

A broad look at clinical research regulations

Clinical research regulations are directives that are aimed at making clinical research more effective and ethically justifiable. The tool or mechanism by which regulators ensure that clinical research regulations serve their purpose is what is called Good Clinical Practice (GCP).

Regulatory bodies around the world, irrespective of whether they function at national or global levels, formulate respective clinical research regulations that are aimed at ensuring that…

Continue

Added by Adam Fleming on June 10, 2016 at 3:16am — No Comments

What are the functions of computer system validation process?

Computer system validation process is described as the documented procedure which assures that a computer system performs the exact functions it is intended to reproducibly, consistently and verifiably. The computer system validation process covers every function and milestone of the computer system:

  • Development of the system
  • Operation of the system
  • The system’s maintenance
  • Its retirement
  • Archiving…
Continue

Added by Adam Fleming on June 7, 2016 at 2:24am — No Comments

Effective Steps for Validation and 21 CFR Part 11 Compliance (CSV)

If one were to define validation; it can be considered the deed of testing an item or system for the level or extent to which it complies with a standard that it has to show compliance with.

In the case of computer systems, validation is a major requirement for these regulatory bodies/practices:

o The US FDA

o European Medicines Agency (EMA)

o Good Manufacturing Practices (GMP)

o Good Laboratory Practices (GLP)

o Good Clinical Practices (GCP)

o All the… Continue

Added by John Robinson on June 6, 2016 at 2:33am — No Comments

The emerging discipline of Hospitals Management Performance Assessments

The emerging discipline of Hospitals Management Performance Assessments

Over the past few years, Hospitals Management Performance Assessments have begun to gain acceptability and credence in healthcare circles. Hospitals Management Performance Assessments came into being as a result of a conscious effort by advanced countries, mainly European, with sufficient backing from the World Health Organization (WHO) to arrive at some sort of metrics…

Continue

Added by Roger Steven on June 2, 2016 at 7:10am — No Comments

Implementation requirements of FDA's Bioresearch Monitoring Program

If there is one common cause for apprehension between the smallest and biggest, and the best known and least known organizations; it has to be an FDA inspection! Any organization that is subject to an FDA inspection has to get absolutely everything of everything about its activities right to a T, to such an extent that it should be sure simply all the time, through all its processes, that an FDA inspection is not going to invite an FDA action such as a 483…

Continue

Added by Adam Fleming on June 2, 2016 at 3:08am — No Comments

It is important to ensure food safety in hospitals

It is important to ensure food safety in hospitals

Food-Services

Hospitals being what they are – where patients of almost all kinds visit or stay – are very potent sources of infection. Infection can arise from any part of the hospital. They can spread from patients to patients, from caregivers to patients, from patients to caregivers, from patients to support or administrative staff and vice versa, and so on. An often overlooked source of infection and contamination…

Continue

Added by Roger Steven on June 1, 2016 at 7:16am — No Comments

What are Factors to Take into Consideration While Choosing Airline and Airport Management Courses.

Airline and airport management courses are designed for those who want to make a career in the skies. Aviation has always been a preferred choice for a career. The existence of thousands of airports across the US -it has more than a third of the entire world's airports -and the large presence of aircraft for military and logistical purposes are major factors that prepare the ground for a career in airline and airport management. The prelude to a career in this field is to choose the right…

Continue

Added by Adam Fleming on May 31, 2016 at 2:33am — No Comments

Monthly Archives

2026

2025

2024

2022

2020

2019

2018

2017

2016

2015

2014

2013

2012

2011

2010

2009

2008

1999

© 2026   Created by CC-Conrad Clyburn-MedForeSight.   Powered by

Badges  |  Report an Issue  |  Terms of Service