All Blog Posts (1,363)

What makes risk management critical? Well, business that comes with no risk is no business at all. It is like the side effect of a medicine. It is impossible to think of the medication without the side effects. Risk being inhered into a business and intricately woven into it; it is necessary to understand why you must keep carrying out risk management throughout your business’ lifetime. This places risk management right up there at the very top…

Requirements set out by the Occupational Safety and Health Administration (OSHA) are aimed at ensuring safety at the workplace. Formulated in 1971 under President Richard Nixon, it was one of the landmark legislations in any part of the world. Today, almost all kinds of workplaces in the US are regulated by OSHA.

Through its concerted efforts, OSHA has largely been a success, if one takes into…

Good Clinical Practice (GCP) is a set of international standards meant for entities that conduct clinical trials. This set of standards, formulated by the International Conference on Harmonization (ICH), when implemented into clinical trials involving human subjects, seeks to ensure the protection of the humans involved in the research, as well as to bring about transparency in the methods of clinical practice.…

HIPAA compliance is, as any healthcare professional involved in work related to it in one or another way would attest, the most important requirement for a HIPAA-governed entity. Covered Entities and Business Associates have to comply with HIPAA regulations and safeguard HIPAA provisions with their lives, so to speak, because it is a matter of their very existence as a business entity.

A look at what happens in the event of HIPAA noncompliance is instructive:

• Fines that…

Regulatory compliance is something organizations in most industries have to deal with. Almost every industry has its own set of regulations that are framed by the respective regulatory bodies. In niche areas such as medical devices, pharmaceuticals, healthcare, finance, aerospace, information technology and such others, the FDA has a very detailed set of regulations.

The aim of these regulations…

Metadata is the Achilles heel of video. These shorthand textual descriptions can be employed for more detailed searching, classification or other organizing, but, when scale is required, machine-generated metadata has accuracy issues.

On the other hand, the huge volume of video on the web makes human validation prohibitively expensive, so much video searching misses a lot of what’s visually…

A HIPAA gap analysis is a crucial step for healthcare organizations in ensuring compliance with the HIPAA Security Rule. Why? An understanding of HIPAA gap analysis will help understand this question:

HIPAA gap analysis is defined by the US Department of Health and Human Services (HHS) as a means to evaluate or assess the extent to which there are lacunae in the implementation by the Covered Entities or their Business Associates, of the safeguards or privacy…

When you work in an industry that is regulated by the FDA, one thing that is as certain as day and night is the fact of FDA regulation. Of course, this is as obvious as saying that solar power is derived from the sun and is as silly as asking if the FDA regulates FDA-regulated industries! The point being made is that regulation is the essence of the FDA’s existence. The FDA has been created to regulate certain industries with the intention of…

Training is the foundation to producing products and services that meet regulatory and quality expectations and industrywide acceptance. This is generally true for all products and services, but in particular, for medical devices. Why? Medical devices are not in the same league as any other ordinary product that can be handled by anyone in any manner.

Training is the only means by which medical device companies that manufacture medical devices and the staff that handle these products…

Well, a few things in life can be planned. A few things cannot. If only healthcare could be planned the way we plan our holidays! Despite all the advancements we have made in medical technology and the tall claims of our knowledge of the human mind and body, we are still a long way away from understanding…

With almost everything under the sun being touched in one or another way by technology; medical devices are not exempt from this influence. Technology and medical devices have always had a strong bond with each other. Newer technologies that have sprung up over the past few years have accentuated their already strong linkage. So, which new technologies have the potential to impact medical devices in a big way? There are many, but let us consider…

Healthcare compliance trainings are undertaken to get a clear idea about the regulatory compliance requirements in the industry. Healthcare is a highly regulated industry, which means that the regulatory bodies keep issuing regulatory guidelines, standards or requirements from time to time, as the regulations come in. One question that could arise in the minds of readers is: is it necessary to get trained…

What is compliance? We all know the commonly used meaning of the term. One of the meanings The Oxford Online Dictionary has for compliance is its being “(t) he state or fact of according with or meeting rules or standards”. So, in the context of the regulated industries, compliance is being in a state of acquiescence or agreement with the regulatory requirements. The rules or requirements are set out by the regulatory authorities such as the US FDA or the European Union’s European Medicines…

Information researchers have a developing scope of alternatives while picking systematic instruments, and another overview of hardware inclinations uncovers a generally even split in inclinations among the three driving programming dialects.

In its…

Food inspections occupy a position of primacy among the FDA’s list of mechanisms aimed at maintaining and enhancing food safety. Since it is the sole regulatory body in the US for food, it is natural that the FDA attaches the highest importance to ensuring the safety and efficacy of food that is consumed across the nation.

Towards ensuring this, the FDA has initiated a number of plans and strategies. A seamless, informal and micro level activity in this list is risk-based food…

It is hard to believe that it has been just over since five months since our second son, Lukas, was born on Feb. 3. His mother, Hollyanne, is doing well, which is something to be thankful for, given the excessive maternal mortality rates in the U.S. Lukas is also healthy and growing, albeit sleeping little at night. What is…