October 2016 Blog Posts (35)

There are offers, and then there are super offers. Finally, there are Compliance4All offers! Yes, Compliance4All has an offer that is so unique that it can be considered a step above being a super offer. What is this offer, then? Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, has just announced that it is offering a 50% off on its webinar packs. Wait. Don’t rush for your reading glasses. You’ve read it right.…

The Anti-Kickback and Stark Law is a vital Act for healthcare practitioners, and it includes several changes for 2016.

Is the implementation of the Stark Law important? It is much more than being just important. It is critical. The reason for this is that lack of proper implementation of this law in its entirety attracts substantial awards and settlements, as…

An organization that needs to be HIPAA compliant has to not only ensure that it provides the appropriate patient rights and controls on its uses and disclosures of Protected Health Information (PHI); it has to also have the proper policies and procedures in place. Any organization that is the subject of a compliance review or is being audited has to demonstrate to the government that it has both the documentation necessary for safeguarding patient PHI, as well as the ability to show…

Any healthcare organization that is active on the social media is vulnerable to some or another kind of Protected Health Information (PHI) breach. Although a healthcare practice or business benefits greatly in terms of marketing and publicity from the judicious use of the social media for; data stored on Facebook, LinkedIn, YouTube or Instagram leaves it susceptible…

In a broad sense, GMPs refer to good manufacturing practices in any field. The main intention of these GMPs is that they enable industries to perform the required practices needed for complying with guidelines set out by the regulatory authorities. GMP guidelines are issued by regulatory authorities all around the world, mainly in the US, Canada, the countries of Europe and many others.

The ambit…

An organization that needs to be HIPAA compliant has to not only ensure that it provides the appropriate patient rights and controls on its uses and disclosures of Protected Health Information (PHI); it has to also have the proper policies and procedures in place. Any organization that is the subject of a compliance review or is being audited has to demonstrate to…

FDA Code of Federal Regulations (CFR) is a huge sea of regulations that the FDA has created for regulating all products that come under its purview of regulation. The FDA codes of federal regulations are numbered and cover all products, processes and the activities that go into their creation.

The FDA Code of Federal Regulations is a compendium of codified general and permanent rules the federal…

Good Clinical Practices are a collectively bunched global scientific, quality and ethical standard relating to the following aspects of a clinical research:

• Design
• Conduct
• Documentation (recording)
• Report making

Relevant Good Clinical Practice regulations are to be followed by the sponsors of a clinical trial, no matter how big or small the trial or…

Contract research organisation (CRO) is a fastest growing segment, provides support to pharmaceutical, biotechnology and medical device industries in the form of research services. The pharmaceutical companies can’t uphold and drop billions due to termination of patent and deficiency of new approvals. So they are approaching strategic alliances to sustain revenue and improve the product pipelines. These companies are increasingly…

Healthcare computer systems implementation can be anything from a headache to nightmare, given its complexity. Things can go wrong at any stage and for any reason. Getting the computer systems right or implementing the right one involves investment of considerable time and money from all kinds of healthcare organizations, big or small.

Fortunately, many of…