All Blog Posts (1,471)

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 the…

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…

HIPAA has regulations concerning the use of the mobile devices to access Protected Health Information PHI). Secure technologies for communications and storage of data should also be considered when using portable technologies. Due to these requirements, the use of portable devices by patients and staff can be complex. It requires careful consideration of the…

Collections and Appeals for past due amounts can be difficult in any industry; adding the Medical Billing office element to it complicates it further. With this, one has the share of cost for patients, Medicare rules and Regulations, Private Payor contracts, and Collectors without experience in medical terminology needed for successful claims appeals to deal with.

Collections and Appeals in the medical billing office can be successful only when one has the right tools, the…

Of late, there has been an explosion in the field of biopharmaceuticals in activities ranging from development to manufacture. Although this augurs well for the industry; there are concerns, nevertheless.

These concerns relate mainly to the inadequacy of the skillsets needed for this industry. There is a widespread feeling in the industry circles that the existing or potential skillsets may not be sufficient for coping with the huge demand the industry is…

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…

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…