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The ongoing Part 11 inspection and enforcement program is the mechanism by which the FDA continues to enforce implementation of Part 11. Using this method, this regulatory agency has, in just the last four years, issued more than 30 Warning Letters for deviations from Part 11. The most important reasons for which citations get issued by the FDA relate to insufficient integrity, security and availability of electronic records, as well as validation of software and computer…
Added by Adam Fleming on September 30, 2016 at 6:57am — No Comments
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…Continue
Added by Roger Steven on September 30, 2016 at 6:21am — No Comments
The fact that between five and eight percent of current recall and shipment rejection issues happen within the cold chain food transportation sector, resulting in fairly high, but preventable financial loss is an indication of how much scope is there to contain seepage in the food and transportation industries.
Is this happening because of lack of regulation? No. Rather, it is…
Added by Adam Fleming on September 29, 2016 at 6:00am — No Comments
A Cyber Security Incident Response Program (CSIRP) or a Cyber Security Incident Response Team (CSIRT) that anticipates and neutralizes a cyber-incident is a critical need for organizations, because an Internet or network security breach results in loss of valuable data, as well as several resources and the organization’s reputation and could potentially invite lawsuits.
While putting a CSIRP in place; the management has to take into consideration…
Added by Adam Fleming on September 23, 2016 at 6:04am — No Comments
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…Continue
Added by Roger Steven on September 22, 2016 at 6:44am — No Comments
Those in the healthcare sector go about their work like they are completing a project. Their work is made up of many parts, all of which they need to approach using many processes and plans. In keeping a tight watch on the budget and the deadline; many aspects of the work get overlooked, as a result of which the outcome suffers.
Each team member has a specific and important task in healthcare. All these have to be done with precision and in close synchrony with the…
Added by Adam Fleming on September 22, 2016 at 6:00am — No Comments
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…Continue
Added by Roger Steven on September 22, 2016 at 12:07am — No Comments
Design of Experiments (DoE) is defined as a systematized means with which the factors that go into a process and its intended output can be determined. DoE makes extensive use of statistical and experimentation means. DoE helps to optimize the processes of production in a number of environments in a huge range of industries.
The varied uses of DoE
DoE is useful in a number of applications. For instance, it:
o Helps determine root…
Added by Adam Fleming on September 21, 2016 at 6:28am — No Comments
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
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…
Added by Adam Fleming on September 20, 2016 at 6:22am — No Comments
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
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…
Added by Adam Fleming on September 19, 2016 at 5:57am — No Comments
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
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…
Added by Adam Fleming on September 16, 2016 at 6:29am — No Comments
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…
Added by Adam Fleming on September 15, 2016 at 6:37am — No Comments
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
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?…
Added by Adam Fleming on September 13, 2016 at 6:52am — No Comments
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
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
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