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Statistical power may be understood as being an indicator of the ability of a test of significance to spot a practical difference, such as the one between the averages of two products that are being compared. In this context, a low power typically means that the sample sizes in the study are too small. Conclusion of what is “non-significant” is justifiably questionable when it is arrived at without an analysis of statistical power. For this reason, unless power is high, a study may be doomed…
ContinueAdded by Adam Fleming on October 25, 2016 at 6:06am — No Comments
The various programs of the CMS, such as Quality Payment Program, MACRA, MIPS and APM incentive implementation need to be given close attention if these programs have to be properly implemented. Healthcare professionals have to pay thorough and full attention to the structure and program-specific details.
This is the right time to start preparing, because the…
ContinueAdded by Roger Steven on October 25, 2016 at 5:57am — No Comments
Added by Adam Fleming on October 24, 2016 at 6:00am — No Comments
Added by Adam Fleming on October 24, 2016 at 5:59am — No Comments
Added by Adam Fleming on October 24, 2016 at 5:58am — No Comments
All the major players in an organization that is required to carry out HIPAA audits, such as information technology managers, business managers and compliance officers, have to be conversant with all aspects of the HIPAA Security Rule as it relates to portable devices. They need to be thoroughly clear about all areas such as…
ContinueAdded by Roger Steven on October 24, 2016 at 5:31am — No Comments
Healthcare providers have to pay close attention to the structure and program-specific details on CMS's Quality Payment Program, MACRA, MIPS and APM incentive implementation. Since the first performance year for these programs begins on January 1, 2017 and payment adjustments will follow in 2019 (as the 2019 bonus/penalty adjustments will be based on the 2017…
ContinueAdded by Roger Steven on October 21, 2016 at 5:58am — 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…
Added by Adam Fleming on October 21, 2016 at 5:53am — No Comments
Annual registration is a requirement for any device firm, establishment or facility whose business relates to the production and distribution of medical devices intended for use in the US in some or another way.
Such business establishments have to register with the FDA and also need to list the devices that are made there and the activities that are performed on those devices.…
Added by Adam Fleming on October 20, 2016 at 5:59am — No Comments
An audit management system can be understood as a set of audit systems that an organization puts in place to ensure that it meets its objectives. All organizations need to have their own audit management systems. An audit management system is a system that facilitates the management of…
Added by Adam Fleming on October 19, 2016 at 5:40am — No Comments
Verification and Validation (V & V) are two important aspects of regulatory compliance for software. What all are needed for achieving this? The FDA, GAMP and others provide guidance in the methodology and documentation needed for this. This apart; consideration of the principles in ISO 14971 can assist in providing an acceptable vehicle by which to perform and document risk-based software V&V.…
Added by Adam Fleming on October 18, 2016 at 5:50am — No Comments
A very big misconception in the field of medicine is that biomedical writing is highly technical and replete with jargon, and therefore not creative. There is enough scope in biomedical writing for creativity and the use of artistic and imaginative words without compromising on the meaning or import of the words. In fact, resorting to the use of imaginative words…
ContinueAdded by Roger Steven on October 17, 2016 at 6:00am — No Comments
A good portion of the current recall and shipment rejection issues happen within the cold chain food transportation sector, resulting in fairly high, but preventable financial loss. This 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 the lack of proper…
Added by Adam Fleming on October 17, 2016 at 5:53am — No Comments
Practice managers, business managers and compliance officers need to have all their points in order before a HIPAA audit. They need to be fully educated about the misconceptions and realities of a HIPAA audit, since there is a lot of misinformation about HIPAA that keeps doing the rounds most of the time. These professionals who deal with HIPAA audits for their…
Added by Roger Steven on October 14, 2016 at 6:24am — No Comments
MS Excel is a program that has an amazing number of features that make it highly capable and suited for a number of usages. Although it has innumerable features; they come with simple shortcuts and methods. These are not always visible to the casual user. The use of these shortcuts is of tremendous use to users, because it saves them precious time, which can be put to more valuable uses. Employees who know the secrets of MS Excel are certainly likely to be more…
Added by Adam Fleming on October 14, 2016 at 5:40am — No Comments
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.…
ContinueAdded by Adam Fleming on October 13, 2016 at 7:00am — No Comments
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…
ContinueAdded by Roger Steven on October 13, 2016 at 5:55am — No Comments
Although the news of a company receiving strictures from the FDA in the form of 483s, Warning Letters, and even Consent Decrees is a near daily occurrence in the industry; when it happens, it takes such companies by surprise. Not only is the company’s executive management caught off guard by these events; they are also embarrassed by the bad press they get, as well by the very expensive and damaging investigations and corrective and preventive action that follow.…
Added by Adam Fleming on October 13, 2016 at 5:32am — No Comments
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…
ContinueAdded by Roger Steven on October 12, 2016 at 5:54am — No Comments
It is a disturbing, but true fact that medical devices are hacked. Medical devices have inbuilt software, and hackers try to breach this. Medical device cyber security is thus critical, because lack of it can bring harm to patients who use medical devices that come with software built…
Added by Adam Fleming on October 12, 2016 at 5:41am — No Comments
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