All Blog Posts (1,471)

Getting the CMS’ Quality Payment Program right

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…

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Added by Roger Steven on October 25, 2016 at 5:57am — No Comments

How is Process Capability Analysis of Extremely Non-Normal Data Done?

The most informative method for analyzing the data that results from QC, Validation, or Engineering activities is the calculation of the product's or lot's “reliability” at a chosen “confidence” level (where “reliability” means “in-specification”). Such calculations are relatively simple when data is “normally distributed”; but if the data is non-normal and cannot be transformed to normality, then there is typically no simple way to calculate a reasonably accurate level of… Continue

Added by Adam Fleming on October 24, 2016 at 6:00am — No Comments

How is Process Capability Analysis of Extremely Non-Normal Data Done?

Added by Adam Fleming on October 24, 2016 at 5:59am — No Comments

How is Process Capability Analysis of Extremely Non-Normal Data Done?

Added by Adam Fleming on October 24, 2016 at 5:58am — No Comments

Texting and emailing as part of HIPAA 2016

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…

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Added by Roger Steven on October 24, 2016 at 5:31am — No Comments

MIPS and the New Medicare Quality Payment Program that healthcare providers need to be aware

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…

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Added by Roger Steven on October 21, 2016 at 5:58am — No Comments

Elements of a Cyber Security Incident Response Program

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…

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Added by Adam Fleming on October 21, 2016 at 5:53am — No Comments

Device Establishment Registration and Listing in line with the FDA’s Proposed Rule

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.…

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Added by Adam Fleming on October 20, 2016 at 5:59am — No Comments

Understanding an audit management system

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…

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Added by Adam Fleming on October 19, 2016 at 5:40am — No Comments

Identifying and resolving common issues in FDA Software Validation & Verification

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.…

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Added by Adam Fleming on October 18, 2016 at 5:50am — No Comments

Fine-tuning biomedical writing brings a number of benefits

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…

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Added by Roger Steven on October 17, 2016 at 6:00am — No Comments

Tightening carrier food safety issues can save costs for the food and logistics industries

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…

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Added by Adam Fleming on October 17, 2016 at 5:53am — No Comments

Practice Managers need to be thorough in their understanding of HIPAA requirements

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…

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Added by Roger Steven on October 14, 2016 at 6:24am — No Comments

Time-saving tips on MS Excel usage

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…

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Added by Adam Fleming on October 14, 2016 at 5:40am — No Comments

Cost-effective regulatory compliance trainings get even more cost-effective!

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.…

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Added by Adam Fleming on October 13, 2016 at 7:00am — No Comments

Adherence to the Anti-Kickback and Stark Law is more than just a compliance issue

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…

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Added by Roger Steven on October 13, 2016 at 5:55am — No Comments

Avoiding punitive actions from the FDA

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.…

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Added by Adam Fleming on October 13, 2016 at 5:32am — No Comments

Understanding HIPAA Compliance Requirements

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…

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Added by Roger Steven on October 12, 2016 at 5:54am — No Comments

The FDA steps up efforts at bringing about medical device cyber security

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…

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Added by Adam Fleming on October 12, 2016 at 5:41am — No Comments

Know the ropes of social media in healthcare to avoid costly penalties from HIPAA

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…

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Added by Roger Steven on October 11, 2016 at 6:34am — No Comments