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October 2016 Blog Posts (35)

Protecting a business from record breaches resulting from ransomware attacks

When HIPAA investigations relating to ransomware breaches find malpractices; it can be total jolt that can absolutely devastate the said practice or business. Discovery of this kind of breach during a HIPAA investigation can cause a major financial burden, apart of course, from severe embarrassment and ignominy.

This means that practices and businesses that are…

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Added by Roger Steven on October 28, 2016 at 6:47am — No Comments

Standardizing Transportation Procedures is Necessary to Control Food Safety and Quality

Building a standardized sanitary transportation system in compliance with the FSMA’s new Proposed Rules for the sanitary transportation of human and animal foods is included in the FDA's FSMA hazard analysis risk-based preventive controls requirements for improved food safety during transportation processes. For this reason, food transporters need to have a clear understanding of these rules. The consequence of the inability to establish and keep required documentation is predictable: It makes… Continue

Added by Adam Fleming on October 28, 2016 at 5:52am — No Comments

Ensuring HIPAA Compliance and Avoiding Penalties

The combination of the implementation of new HIPAA regulations in the HIPAA Omnibus Update of 2013 and increased enforcement and audit activity has forced healthcare organizations to review their compliance and to ensure that they have the proper policies, procedures, and forms in place.

Because of this, HIPAA Privacy Officers have been renewing their compliance…

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Added by Roger Steven on October 27, 2016 at 6:02am — No Comments

Extracting Information from Geochemical Data

Going beyond just asking the laboratory for geochemical extracting information of a gold test by sampling every meter of the drill core of a trench and using multielement analysis is an approach strongly recommended by most mining specialists. There exist other methods of geochemical data analysis techniques and obtaining geochemical extracting information, but these are largely ignored by the industry.

Making sense of the geochemical extracting…

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Added by Adam Fleming on October 27, 2016 at 5:50am — No Comments

Career development for the Millennials

The Society for Human Resource Management (SHRM) estimated in 2014 that the percentage of the Millennials at the workplace will reach 46% in 2020. In this scenario, it is absolutely essential for organizations to devise ways of managing this group in order to get the best out of them.

Organizations need to identify, grow and develop this young group’s talent. It is a group that needs to be nurtured if its talent and abilities need to be…

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Added by Russel Stuart on October 27, 2016 at 3:03am — No Comments

HR metrics is a critical tool for organizations

HR metrics is a critical tool for organizations To ensure compliance with the requirements that governmental and regulatory expect from them, employers must create, maintain, and demonstrate procedures and activities that are in compliance with the laws. Employers are also under pressure from investors, lending institutions, and third party administrators to ensure that resources are properly used and that results are properly reported. To ensure these, employers need metrics and…

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Added by Russel Stuart on October 26, 2016 at 8:22am — No Comments

Diligence is Necessary for Postmarketing Vigilance Reporting for Medical Device Manufacturers

A few important postmarketing vigilance revisions are now being implemented. One of these is the revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 5), which came into force on January 1, 2008.

Offering greater clarity and more guidance than the previous version, the new document includes new reporting terminology and many new concepts. It has also excised or added new, important terms.…

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Added by Adam Fleming on October 26, 2016 at 5:59am — No Comments

Get a complete understanding of HIPAA Phase 2 audits

With HIPAA Phase 2 audits underway, practice and business managers are on tenterhooks on the implementation part of this requirement. The biggest area of concern for these professionals is understanding ways of carrying out Phase 2 audits with a grasp of what their highest risks are for being fined.

Before the audits happen; practice managers, business managers and compliance offers need to get their HIPAA house completely in order. This preparation requires professional guidance, as any… Continue

Added by Roger Steven on October 26, 2016 at 5:51am — No Comments

Dealing with difficult people is quite an art

Difficult people are, well, difficult, aren't they? These are what make them so: Their number in an organization could be low, but the impact of their negativity is disproportionately high to their small number. Their behavior is erratic and difficult to cope with, but it affects all the people they come into contact with.

In organizations, their baleful influence frustrates and demoralizes other people and results in absenteeism of other employees and loss of…

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Added by Russel Stuart on October 26, 2016 at 2:58am — No Comments

Getting the Millennials to understanding a safety program

The Millennials, those born roughly between 1980 and 2000, will be the next generation that will make up the US workforce. What differentiates this generation from the previous ones is that they were born at around the same time that IT, which has changed our lives in the most dramatic of ways, began to evolve. Being of this generation, they come with a few distinct characteristics:

They are more gadget and social media friendly

Their work life is expected to be more…

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Added by Russel Stuart on October 25, 2016 at 7:35am — No Comments

The ways of Understanding, Calculating, and Using Statistical Power

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…

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Added by Adam Fleming on October 25, 2016 at 6:05am — No Comments

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

Job rotation is a potential panacea for many ills in an organization

One of the mechanisms by which an organization can augment employee engagement and customer retention, close gaps in their operations and facilitate creation of a more diverse workforce is job rotation.

The most important purpose that job rotation serves is that it will help the organization’s management identify talents at all levels of the employee hierarchy. It is only when employees at the lower tier are given alternative roles and responsibilities that the organization…

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Added by Russel Stuart on October 25, 2016 at 2:22am — No Comments

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” leve…

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…

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Added by Adam Fleming on October 24, 2016 at 5:59am — 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 texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT.

In addition, they also need to be aware of the major changes…

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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

How do attorneys and law firms bring about HIPAA compliance?

Any firm that is covered under HIPAA and is privy to Protected Health Information (PHI) needs to be aware of the new burden placed on Business Associates under the Omnibus Rule. This is so because patients can receive remedies for HIPAA violations, and law firms that handle PHI, ipso facto they become Business Associates, must now comply directly with HIPAA Omnibus Rule as part of the major changes to HIPAA set…

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Added by Roger Steven on October 20, 2016 at 6:05am — 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

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

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