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…

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Added by Roger Steven on October 28, 2016 at 6:51am — 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 activities and reviewing their documentation to make sure they can meet…

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Added by Roger Steven on October 27, 2016 at 6:06am — 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

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

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 6:06am — 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

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…