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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…Continue
Added by Roger Steven on October 28, 2016 at 6:51am — No Comments
Added by Compliance4all on October 28, 2016 at 5:52am — No Comments
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…Continue
Added by Roger Steven on October 27, 2016 at 6:06am — No Comments
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…
Added by Compliance4all on October 27, 2016 at 5:50am — No Comments
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.…
Added by Compliance4all on October 26, 2016 at 5:59am — No Comments
Added by Roger Steven on October 26, 2016 at 5:51am — No Comments
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…Continue
Added by Compliance4all 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…Continue
Added by Roger Steven on October 25, 2016 at 5:57am — No Comments
Added by Compliance4all on October 24, 2016 at 6:00am — No Comments
Added by Compliance4all on October 24, 2016 at 5:59am — No Comments
Added by Compliance4all 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…Continue
Added 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…Continue
Added 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.
Added by Compliance4all 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 Compliance4all on October 20, 2016 at 5:59am — No Comments
Added by Compliance4all 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 Compliance4all 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…Continue
Added 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 Compliance4all 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…
Added by Roger Steven on October 14, 2016 at 6:24am — No Comments