All Blog Posts (1,471)

Compliance with the Stark Law has become more than just a compliance issue. It is an Enterprise Risk Management issue, as the substantial awards and settlements in recent enforcement actions indicate. Managing their compliance and enterprise risk by ensuring that their physician employment arrangements are defensible under the Stark Law is now an…

Maintaining clean conditions in the entire food operation is essential for ensuring effective sanitation in the food industry. This can be brought about only when the residual microorganisms are destroyed after the production, storage and service areas of food establishments are cleaned thoroughly.

Ensuring a microorganism-free environment is a huge challenge for those in the food industry. This is because activities related to food, such as food production, handling,…

The European Co smetics Products Regulation (EC) 1223/2009 (CPR), which became fully operational from July 2013, is a game changer in many ways, as it is considered a most contemporary regulatory framework concerning state-of-the-art of cosmetic science and product technology.

It sets out vastly harsher conditions for compliance of cosmetic products that are manufactured…

Rules implementing The Health Insurance and Portability Act of 1996 (HIPAA) and Health Information Technology for Economic and Clinical Health Act of 2003 (HITECH) underwent changes as a result of amendments brought about by the US Department of Health and Human Services in 2013.

Fundraising is among the areas of change these rules covered. Important areas such…

For an organization that needs to show HIPAA compliance; having the proper policies and procedures in place is as important as ensuring that it is providing the appropriate patient rights and controls on its uses and disclosures of Protected Health Information (PHI). It makes sense for an organization that is the subject of a compliance review or is being…

In the field of pharmaceuticals, instrumental liquid chromatography is an analysis widely used to determine purity, the impurities, and the degradation of products. The Standard Operating Procedure (SOP) is the area on which most validation work is focused. However, auditors look for other areas, such as validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals.…

The Office for Civil Rights (OCR) newly released the Phase 2 Audit Program. The audit process has started with the release of the rules and protocols. The need for a clear understanding of this new audit program by all Covered Entities (CE) and Business Associates (BA), or for that matter anyone who accesses, uses or discloses Protected Health Information (PHI) is…

Exposure to silica dust is a serious health hazard for those in construction workers and related jobs. This can result in life long disease or even death due to lung cancer. The Occupational Safety and Health Administration (OSHA) has a new regulation that deals with what employers need to do in order to prevent and offset the damage caused by extensive exposure to…

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…

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…

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…