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HIPAA compliance is, as any healthcare professional involved in work related to it in one or another way would attest, the most important requirement for a HIPAA-governed entity. Covered Entities and Business Associates have to comply with HIPAA regulations and safeguard HIPAA provisions with their lives, so to speak, because it is a matter of their very existence as a business entity.
A look at what happens in the event of HIPAA noncompliance is instructive:
A HIPAA gap analysis is a crucial step for healthcare organizations in ensuring compliance with the HIPAA Security Rule. Why? An understanding of HIPAA gap analysis will help understand this question:
HIPAA gap analysis is defined by the US Department of Health and Human Services (HHS) as a means to evaluate or assess the extent to which there are lacunae in the implementation by the Covered Entities or their Business Associates, of the safeguards or privacy…Continue
Medical devices and drugs clinical research have their differences in approach and methodology. It is necessary to have a clear understanding of these differences if one embarks upon a study involving either or both of these.
Some of the major differences between device and drug clinical research include:
Requirement for a study:
One of the important differences between device and…Continue