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Roger Steven's Blog – November 2017 Archive (3)

Differences between Device and Drug Clinical Research

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…

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Added by Roger Steven on November 23, 2017 at 6:16am — No Comments

HIPAA privacy and the social media

Misuse of social media is a critical area of HIPAA privacy. A random act of carelessness by a healthcare worker can result in a Protected Health Information (PHI) breach, inviting actions from the HHS. As is known, protection of patient health information is what HIPAA is essentially all about. Many safeguards and safety mechanisms have been put into HIPAA to ensure this.

However, the rise of the social media has brought in a new dimension to PHI. Patient confidentiality can be…

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Added by Roger Steven on November 15, 2017 at 5:45am — No Comments

An understanding of Federal-Wide Assurances

The Federal-Wide Assurance (FWA) is an assurance given by an institution that is carrying out NIH-funded studies. Through this written assurance, which is required to be filed with the Office for Human Research Protections (OHRP); the institution commits itself to compliance with the terms of requirements set out in the HHS Protection of Human Subjects regulations at 45 CFR part 46. It is the only type of assurance that the OHRP accepts and approves.

The FWA must clearly outline the…

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Added by Roger Steven on November 10, 2017 at 6:35am — No Comments

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