The Cutting Edge of Medical Technology Content, Community & Collaboration
In this age of outsourcing and globalization, and with it, the emerging potential phenomenon of the Internet of Things (IoT); it is quite a tempting proposition for HIPAA Business Associates or Covered Entities to think of outsourcing their processes relating to Protected Health Information (PHI). However, as is to be expected, there is risk involved in outsourcing this kind of critical information, given the critical importance of these healthcare records and in view of the fact that there…
ContinueAdded by Roger Steven on May 26, 2017 at 8:28am — No Comments
The Comprehensive Error Rate Testing (CERT) is a program used by the Centers for Medicare & Medicaid Services (CMS) for calculating the rate or extent of improper payments of Medicare Fee-for-Service (FFS). The method used by the CMS under CERT is to pick up a stratified random sample of some 40,000 claims that are statistically valid and calculate and audit it to determine if the payments were made in accordance with the rules relevant to items such as coding, Medicare coverage, and…
ContinueAdded by Roger Steven on May 10, 2017 at 8:45am — No Comments
Added by John Robinson on May 10, 2017 at 6:27am — No Comments
Packaging and labeling of commercial and clinical products are very important aspects to an organization involved in a business that relates to these products. While the packaging and labeling of commercial products is important, it is more so with clinical products, because these products play an important role in a clinical trial and also in the very life of a patient or subject.
Commercial products have their own value over time. The FDA has guidances for…
Added by Adam Fleming on April 17, 2017 at 8:42am — No Comments
Regulatory agencies such as the FDA conduct inspections for product-related Good Manufacturing Practice (GMP) in the course of assessing an application for marketing approval. The basic purpose of product-related GMP inspections is to check for compliance with the GMP guidelines set out in the International Conference on Harmonization (ICH) and national and local GMP regulations. GMP is the slightest standard that a manufacturer has to mandatorily meet in its production…
Added by Adam Fleming on April 3, 2017 at 6:29am — No Comments
The Design History File (DHF), the Technical File (TF) and the Design Dossier (DD) are core regulatory documents for a medical device. This is how one can understand the central difference between them: the Design History File (along with Design Control), is the most important among the regulatory documents that the FDA requires for medical devices, while the Technical File and Design Dossier are documents that serve the same purpose, however, within the EU’s regulatory…
ContinueAdded by John Robinson on February 13, 2017 at 7:29am — No Comments
A HIPAA audit is very important for service providing organizations, because the penalties for violations can bring their business down. It is important to understand the nuances of a HIPAA audit if one has to be successful.
A HIPAA audit is, for many service providing organizations, a make or break situation. This is because HIPAA audits are considered stringent. Violations can attract huge penalties, which is why getting it right the first time is extremely…
ContinueAdded by Roger Steven on December 9, 2016 at 4:20am — No Comments
For many professionals, writing skills are learned while they are on the job. In many cases, they would go by a preferred style or other documents or style guides that help to put a certain style in place. Editing, however, is rarely taught. Worse, the perception most people have of editing is that it is revising or rewriting a work. But the truth is different. Editing gives shape to a document. It helps to perfect and sculpt it. The big question most editors face…
ContinueAdded by Roger Steven on November 29, 2016 at 6:10am — No Comments
Nanotechnology, a part of Quantum Physics (QP), is growing fast and has myriad uses. Nanotechnology is all about size and self-assembly. While QP deals with subatomic particles and waves; Nano relates to the atomic and molecular level. Atomic behavior and properties get dramatically changed at the Nano level. Of note are properties such as color change due to refraction of light. Gold, packaging and chemistry are some of the well-known areas into which…
ContinueAdded by Roger Steven on November 25, 2016 at 4:50am — No Comments
The importance of conducting a risk analysis updating it can be gauged from the fact that failure to conduct a written risk analysis qualifies as “willful neglect”, which carries the highest Civil Money Penalty (“CMP”). This cannot be waived by the DHHS unlike violations that happen due to a reasonable cause.
Since risk analysis is a required implementation specification under the Security Rule, failure to do one amounts to willful neglect. If the civil…
ContinueAdded by Roger Steven on November 15, 2016 at 5:23am — No Comments
A common qualifying measure of physician ability is the medical specialty board certification. Because the requirements of the board are increasing; the laws that restrict such use are on the rise.
A webinar from MentorHealth, a leading provider of professional trainings for the healthcare industry, will offer learning on the new laws and qualifications of…
ContinueAdded by Roger Steven on November 11, 2016 at 6:13am — No Comments
What can be and cannot be done with the use of personal devices under HIPAA is something practices and businesses that need to be compliant with the provisions of HIPAA need to be thoroughly aware of.
With changes expected in 2016 relating to personal devices as well as emailing and texting; staying compliant is extremely important to protect one’s practice or…
ContinueAdded by Roger Steven on November 10, 2016 at 5:05am — No Comments
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…
ContinueAdded by Roger Steven on November 9, 2016 at 7:27am — No Comments
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,…
ContinueAdded by Adam Fleming on November 8, 2016 at 5:01am — No Comments
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…
ContinueAdded by Roger Steven on November 8, 2016 at 4:57am — No Comments
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…
ContinueAdded by Roger Steven on November 7, 2016 at 4:33am — No Comments
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…
ContinueAdded by Roger Steven on November 4, 2016 at 6:28am — No Comments
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…
ContinueAdded by Roger Steven on November 3, 2016 at 5:58am — No Comments
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…
ContinueAdded by Roger Steven on November 2, 2016 at 5:49am — No Comments
2022
2020
2019
2018
2017
2016
2015
2014
2013
2012
2011
2010
2009
2008
1999
© 2024 Created by CC-Conrad Clyburn-MedForeSight. Powered by