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May 2017 Blog Posts (37)

HIPAA compliance for offshore vendors

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…

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Added by Roger Steven on May 26, 2017 at 8:28am — No Comments

Meeting equipment validation requirements from the FDA and EU

Putting in place a program for calibrating and maintaining test and measurement equipment is a regulatory requirement from both the FDA, under 21 CFR Part 210 and 211, and relevant EU regulations. Both these agencies have regulations that require this program from manufacturers.

The purpose of this equipment validation program is to ensure these…

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Added by Compliance4all on May 26, 2017 at 6:21am — No Comments

Why IEC 60825 certification cannot be substituted for 21CFR1040

With a few exceptions, it is necessary for manufacturers, system integrators and importers of lasers or laser containing products to implement best practices for compliance with FDA 21 CFR 1040. This is because The Center for Devices and Radiological Health (CDRH) requests documentation using the current version of their Form 3632 Guide for Preparing Product Reports for Lasers or Products Containing Lasers for laser self-certification submittals, which have to comply with…

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Added by Compliance4all on May 24, 2017 at 6:31am — No Comments

Seminar Calendar of Upcoming Courses - June to July - 2017

 

GlobalCompliancePanel’s seminars are a wonderful opportunity for professionals in the regulatory compliance areas to understand the latest happenings and updates in the…

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Added by John Robinson on May 24, 2017 at 5:51am — No Comments

MentorHealth Webinar Calendar of Upcoming Courses

MentorHealth webinars are designed to offer professionals in the healthcare industry the knowledge they need in all the areas of the healthcare industry that enables them to excel in their professions. MentorHealth’s trainings bring experts from all the core areas of healthcare and impart learning to help professionals understand and implement all the important issues that matter to their professions. To keep updating your knowledge of regulatory compliance in the healthcare industry, all…

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Added by Roger Steven on May 23, 2017 at 9:02am — No Comments

Webinar Calendar of Upcoming Courses - May to Jun 2017

webinar-training-online-education.jpg

Below is the event description content:

Compliance4All webinars are just what professionals in the regulatory

compliance areas need for scaling up in their careers. With a collection of

the most erudite experts on regulatory compliance being available at a click

in the comfort of your preferred location; regulatory compliance could not

get any simpler and effective!

Compliance4All’s experts help you unravel all the knowledge you need…

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Added by Compliance4all on May 22, 2017 at 7:53am — No Comments

Understanding CARC and RARC

A Claim Adjustment Reason Code (CARC) is a code used in medical billing to communicate a change or an adjustment in payment. CARCs have to be used to communicate why there was a difference between the amount paid in a claim or service line and the amount that was billed against it. CARCS are to be mentioned only if there is an adjustment of this kind. If there is no adjustment to a claim or…

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Added by Roger Steven on May 19, 2017 at 8:42am — No Comments

Meeting labeling requirements of various drug products

Both the FDA and the European Medicines Agency (EMA) have regulations that cover the labeling requirements of both prescription and over-the-counter (OTC) drugs, cosmetics, generics, medical devices, nutraceuticals and other related products. These regulations have to be strictly complied with. 21 CFR under its various parts, the Federal Food, Drug, and…

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Added by Compliance4all on May 19, 2017 at 6:17am — No Comments

“Understanding the practical application of statistics?”

The application of statistical methods is specified all through 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries for these activities:

o  Setting validation criteria and specifications

o  Performing…

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Added by John Robinson on May 19, 2017 at 5:52am — No Comments

The Stark Law and key considerations for physician employment agreements

One of the major fallouts of the passage of the Affordable Care Act (ACA) or Obamacare is the phenomenal rise in the number of physician practice acquisitions. These are some of the reasons for this rise:

-        Because of physician practice acquisitions, healthcare providers can consolidate and integrate their business better, since acquisition brings about alignment between the business prospects of the referral networks with the hospital’s strategic goals

 

-       …

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Added by Roger Steven on May 17, 2017 at 7:18am — No Comments

Regulations governing how combination products are regulated

The knowledge of combination products and their regulations is essential for regulatory professionals. This is because of the high proportion of combination products in the market, as well as the array of regulations that govern them.

21 CFR 3.2 (e) has a complete definition of a combination product. A combination product is one…

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Added by Compliance4all on May 17, 2017 at 6:40am — No Comments

Knowledge of employment laws is absolutely crucial for organizations

As the new presidential administration settles in in the US, employment law…

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Added by John Robinson on May 17, 2017 at 5:57am — No Comments

EPA’s new Revised Section 608 Refrigerant Management Regulations

In late 2016, the US Environmental Protection Agency (EPA) revised Section 608, which deals with refrigerant management regulations. A number of requirements under this section are set to change. They concern the handling requirements that are applicable to ozone depleting refrigerants, and fortify the existing regulations by…

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Added by Compliance4all on May 16, 2017 at 6:33am — No Comments

Marketing and promotion of drugs and medical devices

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Added by John Robinson on May 16, 2017 at 6:22am — No Comments

MACRA and HIPAA

The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) is a federal Act that determines the way in which physicians need to be paid when they treat patients who come to them under Medicare. It substantially alters and replaces the earlier Act in this regard, namely the Balanced Budget…

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Added by Roger Steven on May 15, 2017 at 8:00am — No Comments

Use OneNote to manage your meetings

Microsoft OneNote is a program that works as a digital notebook. It saves users the trouble of having to scramble for a piece of paper whenever they feel like scribbling some information or idea down. Moreover, it saves the user the trouble of having to preserve a piece of paper on which the info is jotted down.

Microsoft OneNote helps users to type, write or draw on the digital notebook while continuing to have the same feel as a regular paper and pen. It is…

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Added by Compliance4all on May 15, 2017 at 6:08am — No Comments

Key issues in HR auditing

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Added by John Robinson on May 15, 2017 at 5:30am — No Comments

Transiting from paper records to electronic for pharmaceutical companies while being compliant

Following the rapid advances being made in the field of information management in the past quarter of a century or so, computers have increasingly come to replace paper as the source in which important documents are created and stored. Till the last decade of the previous century, organizations used paper to record and document information relating to their research, development and business. From around the start of the 1990’s; the shift towards computerization of paper…

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Added by Compliance4all on May 12, 2017 at 6:06am — No Comments

HIPAA’s compliance expectations from Business Associate

The Health Information Portability and Accountability Act (HIPAA) regards the Business Associate as a major player. HIPAA defines the Business Associate (BA) as either an organization or a person who works with or provides service to a Covered Entity, who in turn is defined as one who handles or discloses Protected Health Information (PHI).

So, a Business Associate is any person or entity that is involved in creating, receiving, maintaining or transmitting PHI to a Covered Entity for…

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Added by John Robinson on May 11, 2017 at 8:23am — No Comments

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