July 2017 Blog Posts (30)

In September 2014, the FDA deployed a new risk-based screening tool for imports called the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT). The main aim of PREDICT was bringing about improvement in screening and targeting of adulterated or misbranded goods or those that flout any of the FDA’s rules. The FDA seeks to bring this about by doing away with its legacy electronic system, OASIS’ admissibility screening function.

PREDICT is an important tool…

Since the Affordable Care Act (ACA) –popularly called Obamacare –came into existence, there has been an exponential increase in the number of physician practice acquisitions. Some of the reasons that can be ascribed for this phenomenon are these:

-        Physician practice acquisitions are an opportunity for healthcare providers in consolidating and…

Carrying out audits is among the most important requirements for any organization that handles Protected Health Information (PHI). HIPAA hosting providers, who implement safeguards in the manner specified in the HIPAA Privacy Rule, must be included in these audits. The indispensability of audits…

Aseptic technique is one of the methods used in eliminating or at least minimizing contamination in pathogens. It is also used to make compounding sterile products. Sterilized equipment, sterile apparel, high degree of processing, and cleaning on a continuous basis make up the important procedures used in aseptic technique.

The main aim of aseptic technique in cleanrooms is to ensure that the sterile product is sterile, safe and effective. Ensuring this is all the more important for…

The North American Free Trade Agreement (NAFTA) came into being on the first day of 1994. While the US and Canada had been having free trade agreements that go back at least three decades culminating in the US-Canada Free Trade Agreement of January 1, 1989; NAFTA became a reality following Canada’s entry in 1991 into the bilateral talks between the US and Mexico, creating the trilateral FTA.

One of the primary objectives of the NAFTA was the elimination of a number of duties and…

Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971.

You’ll learn techniques that can help you identify hazards and potential harms. You’ll learn how to mitigate risk and effectively monitor risk to ensure your customers receive safe and effective products. A rigorous…

Stark Law compliance is now more than just a compliance issue. It has grown to become an Enterprise Risk Management matter, if the substantial awards and settlements in recent enforcement actions are anything to go by. For healthcare organizations that develop and implement provider contracts; managing their compliance and enterprise risk by ensuring that…

The credit card surcharge issue has always been a tricky one in the US. Back in 2005, this issue was the subject of an antitrust lawsuit, and the resultant judgment, which came in mid-2012 prohibited credit card surcharge in ten States. Another 12 States are in the process of implementing their laws.

Although credit card regulations have traditionally opposed surcharging; companies have been circumventing merchant rules to ensure that credit card surcharge continues to be made. Even…

Good Laboratory Practices (GLP’s) are a series of federal regulations passed in the US by the FDA under 21 CFR Part 58. In addition, Environmental Protection Agency (EPA) also has formed GLP’s both for Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in 40 CFR Part 160 and for Toxic Substances Control Act (TSCA) in 40 CFR Part 792.

GLP’s are Quality…

The fact of about 120 million individuals being affected by HIPAA breaches in 2015 highlights two important points:

1. There is a mad demand for these records in the black market, which is why they are being targeted to this extent. Any wonder that PHI is in greater demand in the black market than even social security and credit…

The 60601-1 is a standard that relates to the safety of medical electrical equipment. This harmonized standard is recognized by most countries around the world. Existing and new medical devices have to comply with the requirements set out in IEC 60601-1.

The IEC 60601-1 is going through its latest revision, its 3^rd edition,…