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Regulatory Compliance

[Guide] Machine Learning For AML & KYC Programs

In our guide titled “6 Ways to Mitigate Risk in Cross-Selling for Financial Services,” we briefly touched on the use of artificial intelligence and intelligent machines, along with comprehensive processes, to fight fraud. In combination with ‘know your customer’ (KYC) processes to help catch suspicious banking activity and reduce risk through the analysis of data […]

Leveraging Machine Learning For AML & KYC

In the recent “Shaping Digital Finance” session at the 20th Milken Institute Global Conference, Corrie Elston, chief technology officer, financial services, Google Cloud Platform, said that a financial services institution may experience 80% accuracy in detecting fraud and 99.5% false positives. As mentioned earlier, only about half of money laundering or terrorist financing incidents were […]

Examining The Issues With Today’s AML & KYC Strategies

While anti-money laundering (AML) programs may present the biggest opportunity for machine learning to thrive, there are many issues when it comes to fighting money laundering. The number and high caliber of resources required to battle fraud in today’s highly regulated environment are immense, and the cost – of both personnel and technology required to […]

Defining Anti-Money laundering (AML) & Know Your Customer (KYC)

According to the U.S. Department of the Treasury’s Financial Crimes Enforcement Network (FinCEN), “Money laundering is the process of making illegally gained proceeds (i.e., ‘dirty money’) appear legal (i.e., ‘clean’). Typically, it involves three steps: placement, layering and integration. First, the illegitimate funds are furtively introduced into the legitimate financial system. Then, the money is […]

What The FDA Requires Of Drugs On The Market

This is the final post in a brief series of posts (five in total) designed to demystify the high cost of prescription drugs in the U.S. Today’s post focuses on the fourth and final stage the of the FDA drug approval process: post-marketing. Before we dive into the final stage, here’s a quick recap of […]

Four Steps To Assess And Mitigate Risk With Regulated IT Systems

Over the past several weeks, I’ve published a series of posts that talk about how to assess and mitigate risk with your regulated IT systems. The FDA recommends using a risk-based approach to accomplish this feat, and we agree, so we laid out a four-part approach for you: Assess a system for its regulated status […]

How To Manage Your Aggregate Spend And Sunshine Act Reporting

Imagine with me: In support of your required Physician Payments Sunshine Act reporting, you integrate all of your physician payment source systems to a single platform. Some of those systems are fully integrated, while other systems – mostly legacy, built on older technology – are integrated using robotic process automation (RPA). Over the course of […]

What Happens During NDA Review In The FDA Drug Approval Process

This post is the fourth in a brief series about the FDA drug approval process. The series is designed to answer the question about why U.S. prescription drugs are so expensive by illuminating the FDA drug approval process, stage by stage. In my last post in this series, I focused on the clinical stage, and […]

How To Mitigate Risk When Changing A Regulated System

A few weeks back, I described how to determine the risk level of a proposed change to a regulated IT system. I also talked about how the system risk level (SRL) and change risk level (CRL) work together to determine the level of rigor required to implement a proposed change without disrupting its validated state. […]

Role Of Clinical Trials In The FDA Drug Approval Process

Last time, I published the second in a brief series of blog posts designed to provide insight into why prescription drugs in the U.S. cost as much as they do. The series is focused on explaining the FDA drug approval process in layman’s terms. My previous post focused on the first stage in the process, […]

[Guide] 6 Ways To Mitigate Risk In Cross-Selling For Financial Services

Disciplinary actions. Government fines. Victim restitution. There is no shortage of regulatory compliance issues hitting the headlines these days. In recent years, however, it is news of aggressive sales tactics that has had the general public and several regulatory bodies that oversee financial institutions very concerned. Most financial institutions have critical cross-selling initiatives that encourage […]

Leveraging Regular Risk Control Self-Assessment (RCSA) Programs

A regular risk control self-assessment, commonly referred to as RCSA, is a process of identifying and assessing operational risks to ensure the appropriate controls and oversight are in place so that business objectives can be met. It provides the ability to monitor the gaps and what is being done to close them. RCSAs can lead […]

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