CMS recently released the long-awaited rules for accountable care organizations. Now hospital leaders face the daunting task of sifting through over 400 pages of regulations to understand how to ...

Clinical trials can often take between six and seven years to complete, but that timeline isn’t always practical for the problems pharmaceutical companies are trying to solve. Additionally, six years ...

The interrelated final standards on quality management issued in June 2022 by the AICPA’s Auditing Standards Board and Accounting and Review Services Committee are intended to clarify and improve ...

Editor’s note: This article is the second in a series to help practitioners learn about the AICPA’s new quality management standards and prepare to implement them. The interrelated final standards on ...

Modern software teams are expected to ship faster every quarter. At the same time, the systems they ship become more complex, ...

All medical devices have risk. “You, as the manufacturer, are responsible for determining the risk of your medical device and if that risk is acceptable,” said Joseph Tartal, FDA deputy director in ...

In most organizations, artificial intelligence models are “black boxes,” where only data scientists understand what exactly AI does. That can create significant risk for organizations. Large, ...