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FDA Compliance

Streamlining Compliance

Published: Tuesday, March 25, 2008 - 22:00

(Modulo: New York) -- In an effort to streamline its risk assessment and compliance processes, New York University Medical Center has selected the Modulo Risk Manager, an automated information tool.

As one of the nation’s largest research and academic medical centers, NYUMC is subject to significant oversight and transparency requirements. Participation in federal research grants, accreditation requirements, and varying regulations such as Federal Information Security Management Act of 2002, control objectives for information and related technology, Food and Drug Administration, and Health Insurance Portability and Accountability Act, necessitate the careful maintenance of records and the performance of numerous audits.

"The scope of our activities, medical education, health care, and scientific research, and the fact that we are an organization of more than 20,000 people spread over 40 buildings, made dealing with these complex regulatory standards a major endeavor requiring months of staff time and a large information technology infrastructure," says Hai Ngo, the medical center’s chief information security officer.

Prior to the implementation of Modulo Risk Manager, Ngo and his internal staff executed risk assessment projects and compliance audits through highly labor-intensive processes, particularly problematic given its complex information technology infrastructure. The process required that Ngo and his team maintain a comprehensive and up-to-date list of regulatory requirements and best practices guidelines. The group also gathered information from each department and manually measured it against their requirements.

"We were looking for a solution that would offer an open framework so that we wouldn’t have to perform separate assessments," says Ngo.

Automating the information risk management and regulatory compliance processes at NYUMC has been a success, concludes Hai Ngo, who hopes to expand the software roll-out and its automated model to several other areas

For further information, visit www.modulo.com/press-release/press-release.jsp?p=20080212


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