FDA Compliance Challenges
By Eric Hollister | Apr 5, 2011

IT teams supporting clinical environments at healthcare providers experience significant challenges in managing patient care systems (clinical systems), including balancing FDA compliance, patient privacy, and security. Security best practices, HIPAA and HITECH create challenges for clinical IT teams who have been trained by vendors to not touch systems (per 501K compliance) as vendors place most risk on healthcare provider when it comes to compliant security patching. In this segment, leading practices from healthcare clients are discussed for handling challenges associated with maintaining secure clinical systems without compromising FDA compliance.

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