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How the cloud fast-tracks FDA Class 1 security and privacy for health care applications

January 18, 2016
From the December 2015 issue of HealthCare Business News magazine

The security and privacy mandate
There are a number of reasons — all good ones — why software companies would willingly jump through the necessary hoops to obtain FDA classification. Large integrated health networks increasingly need FDA classification for the applications they use to make medical decisions. It makes life a lot easier for them, especially from a legal standpoint, if these apps are cleared for FDA approval. Health care is also entering an unprecedentedly collaborative era, with a proliferation of joint projects concerned with testing new innovations and technologies.

The market for a promising new product could be bigger with FDA classification. It should be emphasized, however, that vendors need to secure their applications regardless of whether or not they obtain FDA classification. Adherence to security and privacy will only grow in importance as hackers increase their targets to include medical devices and medical device software. But instead of taking this on themselves — a daunting feat — vendors can turn to a cloud partner who has made this a core competency.

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Chris Bowen is founder and chief privacy and security officer at ClearDATA. He is a certified information privacy professional, certified information systems security professional and certified information privacy technologist. ClearDATA provides HITRUST CSF-certified HIPAA-compliant cloud computing used by more than 300,000 health care providers to store, manage, protect and share their patient health information and critical applications.

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