To be or not to be… compliant

There are a number of challenges when designing and building solutions for the collection and delivery of image submissions for clinical trials. One of them is compliance with global regulations governing the process. While regulations set forth by agencies such as the FDA, HIPAA, and their equivalents in Europe and Asia can be complicated, and […]

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Patient privacy regulations and Part 11: How do they relate?

In the world of clinical trials, we are constantly reminded of national privacy regulations and 21 CFR Part 11 restrictions when using electronic means to submit medical imaging data. National regulations (NRs) include the European Union Directive on Data Privacy, The Canadian Personal Information Protection and Electronic Documents Act (PIPEDA), HIPAA, OECD and their equivalents […]

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The balance between privacy and drug discovery

In 2011, Forbes published a somewhat startling article about HIPAA violations in the U.S. The gist  of the piece is that violations are occurring more than one might think, that data that people consider to be non-confidential details are in fact protected by law, and that organizations are being successfully sued for millions of dollars […]

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Compliance is expensive. Now, go get validated!

I was recently catching up on some of my reading, when I bumped into an article about the FDA cracking down on medical diagnosis apps. Bloomberg talks about an iPhone application that lets users check for blood, protein and other substances in their urine. As the article states, “The app relies on users, such as diabetics […]

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