A few items relevant to your interests have crossed the editor’s desk over the past few days.
1. As we mentioned several months ago, laboratories need to provide lab results to patients (or their representative) when requested to do so. The Privacy Rule amendments went into effect on October 6, 2014. Is your lab compliant? Read the regulations to be sure.
2. The Draft Guidance for the FDA regulation of LDTs has been published. You can read them here and here. The FDA will accept comments about the draft for the next 110 days.
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