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Increased Patient Registry Use Has Industry Looking For Direction

This article was originally published in The Gray Sheet

Executive Summary

With registries set to become a more prevalent means of data collection - particularly under CMS' new coverage-with-evidence-development (CED) policy - industry is seeking guidance on how such studies can comply with patient privacy laws

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The Agency for Healthcare Research & Quality releases "Registries for Evaluating Patient Outcomes: A User's Guide" May 16, supported with funding from CMS. The 219-page 1guide, which in large part mirrors a draft version released in October, compiles 23 registry case studies and 343 references, and involved 39 contributors from government, industry and academia (2"The Gray Sheet" Oct. 23, 2006, p. 9). The guide includes chapters on registry design, ethical issues and data ownership, adverse event detection and assessing registry quality...

AHRQ registry handbook

The Agency for Healthcare Research & Quality releases "Registries for Evaluating Patient Outcomes: A User's Guide" May 16, supported with funding from CMS. The 219-page 1guide, which in large part mirrors a draft version released in October, compiles 23 registry case studies and 343 references, and involved 39 contributors from government, industry and academia (2"The Gray Sheet" Oct. 23, 2006, p. 9). The guide includes chapters on registry design, ethical issues and data ownership, adverse event detection and assessing registry quality...

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CMS introduces two distinct categories of coverage-with-evidence-development determinations in long-awaited 1guidelines issued July 12

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