Develop shared understandings of the risks-and benefits-of healthcare technology

摘要

Risk management practitioners in industry exert considerable time and effort parsing inconsistent language found in standards, regulatory guidance documents, and other publications, in an effort to understand the expectations for identifying, analyzing, and mitigating risks, summit participants said. Likewise, language trips them up in determining how good is good enough: How far should they take their risk analysis? What's the appropriate degree of acceptability? Differences in terminology and definitions also show up in pre- and postmarket expectations and in U.S. and international expectations.