According to HHS, biovigilance is an area of growing importance, and has been defined as a comprehensive and integrated national patient safety program to collect, analyze, and report on the outcomes of collection and transfusion and/or transplantation of blood components and derivatives, tissues, cells, and organs.
Specific areas and activities in which a public-private partnership in biovigilance is likely to be involved may include:
Standards and measurements—Identifying areas where standards are lacking or need additional development; proposing definitions for standards; defining measurement approaches or best practices for collecting measurement data.
Safety and surveillance—Identifying areas where greater safety and surveillance measures are needed.
Process improvement—Proposing new processes or process enhancements to improve blood and blood component, tissue, cell, and organ safety for donors and recipients.
Research and analysis—Identifying research needs; proposing and conducting short and long-term research studies; identifying knowledge gaps that prevent effective surveillance or reporting; proposing strategies for closing these gaps. <
Responses received will inform HHS regarding stakeholders, mechanisms, and approaches on issues related to developing and managing a public-private partnership and the scope of the partnership's activities. Replies are invited from public or private entities with an interest in biovigilance, and entities with experience and capabilities managing public-private partnerships in the biological sciences and public health domains.
Comments may be submitted to [email protected] through June 30, 2011.
For further details, read the April 25 or June 10 Federal Register notices.