This paper describes the history, current status, and objectives and potential impact of the new National Institute of Biomedical Imaging and Bioengineering (NIBIB). Three of the authors (Hendee, Chien, and Maynard) have been involved over several years in the effort to raise the identity of biomedical imaging and bioengineering at the National Institutes of Health. The fourth author (Dean) is the Acting Director of the newly formed NIBIB. These individuals have an extensive collective knowledge of the events that led to formation of the NIBIB, and are intimately involved in shaping its objectives and implementation strategy. This special report provides a historical record of activities leading to establishment of the NIBIB, and an accounting of present and potential advances in biomedical engineering and imaging that will be facilitated and enhanced by NIBIB. The National Institute of Biomedical Imaging and Bioengineering represents a "coming of age" of biomedical engineering and imaging, and offers great potential to expand the research frontiers of these disciplines to unparalleled heights.

In December 2000, President Clinton signed legislation establishing the National Institute of Biomedical Imaging and Bioengineering (NIBIB). This action was the result of a multidecade effort of the biomedical imaging and engineering communities to gain increased recognition for biomedical imaging and engineering research within the National Institutes of Health and to enhance the impact of these disciplines on the health and well-being of people worldwide. Beginning in January 2001, several activities were initiated to form NIBIB into a real asset for researchers in biomedical imaging and engineering. These activities reflect a recognition that research in biomedical imaging and bioengineering has the potential of positively influencing research in many other biomedical disciplines, as well as directly affecting the welfare of people everywhere. This potential impact is discussed in this report, together with the history and present status of the formation of NIBIB.

Biomedical informatics, imaging, and engineering are major forces driving the knowledge revolutions that are shaping the agendas for biomedical research and clinical medicine in the 21st century. These disciplines produce the tools and techniques to advance biomedical research, and continually feed new technologies and procedures into clinical medicine. To sustain this force, an increased investment is needed in the physics, biomedical science, engineering, mathematics, information science, and computer science undergirding biomedical informatics, engineering, and imaging. This investment should be made primarily through the National Institutes of Health (NIH). However, the NIH is not structured to support such disciplines as biomedical informatics, engineering, and imaging that cross boundaries between disease- and organ-oriented institutes. The solution to this dilemma is the creation of a new institute or center at the NIH devoted to biomedical imaging, engineering, and informatics. Bills are being introduced into the 106th Congress to authorize such an entity. The pathway is long and arduous, from the introduction of bills in the House and Senate to the realization of new opportunities for biomedical informatics, engineering, and imaging at the NIH. There are many opportunities for medical informaticians to contribute to this realization.

The Final Standards for Privacy of Individually Identifiable Health Information (privacy rule) of the Health Insurance Portability and Accountability Act (HIPAA) of 1996 holds particular importance for academic and research organizations because they use patient information in the provision of experimental healthcare services. In developing a strategy to comply with the final privacy rule, these organizations require an understanding of certain standards that hold significance for them. Specifically, organizations should establish patient privacy guidelines for non-employee researchers the organization should consider partners in business with whom the organization should share its researcher guidelines. These organizations also should understand the difference between consent and authorization, how requirements of the final privacy rule build upon those of the Federal Policy for the Protection of Human Subjects, and the differing roles of privacy boards and institutional review boards.

The GCP Directive 2001/20/EG has been implemented in Germany by the 12th Law Amending the Drug Law of 6 August 2004, thereby introducing new regulations for the performance of clinical trials. The amount of the required documentation has increased, but the assessment and the approval of clinical trials as well as scientific advice procedures (national or by the EMEA) allow the early discussion of many details of the development and the non-clinical and clinical testing of the medicinal product with the experts of the Paul Ehrlich Institute (PEI). This might shorten the times required for later marketing authorisation procedures. To facilitate these new tasks, the PEI has created a new central section "Approval of Clinical Trials", which is responsible for the assessment of the clinical trial applications and will coordinate the procedures within the institute. The main topics of clinical trial applications and the particularities of biological/biotechnological medicinal products such as allergens, blood products, vaccines, sera/mAb and products for cell and gene therapy as well as the differences from chemically defined products are discussed.