Dovepress From a public health perspective, biostatisticians and epidemiologists can monitor the impact of nanomedical applications by carrying out surveillance studies of nano- enabled drugs to monitor their potential toxicity as well as effectiveness in clinical practice.46,60 In the era of personalized medicine – usually referred to as “genomic medicine,” even though nanomedicine is already transforming this character- ization – professionals and researchers must study and assess the use of nanomedical treatments for specific patients, based on individual features. Clinical trials and toxicity Nanomedicine will require new approaches to medical care and clinical trials, which are focused on testing their efficacy but weigh the potentially deleterious side effects of nanoparticles.94,108–110 As Lai110 and Adiseshaiah et al111 have suggested, the potential hazards of nanomaterials must be evaluated by conducting in vitro high-throughput assays and mechanistic studies and comparing the data obtained from the latter with available reference data. Hazard identification of nanoparticles and their effect on humans has been conducted for several ENMs using in vitro and in vivo methods.112 Complementary research on the toxicity of nanomaterials and its impact on environment research can be also carried out, focusing on understanding toxicity mechanisms of ENMs. Additional information is needed to analyze the pathways of biochemical responses to ENMs and how to obtain data from adverse outcomes. Important factors influencing nanotoxicity are size, shape, particle surface, biopersistence, surface chemis- try, chemical components, dosage, free-radical produc- tion, and release of toxic ions through dissolution in biological media.108,110 Nanoparticles can also interact with the immune system, provoking other side effects in humans.113 All these analyses will produce datasets that can inform the design and construction of computational models and simulations that will attempt to predict the toxicity of nanoparticles. Nanoinformatics must help to design and implement predictive models characterizing the interac- tions involved in nanoparticle exposure, the aggregate and cumulative hazards, and the health and environmental risks on various tissues and body organs and systems. Data must be coherently organized, shared, and integrated to allow effective data mining and to explain observed patterns of nanotoxicity. In the section entitled Examples of applications, we provide research examples of how nanoinformatics and nanotoxicity can be related. International Journal of Nanomedicine 2012:7 Nanoinformatics: a new area of research in nanomedicine For nanomedicine to become practical, toxicity information must be available to physicians and included in computerized medical records. There are public databases of toxic effects such as the Nanoparticle Information Library (http:// nanoparticlelibrary.net/index.asp) created by the National Institute for Occupational Safety and Health and administered by the Oregon Nanoscience and Microtechnologies Institute (ONAMI), and the Nanomaterial-Biological Interactions (NBI) Knowledgebase (http://nbi.oregonstate.edu/analysis. php) hosted by ONAMI. Standards For BMI, a large number of standardized nomenclatures, vocabularies, coding standards and terminologies, such as the Health Level Seven International, Logical Observation Identifiers Names and Codes, Systematized Nomenclature of Medicine, Digital Imaging and Communications in Medi- cine, and the tenth revision of the International Classification of Diseases, need to be extended to add concepts and links to nano-related information. The Unified Medical Language System, produced by the US National Library of Medicine is set to incorporate biological vocabularies and ontologies – like Gene Ontology5 – to link clinical- with molecular-level information. To this could be added nanomedical concepts and links that expand the current scope of biomedicine towards the nano level. For instance, nanomaterials require similar types of naming conventions – common and sys- tematic names, computable representations of structures or open-source Chemical Abstracts Service registry number- like codes-for linking data from many sources.108 Nanotechnological research and development requires a comprehensive development pipeline from nanoparticle synthesis to characterization, including in vitro and in vivo empirical approaches. This leads to clinical applications of all the materials and processes involved. For such a substantial requirement, nanoinformaticians must design and develop methods and build software tools to access, share, and inte- grate a large amount of disparate information. As mentioned by Baker et al,83 the integration of these data, methods, and knowledge is likely to become a central challenge for nanoin- formatics. For this, the prior experience of similar challenges in BMI may prove very helpful. An example of such building upon existing biomedical systems for nanoinformatics is the Investigation, Study, Assay (ISA)-Tab file format,114 which shares common “Investiga- tion” (the project context), “Study” (a unit of research), and “Assay” (analytical measurement) metadata categories. The extensible, hierarchical structure of this format enables submit your manuscript | www.dovepress.com Dovepress 3875