Sponsor: EMB Standards Committee, Engineering in Medicine and Biology Society
Sponsor Chair: Carole C. Carey [email protected]
Title: Standard for Bioinformatics Computations and Analyses Generated by High-Throughput Sequencing (HTS) to Facilitate Communication
- Scope: This standard establishes accurate and secure communication of bioinformatics protocols in order to facilitate bioinformatic data analysis workflow related exchange and communication between regulatory agencies, pharmaceutical companies, bioinformatics platform providers and researchers. Accurate communication helps ensure responsibility, verify bioinformatics protocol, track provenance information and promote interoperability. In addition, this standard also defines the assurance program for evaluating and certifying products against those requirements.
- Purpose: The standard allows for the cross platform communications of complex bioinformatic data analysis from inception to manufacturing of medical products, resulting in decreased costs of drug discovery and accelerated delivery of treatment to patients.
- Need for the Project: Computational biology algorithms are affected by a multiplicity of parameters much like a tangible physical, chemical, or biological experiment. This phenomenon is well documented, and is a result of the multitude of environmental and procedural factors. What is often systematically overlooked is that in silico experiments are no less volatile. The complexities of computational protocols and outcomes are only part of the challenge; there are also virtually no standardized and industry-accepted metadata schemas for reporting the computational pipelines and parameters together with their results. Thus, it is often impossible to reproduce the results of a previously performed computation due to missing information on parameters, versions, arguments, conditions, and procedures of application launch.
- Stakeholders for the Standard: Government bodies and Regulatory Agencies; Medical product manufacturers and their suppliers; Laboratories developing clinical testing protocols; Bioinformatics tool and platform developers who wish to operate in a regulatory environment, including cloud service (PaaS, IaaS, SaaS, FaaS) providers; Peer Reviewers for journals / scientific journal publishers; Public cloud companies operating in the Life Sciences sector including electronic health record (EHR) systems.
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