Implementing Procedural Safeguards for the Development of Bioinformatics Interoperability Standards

Abstract

In recent years, the field of bioinformatics has seen a surge of interest in the development of interoperability and compatibility standards. These range from standards for data exchange and controlled vocabularies (ontologies) to minimum experimental information and data analytics. To date, the bioinformatics field has been free of the standards litigation that has affected other technology-based industries. But with the increasing adoption of standards by bioinformatics researchers and vendors, the issues faced by other standards groups will become increasingly relevant. This article reports the results of an industry-wide study of bioinformatics standards development activities and the policies and procedures adopted by each such standards development organization. This study suggests that the majority of bioinformatics standards development organizations are ill-equipped to address or deter process abuse and patent hold-up. In many cases, these organizations either lack written policies entirely, or adopt vague, aspirational statements regarding a desire that materials produced to be “open” and publicly available. Accordingly, I recommend that bioinformatics standards-development organizations carefully review their existing policies and procedures. To the extent that they do not address key points regarding process openness and intellectual property, these policies and procedures should be revised. In order to assist organizations with this exercise, I offer a straightforward policy template that can be adapted to the specific needs and requirements of individual bioinformatics standards organizations. It is hoped that these modest prophylactic measures will enable the bioinformatics community to avoid the disruptive and costly standards-related litigation that has affected other industries.

Keywords: standards, patent, bioinformatics, biomedical, science, research, interoperability, intellectual property, standardization