Overview of the ISCE ECG "genome project".

The International Society for Computerized Electrocardiography (ISCE) "genome" project was begun at the end of 2000 to explore mechanisms for development of a cross-platform electrocardiogram (ECG) database. Ultimate feasibility of this project is based on established interactive cooperation of clinical investigators, engineers, and industry within the ISCE framework. The US Food and Drug Administration (FDA) mandate for centralized access to digitized ECG waveforms used in clinical trials provides a complementary stimulus to technologies that facilitate ECG database development. The constituency of ISCE is interested in acquisition and analysis of data from both standard 12-lead (resting) ECG and ambulatory (monitoring) ECG. Support for project goals from industry, at the Trustee as well as at the engineering level, has led to initial focus on the resting ECG. A one-year pilot project has been proposed to establish and implement software methodology for transmission, storage, and integrated reanalysis of digitized ECG waveforms provided by several major manufacturers. Beyond data acquisition, storage, and analysis, a number of critical issues are associated with database development. These include definition of clinically relevant "gold" standards, acquisition and validation of non-ECG data, protection of patient privacy, control and ownership of data, and accessibility and use of the database. However, implementation of the pilot project is a necessary first step, since all issues become moot without technical cooperation for shared formatting and analysis.