Electrocardiography is the process of producing an electrocardiogram. It is a graph of voltage versus time of the electrical activity of the heart using electrodes placed on the skin. These electrodes detect the small electrical changes that are a consequence of cardiac muscle depolarization followed by repolarization during each cardiac cycle (heartbeat). Changes in the normal ECG pattern occur in numerous cardiac abnormalities, including cardiac rhythm disturbances, inadequate coronary artery blood flow, and electrolyte disturbances.
The QT interval is a measurement made on an electrocardiogram used to assess some of the electrical properties of the heart. It is calculated as the time from the start of the Q wave to the end of the T wave, and approximates to the time taken from when the cardiac ventricles start to contract to when they finish relaxing. An abnormally long or abnormally short QT interval is associated with an increased risk of developing abnormal heart rhythms and sudden cardiac death. Abnormalities in the QT interval can be caused by genetic conditions such as long QT syndrome, by certain medications such as sotalol or pitolisant, by disturbances in the concentrations of certain salts within the blood such as hypokalaemia, or by hormonal imbalances such as hypothyroidism.
SCP-ECG, which stands for Standard communications protocol for computer assisted electrocardiography, is a standard for ECG traces, annotations, and metadata, that specifies the interchange format and a messaging procedure for ECG cart-to-host communication and for retrieval of SCP-ECG records from the host to the ECG cart. It is defined in the joint ANSI/AAMI standard EC71:2001 and in the CEN standard EN 1064:2005.
Logical Observation Identifiers Names and Codes (LOINC) is a database and universal standard for identifying medical laboratory observations. First developed in 1994, it was created and is maintained by the Regenstrief Institute, a US nonprofit medical research organization. LOINC was created in response to the demand for an electronic database for clinical care and management and is publicly available at no cost.
A Wiggers diagram, named after its developer, Carl Wiggers, is a standard diagram that is used in teaching cardiac physiology. In the Wiggers diagram, the X-axis is used to plot time, while the Y-axis contains all of the following on a single grid:
Structured Product Labeling (SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format. The "drug labeling" includes all published material accompanying a drug, such as the Prescribing Information which contains a great deal of detailed information about the drug. As of Release 4 of the SPL standard, 22,000 FDA informational product inserts have been encoded according to the standard.
The ISO/TC 215 is the International Organization for Standardization's (ISO) Technical Committee (TC) on health informatics. TC 215 works on the standardization of Health Information and Communications Technology (ICT), to allow for compatibility and interoperability between independent systems.
CEN ISO/IEEE 11073 Health informatics - Medical / health device communication standards enable communication between medical, health care and wellness devices and external computer systems. They provide automatic and detailed electronic data capture of client-related and vital signs information, and of device operational data.
DailyMed is a website operated by the U.S. National Library of Medicine (NLM) to publish up-to-date and accurate drug labels to health care providers and the general public. The contents of DailyMed is provided and updated daily by the U.S. Food and Drug Administration (FDA). The FDA in turn collects this information from the pharmaceutical industry.
Vectorcardiography (VCG) is a method of recording the magnitude and direction of the electrical forces that are generated by the heart by means of a continuous series of vectors that form curving lines around a central point.
Fabio Badilini is an Italian scientist and business man. He has made major contributions to noninvasive electrocardiography not only through his individual contributions, but also through his truly remarkable ability to foster collaborations across scientific disciplines, academic institutions, governmental agencies, device manufacturers and industries around the world.
Regulated Product Submission (RPS) is a Health Level Seven (HL7) standard designed to facilitate the processing and review of regulated product information. RPS is being developed in response to performance goals that the U.S. Food and Drug Administration (FDA) is to achieve by 2012, as outlined in the Prescription Drug User Fee Act (PDUFA). In addition to the U.S., regulatory agencies from Europe, Canada, and Japan are at varying levels of interest and participation. Currently, the second release of RPS is in development.
In order to comply with government regulatory requirements pertinent to clinical trials, every organization involved in clinical trials must maintain and store certain documents, images and content related to the clinical trial. Depending on the regulatory jurisdiction, this information may be stored in the trial master file or TMF, which today takes the form of an electronic trial master file (eTMF). The International Conference on Harmonization (ICH) published a consolidated guidance for industry on Good Clinical Practice in 1996 with the objective of providing a unified standard for the European Union, Japan, and the United States of America to facilitate mutual acceptance of clinical data by the regulatory authorities in those jurisdictions. This guidance document established the requirement across all ICH regions to establish trial master files containing essential documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced.[2] In some jurisdictions, for example the USA, there is no specific requirement for a trial master file. However, if the regulatory authority requires ICH GCP to be followed, then there is consequently a requirement to create and maintain a trial master file.[2]
International HL7 implementations is a collection of known implementations of the HL7 Interoperability standard. These do not necessarily refer to cross-border health information systems.
An electronic trial master file (eTMF) is a trial master file in electronic format. It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies. The term eTMF encompasses strategies, methods and tools used throughout the lifecycle of the clinical trial regulated content. An eTMF system consists of software and hardware that facilitates the management of regulated clinical trial content. Regulatory agencies have outlined the required components of eTMF systems that use electronic means to store the content of a clinical trial, requiring that they include: Digital content archiving, security and access control, change controls, audit trails, and system validation.
Fasegraphy is a method for processing electrocardiograms (ECG) developed by the International Scientific and Educational Center for Information Technologies and Systems of the National Academy of Sciences of Ukraine and the Ministry of Education and Science of Ukraine [1].
The BioCompute Object (BCO) Project is a community-driven initiative to build a framework for standardizing and sharing computations and analyses generated from High-throughput sequencing. The project has since been standardized as IEEE 2791-2020, and the project files are maintained in an open source repository. The July 22nd, 2020 edition of the Federal Register announced that the FDA now supports the use of BioCompute in regulatory submissions, and the inclusion of the standard in the Data Standards Catalog for the submission of HTS data in NDAs, ANDAs, BLAs, and INDs to CBER, CDER, and CFSAN.
Originally started as a collaborative contract between the George Washington University and the Food and Drug Administration, the project has grown to include over 20 universities, biotechnology companies, public-private partnerships and pharmaceutical companies including Seven Bridges and Harvard Medical School. The BCO aims to ease the exchange of HTS workflows between various organizations, such as the FDA, pharmaceutical companies, contract research organizations, bioinformatic platform providers, and academic researchers. Due to the sensitive nature of regulatory filings, few direct references to material can be published. However, the project is currently funded to train FDA Reviewers and administrators to read and interpret BCOs, and currently has 4 publications either submitted or nearly submitted.
QT interval variability (QTV) refers to the physiological phenomenon of beat-to-beat fluctuations in QT interval of electrocardiograms. Increased QTV appears to be a marker of arrhythmic and cardiovascular death; it may also play a role for noninvasive assessment of sympathetic nervous system activity.
AliveCor is a medical device and artificial intelligence company that sells ECG hardware and software for consumer mobile devices. The company is the first to receive FDA-clearance for a medical-device accessory to the Apple Watch.
