Standard

The objective is to analyse the security issues that can occur at the GNSS SIS level. In order to do so, a full taxonomy of the GNSS SIS attacks are proposed and GNSS SIS attack security model are elaborated and classified. Security metrics for the validation of the GBPT robustness performances are defined. The proposed methodology for this technical report consists in three distinct steps that are described hereunder: I. The first step consists in providing a full taxonomy of the possible GNSS Signal in Space attacks (voluntary or not) to be considered and identify their impact at GBPT level; II. The second step consists in regrouping narrow sets of previouslyidentified GNSS SIS attacks into security attack models. For each security attack model, an assessment of the dangerousness based on beforehand identified key parameters and methodology will be provided; III. The third step consists in providing definition of performance objectives, security control, security metrics, and a specific procedure for a robustness evaluation of a GBPT against the identified security attack models at step II. The results will benefit to the EN16803-3 "Assessment of security performances of GNSS based positioning terminals"

The Common Workflow Language (CWL) is an open standard for describing analysis workflows and tools in a way that makes them portable and scalable across a variety of software and hardware environments, from workstations to cluster, cloud, and high-performance computing (HPC) environments. CWL is designed to meet the needs of data-intensive science, such as Bioinformatics, Medical Imaging, Astronomy, High Energy Physics, and Machine Learning.

CWL is developed by a multi-vendor working group consisting of organizations and individuals aiming to enable scientists to share data analysis workflows. The CWL project is maintained on Github and we follow the Open-Stand.org principles for collaborative open standards development. Legally CWL is a member project of Software Freedom Conservancy and is formally managed by the elected CWL leadership team, however, every day project decisions are made by the CWL community which is open for participation by anyone.

This guide helps describe the laboratory informatics landscape and covers issues commonly encountered at all stages in the life cycle of laboratory informatics from inception to retirement. It explains the evolution of laboratory informatics tools used in today’s laboratories such as laboratory information management systems (LIMS), laboratory execution systems (LES), laboratory information systems (LIS), electronic laboratory notebooks (ELN), scientific data management systems (SDMS), and chromatography data systems (CDS). It also covers the relationship (interactions) between these tools and the external systems in a given organization. The guide discusses supporting laboratory informatics tools and a wide variety of the issues commonly encountered at different stages in the life cycle. The subsections that follow describe the scope of this document in specific areas.

This guide provides guidance for connected consumer products, as defined in 1.1.1, as it relates to physical product safety hazards created by virtue of their connectivity. It applies to connected products that need testing and evaluation to prevent cybersecurity vulnerabilities and weaknesses that could compromise the safety-related performance of the product, create a physical safety hazard in the product or its operation, or result in a noncompliance to the underlying end product safety standard.

The HL7 Version 3 Implantable Device Cardiac (IDC) Follow-up Summary is a message model for describing an observation of an interrogator at a physical location who is performing an interrogation of a therapeutic medical device (bound to a patient) using identifiable interrogation equipment.

The Unique Device Identifier (UDI) Pattern provides the guidelines for exchanging UDI information associated with medical devices, initially implantable devices in patients.  This document will not give implementation guidance for specific use cases and worfklows, but will set the overarching guidelines for all working groups that need to exchange the unique device identification on the fields and format intended for expressing UDI related data using V2, V3, and FHIR.  The goal of the UDI Pattern is to enable semantic interoperability for recording UDI information on medical devices used on or implanted in patients regardless of the information exchange standard used to move the information across (e.g., HL7 Version 2.x, HL7 v3 messages or CDA, HL7 FHIR).

Incremental update to the EHR System Functional Model (EHR-S FM), encompassing all the EHR functions and conformance criteria found in its predecessor Release 2, and incorporating:

1. Changes to the Record Infrastructure Section to accommodate three additional record lifecycle events (verify, encrypt, decrypt) and ensure compatibility with FHIR Core R4 Record Lifecycle Event Implementation Guide (2019) and recent updates to ISO 21089:2018, Trusted End-to-End Information Flows;
2. Changes to the Glossary Section to support the full set of record lifecycle events (now 27 in total) and corresponding descriptions;
3. Previously identified updates included in the EHR-S FM R2.01 errata version;
4. Changes to the Conformance Chapter to align with characteristics and requirements of recent EHR-S FM R2 based Functional Profiles, including FPs developed for the US Meaningful Use (EHR Incentive) Program, 2011/2014 and 2015 Editions;
5. Domain analysis (models and artifacts) companion to EHR system development and implementation.
6. Adding a header in the TI section on clinical model services (DCMs, CIMI models, FHIR, HL7 template) comparable to TI.4 Standard Terminology and Terminology Services.

Incremental update to the EHR System Functional Model (EHR-S FM), encompassing all the EHR functions and conformance criteria found in its predecessor Release 2, and incorporating:

1. Changes to the Record Infrastructure Section to accommodate three additional record lifecycle events (verify, encrypt, decrypt) and ensure compatibility with FHIR Core R4 Record Lifecycle Event Implementation Guide (2019) and recent updates to ISO 21089:2018, Trusted End-to-End Information Flows;
2. Changes to the Glossary Section to support the full set of record lifecycle events (now 27 in total) and corresponding descriptions;
3. Previously identified updates included in the EHR-S FM R2.01 errata version;
4. Changes to the Conformance Chapter to align with characteristics and requirements of recent EHR-S FM R2 based Functional Profiles, including FPs developed for the US Meaningful Use (EHR Incentive) Program, 2011/2014 and 2015 Editions;
5. Domain analysis (models and artifacts) companion to EHR system development and implementation.
6. Adding a header in the TI section on clinical model services (DCMs, CIMI models, FHIR, HL7 template) comparable to TI.4 Standard Terminology and Terminology Services

The scope of the standard is to define the message for exchanging information electronically between Regulators and Industry, and between sets of regulators. The message provides the ability to describe the contents of the regulatory exchange and all information needed to process the exchange between parties. This message is designed to be flexible enough to be used to support regulatory exchanges for any regulated product.

The Privacy and Security Architecture Framework (PSAF) is the overarching package that contains four balloted specifications and an informative guide.  The specific normative components include: 1) Trust Framework for Federated Authorization Conceptual Model, 2) Trust Framework for Federated Authorization Behavioral Model, 3) Provenance Domain Analysis Model and 4) Audit.  The intent of these standards is to provide an integrated package of a set of standards to advance communication and interoperability among partners in a shared trust framework environment.

Many seemingly healthy babies with Critical Congenital Heart Disease (CCHD) may suffer negative health outcomes if the birth defect is not identified shortly after birth. International efforts have precipitated both program and legislative initiatives to promote and/or mandate universal newborn screening for Critical Congenital Heart Disease using pulse oximetry devices. When pulse oximetry devices are able to exchange data with information systems, the use of standards helps with the seamless exchange of data and improve patient safety. This implementation guide focuses on the transmission of CCHD screening data from the device to the public health program, other potential recipients including providers and electronic health records.