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Clinical IoT Data and Device Interoperability

The IEEE Standards Association (IEEE SA) pre-standards workstream for Clinical Internet of Things (IoT) data validation and interoperability with blockchain was initiated to determine if a viable standards framework could be established to enable the validation of data generated from a clinical-grade IoT device and shared through the interoperability of blockchain technology. Participants in the workstream were gathered from an IEEE SA workshop held at Johns Hopkins University in Rockville, Maryland in April 2018, and grew to include their network of healthcare and Health-IT ecosystem players, as well as participants in prior IEEE SA efforts in related areas. The workstream commenced in August 2018 and completed in February 2019. Participants in this pre-standards workstream who are the authors of this paper are listed in Appendix A. The pre-standards workstream led to the recommendation of the development of an IEEE SA Standards effort on Clinical IoT data and device interoperability with TIPPSS-Trust, Identity, Privacy, Protection, Safety and Security-in connected healthcare to improve data sharing and healthcare outcomes. The pre-standards workstream team decided that blockchain is not necessary for clinical IoT data and device interoperability and validation, nor does it necessarily meet the robust TIPPSS needs in connected healthcare. The workstream recommendation includes a draft TIPPSS Architectural Framework for Clinical IoT data validation & interoperability, which could include digital ledger technology but does not need to do so. The resulting IEEE Standards Association P2733 working group to develop a standard for Clinical IoT Data and Device Interoperability with TIPPSS kick off meeting is scheduled for July 17, 2019, sponsored by the IEEE SA Engineering in Medicine and Biology Society (EMBS).

IEEE P2733

Standard for Authentication in a Multi-server Environment

The standard describes an authentication scheme including the following features: 1) User needs single unique login credentials to logon to multi-Server setup 2) It offers a two-factor authentication scheme comprising of password as one and the soft token/hardware token as the second factor for authentication 3) The scheme does not require a password table to be maintained at the server 4) The scheme resists various known authentication related attacks

IEEE P2989

SA6 - Mission-critical applications

The responsibility of SA WG6 includes the following: definition, evolution and maintenance of Stage 2 technical specification(s) for application layer functional elements and interfaces supporting critical communications and other applications (at the application layer), based on Stage 1 service requirements from SA1, including:

  • Relevant application architectural aspects (including both network and terminal aspects)
  • Definition of reference points for interactions between application functional elements
  • Allocation of application functions to particular subsystems and elements
  • Generating information flows between reference points within scope
  • Identification of application layer protocols
  • Necessary support for enabling interworking with non-3GPP applications
  • Identify and provide application level functional requirements to other 3GPP WGs, according to their expertise, where additional functionality needs to be specified that impacts existing architecture, reference points, interfaces, protocols or transport bearer capabilities provided by the 3GPP-based system (e.g. IMS, EPS, ProSe)

SA5 - Management, Orchestration and Charging

Within the 3GPP Technical Specification Group Service and System Aspects (TSG SA), the main objectives of 3GPP TSG SA WG5 (SA5) are Management, Orchestration and Charging for 3GPP systems. Both functional and service perspectives are covered.

TSG SA WG5 is currently responsible for:

  • Management and Orchestration which covers aspects such as operation, assurance, fulfilment and automation, including management interaction with entities external to the network operator (e.g. service providers and verticals).
  • Charging covers aspects such as Quota Management and Charging Data Records (CDRs) generation, related to end-user and service-provider.

TSG SA WG5 specifies Management, Orchestration and Charging requirements, solutions and protocol-specific definitions. The solutions include architecture, service definitions and data definitions.

TSG SA WG5 is committed to engaging in Management, Orchestration and Charging aspects of supporting new services for public and non-public networks.

TSG SA WG5 coordinates with other 3GPP WGs and all relevant Standards Developing Organizations (SDOs), industry fora and Market Representation Partners (MRPs) as well as Open Source communities in the specification work pertinent to Management, Orchestration and Charging.

SA5

Health informatics - Device interoperability - Part 20701: Point-of-care medical device communication - Service oriented medical device exchange architecture and protocol binding (ISO/IEEE 11073-20701:2020)

The scope of this standard is a service-oriented medical device architecture and communication protocol specification for distributed system of Point-of-Care (PoC) medical devices and medical IT systems that need to exchange data or safely control networked PoC medical devices. It identifies the functional components, their communication relationships as well as the binding of the components and communication relationships to protocol specifications.

EN ISO 11073-20701:2020

Health informatics - The International Patient Summary - Guideline for European Implementation

This Technical Specification (TS) provides implementation guidance to support the use of the International Patient Summary dataset in a European context. The focus of this technical specification takes into consideration European specific jurisdictional requirements, needs and contexts that Europe requires to be satisfied for effective implementation. It addresses both functional and non-functional requirements for the dataset’s interchange. As part of the usability of the International Patient Summary, European perspectives, directives and regulations contextualise and add value to generic reference implementations for use by Member States. The TS applies the refined European Interoperability Framework (ReEIF), which describes legal, organisational, semantic and technological considerations for interoperability. These considerations highlight the eHealth Network’s (eHN) guidance for cross-border care and underpin the care process. The TS formalises principles to support the safe and legitimate use of patient summary data and afford protection for efficient cross-border data interchange within scenarios for unscheduled care. This Technical Specification gives selection criteria and provides examples of various transport formats and terminologies shown to be suitable for interchanging the International Patient Summary dataset. Compliance, deployment & migration Guidance are also included. The TS distinguishes between cross-border only requirements for interchanging the dataset and those that are generally applicable within national borders.

CEN/TS 17288:2020

Health informatics - Device interoperability - Part 10201: Point-of-care medical device communication - Domain information model (ISO/IEEE 11073-10201:2020)

The scope of this project is to define a general object-oriented information model that may be used to structure information and identify services used in point-of-care (POC) medical device communications. The scope is primarily focused on acute care medical devices and the communication of patient vital signs information.

EN ISO/IEEE 11073-10201:2020

Health informatics - Standard communication protocol - Computer-assisted electrocardiography

This document specifies the common conventions required for the cart-to-host as well as cart-to-cart interchange of specific patient data (demographic, recording, ...), ECG signal data, ECG measurement and ECG interpretation results. This document specifies the content and structure of the information which is to be interchanged between digital ECG carts and computer ECG management systems, as well as other computer systems where ECG data can be stored

EN 1064:2020

Health Informatics - Requirements for a knowledge base for clinical decision support systems to be used in medication-related processes (ISO/TS 22756:2020)

This document specifies the requirements for developing a knowledge base for drug-related problems that cohere with the intended drug use, to be used in rule-based clinical decision support systems (CDSS), such as the criteria for selecting a raw data source and the quality criteria for the development and maintenance for the rules or clinical rules for drug safety. It also describes the process of how to develop a knowledge base, the topics to be considered by the developers of a knowledge base, and it gives guidance on how to do this. This document gives guidelines for the development of a knowledge base: — with rules to enhance decisions and actions in drug-related problems that cohere with the intended drug use; — which can be used by all kinds of healthcare professionals, such as those who prescribe, dispense, administer or monitor medicines; — which can be used in every care setting, including chronic and acute care, primary and specialized care; — which is a repository of evidence/practice bases rules, assessed by experts; — which is meant to be used in conjunction with a medicinal product dictionary; — whose knowledge is structured in rules and therefore to be used in the type of rule-based CDSS. This document does not: — describe the exact content of a knowledge base i.e. the outcome of the process of developing rules. — provide the requirements for a clinical decision support system, the software that uses the knowledge base combined with the patient's data, and presents the outcome of the rules to the healthcare professional. These requirements are described in ISO/DTS 22703[1]. — give the requirements for non-medication knowledge bases. Some aspects of the requirements in this document are general in nature and applicable to other kinds of knowledge bases, but this document does not address all of the requirements of non-medication knowledge bases. [1] Under preparation. Stage at the time of publication: ISO/DTS 22703.

CEN ISO/TS 22756:2020

Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers (ISO/TS 16791:2020)

This document provides guidelines on identification and labelling of medicinal products from the point of manufacture of packaged medicinal product to the point of dispensing the product. This document outlines best practice for AIDC barcoding solutions for applications. Users can, however, consider the coding interoperability requirements for other AIDC technologies, e.g. Radio Frequency Identification (RFID)

CEN ISO/TS 16791:2020 (EQV)