Standards in health-related data and information are foundational to supporting and enabling all aspects of the health system. Right? Agreed? Maybe?
Knowing, understanding and having confidence in our health informatics standards, while not easy, is an essential part of all digital health care, nationally and globally. As Canadians, we fundamentally believe in a publicly accessible and dependable health care system and experience. We expect our healthcare data to be easily exchanged and shared to support our care – wherever we go and wherever we need it. Safe, secure, accurate, timely, accessible, relevant and reliable data is enabled through health informatics standards. Like the standard electrical outlet or traffic light, health standards make things run smoothly and consistently.
ISO/TC215 is the standards source within the International Standards Organization, tasked with leading the global specification development for the capture, interchange and use of health data, information and knowledge. The ISO/TC215 standards support the foundational, structural, and semantic interoperability of shared health data communication in a secure and private digital environment.
Improvements in the efficiency of health systems around the world provide opportunities for significant payback from investments in digital health. According to the Global Health Data Standards Charter – better health data, enabled through standardization, can improve health outcomes, address disparities, and enable innovation across the health sector.
ISO standards make a positive contribution to the world we live in. They facilitate trade, spread knowledge, disseminate innovative advances in technology, and share good management and conformity assessment practices. In healthcare and specifically digital health, ISO contributes standards, specifications and guides on:
- Health information and data (definition, content, models, representation, identifiers), including new work in Genomics,
- Requirements (medications, EHR’s, use case, security, blockchain),
- Semantic content representation (specifications, terminology resources, models, structure, competencies and content, big data, workforce),
- Health data, software and systems safety and privacy (management of risk),
- Pharmaceutical products information system safety, efficiency and interoperability (medicinal management concepts and definitions, medicinal product identification, implementation guides) and
- Standards sets (starting with Patient Summary and Diagnostic Imaging).
ISO International Standards represent a global consensus on the state of the art in the subject of that standard, as developed by experts from across many countries. For Canada, we are so grateful to our TC215 Mirror Committee experts that serve as writers, reviewers, assessors, voters, comment submitters and meeting delegates, all as volunteers in addition to their busy and successful day jobs. These health informatics experts are part of the 3,200 strong volunteer experts across ALL industries and sectors in Canada that work on ISO standards. A huge thank you goes out to all our Canadian TC215 Mirror Committee members:
• Kelly Abrams
• Chantal Couris
• Finnie Flores
• Neil Gardner
• Grant Gillis
• Andrew Grant
• Kathryn Hannah
• Peter Humphries
• Eugene Igras
• Elizabeth Keller (Chair Elect)
• Faud Khan
• Beverly Knight
• Frederic Laroche
• Marion Lyver
• Aaron Middleton
• Don Newsham (Past Chair)
• Michael Nusbaum
• Mary Raphael
• Derek Ritz
• Ron Parker
• Sari Shapira
• Sue Schneider
• Gordon Webner
Impact And Influence
ISO standards have been making a positive and strong difference for Canadian digital health for many years. Some examples include the following.
- ISO standards, particularly ISO 17791 Guidance on standards for enabling safety in health software, formed the basis and were a key part of the nationally developed, used and adopted guidelines:
- Digital Health Canada (formerly COACH) eSafety Guidelines: 2013 edition, which identified and referenced 14 ISO standards, has been adopted and used in the public health care sector by provincial and national jurisdictions and health agencies.
- ISO TC215 Security and Privacy standards have been used and referenced in provincial jurisdiction security policies and regulations, as an example at Saskatchewan eHealth.
- ISO/TC215 Identification of Medicinal Products forms a foundation for the Canada Health Infoway ePrescribing program
and are in the planning stage for implementation through Health Canada.
- ISO/TC215 Use case standards have formed the basis of use case development in provincial agencies.
- The SKMT – Standards Knowledge Management Tool, used by ISO/TC215 and other international SDOs involved in health informatics, was developed and continues to be provided for the international community by a TC215 SMC member – Andrew Grant as Director Research Group CRED www.cred.ca, the Collaborative research for effective diagnostics and a member WHO collaborative centre.
Not only do we in Canada use the ISO standards, we lead, manage, author and develop ISO standards, based on the expert knowledge and contribution of many in the digital health community of our country. Those standards written and published by Canadians, past and present members of the Mirror Committee, include the following.
ISO/TS 17120:2004 Country identifier standards
ISO/TR 16056-1:2004 Interoperability of telehealth systems and networks — Part 1: Introduction and definitions
ISO/TR 22221:2006 Good principles and practices for a clinical data warehouse
ISO/IS 21667:2010 Health indicators conceptual framework
ISO/TS 27527:2010 Provider identification
ISO/TR 14639-1:2012 Capacity-based eHealth architecture roadmap — Part 1: Overview of national eHealth initiatives
ISO/TR 17791:2013 Guidance on standards for enabling safety in health software
ISO 17090-1,2,3:2013 Public key infrastructure — Part 1, 2, 3
ISO/TR 14639-2:2014 Capacity-based eHealth architecture roadmap — Part 2: Architectural components and maturity mode
ISO/TR 12310:2015 Principles and guidelines for the measurement of conformance in the implementation of terminological systems
ISO 27799:2016 Information security management in health using ISO/IEC 27002
ISO/TS 17975:2015 Principles and data requirements for consent in the Collection, Use or Disclosure of personal health information
Patient Summary Standards Set – Guidance, joint authored for Joint Initiative Council
ISO/TS 22287:2018 Workforce roles and capabilities for terminology and terminology services (TermS) – being published presently
ISO/TS 20405:2018 Framework of event data and reporting definitions for the safety of health software – being published presently
A huge reflection of the ISO/TC215 committee and individual impact and contribution in Canada was demonstrated in the very recent Standards Council of Canada (SCC) 2018 awards. Don Newsham was announced as winner of the Hugh Krentz award recognizing exceptional leadership and contributions of an individual in Canada’s standardization network and the TC215 Mirror Committee, represented by Chair Elect Elizabeth Keller, was winner of the Committee Achievement award recognizing the contributions made by a committee or group in support of Canada’s national standardization network. The committee award looked for a group with exceptional characteristics displayed during standardization activities, including:
- Teamwork, consensus-building
- Productivity, production of deliverables
- Cooperative, inclusive
- Respect of/adherence to established best governance practices/principles
We were so honored and thrilled to receive these awards and share the day with some of our nearby committee members at the SCC World Standards Day October event in Ottawa, and with board, CEO and staff of SCC and leaders across other industry standards communities. We also thank Canada Health Infoway (CHI) and SCC for their ongoing financial support for the delegation.
The influence and impact of our standards leaders in ISO has continued with TC215 MC Head of Delegation, Vice-Chair and members also leading and supporting the international cross-SDO collaboration initiative, called the Joint Initiative on SDO Global Health Informatics Standardization. This initiative was formed to enable common, timely health informatics standards by addressing and resolving issues of gaps, overlaps, and counterproductive standardization efforts. Three TC215 SMC members are members of its governing committee (the JIC) with one being the current chair of the JIC Michael Nusbaum.
International health informatics standards work is targeting some new and exciting fields in the months ahead.
Genomics now makes up more than half of a TC215 working groups’ program. With that growing list of genomics projects, a Genomics Roadmap for standards is being developed. Coordinated at TC215 with a broad range of like-minded organizations (such as GA4GH, HL7 Clinical Genomics, SNOMED International, and the US based NCI) this work, also under consideration as a new sub-committee of TC215, has huge potential to inform and influence the emerging personalized medicine world, along with the benefits to clinical care, chronic disease detection and management and a myriad of other health needs.
Safety is a continued area of focus for the Canadian team, with the increasingly integrated and complex systems we are developing and implementing to support better patient care driving the need to adopt a multi-faceted approach to managing the risks these systems introduce to patient care, and to maximize the benefits. The new set of standards recognize that across the lifecycle there are many (often iterative) steps, where communication between the various parties (developers, integrators, health care delivery organizations, IT operations, clinical system users, etc.) is critical. While the new and revised standards will provide guidance and direction on what individual organizations (and the roles within them) should do, shared responsibility through two-way communication about safety risks and mitigations will also be emphasized.
Collaboration is a key part of standards work, with avoidance of duplication, alignment of complimentary standards artifacts across multiple SDO’s and international digital health standards promotion at signature events, all as targets for the Joint Initiative Council and for our TC215 and Canadian leadership for the upcoming year. STANDARDS SETS, and the uptake of the first published set for Patient Summary continues a priority for collaboration across SDO’s. Check out the PSSS on the JIC website and use it as your starting point for standards evaluation for any related patient summary use case.
An Aging in Communities task force report is expected in the year ahead providing a catalog of use cases, related standards work, a conceptual framework of ageing related informatics standards and a series of recommendations. The opportunity to use digital companions, community computing and self-management apps to support and maintain independence is a key focus of the task force.
Also underway and targeted are healthcare applications of blockchain technologies, the reference standards portfolio for clinical imaging (a new standards set), cloud computing functional, security and privacy specifications, key work on health software safety (building from the 2014 Canadian co-lead framework and guide for medical device and health software safety) and also the leveraging of a dozen medication management and ePrescribing related standards from ISO.
Engagement is a key focus for our Canadian ISO standards community. Broadening our reach and connection to various digital health community stakeholders is a key focus of the Chair-Elect. Our ITAC vendor community, the federal government CIO office, continued work with and leadership with Canada Health Infoway (CHI) and the Canadian Institute for Health Information (CIHI) along with expanding connections to provincial standards committees and Digital Health Canada are all on the agenda for the next year.
We are actively seeking new and additional members of our ISO health informatics standards community. YOU can join our mirror committee and provide your ideas, views and knowledge to the many topics and work items on standards. YOU do have expertise to share and YOU can contribute, at whatever stage of career you are presently. Talk to either of us, reach out to anyone on our current mirror committee, share your ideas and comments and get further involved in the foundation world of standardization of our health data, information, infrastructure and systems.