Health Informatics Standards – Recent Launches and Learnings

From the just concluded ISO/TC215 standards meetings in Bern Switzerland, there are important advances appearing that will bring greater coherence and convergence for digital health standards. With the launch of standards sets, new work on genomic data sets in EHR’s, common use case developments, increasing international interest in FHIR and some welcome rationalization in medical device and health software standards, it is clear that valued new action is underway in our standards community.

First in advances is the work internationally on standards sets, standards bundles and standards reference portfolios, the exact term yet to be landed upon. The Joint Initiative Council of 8 standards development organizations (SDO’S) in its work contributing to better global patient health outcomes, is providing strategic leadership in the specification of sets of implementable standards for health information sharing. Initiating the first standards set (“a coherent collection of standards and standards artefacts that support a specific use case”), the JIC is starting priority work for a Patient Summary, the minimum set of information needed to assure healthcare coordination and the continuity of care. The use case for this standards set is all about accessing a patient summary in an acute care setting. A full Scope and Foundation report for this initiative is available on the JIC website - www.jointinitiativecouncil.org/index.asp. ISO/TC215 is also launching work on a standards bundle for clinical imaging, an important first work for normative standards referencing.

Metadata for describing structured clinical genomic sequence information is a new work item in ISO/TC215 that will provide an easily usable genomics data set for EHR’s and demonstrate how to do a genomics clinical sequence report in an EHR. The standard is based on next generation sequence technology, starts with metadata, adds requirements, optional fields and codes, all for clinical decisions and translational research. This work has the potential to move genomics data further from ‘dark art’ to general practice use.

ISO 19669, Use Cases with Reusable Components, provides a use case structure encompassing scenarios, events and actions and conveys patterns of patient flow, provider flow and information flow. Currently 20 example use cases with 41 multi-step scenarios are being analyzed in the draft standard, which also includes a common template, a reusable repository of core components and a prototype use case authoring tool. This work enables a foundation of consistent infrastructure, requirements traceability and cross industry use.

And, there was growing international interest at ISO in developments on Fast Healthcare Interoperability Resources (FHIR), the new generation standards framework created by HL7. Many are just learning about this standard, are excited about the advantages it seems to incorporate, and are also raising important points on what seems to be some usage, complexity and consistency questions. With the current mobile, apps and web services world we have today, FHIR addresses easier data exchange, a widely usable native data infrastructure, a focus on the common and strong developments informed by real implementations. Whether the inherent complexity and some dynamic inconsistencies can be effectively addressed (some say tamed), this standard is going to be part of our digital health systems and solutions.

Bringing greater coherence and structure to the software as a medical device and health software safety standards, the joint work of ISO/TC215 and IEC TC62/SC62A has resulted in the Task Force report “Health Software and Health IT Safety Standards Future State Architecture / Framework and Roadmap”. A ‘temple diagram’ provides an effective framework for standards development in health software safety. The left columns (design / development) are being addressed through updates to ISO/IEC 82304 and 62304, the right columns (implementation / clinical use) are being addressed through the ISO/IEC 80001 series and the foundation will be addressed through a new standard for which detailed work is now underway with specific drafting beginning after the next TC215 meeting.

With these and other new happenings in digital health standards I hope to connect to many of the Canadian standards players at the Canada Health Infoway Partnership meetings in Vancouver next week, www.infoway-inforoute.ca/en/what-we-do/news-events/events/129-partnership-conference/6541-infoway-partnership-conference-2015. That’s the place for us to share more valuable learnings, ask and answer tough questions and connect with colleagues on what’s new, either in sessions or corridors or in the bar! See you there.

(This message has been cross-posted on my Linkedin blog)