Abbreviation: IEC/ISO JSyC BDC

Title: Systems Committee Bio-digital Convergence

Scope: Systems level standardization activities in the domain of bio-digital convergence for the IEC, including ISO/IEC JTC 1.

• Facilitate outreach and influence the work on bio-digital convergence with ISO, other SDOs, and industry consortia, in collaboration with relevant IEC entities and thus facilitate the advancement and coordination of bio-digital convergence standardization.
• Identify and assess potential new forthcoming bio-digital convergence topics and problematics that may become relevant to IEC activities and recommend to the SMB an appropriate course of action to meet the needs of the global community

Bio-digital convergence can be divided into five landscapes:

• Engineering of Living Systems Landscape
• Life systems and Bioengineering Landscape
• Human Augmentation Technologies Landscape
• Reverse Agricultural Bioengineering Landscape

• Reverse Environmental Bioengineering Landscape

  

  Vice Chairs

• Five Vice Chair are responsible for each landscape:
• Vice Chair Reverse Engineering of Living Systems Landscape
• Vice Chair Life systems and Bioengineering Landscape
• Vice Chair Human Augmentation Technologies Landscape
• Vice Chair Reverse Agricultural Bioengineering Landscape
• Vice Chair Reverse Environmental Bioengineering Landscape
• The Vice Chaires are assigned the following tasks:
• Manage the collaboration with the R Members and liaisons concerned
• Convenor of the Open Forum related to the concerned landscape
• Convener of the Chair Forum related to the concerned landscape
• Maintenance of the related landscape
• Lead the organisations of periodic Webinars

• Member of the SyC DBC CAG

  Open Forums

• Five open forums are established to bring experts together about the five landscapes:
• Open Forum Reverse Engineering of Living Systems Landscape
• Open Forum Life systems and Bioengineering Landscape
• Open Forum Human Augmentation Technologies Landscape
• Open Forum Reverse Agricultural Bioengineering Landscape
• Open Forum Reverse Environmental Bioengineering Landscape

• These open forums will allow keeping the momentum and membership from the former SEG 12 on Bio-digital Convergence.

  Working Groups

• Working groups will be established at the initiation of publications development projects.

  R-Members

• A large set of R-Members have been identified and are listed here under. The JSyC BDC will reach out to them when required by the work and projects active in the committee. R-Members are JTC 1, IEC and ISO committees as well as external organizations.
• JTC 1: Information Technology
• JTC 1/SC 38 - Cloud computing and distributed platforms
• JTC 1/SC 41 - Internet of Things and Digital Twin
• JTC 1/SC 42 - Artificial Intelligence
• JTC 1/SC 43 - Brain-computer interfaces
• IEC/TC 65 - Industrial-process measurement, control and automation
• IEC/TC 91 - Electronics assembly technology
• IEC/TC 124 - Wearable electronic devices and technologies
• IEC/SC 62B - Medical imaging equipment, software, and systems
• IEC/SC 62D - Particular medical equipment, software, and systems
• IEC SyC AAL - Active Assisted Living
• IEC SyC Smart Cities
• ISO/TC 34 - Food products
• ISO/TC 134 - Fertilizers, soil conditioners and beneficial substances
• ISO/TC 146 - Air quality
• ISO/TC 147 - Water quality
• ISO/TC 150 - Implants for surgery
• ISO/TC 168 - Prosthetics and orthotics
• ISO/TC 190 - Soil quality
• ISO/TC 194 - Biological and clinical evaluation of medical devices
• ISO/TC 207 - Environmental management
• ISO/TC 212 - Medical laboratories and in vitro diagnostic systems
• ISO/TC 215 - Health informatics
• ISO/TC 229 - Nanotechnologies
• ISO/TC 234 - Fisheries and aquaculture
• ISO/TC 255 - Biogas
• ISO/TC 266 - Biomimetics
• ISO/TC 276 - Biotechnology
• ISO/TC 282 - Water reuse
• ISO/TC 299 - Robotics
• ISO/TC 304 - Healthcare organization management
• ISO/TC 331 - Biodiversity
• ISO/TC 347 - Data-driven agrifood systems
• IEEE HAWG - Human Augmentation Working Group
• Wearable Robotics Association
• ASTM F48 - Exoskeletons and Exosuits
• EU-STANDS4PM - Standardization framework for data integration and data-driven in silico models for personalised medicine
• GA4GH - Global Alliance for Genomics and Health
• CGE - Center for Genomic Epidemiology
• EDITH - European Virtual Human Twin
• CEN-CENELEC FGOOC - Focus Group Organ-on-Chip

The business environment is described by the global bio-digital landscape described here under:

Main Challenges and constraints:

• Technology focus systems committee covering a wide scope
• Inherently multidisciplinary - convergence of technologies
• Very horizontal: impacting many sectors
• Most of the standardisation activities are currently in ISO and other SDOs

The work of the JSyC BDC will be of benefit to several stakeholders.

For standards developers, it will contribute to a seamless, efficient, harmonious, and fulfilling standards development experience by, among other things:

• Clarity about how their work contributes to a portfolio of standards to deliver the solution required
• Clarity about how their work can re-use work done elsewhere
• Clarity about the resources available to them

For standards users: – Timely publication of a structured portfolio of coherent standards that satisfy their needs / expectations

For National Committees or National Bodies: – Provide the means to internally organize and monitor standardization activities in bioengineering, to holistically and strategically address standardization imparted by this convergence of technologies and to identify and market related standards to the corresponding sectors in their countries.

The convergence of bio-digital technology is widely affecting many other technologies. The JSyC BDC has organized them into five landscapes which have specific trends.

Reverse Engineering of Living Systems:

Bio-Digital standardization opportunities for supporting the reverse-engineering of living systems and systems of systems.

This includes genomics, transcriptomics, proteomics, metabolomics, metagenomics, exposomics, informatics, microbiomic, neurosciences, synthetics, …

Life Systems and Bioengineering:

Bio-Digital standardization opportunities in life systems and bio-engineering.

This includes biosensors, biometrics, bio-foundries, bioprocessing, biofuels, drug discovery and engineering, synthetic biological circuit, metabolic engineering, genetic engineering, artificial life, Organ-on-Chip (OoC), artificial organs, ...

Human Augmentation Technologies:

Bio-Digital standardization opportunities in the area of human augmentation. 

This includes brain-machine interfaces, digital hardware enhancement, ubiquitous and continual monitoring, enhanced strength, enhanced sensing, embodied computing, ambient intelligence, and biohacking.

Agricultural Bioengineering:

Bio-Digital standardization opportunities in the Bioengineering of agricultural systems and systems of systems, including forestry, aquaculture, livestock farming, cellular agriculture, and molecular harming.

This includes internet of things applications (such as precision agriculture), embodied computing for animals, genetic engineering of food as well as the following UN sustainable development goal: zero hunger.

Environmental Bioengineering:

Bio-Digital standardization opportunities in the area of environmental systems of systems. 

This includes geoengineering, sustainability, and the following UN sustainable development goals: climate action, life below water and life on land.

As a Joint Systems Committee, the JSyC BDC has developed and applies the Systems approach adapted to its field of technology and stakeholder’s framework.

Through collaboration and consensus, the JSyC BDC elaborates and maintains a standardization landscape of its sector. Using this landscape and other information such as technology and market trends, the JSyC BDC then cooperatively develops a work plan that involves and supports alignment and coordination between their work as well as identifying opportunities. The work plan is then continuously maintained and updated.

This is not about dictating to TCs what work they must carry out but rather providing information that can help them better judge how to scope out and position their work for maximum effectiveness.

Planned systems deliverables:

• Cross-functional foundational (vocabulary, reference architecture, etc…) standards
• Standardization landscape: sector-level standard portfolios, standards map, gap analysis
• Standardization strategies: roadmaps, collaborative projects, etc..
• Technology reports
• IEC system /sector web sites
• IEC system /sector webinars and workshops

Expected outcomes:

• Facilitation of new cooperative standardization works between existing TCs, be it within the IEC, between the IEC and ISO or with other SDOs
• Facilitation of re-engineering of existing TCs to address more efficiently new standardization challenges
• Enablement of the creation of new TCs to address new standardization challenges
• Value creation from existing standards portfolio
• Outreach 

At this point, no planned work is related to Conformity Assessment.