Yuntao Yu and Phil Troyk IEC SEG 12 Webinar

SEG 12/WG 4 Conenors Bio-Digital Convergence

2022.12.8 Standardization
IEC SEG 12/WG 4
Human Augmentation Technologies
• BioDigital 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.

3
IEC SEG 12/WG 4
Convenors: Ms. Yuntao Yu and Dr. Phil Troyk
Members:
• 39members
• Joined from national bodies, or ISO, IEC partners.
• 9 national bodies: Australia, Canada, China, Germany,
India, Japan, Kenya, UK, US.
14 meetings
4
IEC SEG 12/WG 4
Subgroup 1 Perform a scientific literature review Jiangbo Pu
of the "state-of-the-art" as well as emerging
methods and technologies relevant to ToR
Subgroup 2 Compile a summary of industry Xin Zhang
activities for current and emerging methods and
technologies relevant to ToR
Subgroup 3 List and compile a catalog of existing Fang Lin
world-wide standards relevant to the ToR (need Bruce Peoples
library of standards documents)
Subgroup 4 List on-going standards development Fang Lin
efforts and activities relevant to ToR Bruce Peoples
Subgroup 5 Develop a draft of "gap areas" not Phil Troyk
covered by existing or emerging standards which
need consideration for new standards as relevant
5
to ToR
Introduction

6
What does “Human Augmentation
Technologies” mean?
• Many technologies in development stem from medical
needs (rehabilitation, disease compensation, etc)
• Future work may project to true “augmentation:”
enhancement beyond the accepted norm
• Standards needs for medical vs elective applications
may differ

7
Academic Literature Review

8
Academic Literature Review

9
Industrial Activities

10
Industrial Activities

11
Current standardization status

12
Current standardization status

See https://mapping.iec.ch/#/maps/113
13
Current standardization status

14
Topical Areas covered by current or
emerging standards

15
Topical Gap Areas – preliminary list

16
Possible future work
APIs and Interfaces Ethics & Risks
Communication & Control Evaluation &
Storage & Data Sharing Management Framework

Terminology Scenario-based
Definition Standardization
Boundary Brain-computer Interface &
Stimulation Devices
Prosthesis, Orthosis, &
Exoskeleton
Virtual Reality, Augmented
Recommended Practice Reality, & Mixed Reality

Use cases
Guidelines

17
 Standardization Map

Link: https://mapping.iec.ch/#/maps/113
 Standardization opportunities
in
Environmental Bioengineering
v 1.1

François Coallier, Ph.d., P.Eng. IEC SEG 12 Webinar

Co-convener, IEC SEG 12 WG6 Bio-Digital Convergence
Standardization
 IEC SEG 12/WG 6 Mandate
Title: Environmental Bioengineering

Scope:
BioDigital 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.

2
 Biologic systems of systems

Geary, W.L., Bode, M., Doherty, T.S. et al. A guide to ecosystem models and their environmental
applications. Nat Ecol Evol 4, 1459–1471 (2020). https://doi.org/10.1038/s41559-020-01298-8
3
http://www.bio.miami.edu/dana/160/160S20_23.html
The challenges
Environmental degradations due to human
activities that result in:
• Pollution
• Climate change
• Loss of biodiversity
• ….

4
5
Modified from Maurya, Pradip & Ali, Sk Ajim & Ahmad, Anwar & Zhou,
Q. & Castro, Jonatas & Khane, E. & Ali, A.. (2020). An introduction to
environmental degradation: Causes, consequence and mitigation.
10.26832/aesa-2020-edcrs-01.

‘Natural’ Factors

Climate
Change
6
How Does Agriculture Change Our Climate? Institute on
the Environment at the University of Minnesota
http://www.environmentreports.com/how-does-agriculture-c
hange/
Share of global emissions
 The ‘challenging’ solution

Have a more sustainable usage of

the resources of the planet.
sustainability
state of the global system, including environmental, social and economic aspects, in which the needs
of the present are met without compromising the ability of future generations to meet their own needs
[SOURCE: ISO 23434-1:2021, 3.1]

7
Environmental BioEngineering
the application of bioengineering to create
solutions that will protect and also improve the
health of human and living organisms and
improve the quality of the environment

Modified from
https://en.wikipedia.org/wiki/Environmental_engineering
8
 Zoom out:
Human applications
augmentation
Sensor based
Biohacking epidemiology WG6
monitoring Environmental
WG4 Bio-bots
Engineering
Cyborg Environmental
Biomaterial
Exoskeleton Monitoring Geoengineering
Animat
Embodied
computing Smart
Cities
Artificial
Health
organ Bioengineering
GMO
Organ-on-a
WG3 -chip
Bioelectronics
Cellular
Bioprocessing agriculture
Human
body-on- Smart Farming
Molecular
a-chip Biomanufacturing
farming
Medicine WG5

9
Manufacturing
 Zoom out:
Human applications
augmentation
Sensor based
Biohacking epidemiology
monitoring
Bio-bots Environmental
Cyborg Environmental Engineering
Biomaterial
Exoskeleton Monitoring Geoengineering
Animat
Embodied
computing Smart
Cities
Artificial
Health
organ Bioengineering
GMO
Organ-on-a
-chip Cellular
Bioelectronics
Bioprocessing agriculture
Human
body-on- Smart Farming
Molecular
a-chip Biomanufacturing
farming
Medicine

10
Manufacturing
Pertinent Standards Development Organizations (SDOs)
• ISO/TC 207 Environmental Management
• ISO/TC 331 Biodiversity
• ISO/TC 8/SC 2 Marine environment protection
• ISO/TC 323 Circular Economy
• Smart cities:
− ISO/TC 268 Sustainable cities and communities
− ISO/IEC JTC 1/WG 11 Smart Cities
− ISO SyC Smart Cities
• ISO/TC 190 Soil Quality
• ISO/TC 287 Sustainable processes for wood and wood-based
products
• ….

11
 Selected Bioengineering Contributions
Agriculture:
• Optimization of resource usage: Precision
agriculture (-> SEG 12 WG5)
• Cellular agriculture (-> SEG 12 WG5)
Geoengineering
Environmental monitoring

12
 Nair, Rishi, 2016, Precision Agriculture – A long way to go
for India,
https://news.agropages.com/News/NewsDetail---19211.htm
Precision agriculture (-> SEG 12 WG5)

13
 Cellular Agriculture

https://solarisbiotechusa.com/cellular-agriculture-and-food-fermenters

14
Geoengineering

The full effect of global geoengineering can

only be tested using computer models.
Comprehensive Earth System Models are
required that represent the most important
processes essential to simulate different
potential geoengineering proposals. In
recent years NCAR's state-of-the-art Whole
Atmosphere Community Climate Model
(WACCM) has been developed to include
interactive coupling between aerosols,
chemistry, radiation, and climate. A WACCM
model study performed simulations over the
period of the recent largest volcanic eruption
of Mt. Pinatubo in 1991, and demonstrated
excellent agreement with observations in
terms of aerosol movement, radiative
changes, and chemical response (see
https://www.britannica.com/science/geoengineering Figure). Current and future developments of
https://www2.acom.ucar.edu/modeling/geoengineering ACOM models are essential to provide the
community with important tools for
geoengineering research.
15
Geoengineering
Urban

IN CITIES, CLIMATE CHANGE SOLUTIONS MUST ALSO ADVANCE EQUITY, Washington Nature, February 13, 2018,
https://www.washingtonnature.org/fieldnotes/cities-climate-change-brings-risk-alongside-opportunity-to-advance-equity

16
 Informatics(UCI)
Urban Climate

Middel Ariane, Nazarian Negin, Demuzere Matthias, Bechtel Benjamin, Urban Climate Informatics: An Emerging Research
Field, Frontiers in Environmental Science VOLUME 10, 2022, https://www.frontiersin.org/articles/10.3389/fenvs.2022.867434

17
Geoengineering standardization

ISO/TC 207 Environmental Management

ISO/AWI TR 14082 Radiative Forcing Management—
Guidance for the quantification and reporting of radiative
forcing-based climate footprints and mitigation efforts
https://www.iso.org/news/ref2425.html

18
 Environmental monitoring
the systematic sampling of air, water, soil, and
biota in order to observe and study the
environment, as well as derive knowledge from
this process.
https://www.slideshare.net/ShivangiSomvanshi/environmental-monito
ring-61608986

19

https://www.digi.com/blog/post/what-is-environmental-monitoring
19
20
Elmustafa Sayed Ali Ahmed1, Mujtaba Elbagir Yousef,Internet
of things in Smart Environment: Concept, Applications,
Challenges, and Future Directions,WSN 134(1) (2019) 1-51,
http://www.worldscientificnews.com/wp-content/uploads/2019/
06/WSN-1341-2019-1-51-1.pdf
IT enabled environmental monitoring
 + Biosensors
sensor (3.3.29) that
uses specific
+ Quantum
biochemical reactions sensors
mediated by isolated
enzymes,

Sensors
nternet-of-things-infographic/
https://www.postscapes.com/what-exactly-is-the-i

immunosystems,
tissues, organelles or
whole cells to detect
chemical compounds
usually by electrical,
thermal or optical
signals

[SOURCE: Modified
from IUPAC GoldBook
(DOI:
10.1351/goldbook.B006
63)]

[SOURCE IEC/SEG 12
Biodigital convergence
- vocabulary Draft 1.1,
3.2.24]

21
https://www.iec.ch/iot/sensors
22
 Sensor standardization
• IEC/TC 47 Semiconductor devices
• IEC/TC 44 Safety of machinery - Electrotechnical aspects
• IEC/TC 86/SC 86C - Fibre optic systems and active
devices
• ISO/IEC JTC 1/SC 31 Automatic identification and data
capture techniques
• ISO/TC 211 Geographic information/Geomatics (remote
sensing)
• IEEE
• ….
Are the requirements for environmental monitoring properly covered?
23
Sensor Networks standards: ISO/IEC JTC 1/SC 41

• ISO/IEC 29182 series on Sensor networks: Sensor

Network Reference Architecture (SNRA)
• ISO/IEC 30128:2014 Information technology --
Sensor networks - Generic Sensor Network
Application Interface
• ….

24
 A Decade Bibliometric Analysis of Underwater Sensor Network Research on the
Internet of Underwater Things: An African Perspective
Trends in Cloud-based IoT, 2020
ISBN : 978-3-030-40036-1
Abdulazeez Femi Salami, Eustace M. Dogo, Tebogo Makaba, Emmanuel
Adewale Adedokun, Muhammed Bashir Muazu, Bashir Olaniyi Sadiq,
Ahmed Tijani Salawudeen
Underwater sensors networks 10.1007/s12145-020-00538-6.
underwater things. Earth Science Informatics. 14.
routing management for autonomous underwater vehicle in the internet of

25
Expósito-Izquierdo, Christopher & Martínez, Javier. (2021). Hybrid optimization
Robinson, Y. & Shanmuganathan, Vimal & Julie, Golden & Khari, Manju &
 Soo-Hyun Park, Maritime IoT and Digital Twin, JTC
1/SC 41/WG7, April 28th, 2022
Underwater sensors networks standards

26
 Pertinent IT SDO’s
• ISO/IEC JTC 1/SC 41 Internet of Things and Digital Twin
• ISO/TC 211 Geographic information/Geomatics
• ISO/IEC JTC 1/SC 42 Artificial Intelligence (NOTE:
includes Big Data)
• ..

27
Standardization work and opportunities

Current work:
• ISO/IEC JTC 1/SC 4: FDIS 30179 Internet of Things (IoT) -
Overview and general requirements of IoT system for ecological
environment monitoring
Some possible opportunities:
• Reference architecture for IoT system for ecological
environment monitoring
• Reference architecture for underwater sensors network for
ecological environment monitoring

28
Wastewater-based epidemiology
the systematic sampling of air, water, soil, and
biota in order to observe and study the
environment, as well as derive knowledge from
this process.
https://www.slideshare.net/ShivangiSomvanshi/environmental-monito
ring-61608986

29

Kang Mao, Hua Zhang, Yuwei Pan, Zhugen Yang,

Biosensors for wastewater-based epidemiology for monitoring public health, Water Research,Volume 191, 2021, 116787,
ISSN 0043-1354,
https://doi.org/10.1016/j.watres.2020.116787.
 Digital Twin

https://www.plm.automation.siemens.com/global/cz/webinar/digital-twin-in-manufacturing/68561
https://medium.com/@yashbajaj900/digital-twin-application-in-healthcare-69bf4c0f87e7
https://www.cadalyst.com/collaboration/digital-twin/road-and-bridge-digital-twins-action-four-case-studies-75827
https://www.sciencemag.org/news/2020/10/europe-building-digital-twin-earth-revolutionize-climate-forecasts
30
 Digital Twin - tutorial slide
According to Gartner and Deloitte, a digital twin as a digital representation of a real-world entity or system. It is
an evolving digital profile of the historical and current behavior of a physical object or process.

The implementation of a digital twin is an encapsulated software object or model that mirrors a unique
physical object, process, organization, person or other abstraction. The digital twin is thus based on massive,
cumulative, real-time, real-world data measurements across an array of dimensions.

Data from multiple digital twins can be aggregated for a composite view across a number of real-world
entities, such as a ship, a bridge, a building, a factory, a supply-chain or a city.

Mirroring is done through synchronization using data streams. The data streams are generated by sensors,
but also transactions and other sources (virtual sensors).

Digital Twin (DT) is an enabler Smart Everything, being based on measurements that creates an evolving
profile of the entity or system in the digital world, it provides important insights on system performance,
leading to actions in the real world such as a change in system and process design, or optimizing business
performance.

31
 JTC 1/SC 41 Digital Twin projects
Standard Title Status Abstract
ISO/IEC 30173 Digital twin - Concepts and Ed 1 This document establishes terminology for Digital Twin (DT) and
terminology CD describes concepts in the field of Digital Twin, including the terms
and definitions of Digital Twin, concepts of Digital Twin (e.g., Digital
Twin ecosystem, lifecycle process for Digital Twin, and classifications
of Digital Twin), Functional view of Digital Twin and Digital Twin
stakeholders.
ISO/IEC TR 30172 Digital twin - Use cases Ed 1 This document provides a collection of representative use cases of
CD DT applications in a variety of domains.

PWI JTC1-SC41-5 Digital Twin - Reference Ed 1

Architecture PWI

PWI JTC1-SC41-6 Guidance for IoT and Digital Ed 1

Twin use cases PWI

PWI JTC1-SC41-7 Digital Twin – Maturity model Ed 1

PWI

32
Pertinent Digital Twin applications
• Smart City environment
− Joint Work being considered by ISO/IEC JTC 1 (SC
41 & WG11) and other SDO’s on a Smart City Digital
Twin Reference Architecture
• Ecosystem
• …

33
 https://ec.europa.eu/research-and-innovation/en/horizon-magazine/tale-two-oceans-scie
ntists-are-building-digital-twins-ocean

34
35
GAIA
Level

https://copernicus-masters.com/challenges/esa-challenge/
https://www.sciencemag.org/news/2020/10/europe-building-digital-twin-earth-revolutioni

The European Union is

finalizing plans for an
ambitious “digital twin” of
planet Earth that would
simulate the atmosphere,
ocean, ice, and land with
unrivaled precision, providing
forecasts of floods, droughts,
and fires from days to years in
advance. Destination Earth, as
the effort is called, won’t stop
there: It will also attempt to
capture human behavior,
enabling leaders to see the
impacts of weather events and
climate change on society and
ze-climate-forecasts

gauge the effects of different

climate policies.

36
Thank You
Andrea Romaoli WG7: Standardization
Convenor SEG12- WG7 Opportunities – Bio Digital,
Ethical Reviewer Social, Risks & Ethical Aspects
OCHA /ITU
Andrea Romaoli
Convenor of IEC/SEG 12 WG7 Dr. Jiangbo Pu
Ethical Reviewer Expert member of IEC/SEG 12 WG7
OCHA/ITU
WG7 Scope
Social, ethical, risk, resilience, safety
management issues pertinent to BioDigital
convergence to be considered in an
international standardization context.
Include data governance and related issues.

3
Ethical and regulatory-related critical
issues:
1. Capacity of Governability
2. Digital Sovereignty
3. Bio-threats
4. Robotic: Accountability and Trustworthy versus
unpredictability
5. Growing Inequalities
6. Dual-use dilemma
7.Military use
8. Bioengineering: Hybrid Ethical approach
9. Climate Engineering Convergence
4
Ethical and regulatory-related critical
issues:
Capacity of Governability:

• fast technological innovation

• World events: pandemic, war, crime, climate, hunger, poverty, moral
degeneration, corruption
• Soft Law (no binding effect)
• Inequalities
• Dual-use dilemma
• Military use
5 • Human Augmentation
Ethical and regulatory-related critical
issues:
Digital Sovereignty:

• intimate life of people

• arms race
• international and intra-state tensions
• data security X big tech companies

6
Ethical and regulatory-related critical
issues:
Robotic: Accountability and Trustworthy
X
unpredictability of decisions of robots

- level of autonomy and cognitive robots

- accountability, trustworthy and liability
- traceability

7
Ethical and regulatory-related critical
issues:
Climate Engineering Convergence

WHAT IS IMPORTANT FOR SUCCESSFUL CLIMATE CHANGE

ACROSS TECHNOLOGICAL INNOVATION?

World leaders through the DECLARATION ON ETHICAL PRINCIPLES IN

RELATION TO CLIMATE CHANGE (2017) reinforced ethics
at the baseline of the discussion.

It sets out six ethical principles:

• Prevention of harm
• Precautionary approach
• Equity and justice
• Sustainable development
• Solidarity
8 • Scientific knowledge and integrity in decision-making
GAPS AND RISK

Risk assessment and Risk

TRIPARTITE SYSTEM OF management: framework,
SECURITY standardization and
+ Governance:
GOVERNANCE • safety
• probability of reversibility
• challenges of quantitative
analysis
HARMONY • combined methods: SWOT +
Ethical Matrix
• capacity of governability + IEC
Tripartite System for Safety
Human • ISO/IEC Guide 73:2009
Machines
• ISO/IEC Guide 73:2009, 2.1
Environment
Resilient/Transformational • ISO/IEC 31000:2018 (2009)
Governance

9
Social Impacts
Concerns Opportunities

• Regulatory barriers to entry • Employability

• Regulatory gap: security, safety, • Active Assisted Living
pricing, access, and labour rights
• Human augmentation will
• Health as status symbol transform health and social care
• Taxation • Health care systems
• Data security and data privacy • Life extension
• Competition among human being • Education & work
and robots
• Agriculture
• Bioweapons
• CRISPR-Cas9
• Climate Engineering Convergence
• Transportation
5 key-principles under Sixth Dimension of
Human Rights in the BioDigital Convergence

11
 • Values: • Values: • Values:
• Values: • Values:
• Human – • Freedom • Impact on
• ‘Do not harm’ • Sustainability
centric trust
1. SOVEREIGNTY OF LIFE

• Equality principle (no lethal • Well-being

• Autonomy • Fairness

5. TO PROMOTE PLANET
RESILIENCE CAPABILITY
• Fraternity machines)

3. SOCIAL JUSTICE
• Knowledge
• Privacy and • Transparency
2. HUMAN RIGHTS

• Autonomy (about solutions

4. ETHICAL PROFESSIONAL
RESPONSIBILITY
• Knowledge Cooperati • Accountability • Responsibility and impacts)
(right to on: people • Control
and • Accountability • Accountability
awareness (Sovereignty of
about dual- countries Life + Human- • Trustworthy • Beneficence
use and • Human • Respect for (machines
centric)
impacts). dignity stakeholder interest designed to
• Fair cost and promote active
• Democracy • No torture/ Fair taxation • Security
assisted living
inhuman • Accessibility • Honesty
and health or
or • Equity
• Equitable well being)
degrading • Integrity
Justice • Democracy
treatment
• Respect for • Security
• To international norms
mitigate • Innovation
of behavior
bias through harmony
• Respect for rule
of law

12
Risks and Social Impacts
Definition of Risk

• Effect of uncertainty on objectives.

Uncertainty: The state, even partial, Effect: Deviation from the Object: Different aspects (such as financial,
of deficiency of information related to expected result that could be environmental goal, health, and safety) &
understanding or knowledge of an positive or negative Applied at different levels (such as strategic,
event, its consequence, or likelihood. organization-wide, project, product, and
process)

International International BioDigital

Standards Organizations Convergence
• ISO Guide 73:2009 • United Nations • Social impacts and ethical concerns
• ISO 31000:2018 • World Health Organization • Digital Transformation
• ISO 34101-1:2019 • OECD • Fast Spreading
• IEC 31010:2019 • ISO/IEC/ITU/IEEE/…… • Structural Ethical Issue
• …… • COPANT • Multidisciplinary: Professionals and
Regulation
Risks and Social Impacts
Risk Management

Risk Management Social Impacts

Framework

• Risk Definition, Elements, • People, Community, Society

Dimensions, and Risk Sources
• Governance and Regulation
• Evaluation, Grading, Management
• Sustainable Development Goals
• Technical, Economical, Geopolitical,
• Use cases:
Ethical, and Social factors
• Diversity and Inclusive − Medical / Healthcare
• Use cases: − Education
− Genetic Editing − Foods
− Brain-computer Interfaces − Environment / Climate change
− Nanotechnology
− Bioweapons
Risks and Social Impacts
UNSDGs

Technical:
• WG 2: Reverse Engineering of Living Systems
• WG 3: Life systems and Bioengineering
• WG 4: Augmentation Technologies
• WG 5: Agricultural Bioengineering
• WG 6: Environmental Bioengineering

Social:
• WG 7: BioDigital Social, Risk & Ethical Aspects
Risks and Social Impacts
Brain-computer Interface

Risks from The “Bio” Side

• Biocompatibility Diversity, Equality, and Inclusive
• Short-term and Long-term effects to
• Technical Bias: Discrimination towards BCI Users
the brain and neural system
• Accessibility: “Only rich people get to use BCI?”
• Clinical: Injury, Death
• Rehabilitation vs. Augmentation
• Change in Depth: Communication, Society, Politics
Risks from The “Digital” Side
− Internet: Cocoon of Information
• Data Security
− Metaverse
• Leakage of Neural Data
− Virus (Biological or Computer)
• Unauthorized Neural Recording (without
− Fast Spreading
Informed Consent)
• Unauthorized Neural Modulation/Stimulation
• Faked Personal Identity with Neural Features
Risks and Social Impacts
Discrimination, Accessibility, Safety, & Equality

Discrimination Privacy and Consent

• The New Normal? • Personal Data • Informed Consent
− What is Normal / Natural / Healthy? − Walking Steps Become Public? − Change of Cognition
− Changes in Daily Routine − Comparation among Friends − Comparation between Wearable
• Aging Society Devices & Traditional Medical Devices
− Potential Stress
− Insurance Fee
− Potentially Increasing BCI Users? − Security: Large-scale Leakage
− Rethinking of the Technology
− Better Life for All (IEC SyC AAL)
Safety and Regulations
Accessibility
• Direct Threat to Life
• Same Clinical Support for
− Safety and Quality Control
− People in remote area
− Regulation during Design /
− Developed / Developing Countries Manufacture / Usage / Maintenance
Risks and Social Impacts
Standardization

IEC
• IEC/SC 62A - Common aspects of electrical equipment used in medical practice
− IEC TR 60513:1994 − IEC TR 80001-2-2:2012
− IEC 62366-1:2015 − IEC TR 80001-2-3:2012
− IEC 62366-1:2015+AMD1:2020 CSV − IEC TR 80001-2-5:2014
− IEC TR 62366-2:2016 − IEC TR 80001-2-8:2016
− IEC 80001-1:2021 − IEC TR 80001-2-9:2017
− IEC TR 80001-2-1:2012 − IEC 82304-1:2016

• IEC/TC 113 Nanotechnology for electrotechnical products and systems

− IEC/IEEE 62659:2015 − IEC TS 62844:2016
Risks and Social Impacts
Standardization

ISO
• ISO/TC 215 - Health informatics
− IEC 80001-1:2021 − IEC/TR 80001-2-8:2016
− IEC/TR 80001-2-1:2012 − IEC/TR 80001-2-9:2017
− IEC/TR 80001-2-2:2012 − ISO 13606-4:2019
− IEC/TR 80001-2-3:2012 − ISO/TR 17791:2013
− IEC/TR 80001-2-4:2012 − ISO/TS 20405:2018
− IEC/TR 80001-2-5:2014 − IEC 80001-1:2021
− ISO/TR 80001-2-6:2014 − ISO 81001-1:2021, 81001-5-1:2021
− ISO/TR 80001-2-7:2015 − IEC 82304-1:2016, 82304-2:2021

• ISO/TC 215/SC 1 Genomics Informatics

− ISO/TS 20428:2017 − ISO/TS 22692:2020
− ISO/TS 22690:2021 − ISO/TS 22693:2021
Risks and Social Impacts
Standardization

ISO
• ISO/TC 262 Risk management
− ISO 31000:2018 − ISO 31022:2020
− IEC 31010:2019

• ISO/IEC JTC 1/SC 37 Biometrics

− ISO/IEC TR 29144:2014 − ISO/IEC TR 30110:2015
− ISO/IEC TR 29156:2015 − ISO/IEC TR 22116:2021
− ISO/IEC TR 29194:2015

• ISO/IEC JTC 1/SC 42 Artificial intelligence

− ISO/IEC 38507:2022 − ISO/IEC TR 24028:2020
Risks and Social Impacts
Standardization

IEEE
• Engineering in Medicine and Biology Society
− IEEE 1752.1-2021 − IEEE/ISO 11073-40102-2022
− IEEE 11073-40101-2020 − IEEE 2621.3-2022
− IEEE 2621.1-2022 − IEEE 2621.1-2022
− IEEE 2791-2020

• Systems, Man, and Cybernetics Society

− IEEE 3333.2.1-2015

• Software & Systems Engineering Standards Committee

− IEEE 730-2014 − IEEE 730-1998
− IEEE 828-2005
Risks and Social Impacts
Standardization Map
A Knowledge Graph
Link: https://mapping.iec.ch/#/maps/126
 THANK YOU!!!!

The ethical risk triggered by dual-use consequences would be

mitigated by strengthening UN SDG's by promoting a
transformational and resilient society: human beings should not
compete with machines. It is necessary to change the way
children and adolescents get education in order to develop
capacities like communication, partnerships as well as skills to
manage conflicts and make solutions suitable.
Children and adolescents should be prepared to acquire
principles and ethics.

24
 FUTURE WORK
• Materialize the "human- • Biodigital Convergence for
Good: strengthening the
centric value” UN SDGs

• Bioengineering for • Ethical standards as

climate and humanity: a binding norm to safe
implementation and to
Task Force combat corruption in the
technological convergence

25
CONTACT FOR QUESTIONS:

ANDREA ROMAOLI
[email protected]

IEC – WG7: Bio Digital, Social, Risks & Ethical Aspects

CONVENOR
OCHA/ITU Ethical Reviewer
Mandate Holder - UN Human Rights Council

26
ANNEX A – Q&A
1. What are implications of the dual-use dilemma?

The DUAL USE DILEMMA should not be understanding as a barrier for deployment of technologies...Indeed,
technologies has potential to solve complex issues on healthcare and climate. Dual use should be understood in order to
be managed.
Would be unethical if convergence technologies would not be released because the Good results is bigger than harm
perspective when considered in realistic scenarios with resilient and holistic governability.
The legal implications of scientific uncertainty are addressed by precaution as a principle applying together with legal
criteria within risk assessment and the protection of human rights in situations where the risks and scale of impacts are
uncertain.
Whether a given option should be pursued despite scientific uncertainty about its impacts should be evaluated against
alternative options, including those about which there is more scientific certainty. In the event that there is all a full or
partial governance gap, precaution is potentially legally significant. Thus, as preferable, the least potentially harmful
option.
27
ANNEX A – Q&A
2. What means Ethical?

Justice means moral virtue guiding individual belief for fighting against biological and organic selfishness of each one.
Justice harmonizes conflicting claims and interests in the social life within a community mindset in accordance with law
and equity to promote social behaviors through principles, human rights, honor, duty and freedom.
Ethics perform a role of mediator between Justice and optimal human behavior. Thus, there would not be Justice without
ethics.
Ethical can be defined as all possible and available choices where a level of consciousness defines the best option.
Values and principles are limits that guide the conscience into this choice. Alongside purposes, ethics is a mediator
process to materialize full Justice.
In terms of Ethics for BioDigital Convergence, the process for discovering what is "Good and Right" means to choose
among all possible and available applications which one best option applies to hit full protection for all forms of life
through holistic Human-Centric approach which human, machine and environment are combined to harmonious
transformational and resilient standardization and governance processes.

28
ANNEX A – Q&A
3. What would be an example about military use in the context
of BioDigital Convergence?

On instance, would come from unaccountability stemming from events where there is proof os liability for a military crime
where soldiers would get an impunity sentence because they would cite human augmentation as legal excuse (exception)
and it creates a gap in the regulatory field with grave ethical consequences.
The Biological Weapons Convention (BWC) doesn't cover a situation where soldiers use human augmentation through
exoskeletons and nano Biodigital Convergence.
Convergence technologies can be used for good military applications but the unwanted result would come from dual-use
in case it would serve to expand the potential harm of terror industry.

29
ANNEX A – Q&A
4. Forced displacement is among consequences of climate crisis
and it impacts more women and girls than men and boys. How
would climate technological tools help?
Vulnerable people are living in developing countries but climate disaster can become anyone as vulnerable and target for
human rights violation from criminal actors. Internal displacement impacts all affected people at different manners: men,
boys, elderly, women, girls and people from minority sexual groups.
Men and boys: increased risk of forced recruitment by armed groups or extremists; forced into child labor; human
trafficking.
Women and girls: suffer greater inequalities in labor when compared with displaced men. Also they are at higher risk of
sexual and gender-based violence. Regarding to girls, they are going out of school and recruited for child marriage.
These circumstances reinforce a vicious circle of lasting vulnerability.
Technological climate tools can help through anticipatory actions notably in places facing flooding and drought where
climate tools would anticipate: is possible to provide indication of increased drought risk within a forecast lead times
between 1-6 month. In this manner, anticipatory actions would provide a faster response to address women and girls
specific needs.
30
ANNEX B - REFERENCE
• Garcia A.R. (2020) AI, IoT, Big Data, and Technologies in Digital Economy with Blockchain at Sustainable
Work Satisfaction to Smart Mankind: Access to 6th Dimension of Human Rights. In: Lopes N. (eds) Smart
Governance for Cities: Perspectives and Experiences. EAI/Springer Innovations in Communication and
Computing. https://link.springer.com/chapter/10.1007/978-3-030-22070-9_6
• GOV. UK: Human Augmentation – The Dawn of a New Paradigm
• IEC: Safety in the future
• IEC: Artificial intelligence across industries
• NASA: Agriculture - Ensuring Food Security
• OECD: Biotechnology Update -n. 40
• Rousseau on Equality: Social Philosophy and Policy
• UNESCO: REPORT OF COMEST ON ROBOTICS ETHICS
• Unido: What is the Fourth Industrial Revolution?

• WHO: Human genome editing: recommendations

31
 Closing Panel
Bio-Digital convergence
standardization,
view forward
v 1.1

François Coallier,PhD, P.Eng. IEC SEG 12 Webinar

IEC SEG 12 Bio-Digital Convergence
Convener Standardization
 BioDigital Convergence
convergence of engineering,
nanotechnology, biotechnology,
information technology and cognitive
science
Note 1 to entry: convergence means the creative union of sciences, technologies, engineering and
peoples, focused on mutual benefit; this is a process requiring increasing integration across
traditionally separate disciplines, areas of relevance, and across multiple levels of abstraction and
organization.

[SOURCE: Modified from: M. C. Roco, W. S. Bainbridge, B. Tonn, and G. Whitesides, Eds., Convergence of Knowledge, Technology and Society: Beyond Convergence of
Nano-Bio-Info-Cognitive Technologies. Cham: Springer International Publishing, 2013. doi: 10.1007/978-3-319-02204-8.]

2
 Webinar Topics

● Reverse Engineering of Living Systems (WG2)

● Life systems and Bioengineering (WG3)
● Human Augmentation Technologies (WG4)
● Agricultural Bioengineering (WG5)
● Environmental Bioengineering (WG6)
● Biodigital Social, Risks and Ethical Aspects (WG7)
 Nanotechnologies
Zoom in:
WG2 decomposing
Epigenetic
Exposomics
Proteomics
WG2 Genomics Biosensors WG3
Biotechnologies

Metalonomics Bio-data
Synthetic biology science
Bioinformatics
Transcriptomics Computational
Biology biology Informatics
Metabolic Bioengineering
Microbiomics engineering
Bioanalytics
WG2
Genetic Cybernetics BMI
Bioelectronics
engineering engineering
Bioethics
WG7
Biomechanical
engineering
Neurobotics ICT
Bionics BIO-MEMS
Ecology
Systems
engineering
Engineering
 Zoom out:
Human
applications
augmentation
Sensor based
Biohacking epidemiology WG6
monitoring Environmental
WG4 Bio-bots
Engineering
Cyborg Environmental
Biomaterial
Exoskeleton Monitoring Geoengineering
Animat
Embodied
computing Smart
Cities
Artificial
Health
organ Bioengineering
GMO
Organ-on-a
WG3 -chip
Bioelectronics
Cellular
Bioprocessing agriculture
Human
body-on- Smart Farming
Molecular
a-chip Biomanufacturing
farming
Medicine WG5

Manufacturing
 Zoom out:
Human applications
augmentation
Sensor based
Biohacking epidemiology
monitoring
Bio-bots Environmental
Cyborg Environmental Engineering
Biomaterial
Exoskeleton Monitoring Geoengineering
Animat
Embodied
computing Smart
Cities
Artificial
Health
organ Bioengineering
GMO
Organ-on-a
-chip Cellular
Bioelectronics
Bioprocessing agriculture
Human
body-on- Smart Farming
Molecular
a-chip Biomanufacturing
farming
Medicine

Manufacturing
 Panel Members
Chair: Dr. François Coallier
Chair IEC/SEG 12 & Co-Convener of its WG6

Dr. Yong Zhang - Co-Convener IEC/SEG 12 WG2

Dr. Zhiwei Cao - Co-Convener IEC/SEG 12 WG2
Dr. Joerg Geiger - Co-Convener IEC/SEG 12 WG3
Dr. William Wasswa - Co-Convener IEC/SEG 12 WG3
Ms. Yuntao Yu - Co-Convener IEC/SEG 12 WG4
Dr. Philip Troyk - Co-Convener IEC/SEG 12 WG4
Dr. Raymond Shillito - Co-Convener IEC/SEG 12 WG5
Ms. Andrea Romaoli - Co-Convener IEC/SEG 12 WG7
Given the current findings in your respective
areas:
• How can you characterize the needs for
technical standardization in the next 5 years?
• How important will it be to have an international
consensus for these standards?
• How significant are societal (ethical, social,..)
issues? How could international standards
contribute?
Thank you!