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2019 ITU Kaleidoscope Academic Conference
In contrast to the growing interest and impressive exchanged liaison statements, in view of common use cases
advancements, the healthcare sector has only hesitantly addressed.
adopted these powerful innovations in practice so far,
because any technical fault can affect people’s health, The Institute of Electrical and Electronics Engineers (IEEE)
privacy, and lives [25]. Providing conclusive evidence about has established an “Artificial Intelligence Medical Device
the performance, reliability and limits of the ML/AI models Working Group” that has started working on two projects for
is required for harnessing the benefits of trustworthy new IEEE standards in 2018. “P2802” is a “Standard for the
solutions, while avoiding the risks of inadequate Performance and Safety Evaluation of Artificial Intelligence
implementations. Due to the high complexity of the ML/AI Based Medical Device: Terminology” and “P2801” is about
models and the addressed health tasks, it is not trivial to the “Recommended Practice for the Quality Management of
demonstrate conclusively whether a particular Datasets for Medical Artificial Intelligence” [30].
implementation solves a task adequately and reliably under
realistic conditions. For safe usage, it is of paramount The U. S. Consumer Technology Association (CTA) started
importance that future international standards can give clear a working group on “Artificial Intelligence in Health Care
recommendations about how to validate the models. These (R13 WG1)” in April 2019, with the participation of AT&T,
standards are expected to promote interoperability and Google, IBM, Philips, Samsung, and other companies [32].
dismantle trade barriers too. Moreover, the development of This initiative has “launched a new standards effort
these standards is in line with the Sustainable Development addressing The Use of Artificial Intelligence in Health Care:
Goals (SDG) of the United Nations (UN), in particular with Trustworthiness”. Moreover, CTA has released a “White
“SDG 3: Ensure healthy lives and promote wellbeing for all Paper on Use Cases in Artificial Intelligence” in December
at all ages” [26]. 2018, which includes use cases in healthcare [33].
2. INTERNATIONAL STANDARDIZATION The U. S. National Institute of Standards and Technology
ACTIVITIES RELATED TO AI (NIST) was directed by the President in February 2019 with
Executive Order 13859 to “issue a plan for Federal
Several standardization bodies have begun addressing the engagement in the development of technical standards and
subject area of AI over the past two years. The International related tools in support of reliable, robust, and trustworthy
Telecommunication Union (ITU) and the WHO are two systems that use AI technologies” [34]. NIST submitted the
specialized agencies of the UN authorized for creating global plan in August 2019 and recommends to “commit to deeper,
standards. ITU establishes standards (“Recommendations”) consistent, long-term engagement in AI standards
for information and communication technologies, which development activities (…) to speed the pace of reliable,
include ML and AI. WHO considers the “development of robust, and trustworthy AI technology development”. The
global guidelines ensuring the appropriate use of evidence” plan advises to “promote focused research to advance (…)
as a “core function” [27], e.g. “recommendations on the understanding of how aspects of trustworthiness can be
diagnosis and treatment of malaria” [28]. Standards setting practically incorporated within standards and standards-
organizations are aware that the multidisciplinary field of related tools”. In particular, the plan recommends to “spur
health AI requires cooperation. Therefore, ITU and WHO benchmarking efforts to assess the reliability, robustness,
have joined forces and have created a focus group on “AI for and trustworthiness of AI systems” and to “ensure that these
Health” in July 2018 [29]. The group has begun working benchmarks are widely available, result in best practices, and
towards establishing a rigorous evaluation process for AI improve AI evaluations and methods for verification and
solutions for health that a global community of experts–from validation” [35, 36].
health, ML, AI, regulation, ethics, industry and academia
supports, which comprises an important first step towards In China, “a joint effort by more than 30 academic and
international standards for AI in health. A dedicated section industry organizations overseen by the Chinese Electronics
below presents this joint global standardization activity in Standards Institute” published an “Artificial Intelligence
more detail. The authors are members of the focus group. Standardization White Paper” in January 2018 [37, 38].
“Clinical medical imaging diagnosis” is mentioned as one of
The International Organization for Standardization (ISO) ten “real-world AI commercial application cases” according
subcommittee ISO/IEC JTC 1/SC 42 “Artificial intelligence” to a review available in English [39].
[31] has been developing a framework for AI systems using
ML (ISO/IEC WD 23053), addressing AI concepts and The European Committee for Standardization (CEN) and the
terminology (ISO/IEC WD 22989) and AI risk management European Committee for Electrotechnical Standardization
(ISO/IEC AWI 23894). Furthermore, ISO is working on (CENELEC) “launched a new Focus Group on Artificial
robustness (ISO/IEC NP TR 24029-1), trustworthiness Intelligence” in April 2019 [40] as a “starting point to
(ISO/IEC PDTR 24028), bias (ISO/IEC NP TR 24027) and support the identification of specific European
use cases (ISO/IEC NP TR 24030) in AI. While these Standardization needs”. Additionally, the EU High-Level
documents address AI in more general terms, the use cases Expert Group on AI published “Ethics Guidelines for
include healthcare applications too. Again, standard setting Trustworthy Artificial Intelligence” in April 2019 with
organizations are beginning to cooperate: ISO/IEC JTC 1/SC “technical robustness and safety” as one of seven key
42 “AI” and the ITU/WHO focus group have recently requirements for trustworthy AI [41]. In Germany, the
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