Page 161 - ITU KALEIDOSCOPE, ATLANTA 2019
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ICT for Health: Networks, standards and innovation




               financing.  It  includes  major  R&D  project  budget   agencies  need  to  answer.  Recently,  the  International
               support,  profit  distribution  and  national  health   Telecommunication  Union  (ITU)  established  an
               insurance  management,  etc.  Especially  with  the   ITU/WHO  Focus  Group  on  artificial  intelligence  for
               progress of aging, how to effectively reduce the cost of   health  (FG-AI4H),  which  works  in  partnership  with
               medical insurance has become a common problem that   WHO to especially establish a standardized assessment
               needs to be solved in various countries.           framework for the evaluation of AI-based methods for
                                                                  health, diagnosis, triage or treatment decisions [42]
           5.2    Standardization
                                                              ➢   Security:It  includes  the  concerns  of  data  security,
           Under the overview control of the collaboration mechanism,   network  security  and  product  security.  Data  security
           standardization  could  technically  act  as  an  accelerator  for   refers  to  data  ownership,  data  handling  policy  and
           integration  innovation.  Consideration  on  standardization   privacy  protection  during  usage.  Network  security
           could be prepared as the following part.               refers  to  cybersecurity,  avoiding  products  being
                                                                  attacked by illegal cyberattacks. Product security refers
           ➢   Data format and interface: Much previous efforts have   to the safe use of the product. Currently with the rapid
               been  made  to  meet  the  demand  of  medical  system   development of AI for health application, most of the
               interconnection  and  compatibility.  Personal  health   applications  investigated  could  not  provide  relevant
               device  standards  (ISO  /  IEEE  11073)  and  Digital   evidence  or  peer-reviewed  research  to  support  their
               Imaging and Communications in Medicine (DICOM)     products.  According  to  a  study  published  in  Nature
               are known as addressing the interoperability. Though   Digital  Medicine,  only  two of  the  73  applications  in
               AI  for  health  focuses  more  on  the  application  layer,   their survey provided evidence of research [43].
               updates on data formats and interfaces should also be
               considered to meet the development requirement.   ➢   Ethics:Ethics are important to consider especially for
                                                                  the  health  field.  Major  countries  and  international
           ➢   Data quality: It refers to the standardization of content   organizations  have  established  AI  ethics  institutions
               requirement  input  to  AI  algorithms,  and  it  is  a  new   focusing  on  the  discussion  of  ethical  guidelines  and
               demand due to new technology of AI. Medical images   standards.  In  June  2019  the  US  Food  and  Drug
               used  by  AI  may  contain  undesirable  artefacts  (e.g.   Administration released a discussion paper of proposed
               background  noise),  lack  focus,  exhibit  uneven   ‘Regulatory Framework for Modifications to Artificial
               illumination  or  under/overexposure,  etc.  [35].   Intelligence/Machine   Learning   (AI/ML)-Based
               Moreover, the quality of the annotation for AI training   Software  as  a  Medical  Device  (SaMD)’  and  also
               is  also  critical.  To  form  a unified  understanding  and   requested feedback including on ethical aspects [44].
               workflow  on  annotation  among  different  groups  of
               clinicians  is  a  difficult  but  necessary  task.  Several   6.  CONCLUSION
               public  datasets  are  released  for  research,  including
               Kaggle, ImageNet, Messidor database [36-40], but for   In this work, we choose the perspective of interaction of ICT
               long-term  development  and  scaled  application,   on the health industry. An industrial framework of the digital
               standardization on data content and annotation are very   health  industry  was  proposed  to  better  understand  the
               necessary requirements for sustainable development.   interaction between component factors from the health and
                                                              ICT  sides.  We  extracted  and  reconstructed  different
            5.3   Regulation                                  component  factors  to  expand  the  framework  from  the
                                                              traditional health industry to digital health. The traditional
           With  collaboration  mechanism  acting  as  a  macro-control,   health  industrial  framework  is  divided  into  service  and
           standardization  as  a  technical  accelerator,  regulation  is  to   management  parts,  and  ICT  factors  are  listed  as  sensors,
           define  the  bottom  line  of  the  industry  and  maintain  its   networks,  data  resources,  platforms,  applications  and
           legality.  The  International  Medical  Device  Regulators   solutions. This paper also tracks the interaction through the
           Forum  (IMDRF)  was  established  to  discuss  the  common   development  history  of  the  digital  health  industry,  from
           problems  in  international  medical  device  regulation,  with   institutional   informationization   to   regional
           representatives  from  regulatory  authorities  in  Australia,   informationization, and finally to service intelligentization.
           Brazil,  Canada,  China,  European  Union,  Japan  and  the   Following such a developmental roadmap, AI was chosen as
           United  States,  as  well  as  WHO  [41].  From  their  working   one  of  the  most  powerful  technologies  to discuss  the  key
           group setting, main concerns on regulation can be divided   trends from data, computing power and algorithms. Service
           into reliability, security and ethics parts.       and  management  processes  in  the  health  industry  were
                                                              observed  on  the  effects  of  ICT  penetration.  In  the  end,
           ➢   Reliability: The performance of AI algorithms can be   exogenous  factors  such  as  a  collaboration  mechanism,
               evaluated in the metrics of accuracy, precision, ROC,   standardization and regulation were proposed and discussed
               F-measures, interpretability, robustness, generalization,  to better prepare for supporting the sustainable development
               etc. In the face of such an emerging technology, how to   of digital health in the AI era.
               evaluate  AI/ML-based  software  as  a  medical  device
               (SaMD)  is  a  problem  that  all  national  regulatory




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