Journal of Medical Imaging and Radiation Oncology 66 (2022) 225–232

MEDICAL IMAGING—REVIEW ARTICLE

Quality use of artificial intelligence in medical imaging: What do

radiologists need to know?

Journal of Medical Imaging and Radiation Oncology

Stacy K Goergen,1,2 Helen ML Frazer3,4 and Sandeep Reddy5
1 Monash Imaging, Monash Health, Melbourne, Victoria, Australia
2 Department of Imaging, School of Clinical Sciences, Monash University, Melbourne, Victoria, Australia
3 St Vincent’s BreastScreen, St Vincent’s Hospital Melbourne, Melbourne, Victoria, Australia
4 BreastScreen Victoria, Melbourne, Victoria, Australia
5 School of Medicine, Deakin University, Geelong, Victoria, Australia

SK Goergen MBBS, MClinEpi, FRANZCR; Abstract

HML Frazer MBBS, FRANZCR, M.Epi;
S Reddy MBBS, MSc, PhD.
Correspondence
Dr Stacy K Goergen, Monash Imaging, Monash
Health, 246 Clayton Rd, Clayton, Vic. 3168,
Australia.
Email: stacy.goergen@monashhealth.org
The application of artificial intelligence, and in particular machine learning, to
the practice of radiology, is already impacting the quality of imaging care. It
will increasingly do so in the future. Radiologists need to be aware of factors
that govern the quality of these tools at the development, regulatory and clini-
cal implementation stages in order to make judicious decisions about their
use in daily practice.
Key words: artificial intelligence; medical imaging.

Submitted 29 November 2021; accepted 14

December 2021.

doi:10.1111/1754-9485.13379

communication about, medical imaging studies will be at

Introduction
Quality in health care can be defined as consistent provi-
sion of safe, effective, timely, patient-centred and appro-
priate care.1 The recent exponential growth of artificial
intelligence (AI) and machine learning (ML) applications
for medical imaging has the potential to profoundly
impact our ability as clinicians to provide quality care.
Development of AI / ML tools for medical imaging
interpretation is rapidly accelerating due to increasingly
large digitised image data sets, availability of open-
source algorithms, increased computing power and cloud
services alongside developments in deep-learning tech-
niques like convolutional neural networks (CNNs), which
analyse ‘non-linear’ relationships between input data to
draw conclusions about outputs. The demonstration of
the potential for CNNs, the prototype deep-learning
application for analysis of image data, for analysis of
high-resolution images is as recent as the ImageNet
Challenge of 2012. In this competition, Russakovsky
et al.2 utilised a form of CNN termed ‘AlexNet’ that signif-
icantly advanced the ability of AI to detect and interpret
images.
It is highly likely that the application of AI to the acqui-
sition, reconstruction, triage, presentation, interpretation
and reporting of, as well as post-interpretative
least as impactful to the field and to patient care as was
the introduction of cross-sectional imaging in the previ-
ous century. The opportunity to transform the capacity
and accuracy of image interpretation enabling radiolo-
gists to spend more time in examining complex cases,
personalising patient care and conducting research is
now envisioned. Topol’s concept of ‘Deep Medicine’ is
that humans and AI can work synergistically, in contrast
to ‘Shallow Medicine’ characterised by brief clinical
encounters, poor evidence support and inaccurate tools.
‘Deep Medicine’ enabled by AI tools can promote better
care, better evidence and greater accuracy.3 Such appli-
cations have also been suggested as remedies for radiol-
ogist burnout that, somewhat paradoxically, has
developed in parallel with the transition from paper and
film to digital, bringing with it a less relenting cognitive
load.4
Automation of tasks that radiologists probably perform
suboptimally, such as rib fracture and lung nodule detec-
tion with CT,5,6 reassessment of the size of a pleural effu-
sion on sequential chest radiographs, or mammographic
screening7 seems like an attractive way to free the radi-
ologist to perform higher level interpretive tasks that
may not be amenable to automation and conduct activi-
ties like multidisciplinary team meetings. Triaging with AI

© 2022 Royal Australian and New Zealand College of Radiologists. 225

SK Goergen et al.
of the most urgent cases for reporting, such as CT scans
harbouring pulmonary embolism,8 chest radiographs
demonstrating pneumothorax9 or head CTs containing
haemorrhage10 could reduce patient morbidity and
length of stay in emergency departments. Synthetic MRI,
which utilises deep-learning systems to post-process and
reconstruct MR image data such that image acquisition
time is reduced without noticeable degradation of image
quality, may improve efficiency, reduce costs and
improve access.11
However, the rapidly increasing development of AI
applications for medical imaging, their commercialisa-
tion, and subsequent approval by regulators for clinical
use, have come with concerns regarding the actual per-
formance of these tools in day-to-day clinical practice
(12–15). Furthermore, bias within training and / or valida-
tion data sets and lack of uniformity of reporting stan-
dards in scientific publications relating to algorithm
performance, as well as absence of postmarket surveil-
lance or transparent processes to define, monitor and
remediate performance that falls below that which led to
regulatory approval in the first place, are significant
quality issues at the heart of our work as clinicians. Lack
of sufficient validation of many commercially available
algorithms is a direct result of lack of access of AI devel-
opers to enough appropriate quality labelled clinical
image data.
Radiologists largely take for granted that our imaging
equipment will perform within the specifications provided
by the vendor, and that automatic checks on things such
as gradient and main field homogeneity, CT exposures,
focal spot size and CT detector performance will occur.
However, these quality assurance features are not a rou-
tine part of ML applications for interpretative or non-
interpretative tasks, and the ability of such applications
to continuously modify their performance, or ‘learn’, over
time poses both regulatory and implementation chal-
lenges. Put simply, how do radiologists know that the AI
software application they implemented to replace or aug-
ment an interpretative or other task is still doing what it
is supposed to be doing?
Measuring, maintaining and improving quality in the AI
era pose new challenges at both the regulatory and clini-
cal level. There is a clear need to require documentation
of intended use and performance of AI tools and need for
a quality assurance programme that enables audit and
testing to detect drift and bias in high stakes health deci-
sions. While the solutions to these challenges are neither
simple nor necessarily obvious, an awareness of the
issues themselves is essential. Radiologists remain ulti-
mately responsible for the systems we put in place to
deliver care to our patients and community; as such, we
need to be educated users of the technological advances
that are a rapidly changing fact of life in our specialty.
The remainder of this article will focus on 3 main
themes relating to quality use of AI / ML applications in
medical imaging:
226
1 Design and reporting of studies of AI / ML applications
in imaging—standardisation to improve quality
2 Regulation of ML software applications as medical
devices—what is needed to support quality care?
3 Clinical evaluation and implementation of AI / ML
algorithms to measure and improve quality
Design and reporting of AI / ML studies:
Standardisation to improve quality
All tools used to support clinical decision-making require
validation. The standard has been reporting of ran-
domised clinical trials. The SPIRIT (Standard Protocol
Items: Recommendations for Interventional Trials) and
CONSORT (Consolidated Standards of Reporting Trials)
statements are reporting guidelines for protocols of and
completed randomised controlled trials (RCTs) respec-
tively.16,17 Recently, these consensus-based statements
have been extended as SPIRIT-AI18 and CONSORT-AI19
statements due to recognition that existing appraisal
tools for evaluation of the quality of randomised RCTs do
not adequately address key issues relating to AI / ML
interventions. Draft item lists were reviewed and modi-
fied by stakeholders in 2 online Delphi surveys, where
they were refined and modified. The 98 stakeholders
that developed the Statements included clinicians, com-
puter science/ML experts, methodologists, statisticians,
funders, regulators, journal editors, patients and policy-
makers.
The final SPIRIT-AI and CONSORT-AI statements were
published in Nature Medicine, The British Medical Journal
and The Lancet Digital Health in September 2020.17–19
There are 26 candidate items for SPIRIT-AI and 29 for
CONSORT-AI including description of the inputs and out-
puts of the algorithm, how the algorithm makes recom-
mendations and fits into a clinical pathway,
considerations for continuously improving algorithms,
sources of bias and poor generalisability and statements
on algorithm ownership and potential / actual conflicts of
interest. Journals that publish scientific papers relating
to ML / AI algorithms are being asked by the SPIRIT-AI
and CONSORT-AI initiative to formally endorse the state-
ments and use them in their peer-review processes in
order to standardise review criteria applied by journals,
and thus, the ‘burden of proof’ before manuscripts are
accepted and published. Tools for assessment of the risk
of bias (PROBAST-AI) and for the reporting of AI diag-
nostic and risk prediction studies (TRIPOD-AI) are under-
way.20 These too will support greater transparency and
more uniform peer-review and critical appraisal pro-
cesses and thus indirectly improve the quality of pub-
lished work.
Of particular relevance to diagnostic radiologists is the
work to develop STARD-AI (Standards for Reporting of
Diagnostic Accuracy Studies—Artificial Intelligence), an
extension of the original STARD Statement, which was
updated in 2016. Sounderajah21 et al. state, in their
© 2022 Royal Australian and New Zealand College of Radiologists.

paper, describing the STARD-AI methodology: ‘. . .. . .much
of the evidence supporting diagnostic algorithms has
been disseminated in the absence of AI-specific reporting
guidelines’. Varying definitions of the term ‘validation’
and unfamiliar outcome measures (e.g. Jaccard similarity
coefficient and F-score) limit the ability of clinicians to
translate AI tools into better health outcomes, because
they do not necessarily understand or trust their perfor-
mance’.
To date, there are only 10 recorded RCTs of AI models
in health care and only two published (one in gastroen-
terology, one in ophthalmology) with the largest sample
size being 1,000 participants.22 A recent systematic
review of one of the more advanced areas of AI develop-
ments in image interpretation, the classification of mam-
mograms, concluded that no study had adequately
validated its use in screening programmes.15
Regulation and regulatory frameworks:
What is needed to support quality care?
Regulators have had to consider how to adapt their eval-
uation frameworks to be fit for purpose for medical
devices that are based on AI / ML, in the face of rapidly
growing demand for regulatory approval of commer-
cialised products. Last month, the U.S. Food and Drug
Administration (FDA) along with Health, Canada, U.K.’s
Medicines and Healthcare products Regulatory Agency
(MHRA) released a list of 10 guiding principles to inform
development of regulatory frameworks for AI / ML appli-
cations (Fig. 1).23 This was one of the intended outputs
of the FDAs Software as a Medical Device (SaMD) Action
Plan, announced in January 2021.24
Standardisation of reporting of the key attributes and
performance of a product, as described in the previous
paragraph, could be extremely helpful in this regard. Apart
from the various attributes and development methods of
the application that exist at the time of regulatory consid-
eration, is the important concept of ‘continuous learning’.
Unlike a hip prosthesis or contrast injection pump, the
performance of algorithms may not be ‘static’ following
their approval for clinical use, depending upon their
design and what is stipulated in the approval process. In
Fig. 1. FDA / MHRA / Health Canada.
© 2022 Royal Australian and New Zealand College of Radiologists.
Quality use of artificial intelligence in radiology
fact, without intervention, their performance normally
deteriorates over time, due to ‘concept drift’ arising from
changes to the statistical input to the algorithm that, in
turn, is due to changes in things like patient population,
scanner platform, scanning protocols or contrast dosage,
to name a few. Such ‘drift’ can potentially be ameliorated
by continuous learning AI that continues to improve as a
consequence of changing environments and data. How-
ever, this requires a specific ‘feedback loop’ to exist from a
reference standard or ‘ground truth’, whether this be a
diagnosis (e.g. a breast cancer on a mammogram) or a
particular outcome (e.g. generation of a diagnostic quality
image following application of a denoising algorithm). In
addition, this brings with it the potential for ‘catastrophic
forgetting’ or ‘catastrophic inference’, whereby model per-
formance deteriorates abruptly following retraining of a
model with new data.25 Hence, an essential component of
any clinically implemented ‘continuous learning’ model is
a feedback loop from accurately labelled and appropriate
data sets of sufficient size and composition and a clear
operational and measurable definition of what it is that the
model is supposed to be doing.
While the important details of regulatory frameworks
specific to AI in medical imaging continue to evolve
internationally, albeit more slowly than the applications
for device approval, Gilbert et al.26 in a review of the
current state of these frameworks highlight the primary
need for international harmonisation of regulations that
govern transparency of AI quality management systems
and algorithm change protocols.
This raises the issue of the regulatory challenges of
approving of a medical device whose performance
changes; specifically, is a re-approval process required,
and if so, what constitutes a significant change to the
device when this is a continuous learning AI algorithm?
Is it practical for this to occur or does it represent a
major impediment to dissemination of AI applications in
clinical practice? The recently released FDA Action Plan
provides an important modification to their decades—
long principle that medical device should be defined,
thoroughly tested and meticulously documented before
approval, and their subsequent safety, efficacy and
patient benefit should be continuously monitored by both
227
SK Goergen et al.
clinical (postmarket) surveillance and tight regulatory
controls about any fundamental changes to the device
that are made following initial regulatory approval. The
Action Plan poses a solution to the challenges to continu-
ous learning of AI SaMD, in particular, by defining, at the
time of original regulatory approval, some limits regard-
ing the expected change in the clinical behaviour of
adaptive ML-based SaMD along with methods to continu-
ously monitor the extent of change, and to determine its
conformity with these a priori ‘set’ boundaries. This
equates to what Gilbert et al. have defined as ‘premarket
comprehensive consideration’ of the changes that would
be acceptable for the device. The Australian Therapeutic
Goods Administration (TGA) made changes to the regu-
lation of SaMD in February 202127 and a further guidance
document relating to regulation of SaMD (which is still in
draft form) in October 2021,28 but this guidance does
not provide specific detail relating to adaptive or ‘contin-
uous learning’ AI. It remains to be seen whether it will
follow FDA recommendations for such devices or develop
more prescriptive requirements; the latter decision will
have a significant influence on the development and
implementation of AI tools in medical imaging in Aus-
tralia and New Zealand. In addition, it is self-evident that
there will be a room for interpretation regarding whether
a change to the performance of a software product as a
result of continuous learning is consistent, or not, with
the ‘premarket comprehensive consideration’; this inter-
pretation has clear cost implications for AI / ML SaMD
developers and safety implications for patients. While
the concept itself is simple and logical, its implementa-
tion may not be.
The importance of appropriately qualified individuals
from multiple disciplines being involved in creating the
new frameworks within which regulation of medical AI will
be delivered cannot be overstated. Ethical considerations
relating to bias in algorithm development and deployment
as well as privacy and data security, especially when data
sharing agreements are entered into to facilitate continu-
ous learning of AI applications, need urgent integration
into regulatory frameworks.29 The Royal Australian and
New Zealand College of Radiologists released its position
statement ‘Ethical Principles for Artificial Intelligence in
Medicine’ in August 2019 setting out nine principles to
guide the development of professional and practice stan-
dards regarding the research and deployment of AI and,
subsequently, its Standards of Practice for Artificial Intelli-
gence in September 2020, to lead the profession and
inform regulators, patients, consumers and AI developers
/ vendors about quality use of AI in medical imaging.30,31
Clinical evaluation and implementation
of AI applications: Measurement and
improvement of quality
One of the key enablers to clinical implementation, along
with interoperability of AI algorithms with current
228
radiology systems and standards (such as \ Digital Imag-
ing and Communications in Medicine [DICOM], Health
Level-7 [HL7] and Fast Healthcare Interoperability
Resources-1 [FHIR]), is trust. While post hoc explanation
of what is in the ‘black box’ of AI has previously been
proposed as the best way to achieve this, using tech-
niques such as heat or saliency maps for a radiologist to
‘understand’ how a model reaches a decision in an indi-
vidual case can be unrealistic in practice32,33 (Fig. 2).
Indeed, the term ‘explainability’ itself is variously
defined and used in the context of AI and ‘explainable AI’
(XAI) is itself a growing field of research. Explainability
can be the best thought of as a combination of various
techniques to make the decision-making process of algo-
rithmic models understandable and closer to trans-
parency. This concept encompasses comprehensibility,
interpretability, explainability, causability and under-
standability.
The well-known example of the ML algorithm that was
highly accurate for pneumothorax detection on chest
radiographs, until the chest tube was masked9 and its
performance plummeted, is not reproducible in its simple
‘understandability’ across the increasingly broad range of
AI applications in imaging. In addition, the human ten-
dency to try to determine whether the model used the
same information that we would have, as radiologists, to
reach a diagnosis can actually confound our ability to
comprehend and understand how a model is reaching a
conclusion or prediction, and to even identify when a
model makes clinically important errors.32 Reddy et al.,
Kelly et al. and Amman et al. (34–36) have suggested that
explainability may be the first casualty of deep-learning
algorithm high performance. The balance between ‘ex-
plainability’ and accuracy remains controversial, and
medical applications of AI / ML are perhaps the most dif-
ficult domain in which this controversy will play out in
the near future.
Larson et al.37 and Ghassemi et al. advocate that
‘meticulous’ and extensive validation and ongoing auto-
mated monitoring of the performance of AI systems are
essential components of any AI implementation, particu-
larly where explainability may not be achievable. In par-
ticular, Larson et al. point out that the guard rails we
place around the performance of other medical devices
are often absent in medical AI applications. Furthermore,
of the eight basic elements of a quality control process,
performance measures, targets, monitoring and feed-
back are the most important; prediction and optimisation
models (akin to Google maps and satellite navigation,
respectively) are the least critical of these but are the
elements of process control where AI performs best.
Indeed, the parameters within which AI applications are
supposed to perform are currently not defined nor read-
ily monitored for many commercial applications except
by relatively laborious, manual processes that involve
comparison with actual reader interpretations. This is
costly. In a recent description of implementation of AI
© 2022 Royal Australian and New Zealand College of Radiologists.

Fig. 2. Saliency maps. Visualisation of saliency maps generated for three breast cancer examples (from Ref. 33).
software to detect pneumothorax,38 the first step was to
assess the performance of the software using local chest
radiographs. This involved identification of chest radio-
graphs with large and small pneumothoraces, and then,
two subspecialist thoracic radiologists reading 150 cases
mixed with chest radiographs demonstrating no pneu-
mothorax. This process needed regular repetition in
order to monitor the application for drift in performance.
The importance of transparent performance metrics,
pre-implementation validation on large, diverse data sets
and ongoing monitoring of performance is no less for AI
applications performing non-interpretive tasks. These
include natural language processing to determine compli-
ance of referrals with required descriptors for the
© 2022 Royal Australian and New Zealand College of Radiologists.
Quality use of artificial intelligence in radiology
examination or use of standardised reporting templates39
or the reduction in radiation dose and artefacts.
When considering the purchase and / or implementa-
tion of an AI application, Filice et al.40 suggest that the
first questions should be ‘Is there a problem that needs
fixing?’ and ‘does the AI tool deliver value?’ that is
improved quality and / or reduced cost. Many commer-
cially available applications are designed to do just one
thing, such as identifying a pneumothorax or pulmonary
embolism. If there is no evidence that the task is cur-
rently being done in a manner detrimental to timely and
/ or safe patient care, it may not be cost-effective to del-
egate this piece of the overall interpretation task to AI.
Consideration of the ‘value proposition’ is just as
229
SK Goergen et al.
important for AI tools that perform non-interpretive
tasks intended to improve quality.41,42
Current AI applications generally do not have any ‘built
in’ tools to assess the value that they deliver to their cus-
tomers. Furthermore, many customers do not have the
informatics infrastructure to determine the added finan-
cial value, or costs, of AI algorithms. For example, if an
AI tool designed to identify cerebral haemorrhage on a
CT scan, and then prioritise the study on a worklist, can
only identify haemorrhages large enough to be recog-
nised and flagged by the CT technologist, the cost of pur-
chase and ongoing performance monitoring of such
applications may not be outweighed by the benefits. This
will obviously depend on the frequency of occurrence of
cerebral haemorrhage and the efficiency of existing com-
munication between technologist and radiologist, the lat-
ter potentially facilitated by inexpensive messaging
applications. However, in resource-constrained settings
where there is no radiological interpretation available,
such tools may play a very important role in improving
health equity, by expediting recognition of conditions
requiring emergency treatment or patient transfer. Auto-
mated mechanisms that allow ongoing evaluation of tool
performance and value delivery need to become an inte-
gral part of AI applications in medical imaging; develop-
ers should recognise incorporation of these into their
offerings as a potential competitive advantage in the
marketplace.
Data sharing arrangements improve the quality of AI
tools in medical imaging through training and validation
on a wide range of data, whether this be images, text or
numeric output from imaging equipment. This can, but
does not always, reduce bias and unintentional widening
of health disparities based on design of algorithms using
data unrepresentative of the population to which it will
be applied. However, access to high quality, curated and
accurately labelled data has now become more valuable
than the algorithms themselves. Along with the need to
confirm purported performance of AI software prior to
implementation, and then plan and resource an ongoing
quality monitoring programme, this issue represents the
greatest impediment to more widespread integration of
AI tools into medical imaging workflow.
Health services may be approached by AI developers
who need access to their patients’ imaging data in order
to train and validate algorithms. However, health ser-
vices are often less sophisticated than universities in
negotiating appropriate fair value, royalty and intellectual
property arrangements with developers. This is to the
detriment of the health service itself, patients, radiolo-
gists (who are de facto providing ground truth and
labelled data through their reports), taxpayers and the
health system as a whole.
Innovative approaches to the sharing and / or use of
sensitive health data, including identified images, while
protecting patient privacy and data security are urgently
needed if AI algorithm development, validation, and pre-
230
clinical implementation performance assessment are to
be potentiated. The Secure Research Platform (SeRP) at
Monash University (43) and the ACR AI Lab Federated
Learning initiative, commencing 2022, are examples of
strategies to address this problem in different ways. The
former allows sensitive health data to be used and
shared within a secure environment, and the latter
enables multiple actors to build a common, robust
machine learning model without sharing data, thus
addressing critical data sovereignty issues such as pri-
vacy, security and access rights.
Conclusion
Apart from the quality-related issues described here in
relation to AI / ML applications at the development, reg-
ulatory and clinical implementation stages, there remain
a range of ethical, legal and social dilemmas to solve if
AI, particularly when this includes autonomous decision-
making and continuous learning, is to be widely and suc-
cessfully implemented in clinical settings.42 Radiologists
are at the forefront of AI application to medical practice
and as such have a special responsibility to understand
and judiciously apply these new tools protect and
enhance the quality of care we provide to our patients
and community.
Data availability statement
Data sharing is not applicable to this article as no new
data were created or analyzed in this study.
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