CTQM

Total Quality Management & Business Excellence
Fo
Healthcare 4.0 digital technologies impact on quality of
care: A systematic literature review
rP
Journal: Total Quality Management & Business Excellence
Manuscript ID CTQM-2022-0280.R1
ee
Manuscript Type: Research Article
Industry 4.0, Healthcare 4.0, Digital health, Quality measures, Quality,

Keywords:
rR
Clinical effectiveness
As a socio-technical system, the healthcare industry is at the dawn of a

foundational change into the new era of smart and connected healthcare,
ev
referred to as Healthcare 4.0 (H4.0). This research aims to provide a

conceptual framework to classify H4.0 digital technologies into bundles
of information and communication technologies used in the healthcare
value chain and examine their impact on quality measures such as
iew
patient safety, patient experience/satisfaction, and clinical effectiveness

through a systematic literature review of peer-reviewed journal articles.
Scopus, Web of Science, and PubMed are used to search the articles, and
systematic review and meta-analysis (PRISMA) protocol is applied to
Abstract:
evaluate the articles. Findings reveal that digital technologies
traditionally consist of two groups: sensing-communication and
On
processing-actuation. Further, the outcomes indicated that H4.0 digital

technologies could greatly influence quality metrics, but they can also
bring several challenges to patients and clinicians. This framework can
assist stakeholders in selecting H4.0 digital technologies to prioritize,
review and analyze appropriate technologies to improve and support
ly
patient safety, experience, and clinical effectiveness. Further, this

research contributes to the literature as it is the first analysis addressing
the impact of H4.0 technologies on the quality of care.
URL: https://mc.manuscriptcentral.com/ctqm Email: CTQM-peerreview@journals.tandf.co.uk

Page 1 of 35 Total Quality Management & Business Excellence
1
2
3 Table 1. Objectives of existing SLR on H4.0
4
5 Reference Objective
6 Mwanza et al. This review assesses the effect of I4.0 on the healthcare systems of
7
(2023) low- and middle-income countries.
8
9 Jose et al. (2022) The goal of this study is to analyze prior studies on the
10 competencies needed to deploy H4.0 technologies.
11 Sood et al. (2022) This article gives a scientometric examination of the literature on
12 the use of I4.0 technology in the healthcare industry in the
13 context of COVID-19.
14
15
Ahsan and Siddique This study examines how I4.0 will affect healthcare systems.
16 (2022a)
Fo
17 Sony et al. (2022) This study's objective is to evaluate the effect of MCPS on the
18 standard of healthcare service delivery.
19 Sibanda et al. (2022) This study examines the current status of using I4.0 technologies in
rP
20 maternity healthcare.
21
22
Alloghani et al. This study focuses on articles that discuss theoretical or analytical
23 (2022) work for the use of data mining in healthcare analytics.
ee
24 Vassolo et al. (2021) This study attempts to identify the most prevalent investment
25 methodologies employed and assess prior research on the
26 evaluation of H4.0 technologies in hospitals.
rR
27 Mustapha et al. This research intends to examine how I4.0 will affect the healthcare
28
29
(2021) system.
ev
30 Sisodia and Jindal This study presents a meta-analytic approach for interpreting,
31 (2021) integrating, and critically analyzing I4.0 design principles used in
32 the healthcare industry.
iew
33 Narkhede et al. This research intends to present a systematic literature evaluation of

34 (2020) cloud computing in healthcare's capabilities, usages, and other
35
difficulties across nations over a time frame.
36
37
On
38
39 Table 2. Articles information
40
41 Paper Title Year Country Main
ly
42 Technology
43 It is in the box! Improving the usability and benefits 2021 USA Hand gesture
44 of surgical safety checklists – A feasibility study sensor
45
46
Evaluating the experiences of new and existing 2021 USA Tele-
47 teledermatology patients during the COVID-19 dermatology
48 pandemic: Cross-sectional survey study
49 The effects of a digital mental health intervention in 2021 USA mHealth App
50 adults with cardiovascular disease risk factors: (Happify)
51 Analysis of real-world user data
52
53
Differences in secure messaging, self-management, 2021 USA Secure
54 and glycemic control between rural and urban Messaging in a
55 patients: Secondary data analysis web-based
56 patient portal
57
58
59
60 URL: https://mc.manuscriptcentral.com/ctqm Email: CTQM-peerreview@journals.tandf.co.uk
Total Quality Management & Business Excellence Page 2 of 35
1
2
3 Asthma on the move: How mobile apps remediate 2016 USA mHealth App
4
5
risk for disease management
6 Health-related quality of life improvements in 2020 USA mHealth App
7 systemic lupus erythematosus derived from a digital
8 therapeutic plus tele-health coaching intervention:
9 Randomized controlled pilot trial
10 Toward using wearables to remotely monitor 2020 USA Chest-worn
11
12
cognitive frailty in community-living older adults: sensor
13 An observational study
14 Use of digital health kits to reduce readmission after 2016 USA Web-based
15 cardiac surgery digital health
16 kits (DHK)
Fo
17 Usability and feasibility of consumer-facing 2020 USA mHealth App
18
19
technology to reduce unsafe medication use by older
adults
rP
20
21 COVID-19 pandemic accelerates need to improve 2020 USA Hospital website
22 online patient engagement practices to enhance
23
ee
patient experience
24 Qualitative and quantitative analysis of patient's 2019 USA Patient Portal
25
26
perceptions of the patient portal experience with
rR
27 open notes
28 User engagement and clinical impact of the manage 2021 Canada mHealth App
29 my pain app in patients with chronic pain: A real- (MMP)
ev
30 world, multi-site trial

31 Delivering mental healthcare virtually during the 2021 Canada Telehealth
32
COVID-19 pandemic: Qualitative evaluation of (Zoom)
iew
33
34 provider experiences in a scaled context
35 Exploring how virtual primary care visits affect the 2020 Canada Telehealth
36 patient burden of treatment (video)
37 Measuring the effect of Healthcare 4.0 2020 Brazil H4.0
On
38 implementation on hospitals’ performance

39
40
Impacts of Healthcare 4.0 digital technologies on the 2021 Brazil H4.0
41 resilience of hospitals
Information and communication technologies in 2021 Brazil ICTs
ly
42
43 emergency care services for patients with COVID-
44 19: A multi-national study
45 Digital technologies: An exploratory study of their 2021 Brazil H4.0
46
47
role in the resilience of healthcare services
48 Why #wearenotwaiting-motivations and self- 2021 Germany Automated
49 reported outcomes among users of open-source insulin delivery
50 automated insulin delivery systems: Multi-national (AID) system
51 survey
52 Measuring atopic dermatitis disease severity: The 2021 Germany mHealth
53
potential for electronic tools to benefit clinical care Technology
54
55
56
57
58
59
1
2
3 Using postmarket surveillance to assess safety- 2021 Germany mHealth App
4
5
related events in a digital rehabilitation app (Kaia (Kaia App
6 App): Observational study
7 Postmarketing safety monitoring after influenza 2021 Germany mHealth App
8 vaccination using a mobile health app: Prospective (SafeVac)
9 longitudinal feasibility Study
10 Wound image quality from a mobile health tool for 2021 Switzerla mHealth App
11
12
home-based chronic wound management with real- nd
13 time quality feedback: Randomized feasibility study
14 User experiences with and recommendations for 2020 Netherlan mHealth
15 mobile health technology for hypertensive disorders ds Technology
16 of pregnancy: Mixed methods study
Fo
17 Remote consultations versus standard face-to-face 2021 UK Telehealth
18
19
appointments for liver transplant patients in routine (Videoconferenc
hospital care: Feasibility randomized controlled trial ing software)
rP
20
21 of myvideoclinic
22 Effects of an innovative telerehabilitation 2020 Italy Virtual Reality
23
ee
intervention for people with Parkinson's disease on (VR)

24 quality of life, motor, and non-motor abilities
25
26
Design, implementation, and metrological 2021 Italy Augmented
rR
27 characterization of a wearable integrated AR-BCI Reality (AR)

28 hands-free system for health 4.0 monitoring
29 A telemedicine service system exploiting BT/BLE 2019 Italy Wireless Sensors
ev
30 wireless sensors for remote management of chronic

31 patients
32
BeyondSilos, a telehealth-enhanced integrated care 2020 Spain Telehealth
iew
33
34 model in the domiciliary setting for Older Patients: (BeyondSilos
35 Observational prospective cohort study for platform)
36 effectiveness and cost-effectiveness assessments
37 Blockchain for increased trust in virtual health care: 2021 Norway Blockchain
On
38 Proof-of-concept study Technology

39
Fog computing for Healthcare 4.0 environment: 2019 India Fog Computing
40
41 Opportunities and challenges
Automatic medical code assignment via deep 2020 China Deep Learning
ly
42
43 learning approach for intelligent healthcare
44 Recommendation system using feature extraction 2019 China N/A
45 and pattern recognition in clinical care systems
46
47
An interactive voice response software to improve 2021 Uganda Interactive
48 the quality of life of people living with HIV in Voice Response
49 Uganda: Randomized controlled trial (IVR)
50 Digital health tools and patients with drug use 2020 Australia eChat
51 disorders: Qualitative patient experience study of the
52 electronic case-finding and help assessment tool
53
(eCHAT)
54
55
56
57
58
59
1
2
3
4
5
Table 3. Bundles of H4.0 Technologies in Literature
6
7 Bundles Technology References
8 Digital Sensors Boillat and Rivas (2020)
9 Razjouyan et al. (2020)
10 Donati et al. (2019)
11
12
Remote Patient Monitoring Hamad et al. (2021)
13 Budhwani et al. (2021)
14 Kelley et al. (2020)
15 Damery et al. (2021)
16 Piera-Jiménez et al. (2020)
Fo
17 Blockchain Technology Hasselgren et al. (2021)
18
19
IoT Braune et al. (2021)
rP
20
21 McElroy et al. (2016)
22 Sensing– Messaging Choy et al. (2020)
23
ee
Communication Meyer (2020)

24
Mishra et al. (2019)
25
26 Robinson et al. (2021)
rR
27 mHealth Apps Bhatia et al. (2021)

28 Montgomery et al. (2021)
29 Kenner (2016)
ev
30 Zhang et al. (2021)

31 Holden et al. (2020)
32
Jain et al. (2021)
iew
33
34 Nguyen et al. (2021)
35 Maintz et al. (2021)
36 Khan et al. (2020)
37 Jongsma et al. (2020)
On
38 Machine/Deep Learning Bhatti et al. (2019)

39
40
Teng et al. (2020)
41 Processing–Actuation Augmented Reality Arpaia et al. (2021)
Virtual Reality Isernia et al. (2020)
ly
42
43 Fog Computing Kumari et al. (2018)
44
45
46 Table 4. Consolidation of H4.0 Implementation barriers and challenges
47
48 H4.0 Implementation
References Description
49 Challenges
50 Boillat and Rivas Medical device Managing, maintaining, and
51 (2021) management designing medical devices,
52
53
applications, and systems to fit
54 various healthcare settings can be
55 challenging.
56
57
58
59
1
2
3 Tortorella et al. Technical issues Technical issues were noted such as
4
5
(2020b), Kelley et  Internet coverage issues with the portal, appointments,
6 al. (2020),  Quality of image and the inability to print results.
7 Hasselgren et al.  Lack of system
8 (2021), Mishara et interoperability
9 al. (2019), Robinson  Lack of usability
10 et al. (2021), Zhang
11  Internet and system
et al. (2021), Maintz failures
12
13 et al. (2021), Teng et  Device malfunctions
14 al. (2020), Isernia et
 Scalability
15 al. (2020), Kumari et
16 al. (2018),
Fo
17 Byonanebye et al.
18 (2021)
19
Choy et al. (2020), Privacy and data security Patients identified privacy breaches
rP
20
21 Kumari et al. (2018) and data security as more significant
22 concerns than the cost of healthcare.
23 Tortorella et al. Social barriers Patients with specific characteristics
ee
24 (2020b), Budhwani  Digital illiteracy (e.g., past trauma history, older age,
25 et al. (2021), not speaking English as a first
 Poor engagement with
26
rR
Damery et al. technology language) had more difficulties

27
28 (2021), Meyer  Preference for in-person accessing and navigating the video
29 (2020), Khan et al. attendance visit technology and registration
ev
30 (2020)  Smartphone ownership processes.

31
 Remote follow-up
32
dislike
iew
33
34 Choy et al. (2020) Physical disabilities of Patients with weak eyesight, for
35 patients instance, find it hard to use digital
36 technologies.
37 Hasselgren et al. Cost Varying healthcare regulations and
On
38
39
(2021), Jongsma et  The initial investment accrediting organizations impose
40 al. (2020) for technology different requirements on hospitals
41 implementation that invest significant efforts to
achieve compliance. Such actions
ly
42  High transaction fees

43 (blockchain) are usually capital consuming.
44 Meyer (2020) Regulations Patients claimed that the regulations
45
46  Regulatory changes regarding using some digital
47  Different regulations technologies could be confusing and
48 across geographies vary from place to place.
49
50
51
52
53
54
55
56
57
58
59
1
2
3 Table 5. Summary of H4.0 Technologies Impact on Quality Measures
4
5 H4.0 Technologies Patient Safety Patient Clinical Effectiveness
6 Experience/Satisfaction
7
Sensing–Communication Bundle
8
Biomedical/Digital Sensors.  Limit the number of missed  Reduce the frequent  Complete digitalizing of
Fo
9
10 Hand gesture sensors (Boillat elements (Boillat and domiciliary or in- processes and sharing clinical
11 and Rivas, 2021), chest-worn Rivas, 2021). hospital visits (Donati information without the time and
rP
12 sensors (Razjouyan et al.,  Identify modifiable risk et al., 2019). distance barriers (Donati et al.,
13 2020), wireless sensors factors for cognitive frailty 2019).
ee
14
(Donati et al., 2019) (Razjouyan et al., 2020).  Improve identification of high-
15
16 risk individuals who develop
rR
17 cognitive frailty or associated
18 adverse health outcomes (i.e.,
ev
19 dementia) (Razjouyan et al.,
20 2020).
iew
21
22
 Ensure going through all the
23 elements guarantees better
24 quality of care (Boillat and
Rivas, 2021).
On
25
26  Optimize the chronic patient
27 management processes (Donati
ly
28
29
et al., 2019).
30  Enable the care team to remotely
31 assign personalized care plans
32 and monitor distance patients’
33 health status (Donati et al.,
34 2019).
35
36
mHealth Apps. MMP (Bhatia  Highlight overlooked  Enhance the  Decrease in anxiety and pain
37 et al., 2021), Happify components of disease, connectivity between catastrophizing.
38 (Montgomery et al., 2021), risk, and care. patients and their  The users experienced significant
39 mAsthma (Kenner, 2016),  Routine medication use and HCPs. improvement in subjective well-
40 Wound Management (Zhang et doctor visits. being and anxiety over time.
41
42
43
44
46
47
1
2
3 al., 2021), Brain Buddy  Track medical  The apps resulted in  Share data and risk patterns with
4
5
(Holden et al., 2020), Kaia performance. positive health the provider to create new, more
6 App (Jain et al., 2021),  Improve patient literacy. outcomes, impacting refined care practices.
7 SafeVac (Nguyen et al., 2021),  Stay better informed about patients' experiences.  Meaningful improvements when
8 others (Khan et al., 2020; medications that may be  Reduce unnecessary added to usual care, compared
Fo
9 Jongsma et al., 2020). unsafe (Holden et al., travel to the clinics. with routine care alone (Khan et
10
2020). al., 2020).
11
rP
12  Report adverse events (Jain  Just-in-time information access,
13 et al., 2021; Nguyen et al., efficient and effective
ee
14 2021). communication channels and
15  Allow feedback which can continuous support (Holden et
16
rR
improve safety (Nguyen et al., 2020).
17
18
al., 2021).
ev
19
20 Remote Patient Monitoring.  Easy access to primary care  Saving time and  Virtual visits appeared to
Tele-dermatology (Hamad et
iew
21 through timely money (Hamad et al., improve access to primary care
22 al., 2021), Zoom meetings appointments with no 2021). through timely appointments
23 (Budhwani et al., 2021),
24
booking required.  Easier routine follow- with no booking required and
videoconferencing software  Reduce the risk of infection up (Damery et al., reducing the risk of infection by
On
25
26 (Kelley et al., 2020; Damery et by not going to a healthcare 2021). not going to a healthcare facility.
27 al., 2021), telehealth platform facility.  Routine medication use and
(Piera-Jiménez et al., 2020)
ly
28 doctor visits.
29  Track medical performance, and
30
improve patient literacy.
31
32 IoT (i.e., Automated insulin  Improving the management  Positive improved  Highlight the unmet needs of
33 delivery (AID) system (Braune of existing diabetes-related sleep quality thanks people with chronic diseases
34 et al., 2021), digital health kits complications and to technology. (Braune et al., 2021).
35 (DHK) (McElroy et al., 2016) increasing safety by
36 avoiding severe
37
hypoglycemia.
38
39
40
41
42
43
44
46
47
1
2
3 Messaging (Patient Portal  Improve understanding  Communicate the  Improve self-care thanks to
4
5
(Mishra et al., 2019), eChat (education) and refresh the situation more medication adherence.
6 (Choy et al., 2020), Hospital memory of patients. effectively.  Engage more with healthcare
7 Website (Meyer, 2020))  Reduce experiences providers.
8 of stigma
Fo
9
10 Processing–Actuation
11
rP
12
Fog Computing (Kumari et  Assist doctors in making  Patients can manage  Increased collaboration between
13 al., 2018) smart decisions during an current and historical stakeholders as FC allows
emergency. medical history/bills patients and medical
ee
14
15 using a mobile practitioners to access the data
16 application or a web anytime, anywhere.
rR
17 interface which
18
makes their overall
ev
19
20 experience positive.
Machine/Deep Learning (i.e.,  The system helps providers  Improve the quality of health
iew
21
22 Feature extraction and pattern detect some rare diseases. monitoring, disease-trend
23 recognition (Bhatti et al.,  Highlight issues in a real- modeling, and early intervention
24 2019), Automatic medical time environment. with evidence-based medical
On
25 code assignment via DL (Teng  Assist management and treatment.
26 N/A
27
et al., 2020)). providers in analyzing the  Identify causes of diseases.
drastic change in chronic  Establish diagnoses
ly
28
29 diseases.  Detect side effects of beneficial
30 treatments
31
 Monitor clinical outcomes.
32
33 Augmented Reality (AR)  Reduce the number of  Patients had a positive global
34 (Arpaia et al., 2021) and times the operator has to cognitive level, memory,
35 Virtual Reality (VR) (Isernia shift attention from the positive affect, and mental health
36 et al., 2020) patient to the equipment, N/A results.
37 thus, fewer medical errors.
38
39
 Decrease incidents of
40 falling
41
42
43
44
46
47
1
2
3
4 Healthcare 4.0 digital technologies impact on quality of care: A
5
6 systematic literature review
7
8
9
10 Abstract
11
As a socio-technical system, the healthcare industry is at the dawn of a foundational change
12
13 into the new era of smart and connected healthcare, referred to as Healthcare 4.0 (H4.0). This
14
15 research aims to provide a conceptual framework to classify H4.0 digital technologies into
16
17 bundles of information and communication technologies used in the healthcare value chain and
18
Fo
examine their impact on quality measures such as patient safety, patient

19
20 experience/satisfaction, and clinical effectiveness through a systematic literature review of
21
rP
22 peer-reviewed journal articles. Scopus, Web of Science, and PubMed are used to search the
23
articles, and systematic review and meta-analysis (PRISMA) protocol is applied to evaluate
24
ee
25 the articles. Findings reveal that digital technologies traditionally consist of two groups:
26
27 sensing-communication and processing-actuation. Further, the outcomes indicated that H4.0
28
rR
29 digital technologies could greatly influence quality metrics, but they can also bring several
30 challenges to patients and clinicians. This framework can assist stakeholders in selecting H4.0
31
ev
32 digital technologies to prioritize, review and analyze appropriate technologies to improve and
33
34 support patient safety, experience, and clinical effectiveness. Further, this research contributes
iew
35
36
to the literature as it is the first analysis addressing the impact of H4.0 technologies on the
37 quality of care.
38
39
40
On
41 Keywords: Industry 4.0; healthcare 4.0; digital health; quality measures; quality; clinical
42
effectiveness
43
44
ly
45
46 Introduction
47
48 The Fourth Industrial Revolution, also known as Industry 4.0 (I4.0), refers to the trend towards
49 automation and data exchange in industry, supported by modern digital technologies such as
50
51 the internet of things (IoT), fog computing, artificial intelligence (AI), and blockchain
52
53 technology (Tortorella et al., 2020; Jamkhaneh et al., 2022). I4.0 has transformed several
54
55
industries into a new paradigm–smart, cyberized, and sustainable, and produced substantial
56 improvements in quality and satisfaction (Sakr & Elgammal, 2016). I4.0 has also
57
58 revolutionized all sectors, including healthcare, moving it away from the traditional “one-size-
59
60 fits-all” healthcare management approach towards real-time personalized monitoring and

1
2
3 therapeutic care (Ramori et al., 2021). Such revolutionary changes brought about a significant
4
5 impact on healthcare (Hundal et al., 2021). Healthcare delivery started to embrace these
6
7 technological innovations and reached a new era of change, referred to as Healthcare 4.0 or
8
9
H4.0 (Thuemmler & Bai, 2017). Healthcare continuously introduces various diagnoses and
10 treatment options and generates and reports extensive data. The data collection requires
11
12 installing considerable wired and wireless equipment, sensors, and devices in hospitals, clinics,
13
14 homes, pharmacies, and many other care environments (Antony et al., 2022).
15
16
17 H4.0 can improve the ability to diagnose accurately, enhance healthcare delivery for patients,
18
Fo
19 and empower patients to have more control over and make better-informed decisions about
20
21 their health (Arden et al., 2021). The concept also offers numerous opportunities to facilitate
rP
22 prevention, early diagnosis of life-threatening diseases, and management of chronic conditions

23
24 outside traditional healthcare settings (Awad et al., 2021). The recent COVID-19 pandemic has
ee
25
26 also highlighted the critical importance of digital technologies in healthcare (Kumar & Pumera,
27
28
2021; Marbouh et al., 2020), with many people relying on the internet and digital devices for
rR
29 access to medical services, diagnosis, and treatments.

30
31
ev
32
33 Healthcare systems gradually recognize that adopting H4.0 technologies can streamline the
34
patient pathway, from identifying symptoms to treatment and long-term support (Jamkhaneh
iew
35
36 et al., 2022). This paradigm shift has the potential to widen access to healthcare provision,
37
38 reduce costs, and provide services tailored to individual needs (Al Muammar, Ahmed, and
39
40 Aldahmash, 2017). These technologies allow medical care to percolate in traditional clinical
On
41 settings, homes, workplaces, and travel locations. In this manner, participatory medicine
42
43 lessens the burden on physical healthcare establishments while providing patients with care
44
ly
45 that integrates with their daily lives. These technologies can empower patients to self-advocate,
46
gain control over their care, and make better-informed decisions about their health (Awad et
47
48 al., 2021).
49
50
51
52 These technological developments have generated numerous opportunities to improve the
53 quality of care and offer a chance to move beyond the traditional scope of healthcare
54
55 engineering, such as process improvement and technology implementation. However, using
56
57 these technologies to improve quality measures is complex, with challenges as several barriers
58
59
hinder their full effective implementation (Ramori et al., 2021). There are many systematic
60 reviews articles available to date that discuss the application of I4.0 technologies in the

1
2
3 healthcare sector or systematic literature review (SLR) on H4.0 (Narkhede et al., 2020; Vassolo
4
5 et al., 2021; Sisodia & Jindal, 2021; Alloghani et al., 2022; Sibanda et al., 2022; Ahsan &
6
7 Siddique, 2022a; Jose et al., 2022; Sood et al., 2022). Only a few systematic reviews of the
8
9
literature related to the impact of various I4.0 applications on the healthcare sector (Mustapha
10 et al., 2021; Sony et al., 2022; Mwanza et al., 2023). There is a lack of SLR studies focusing
11
12 on H4.0 on quality measures, or no studies currently exist concerning H4.0 and quality
13
14 measures relationship. Hence, there is a need for conducting a thorough review of the literature
15
in the field of H.40 to identify its impact on quality care in a healthcare setting to guide
16
17 stakeholders and propose future research directions.
18
Fo
19
20
21 Quality in healthcare is one of the most frequently quoted health policy principles, which is
rP
22 currently high on policymakers' agendas. Measuring the quality of care is essential for various
23
24 stakeholders within healthcare systems as it builds the basis for numerous quality assurance
ee
25
26 and improvement strategies (Busse et al., 2019). Quality performance measures are the
27
28
instruments that assist in measuring/quantifying healthcare processes, results, patient
rR
29 perceptions, systems, and organizational structure related to the ability to offer high-quality
30
31 healthcare and facilitate achieving quality goals in the healthcare sector (CMS, 2022; Ramori
ev
32
33 et al., 2021). According to the World Health Organization (WHO), clinical effectiveness,
34
patient safety, and patient-centeredness/experience/satisfaction have become universally
iew
35
36 accepted as core measures of quality of care (WHO, 2018; National Health Services, 2011).
37
38 However, other measures exist for quality other than the ones mentioned previously; these
39
40 include attributes such as appropriateness, timeliness, efficiency, access, and equity. This
On
41 research aims to discuss the impacts of H4.0 on key quality measures and its opportunities and
42
43 challenges. Locating, retrieving, and reading the literature is time-consuming for academicians
44
ly
45 (Thomas, 2018). Therefore, to achieve the aims of the present study and provide healthcare
46
providers and academics with valuable insights into the impact of H4.0 technologies on quality
47
48 measures, this research undertook a comprehensive review of the existing literature. Hence,
49
50 this paper conducted an SLR to locate relevant existing studies based on prior formulated
51
52 research questions to evaluate and synthesize their respective contributions. Therefore, this
53 study attempts to answer the following research questions through a comprehensive SLR:
54
55 Q1. What are the different bundles of digitalized information and communication
56
57 technologies used in the healthcare value chain?
58
59
Q2. What are the barriers to H4.0 digital technologies and their implementation
60 challenges?

1
2
3 Q3. How do H4.0 digital technologies impact quality measures such as patient safety,
4
5 patient experience/satisfaction, and clinical effectiveness?
6
7
8
9
The rest of this article is structured as follows. Section 2 presents the methodology, including
10 the review process and selection of relevant studies. Section 3 presents the results by discussing
11
12 the descriptive analysis of studies and the analysis of findings. Section 4 discusses the paper's
13
14 conclusions and generates insights for practitioners and managers on implementing H4.0
15
digital technologies to improve patient safety, experience, and clinical effectiveness. Finally,
16
17 section 5 presents the study's limitations and opportunities for future research.
18
Fo
19
20
21 Theoretical background
rP
22 Existing literature review studies on H4.0

23
24 Before starting a literature review, it is vital to examine the current literature reviews in the
ee
25
26 area to gain an overview of existing H4.0 articles and to guarantee the absence of literature
27
28
reviews focusing on H4.0 technologies' impact on care quality. Table 1 shows the aims of prior
rR
29 H4.0 literature review studies that differ from the objectives of the present study.
30
31
ev
32
33 Mwanza et al. (2023) reviewed the impact of I4.0 on the healthcare systems of low- and middle-
34
income countries. The analysis reveals a significant bias toward mobile health and telemedicine
iew
35
36 technology adoption, with notable research gaps in the usage of additive
37
38 manufacturing, augmented reality, simulation, and digital twin technologies. Jose et al. (2022)
39
40 examined the previous research on the competency criteria for implementing H4.0 technology.
On
41 The findings indicate that the literature frequently discusses the competencies required for
42
43 implementing H4.0 in non-clinical deployments of I4.0 applications. Sood et al. (2022)
44
ly
45 presented a scientometric study of the literature on using artificial intelligence and I4.0 in the
46
healthcare industry in the context of COVID-19. The findings reveal that China has created the
47
48 most research outputs, even though India is the most collaborative country in this subject.
49
50 Ahsan and Siddique (2022a) examined the influence of I4.0 on healthcare systems.
51
52
53 The outcomes observed that healthcare and I4.0 merged and matured together during COVID-
54
55 19, addressing concerns such as data security, resource allocation, and data openness. Sony et
56
57 al. (2022) investigated the effect of medical cyber-physical systems (MCPS) on the quality of
58
59
healthcare service delivery. The results reveal that MCPS positively impacts all healthcare
60 service delivery dimensions. Sibanda et al. (2022) examined the current status of the

1
2
3 implementation of I4.0 technology in maternity healthcare. Findings show that most of the
4
5 research focuses on providing solutions for low- to medium-income countries and focuses more
6
7 on four technologies: the internet of things, Cloud computing, Big data analytics, and Artificial
8
9
intelligence. Alloghani et al. (2022) reviewed studies that deal with theoretical or analytical
10 research for data mining applications in the healthcare environment. Vassolo et al. (2021)
11
12 examined past research on evaluating H4.0 technologies in hospitals and identified the most
13
14 frequent investment methodologies employed. This study found that the most popular
15
investment techniques center on a single technology, cost analysis, and single decision-maker
16
17 engagement, which outnumber H4.0 technology value considerations, bundle analysis, and
18
Fo
19 multiple decision-maker involvement. Mustapha et al. (2021) reviewed the impact of I4.0 on
20
21 the healthcare environment. The study's findings suggest that I4.0 is considerably improving
rP
22 healthcare standards. Sisodia and Jindal (2021) reviewed the literature on I4.0 design principles
23
24 applied in the health sector. The findings highlight the criteria employed in the fundamental
ee
25
26 research directions and any current gaps in this field. Narkhede et al. (2020) reviewed the
27
28
literature on cloud computing applications in the healthcare sector. We identified twelve
rR
29 significant difficulties for retail sectors that operated as operational bottlenecks and proposed
30
31 using I4.0 technology to address them.
ev
32
33
34
Table 1 shows that many systematic reviews article available up to date discuss the application
iew
35
36 of I4.0 technologies in the healthcare sector (Narkhede et al., 2020; Vassolo et al., 2021; Sisodia
37
38 & Jindal, 2021; Alloghani et al., 2022; Sibanda et al., 2022; Ahsan & Siddique, 2022a; Jose et
39
40 al., 2022; Sood et al., 2022). Only a few SLRs exist that examine the impact of I4.0 applications
On
41 on the healthcare sector (Mustapha et al., 2021; Sony et al., 2022; Mwanza et al., 2023).
42
43 Further, no SLR studies focused on H4.0 technologies' impact on quality measures. Thus, this
44
ly
45 study fills such a gap and supports industries by providing a conceptual framework to classify
46
H4.0 digital technologies into bundles of information and communication technologies used in
47
48 the healthcare value chain and examine their impact on quality measures.
49
50
51
52 <<<<<<<<<<Insert Table 1 Here>>>>>>>>>>
53
54
55 Research Methodology
56
57 Considerable literature exists in numerous databases and journals regarding digital health
58
59
technologies. This body of knowledge, however, is not easily accessible to healthcare providers
60 and managers. Furthermore, finding, extracting, and reading literature requires considerable

1
2
3 academic time (Thomas et al., 2004). Thus, to meet this study's goals and offer practitioners
4
5 and academics relevant insights into the practical implications of the impact of H4.0
6
7 technologies on quality measure studies and the future research agenda, a thorough evaluation
8
9
of the current literature in the concerned field was conducted. This research used an SLR for
10 the following reasons. First, an SLR varies from typical literature reviews in that it employs a
11
12 more reproducible, scientific, and transparent approach to search and analyze the literature
13
14 (Tranfield, 2003; Sangwa & Sangwan, 2018b). Second, it provides more transparent and
15
specific guidelines to aid researchers in doing the literature review and presenting the results,
16
17 as well as a more in-depth discussion of how to analyze the literature (Hu et al., 2015). Third,
18
Fo
19 it reduces bias and mistakes by providing high-quality evidence and an audit trail of the
20
21 reviewers' judgments, methods, and findings (Tranfield, 2003). Fourth, studies demonstrated
rP
22 that an SLR is adequate for comprehensive, in-depth evaluations (Alkhoraif et al., 2019).
23
24 Finally, the authors of the current study were inspired to perform an SLR by the recent growth
ee
25
26 in academic interest in SLR studies in the field of digitalized healthcare (Narkhede et al., 2020).
27
28
The present study adopted the SLR methodology suggested by Tranfield 2003 and detailed the
rR
29 steps in the following sections.

30
31
ev
32
33 Planning the Review
34
In this stage, the research team formed a panel of four academic experts consisting of experts
iew
35
36 in healthcare and I4.0. Motivated by the justified rationale of the review, the panel members
37
38 determined the review protocol at their first meeting. Specifically, the panel clarified the
39
40 research questions and research objectives. The quality measures for this study were limited to
On
41
42
patient safety, patient experience/satisfaction, and clinical effectiveness. According to the
43 WHO (2018), these measures are the key and core dimensions of quality of care.
44
ly
45
46
47 Database selection and keyword identification are critical to a comprehensive and unbiased
48 review (Caiado et al., 2020). This study selected the following databases: Scopus, Web of
49
50 Science (WoS), and PubMed. The study considered these three databases due to their
51
52 comprehensive coverage of peer-reviewed journal articles, review papers, books, conference
53
54
proceedings, and short surveys. Further, the databases contain different subject areas, including
55 medicine, biochemistry, scientific, social science, engineering, healthcare, economics, science,
56
57 biology, management, and accounting, among other areas (Zulfiquar et al., 2017; Vassolo et
58
59 al., 2021; Mwanza et al., 2023). However, these databases captured all the relevant scientific
60

1
2
3 articles sufficient to perform an SLR (Ahsan & Siddique, 2022a; Mwanza et al., 2023). Many
4
5 researchers and practitioners rely only on Scopus and Web of Science databases for extracting
6
7 the articles and conduct the SLR (Ahsan & Siddique, 2022b; Ahsan & Siddique, 2022c;
8
9
Mustapha et al., 2021).
10
11
12 Further, the research limited the search to keywords using the two axes of digital health
13
14 technologies and quality measures. The following keywords were applied to search the
15
literature: Industry 4.0, hospital 4.0, healthcare 4.0, digital health, patient safety, medical risk,
16
17 adverse event, medical error, patient experience, patient satisfaction, quality of care, clinical
18
Fo
19 effectiveness, clinical care, and effective care. The keyword search used the Boolean
20
21 expressions “AND” and “OR”.
rP
22
23
24 Conducting the Review
ee
25
26 The review team applied the search strings in the three selected databases in the second stage.
27
28
This initial search resulted in 534 related articles. Then, the search results were screened and
rR
29 examined for their fit with the targeted study objectives, focusing on the title, abstract, and
30
31 keywords. Literature screening is one of the rigorous processes to refine the extracted articles
ev
32
33 from the selected databases. The review team used the inclusion and exclusion criteria to refine
34
the articles found during the initial search. This article followed the guidelines and strategy for
iew
35
36 inclusion and inclusion criteria similar to other SLR articles published in the high ranking
37
38 journals in the healthcare field (Vassolo et al., 2021; Ahsan & Siddique, 2022a; Mwanza et al.,
39
40 2023). Considering the inclusion criteria, the review team selected only articles that appeared
On
41 in the selected databases, academic journals, original research articles focusing on patient
42
43 safety, satisfaction/experience, and quality of care, and articles published in English. The
44
ly
45 review team excluded those articles published before 2010, articles not included from non-
46
academic databases, grey literature, books, book chapters, conference papers, letter notes,
47
48 meeting abstracts, editorials, comments, technical reports, and theses. In addition, the review
49
50 team excluded articles focused on providers (hospitals) rather than patients (customers), review
51
52 articles, and articles published in non-English language articles. While there is debate about
53 when I4.0 began, predominant research shows that it was in approximately 2010
54
55 (Fadilurrahman et al., 2021), which is the reason for including the literature from 2010 in this
56
57 study. Figure 1 describes the process of including and excluding articles during the evaluation
58
59
and selection of studies, following the preferred reporting items for systematic reviews and
60 meta-analysis (PRISMA) protocol.

1
2
3
4
5 <<<<<<<<<<Insert Figure 1 Here>>>>>>>>>>
6
7
8
9
The review team members individually read the full text of the articles and excluded those
10 which focused on the impacts on providers rather than patients. Each reviewer recorded
11
12 rejected articles. The review team checked the process of article search and selection.
13
14 Concurrently, the research team discussed the results. The research team resolved disputes over
15
the inclusion and exclusion of studies during team meetings. The review team checked the list
16
17 in a meeting, and there was consent to remove 232 articles. On the other hand, the reviewers
18
Fo
19 selected those that fulfilled the eligibility criteria for investigation and content assessment. The
20
21 focus of the searches was limited to articles published in the H4.0 literature and included an
rP
22 adequate level of detail on quality measures. Thus, the final sample included 35 relevant
23
24 articles listed in Table 2.
ee
25
26
27
28
<<<<<<<<<<Insert Table 2 Here>>>>>>>>>>
rR
29
30
31 The quality of the articles included in the sample was ensured by evaluating the fit between the
ev
32
33 research methodology and research questions formulated for the study. The research team also
34
created an Excel spreadsheet that gathered general information from the sample articles. The
iew
35
36 information included the title, year of publication, journal title, authors, paper type,
37
38 geographical research area, primary objective, technology discussed, main results, and other
39
40 features that covered the impacts of H4.0 technologies on quality measures and their
On
41 implementation barriers.
42
43
44
ly
45 Reporting and Dissemination

46
The prime objective of this phase is presenting the report, followed by suggestions and
47
48 translating this into practice (Tranfield, 2003). The "current map" presents the gathered articles
49
50 and an in-depth look at the practical consequences of the impact of H4.0 technologies on quality
51
52 measures studies. The future research agenda is offered based on the excel spreadsheets
53 generated during the second stage. This phase provides a transparent background of the major
54
55 concerns for researchers, practitioners, and academics.
56
57
58
59
Results and Findings
60

1
2
3 Descriptive analysis of the reviewed articles
4
5 An analysis of the journals indicates that 26 different journals published the 35 reviewed
6
7 articles. Figure 2 presents the reviewed articles in the academic journals considered. Out of 35
8
9
sample articles, the Journal of Medical Internet Research published six articles, JMIR mHealth
10 and uHealth journals published five articles, and the remaining 24 journals each published one
11
12 article. Further, Journals related to medicine and health published most of the sample articles
13
14 (56.4%). These journals include the Journal of Medical Internet Research, JMIR mHealth,
15
uHealth, JMIR Dermatol, JMIR Cardio, JMIR Diabetes, and Journal of Allergy and Clinical
16
17 Immunology.
18
Fo
19
20
rP
22
23
24 Regarding the diachronic evolution of H4.0 technologies publication, Figure 3 shows that the
ee
25
26 number of published articles increased from 2016 to 2021. The results show that researchers
27
28
published two articles in 2016, four in 2019, 11 in 2020, and a high publication (18) appeared
rR
29 in 2021. The analysis reveals that researchers did not publish any articles before 2016, and no
30
31 authors showed interest in this topic in 2017 and 2018. Specifically, the authors published
ev
32
33 17.1% of the articles before the end of 2019, while more than three quarters (82.8%) were
34
published between 2020 and 2021; in other words, within the last few years. This diachronic
iew
35
36 increase verifies the academic community's continuous interest in studying I4.0
37
38 implementation in the healthcare sector.
39
40
On

42
43
44
ly
45 Figures 4 and 5 show that the authors from 14 countries on six continents conducted the
46
research. Further, the authors conducted most of the research in North America (39%) and
47
48 Europe (35%). Finally, the countries with the highest H4.0 studies were the USA, Germany,
49
50 Brazil, Canada, Italy, and China.
51
52
54
56
57
58
59
Figure 6 shows the different H4.0 technologies the hospitals adopted in their healthcare value
60 chain. The analysis observed that in the majority of the literature (23%), healthcare

1
2
3 organizations adopted mHealth apps (23%) to solve their problems and improve service
4
5 quality, reduce efforts, make effective use of resources and satisfy the patients. Similarly, 14%
6
7 of articles mentioned using a remote patient monitoring system, and 11% applied general H4.0
8
9
technology (i.e., no specific mention of the H4.0 technology). Further, it is also worth noting
10 that Biomedical digital sensors (9%), IoT (9%), secure messaging (6%), patient portal (6%),
11
12 and machine/deep learning (6%) were among the commonly discussed technologies discussed
13
14 in the sample articles. The minimum adoption of other H.40 technologies in hospitals has also
15
been highlighted in the sample literature, including fog computing (3%), augmented reality
16
17 (3%), blockchain (3%), VR (3%), IVR (3%), and HER (3%).
18
Fo
19
20
rP
22
23
24 Findings Analysis
ee
25
26 This section presents the findings of the SLR analysis by synthesizing knowledge about the 35
27
28
selected articles. Table 3 summarizes the most commonly cited H4.0 technologies in the
rR
29 literature. Following the suggestions of Aceto, Persico, and Pescapé (2018) and Tortorella et
30
31 al. (2020), the H4.0 technologies separate into two principal bundles, including sensing-
ev
32
33 communication and processing-actuation bundle. The Sensing–Communication bundle
34
combines six H4.0 technologies, including digital sensors, remote patient monitoring,
iew
35
36 blockchain, IoT, messaging, and mHealth apps. In these technologies, digital sensors mainly
37
38 focus on providing means for data acquisition from patients and equipment. Once data and
39
40 information are acquired, they should be transmitted. Information availability allows real-time
On
41 and remote monitoring of processes, patients, materials, and equipment.

42
43
44
ly
45 Remote patient technology can facilitate information monitoring. Blockchain creates an

46
efficient, safe, and transparent platform to communicate data across global healthcare
47
48 (Hasselgren et al., 2021). It can also help save money, time, resources, and support in healthcare
49
50 development. IoT enables the interconnection between people, materials, and equipment,
51
52 favoring the agile exchange of information in the hospital. Due to such enhanced
53 interconnection, there is a constant generation of large amounts of diversified data, which
54
55 establishes the need for proper storing and organizing/synthesizing data into useful
56
57 information. Cloud computing and AI provide the means for that, contributing to a successful
58
59
communication process within hospitals.
60

1
2
3 Furthermore, secure messaging allows doctors and nurses to interact and collaborate in real
4
5 time with essential care team members through their mobile devices via a secure network
6
7 (Mishra et al., 2019). Secure messaging improves clinical workflows and protects patient
8
9
privacy, increasing the company's overall care and safety. Finally, healthcare organizations
10 utilize the mHealth app to gather health data, deliver public healthcare information, remotely
11
12 monitor patients, make medical diagnoses, access health records, and aid in disease prevention
13
14 and management (Vaghefi & Tulu, 2019).
15
16
17 The second bundle included technologies that may change or process data and move or control
18
Fo
a system, mechanism, or software based on such information (Tortorella et al., 2020a; Teng et
19
20 al., 2020). These technologies include machine/deep learning, augmented reality/simulation,
21
rP
22 virtual reality, and fog computing. The second bundle is processing–actuation. In healthcare,
23
24 machine learning can create better diagnostic tools for analyzing medical pictures (Ahmad et
ee
25 al., 2018). A machine learning algorithm, for example, may be used in medical imaging (such
26
27 as X-rays or MRI scans) to seek patterns that suggest a specific condition using pattern
28
rR
29 recognition.
30
31
ev
32 Similarly, Augmented Reality can simplify various clinical practices, including accurate vein
33
34 visualization, operating room preparation, medical training, dental practice, real-time access to
iew
35
36 patient data, 3D medical imaging, and precise symptom detection (Fingent, 2023). VR
37 simulations assist doctors in better understanding what their patients are experiencing. Finally,
38
39 fog computing aids in the monitoring of patients suffering from chronic illnesses by ensuring
40
On
41 that data is captured and processed efficiently (Kim et al., 2019).

42
43
ly
45
46
47
48 Incorporating these digital technologies and design principles into healthcare originated the
49
concept of H4.0. The H4.0 approach is driven by digital technology adoption, requiring vital
50
51 changes in healthcare organizations in both technical and social aspects. The introduction of
52
53 H4.0 also raised the level of interconnectivity and automation in hospitals, enabling patient
54
55 care and administrative processes to become more effective. However, several barriers and
56 challenges hinder a successful H4.0 implementation. For instance, Boillat and Rivas (2021)
57
58 stated that managing, maintaining, and designing medical devices, applications, and systems
59
60 for various healthcare settings are challenging tasks that hinder a successful H4.0

1
2
3 implementation in hospitals. Tortorella et al. (2020b) highlighted that several technical
4
5 challenges, such as internet coverage, system failures, usability, scalability, portal-related
6
7 problems, patient appointments, and inability to print results, highly affect the H4.0
8
9
implementation process within the healthcare sector or hospitals. Meyer (2020) and Khan et al.
10 (2020) discussed digital illiteracy, poor engagement with technology, and preference for in-
11
12 person attendance as barriers to adopting H.40 in hospitals. Similarly, patients with weak
13
14 eyesight find difficulties in using digital technologies is one of the common barriers that affect
15
H4.0 implementation in the healthcare sector. Table 4 summarizes the list of barriers and
16
17 challenges extracted from the literature.
18
Fo
19
20
rP
22
23
24 Table 5 summarizes the numerous impacts that H4.0 technologies can have on quality in a
ee
25
26 healthcare setting from the literature. This summary comprises two main sections. The first
27
28
section includes the sensing-communication bundle comprising digital sensors, mHealth apps,
rR
29 remote patient monitoring/telehealth, IoT, and messaging services. The second section
30
31 discusses the processing-actuation bundle that comprises fog computing, deep
ev
32
33 learning/machine learning, and virtual reality/augmented reality. The findings summarized in
34
Table 5 clarify that there is a difference in the impact of H4.0 technologies on those three
iew
35
36 quality measures. Based on the inference provided in Table 5, we can understand the impact of
37
38 H4.0 on quality measures in the following manner. For instance, from the category of Sensing–
39
40 Communication Bundle, digital sensors have an impact on patient safety because they can help
On
41 to limit the number of missed elements (Boillat & Rivas, 2021) and helps to identify modifiable
42
43 risk factors for cognitive frailty (Razjouyan et al., 2020).
44
ly
45
46
Further, it also impacts patient experience/satisfaction because digital sensors can help reduce
47
48 the frequent domiciliary or in-hospital visits, which gives some mental and financial relaxation
49
50 to patients and their dependents (Donati et al., 2019). Digital sensors can significantly impact
51
52 clinical effectiveness because they can help to digitalize the process and share information
53 within the stipulated time (Donati et al., 2019). Digital sensors also improve the identification
54
55 of high-risk individuals (Razjouyan et al., 2020), guarantee a better quality of care (Boillat &
56
57 Rivas, 2021), Optimize the chronic patient management processes (Donati et al., 2019) and
58
59
enable the care team to remotely assign personalized care plans and monitor distance patients’
60

1
2
3 health status (Donati et al., 2019). Table 5 provides a detailed discussion of the impact of
4
5 several other H4.0 technologies on quality measures.
6
7
8
9
<<<<<<<<<<Insert Table 5 Here>>>>>>>>>>
10
11
12 Discussion and Implications
13
14 This study reviewed the impact of H4.0 technologies on key quality measures and discussed
15
their opportunities and challenges. This research suggests two significant findings. First, H4.0
16
17 technologies can have a significant impact on quality. For instance, the sensing-communication
18
Fo
19 bundle greatly influences all quality measures. Within this bundle, digital sensors and mHealth
20
21 apps significantly impacted clinical effectiveness rather than other quality measures (i.e.,
rP
22 remote patient monitoring, IoT, and messaging). The findings summarized in Table 5 highlight
23
24 how adopting digital technologies can help digitalize healthcare processes and share clinical
ee
25
26 information without time and distance barriers (Donati et al., 2019). Digital technologies also
27
28
improve the identification of high-risk individuals (Razjouyan et al., 2020) and ensure a better
rR
29 quality of care (Boillat & Rivas, 2021), which optimizes chronic patient management processes
30
31 (Donati et al., 2019). Finally, digital technologies enable remote assign personalized care plans
ev
32
33 and monitor distance patients' health status (Donati et al., 2019). Whereas adopting mHealth
34
apps can decrease anxiety and pain catastrophizing (Bhatia et al., 2021) and improve subjective
iew
35
36 well-being and anxiety over time (Montgomery et al., 2021). mHealth apps help share data and
37
38 risk patterns with the provider to create new, more refined care practices (Jongsma et al., 2020),
39
40 improve usual care when compared with routine care alone (Khan et al., 2020), and provide
On
41 access to information, communication and continuous support (Holden et al., 2020). Thus, this
42
43 bundle proved very useful in enabling the care team to remotely assign personalized care plans
44
ly
45 and monitor distance patients’ health status.

46
47
48 The second bundle had the most significant impact on patient safety and minimal impact on
49
50 patient satisfaction. The research noted little influence on patient satisfaction measures after
51
52 adopting H4.0 technologies of the second bundle based on the inference summarized in Table
53 5. The present study findings have similarities with the findings of Damery et al. (2021) and
54
55 Jongsma et al. (2020), in which the patients said they did not see a significant improvement in
56
57 the quality of care and preferred conventional care delivery. Therefore, while technologies such
58
59
as remote patient monitoring (RPM) can save time/money for patients and reduce the chances
60 of getting an infection in a health facility, they can also make patients unsatisfied with the care

1
2
3 quality as the engagement can be poor (Hamad et al., 2021). However, the finding suggests
4
5 that their barriers explain the little impact on patient satisfaction with these technologies. As
6
7 shown in Table 4, H4.0 technologies bring about several technical and social challenges for
8
9
patients. For instance, most of the authors reported several technical challenges such as “lack
10 of usability, quality of image, internet coverage, lack of system interoperability, internet and
11
12 system failures, device malfunctions, scalability” (Tortorella et al., 2020b; Kelley et al., 2020;
13
14 Hasselgren et al., 2021; Mishara et al., 2019).
15
16
17 Similarly, several studies highlight social barriers such as digital illiteracy, poor engagement
18
Fo
19 with technology, preference for in-person attendance, smartphone ownership, and dislike of
20
21 remote follow-up (Budhwani et al., 2021; Damery et al., 2021; Meyer, 2020). These barriers
rP
22 affect H4.0 technologies implementation in healthcare organizations (Budhwani et al., 2021;

23
24 Mishara et al., 2019; Kumari et al., 2018). Although, the H4.0 technology interaction with H4.0
ee
25
26 barriers is relevant for improving H4.0 implementation. Hence, it is vital to concurrently
27
28
consider H4.0 technologies and barriers to understand their impact on hospitals. Therefore,
rR
29 removing these barriers can help implement H4.0 technologies in the healthcare sector.
30
31 Therefore, healthcare managers should focus on these barriers before implementing H4.0 in
ev
32
33 hospitals or anywhere within the healthcare environment.
34
iew
35
36 Implications
37
38 There is a clear consensus that quality health services worldwide should be effective, safe, and
39
40 people-centered. In addition, health services must be timely, equitable, integrated, and efficient
On
41 to realize the benefits of quality healthcare. Digital technologies play an essential role in
42
43 recording and transmitting patient data. This study sought to classify H4.0 digital technologies
44
ly
45 affecting healthcare quality by grouping them under two bundles. This study also provides a
46
framework for selecting emerging 4.0 technologies. The framework provides a structure for
47
48 adopting and selecting digital technologies in healthcare facilities to meet quality standards
49
50 while understanding their challenges. There are significant managerial implications associated
51
52 with the results. First, the findings of this study will provide information about digitalized
53 information and communication technologies used in the healthcare sector, which will help
54
55 managers understand the existing technologies and their importance. Second, the outcomes
56
57 provide explicit knowledge about the barriers and challenges of H4.0 technologies adoption in
58
59
the healthcare environment, which motivates organizations for digital transformation and
60 guides managers to grasp the challenges. Third, it will give the idea to healthcare managers

1
2
3 understand the real impact of H4.0 technologies on quality measures. These findings will help
4
5 managers to choose the right H4.0 technologies for implementation in their organization based
6
7 on the problem or issue facing them. With the outcome of the present study, organizational
8
9
managers can choose the right technology and save a lot of time and resources from the
10 complicated selection process. The selection of the right H4.0 technology to solve the real
11
12 industrial problem is challenging as this technology is nascent and unfamiliar to people.
13
14 Therefore, the present study's findings work as a solution approach or roadmap for healthcare
15
managers to select the right technology. This roadmap will help prepare healthcare
16
17 organizations to embrace digital transformation and motivate academicians to develop a
18
Fo
19 structured roadmap for H4.0 adoption. Further, the findings support the need to create a
20
21 systematic framework for H4.0 technologies, and parallel, it opens a new path for researchers
rP
22 to work on it and fulfill the gap.

23
24
ee
25
26 Conclusions, Limitations, and Future Research
27
28
The extensive integration of new digital technologies into healthcare organizations is
rR
29 associated with new opportunities and applications that lead to better patient safety, patient
30
31 satisfaction, and clinical effectiveness. Hospitals’ interactions with patients and stakeholders
ev
32
33 also benefit from the envisioned quality measures improvements. Nevertheless, the
34
implications of H4.0 adoption still need to be better investigated. This study aimed to provide
iew
35
36 a conceptual framework for classifying H4.0 digital technologies influencing healthcare quality
37
38 measures. Findings showed that H4.0 technologies could greatly influence quality metrics, but
39
40 they can also bring several challenges to patients and clinicians. Also, the proposed framework
On
41 can assist stakeholders in selecting H4.0 digital technologies to prioritize, review, and analyze
42
43 appropriate technologies to improve and support patient safety, experience, and clinical
44
ly
45 effectiveness.
46
47
48 This study has some limitations that fall into four main categories. The first limitation is that
49
50 this study sought to analyze the diversity of H4.0 in the literature published in the healthcare
51
52 sector. However, this study only captured articles that discussed diverse H4.0 technologies
53 focused on patients (customers) rather than providers (hospitals). The second limitation is that
54
55 this study attempted to identify the impact of H4.0 technologies on healthcare quality measures.
56
57 The present review analyzed the impact only on patient safety, patient experience/satisfaction,
58
59
and clinical effectiveness. Additional analysis of the literature could investigate other quality
60 measures (e.g., equity, efficiency, timeliness). The third limitation is that studies on H4.0

1
2
3 implementation primarily focus on the early stages, reporting isolated applications in specific
4
5 departments or processes. This limitation suggests that the extension of H4.0 implementation
6
7 and its maturity level may vary significantly across hospitals, influencing perceptions of the
8
9
subject. Moreover, the fourth limitation is that the current review only discussed examining
10 sample articles using descriptive analysis. Studies could also examine the literature using
11
12 categorical analysis.
13
14
15
Further research in this field can examine the various technical, social, economic, and even
16
17 environmental factors of healthcare services and their value chain to provide a sustainable
18
Fo
19 framework for selecting digital technologies. Future studies can also examine and analyze the
20
21 proposed framework in the particular services of specialized hospitals and compare it with the
rP
22 findings of this study conducted in general and teaching hospitals. Using new technologies in
23
24 complex healthcare systems may cause unwanted changes that future studies should evaluate.
ee
25
26
27
28
References
rR
29 Al Muammar, A. M., Ahmed, Z., & Aldahmash, A. M. (2017). Paradigm shift in healthcare
30
31 through technology and patient-centeredness. Int. Arch. Public Health Community Med.,
ev
32
33 2(1), doi: 10.23937/iaphcm-2017/1710015.
34
Aceto, G., Persico, V., & Pescapé, A. (2018). The role of information and communication
iew
35
36 technologies in healthcare: Taxonomies, perspectives, and challenges. J. Netw. Comput.
37
38 Appl., 107, 125–154, doi: 10.1016/j.jnca.2018.02.008.
39
40 Ahmad, M. A., Eckert, C., & Teredesai, A. (2018, August). Interpretable machine learning in
On
41 healthcare. In Proceedings of the 2018 ACM international conference on bioinformatics,

42
43 computational biology, and health informatics (pp. 559–560).
44
ly
45 Ahsan, M. M., & Siddique, Z. (2022a). Industry 4.0 in healthcare: A systematic

46
review. International Journal of Information Management Data Insights, 2(1), 100079.
47
48 Ahsan, M. M., & Siddique, Z. (2022b). Machine learning-based disease diagnosis: A
49
50 bibliometric analysis. arXiv preprint arXiv:2201.02755.
51
52 Ahsan, M. M., & Siddique, Z. (2022c). Machine learning-based heart disease diagnosis: A
53 systematic literature review. Artificial Intelligence in Medicine, 128, Article 102289.
54
55 10.1016/j.artmed.2022.102289.
56
57 Alkhoraif, A., H. Rashid, and P. McLaughlin. 2019. Lean implementation in small and medium
58
59
enterprises: Literature review. Operations Research Perspectives, 6: 100089.
60 doi:10.1016/j.orp.2018.100089.

1
2
3 Alloghani, M., Subair, S., & Thron, C. (2022). A systematic review on application of data
4
5 mining techniques in healthcare analytics and data-driven decisions. Artificial Intelligence
6
7 for Data Science in Theory and Practice, pp. 119–138.
8
9
Antony, J., McDermott, O., Sony, M., Toner, A., Bhat, S., & Cudney, E. (2022). Benefits,
10 challenges, critical success factors, and motivators of Quality 4.0: A qualitative global
11
12 study and directions for future research. Total Quality Management & Business Excellence.
13
14 doi: 10.1080/14783363.2022.2113737.
15
Arden, N. S., Fisher, A. C., Tyner, K., Yu, L. X., Lee, S. L., & Kopcha, M. (2021). Industry
16
17 4.0 for pharmaceutical manufacturing: Preparing for the smart factories of the future, Int.
18
Fo
19 J. Pharm., 602, 120554, doi: 10.1016/j.ijpharm.2021.120554.

20
21 Arpaia, P., De Benedetto, E., & Duraccio, L. (2021). Design, implementation, and
rP
22 metrological characterization of a wearable, integrated AR-BCI hands-free system for

23
24 health 4.0 monitoring, Measurement, 177, 109280, doi:
ee
25
26 10.1016/j.measurement.2021.109280.
27
28
Awad, A., Trenfield, S. J., Pollard, T. D., Ong, J. J., Elbadawi, M., McCoubrey, L. E.,
rR
29 Goyanes, A., Gaisford, S., & Basit, A. W. (2021). Connected healthcare: Improving
30
31 patient care using digital health technologies. Advanced Drug Delivery Reviews, 178,
ev
32
33 https://doi.org/10.1016/j.addr.2021.113958
34
Bhatia, A., Kara, J., Janmohamed, T., Prabhu, A., Lebovic, G., Katz, J., & Clarke, H. (2021).
iew
35
36 User engagement and clinical impact of the manage my pain app in patients with chronic
37
38 pain: A real-world, multi-site trial, JMIR MHealth UHealth, 9(3), e26528, doi:
39
40 10.2196/26528.
On
41 Bhatti, U. A., Huang, M., Wu, D., Zhang, Y., Mehmood, A., & Han, H. (2019).
42
43 Recommendation system using feature extraction and pattern recognition in clinical care
44
ly
45 systems, Enterp. Inf. Syst., 13(3), 329–351, doi: 10.1080/17517575.2018.1557256.

46
Boillat, T., & Rivas, H. (2021). It is in the box! Improving the usability and benefits of
47
48 surgical safety checklists – A feasibility study, Int. J. Ind. Ergon., 86, 103217, doi:
49
50 10.1016/j.ergon.2021.103217.
51
52 Braune, K., Gajewska, K. A., Thieffry, A., Lewis, D. M., Froment, T., O’Donnell, S.,
53 Speight, J., Hendrieckx, C., Schipp, J., Skinner, T., Langstrup, H., Tappe, A., Raile, K.,
54
55 & Cleal, B. (2021). Why #WeAreNotWaiting—motivations and self-reported outcomes
56
57 among users of open-source automated insulin delivery systems: Multinational survey, J.
58
59
Med. Internet Res., 23(6), e25409, doi: 10.2196/25409.
60

1
2
3 Budhwani, S., Fujioka, J. K., Chu, C., Baranek, H., Pus, L., Wasserman, L., Vigod, S.,
4
5 Martin, D., Agarwal, P., & Mukerji, G. (2021). Delivering mental health care virtually
6
7 during the COVID-19 pandemic: Qualitative evaluation of provider experiences in a
8
9
scaled context, JMIR Form. Res., 5(9), e30280, doi: 10.2196/30280.
10 Busse, R., Klazinga, N., Panteli, D., & Quentin, W. (2019). Eds., Improving healthcare
11
12 quality in Europe: characteristics, effectiveness, and implementation of different
13
14 strategies. Copenhagen, Denmark: WHO Regional Office for Europe.
15
Byonanebye, D. M., Nabaggala, M. S., Naggirinya, A. B., Lamorde, M., Oseku, E., King, R.,
16
17 Owarwo, N., Laker, E., Orama, R., Castelnueovo, B., Kiragga, A., & Parkes-Ratanshi, R.
18
Fo
19 (2021). An interactive voice response software to improve the quality of life of people
20
21 living with HIV in Uganda: Randomized controlled trial, JMIR MHealth UHealth, 9(2),
rP
22 e22229, doi: 10.2196/22229.

23
24 Caiado, R. G. G., Carocha, D. M., Goulart, A. K., & Tortorella, G. L. (2020). Critical success
ee
25
26 factors-based taxonomy for lean public management: A systematic review, Production,
27
28
30, e20200030, doi: 10.1590/0103-6513.20200030.
rR
29 Choy, M. A., Sturgiss, E., Goodyear-Smith, F., & Smith, G. J. (2020). Digital health tools
30
31 and patients with drug use disorders: Qualitative patient experience study of the
ev
32
33 electronic case-finding and help assessment tool (eCHAT)’, J. Med. Internet Res., 22(9),
34
e19256, doi: 10.2196/19256.
iew
35
36 CMS – Centers for Medicare & Medicaid Services, An official website of the United States
37
38 Government, 2022. [Online]. Available: https://www.cms.gov/Medicare/Quality-
39
40 Initiatives-Patient-Assessment Instruments/QualityMeasures#:~:text=Quality%20measure
On
41 s%20are%20tools%20that,quality%20goals%20for%20health%20care.
42
43 Damery, S., Jones, J., O’Connell Francischetto, E., Jolly, K., Lilford, R., & Ferguson, J.
44
ly
45 (2021). Remote consultations versus standard face-to-face appointments for liver

46
transplant patients in routine hospital care: Feasibility randomized controlled trial of
47
48 myVideoClinic, J. Med. Internet Res., 23(9), e19232, doi: 10.2196/19232.
49
50 Donati, M., Celli, A., Ruiu, A., Saponara, S., & Fanucci, L. (2019). A telemedicine service
51
52 system exploiting BT/BLE wireless sensors for remote management of chronic patients,
53 Technologies, 7(1), 13, doi: 10.3390/technologies7010013.
54
55 Fadilurrahman, M., Ramadhani, R., Kurniawan, T., Misnasanti, M., & Shaddiq, S. (2021).
56
57 Systematic literature review of disruption era in Indonesia: The resistance of industrial
58
59
revolution 4.0. Journal of Robotics and Control (JRC), 2(1), 51-59.
60

1
2
3 Fingent blog Access date: 19 January 2023 at 04:42 pm link:
4
5 https://www.fingent.com/blog/augmented-reality-in-healthcare-use-cases-examples-and-
6
7 trends/#:~:text=Augmented%20Reality%20is%20used%20to,from%20EMRs%2C%20pr
8
9
ecise%20symptom%20detection%2C
10 Hamad, J., Fox, A., Kammire, M. S., Hollis, A. N., & Khairat, S. (2021). Evaluating the
11
12 experiences of new and existing teledermatology patients during the COVID-19 pandemic:
13
14 Cross-sectional survey study, JMIR Dermatol., 4(1), e25999, doi: 10.2196/25999.
15
Handbook for national quality policy and strategy: a practical approach for developing policy
16
17 and strategy to improve quality of care, World Health Organization, Geneva,
18
Fo
19 Switzerland, 2018. [Online]. Available:

20
21 https://www.who.int/publications/i/item/9789241565561
rP
22 Hasselgren, A., Hanssen Rensaa, J.-A., Kralevska, K., Gligoroski, D., & Faxvaag, A. (2021).
23
24 Blockchain for increased trust in virtual health care: Proof-of-concept study, J. Med.
ee
25
26 Internet Res., 23(7), e28496, doi: 10.2196/28496.
27
28
Holden, R. J., Campbell, N. L., Abebe, E., Clark, D. O., Ferguson, D., Bodke, K., Boustani, M.
rR
29 A., & Callahan, C. M. (2020). Usability and feasibility of consumer-facing technology to

30
31 reduce unsafe medication use by older adults, Res. Soc. Adm. Pharm., 16(1), 54–61, doi:
ev
32
33 10.1016/j.sapharm.2019.02.011.
34
Hu, Q., R. Mason, S. J. Williams, and P. Found. 2015. Lean implementation within SMEs: A
iew
35
36 literature review. Journal of Manufacturing Technology Management, 26 (7): 980–1012.
37
38 doi:10.1108/JMTM-02-2014-0013.
39
40 Hundal, G. S., Thiyagarajan, S., Alduraibi, M., Laux, C., Furterer, C., Cudney, E., & Antony,
On
41 J. (2021). Lean Six Sigma as an organizational resilience mechanism in healthcare during

42
43 the era of COVID-19. International Journal of Lean Six Sigma, 12(4), 762-783.
44
ly
45 Isernia, S., Di Tella, S., Pagliari, C., Jonsdottir, J., Castiglioni, C., Gindri, P., Salza, M.,
46
Cramigna, C., Paulumbo, G., Molteni, F., & Baglio, F. (2020). Effects of an innovative
47
48 telerehabilitation intervention for people with Parkinson’s disease on quality of life, motor,
49
50 and non-motor abilities, Front. Neurol., 11, 846, doi: 10.3389/fneur.2020.00846.
51
52 Jain, D., Norman, K., Werner, Z., Makovoz, B., Baker, T., & Huber, S. (2021). Using
53 postmarket surveillance to assess safety-related events in a digital rehabilitation app (Kaia
54
55 App): Observational Study’, JMIR Hum. Factors, 8(4), e25453, doi: 10.2196/25453.
56
57 Jamkhaneh, H. B., Luz Tortorella, G., Parkouhi, S. V., & Shahin, R. (2022). A comprehensive
58
59
framework for classification and selection of H4.0 digital technologies affecting healthcare
60

1
2
3 processes in the grey environment’, TQM J., vol. ahead-of-print, no. ahead-of-print, doi:
4
5 10.1108/TQM-08-2021-0232.
6
7 Jongsma, K. R., van den Heuvel, J. F. M., Rake, J., Bredenoord, A. L., & Bekker, M. N. (2020).
8
9
User experiences with and recommendations for mobile health technology for hypertensive
10 disorders of pregnancy: Mixed methods study, JMIR MHealth UHealth, 8(8), e17271, doi:
11
12 10.2196/17271.
13
14 Jose, A., Tortorella, G. L., Vassolo, R., Kumar, M., & Mac Cawley, A. F. (2022). Professional
15
competence and its effect on the implementation of healthcare 4.0 technologies: Scoping
16
17 review and future research directions. International Journal of Environmental Research
18
Fo
19 and Public Health, 20(1), 478.

20
21 Kelley, L. T., Phung, M., Stamenova, V., Fujioka, J., Agarwal, P., Onabajo, N., Wong, I.,
rP
22 Nguyen, M., Bhatia, R. S., & Bhattacharyya, O. (2020). Exploring how virtual primary care
23
24 visits affect patient burden of treatment, Int. J. Med. Inf., 141, 104228, doi:
ee
25
26 10.1016/j.ijmedinf.2020.104228.
27
28
Kenner, A. (2016). Asthma on the move: how mobile apps remediate risk for disease
rR
29 management, Health Risk Soc., 17(7–8), 510–529, doi: 10.1080/13698575.2015.1136408.

30
31 Khan, F., Granville, N., Malkani, R., & Chathampally, Y. (2020). Health-related quality of life
ev
32
33 improvements in systemic lupus erythematosus derived from a digital therapeutic plus tele-
34
health coaching intervention: Randomized controlled pilot trial, J. Med. Internet Res.,
iew
35
36 22(10), e23868, doi: 10.2196/23868.
37
38 Kim, M., Man, K. L., & Helil, N. (2019). Advanced internet of things and big data technology
39
40 for smart human-care services. Journal of Sensors, 2019. Volume 2019 | Article
On
41 ID 1654013 | https://doi.org/10.1155/2019/1654013
42
43 Kumar, K. P. A., & Pumera, M. (2021). 3D‐printing to mitigate COVID‐19 pandemic, Adv.
44
ly
45 Funct. Mater., 31(22), 2100450, doi: 10.1002/adfm.202100450.

46
Kumari, A., Tanwar, S., Tyagi, S., & Kumar, N. (2018). Fog computing for Healthcare 4.0
47
48 environment: Opportunities and challenges, Comput. Electr. Eng., 72(1–13), doi:
49
50 10.1016/j.compeleceng.2018.08.015.
51
52 Maintz, L., Bieber, T., Bissonnette, R., & Jack, C. (2021). Measuring atopic dermatitis disease
53 severity: The potential for electronic tools to benefit clinical care, J. Allergy Clin. Immunol.
54
55 Pract., 9(4), 1473-1486.e2, doi: 10.1016/j.jaip.2021.02.027.
56
57 Marbouh, D., Abbasi, T., Maasmi, F., Omar, I. A., Debe, M. S., Salah, K., Jayaraman, R., &
58
59
Ellahham, S. (2020). Blockchain for COVID-19: Review, opportunities, and a trusted
60

1
2
3 tracking system, Arab. J. Sci. Eng., 45(12), 9895–9911, doi: 10.1007/s13369-020-04950-
4
5 4.
6
7 McElroy, I., Sareh, S., Zhu, A., Miranda, G., Wu, H., Nguyen, M., Shemin, R., & Benharash,
8
9
P. (2016). Use of digital health kits to reduce readmission after cardiac surgery, J. Surg.
10 Res., 204(1), 1–7, doi: 10.1016/j.jss.2016.04.028.
11
12 Meyer, M. A. (2020). COVID-19 pandemic accelerates need to improve online patient
13
14 engagement practices to enhance patient experience, J. Patient Exp., 7(5), 657–664, doi:
15
10.1177/2374373520959486.
16
17 Mishra, V., Hoyt, R., Wolver, S., Yoshihashi, A., & Banas, C. (2019). Qualitative and
18
Fo
19 quantitative analysis of patients’ perceptions of the patient portal experience with

20
21 OpenNotes’, Appl. Clin. Inform., 10(01), 10–18, doi: 10.1055/s-0038-1676588.
rP
22 Montgomery, R. M., Boucher, E. M., Honomichl, R. D., Powell, T. A., Guyton, S. L.,
23
24 Bernecker, S. L., Stoeckl, S. E., & Parks, A. C. (2021). The effects of a digital mental health
ee
25
26 intervention in adults with cardiovascular disease risk factors: Analysis of real-world user
27
28
data, JMIR Cardio, 5(2), e32351, doi: 10.2196/32351.
rR
29 Mustapha, I., Khan, N., Qureshi, M. I., Harasis, A. A., & Van, N. T. (2021). Impact of industry
30
31 4.0 on healthcare: A systematic literature review (SLR) from the last decade. International
ev
32
33 Journal of Interactive Mobile Technologies, 15(18).
34
Mwanza, J., Telukdarie, A., & Igusa, T. (2023). Impact of industry 4.0 on healthcare systems
iew
35
36 of low-and middle-income countries: a systematic review. Health and Technology, 1-18.
37
38 https://doi.org/10.1007/s12553-022-00714-2
39
40 Narkhede, B. E., Raut, R. D., Narwane, V. S., & Gardas, B. B. (2020). Cloud computing in
On
41 healthcare-a vision, challenges, and future directions. International Journal of Business

42
43 Information Systems, 34(1), 1-39.
44
ly
45 Nursing dashboards – measuring quality, NHS, United Kingdom, 2011. [Online]. Available:
46
https://www.networks.nhs.uk/nhs-networks/leadership-for-informed-practice/links-to-
47
48 resources/RCN%20Nursing%20dashboards.pdf
49
50 Nguyen, M. T. H., Krause, G., Keller-Stanislawski, B., Glöckner, S., Mentzer, D., & Ott, J. J.
51
52 (2021). Postmarketing safety monitoring after influenza vaccination using a mobile health
53 app: Prospective longitudinal feasibility study, JMIR MHealth UHealth, 9(5), e26289, doi:
54
55 10.2196/26289.
56
57 Piera-Jiménez, J., Daugbjerg, S., Stafylas, P., Meyer, I., Muller, S., Lewis, L., da Col, P.,
58
59
Folkvord, F., & Lupianez-Villanueva, F. (2020). Beyond silos, a telehealth-enhanced
60 integrated care model in the domiciliary setting for older patients: Observational

1
2
3 prospective cohort study for effectiveness and cost-effectiveness assessments, JMIR Med.
4
5 Inform., 8(10), e20938, doi: 10.2196/20938.
6
7 Ramori, K., Cudney, E., Elrod, C., & Antony, J. (2021). Lean business models in healthcare:
8
9
A systematic review. Total Quality Management & Business Excellence, 32(5-6), 558-573.
10 Razjouyan, J., Najafi, B., Horstman, M., Sharafkhaneh, A., Amirmazaheri, M., Zhou, H.,
11
12 Kunik, M. E., & Naik, A. (2020). Toward using wearables to remotely monitor cognitive
13
14 frailty in community-living older adults: An observational study, Sensors, 20(8), 2218,
15
doi: 10.3390/s20082218.
16
17 Robinson, S. A., Netherton, D., Zocchi, M., Purington, C., Ash, A. S., & Shimada, S. L.
18
Fo
19 (2021). Differences in secure messaging, self-management, and glycemic control

20
21 between rural and urban patients: Secondary data analysis, JMIR Diabetes, 6(4), e32320,
rP
22 doi: 10.2196/32320.
23
24 Sakr, S., & Elgammal, A. (2016). Towards a comprehensive data analytics framework for
ee
25
26 smart healthcare services, Big Data Res., 4, 44–58, doi: 10.1016/j.bdr.2016.05.002.
27
28
Sangwa, N. R., and K. S. Sangwan. (2018b). Development of an integrated performance
rR
29 measurement framework for lean organizations. Journal of Manufacturing Technology

30
31 Management, 29(1), 41–84. doi:10.1108/JMTM-06-2017-0098.
ev
32
33 Sibanda, K., Ndayizigamiye, P., & Twinomurinzi, H. (2022). Industry 4.0 technologies in
34
maternal healthcare: A systematic review. IFAC-PapersOnLine, 55(10), 2407-2412.
iew
35
36 Sisodia, A., & Jindal, R. (2021). A meta-analysis of industry 4.0 design principles applied in
37
38 the health sector. Engineering Applications of Artificial Intelligence, 104, 104377.
39
40 Sony, M., Antony, J., & McDermott, O. (2022). The impact of medical cyber-physical systems
On
41 on healthcare service delivery. The TQM Journal, 34(7), 73-94.

42
43 Sood, S. K., Rawat, K. S., & Kumar, D. (2022). A visual review of artificial intelligence and
44
ly
45 Industry 4.0 in healthcare. Computers and Electrical Engineering, 101, 107948.

46
Teng, F., Ma, Z., Chen, J., Xiao, M., & Huang, L. (2020). Automatic medical code
47
48 assignment via deep learning approach for intelligent healthcare, IEEE J. Biomed. Health
49
50 Inform., 24(9), 2506–2515, doi: 10.1109/JBHI.2020.2996937.
51
52 Thomas, A. (2018). Developing an integrated quality network for lean operations systems,
53 Bus. Process Manag. J., 24(6), 1367–1380, doi: 10.1108/BPMJ-02-2018-0041.
54
55 Thomas, B. H., D. Ciliska, M. Dobbins, and S. Micucci. (2004). A process for systematically
56
57 reviewing the literature: Providing the research evidence for public health nursing
58
59
interventions. Worldviews on Evidence-Based Nursing, 1(3): 176–184. doi:10.1111/j.1524-
60 475X.2004.04006.x.

1
2
3 Thuemmler C., & Bai, C. Eds. (2017). Health 4.0: How virtualization and big data are
4
5 revolutionizing healthcare. Cham: Springer International Publishing. doi: 10.1007/978-3-
6
7 319-47617-9.
8
9
Tortorella, G. L., Fogliatto, F. S., Esposto, K. F., Vergara, A. M., Vassolo, R., & Mendoza,
10 D. T. (2020a). Measuring the effect of Healthcare 4.0 implementation on hospitals’
11
12 performance, Prod. Plan. Control, 1–16, doi: 10.1080/09537287.2020.1824283.
13
14 Tortorella, G. L., Fogliatto, F. S., Mac Cawley Vergara, A., Vassallo, R., & Sawhney, R.
15
(2020b). Healthcare 4.0: Trends, challenges and research directions, Prod. Plan. Control,
16
17 31(15), 1245–1260, doi: 10.1080/09537287.2019.1702226.
18
Fo
19 Tranfield, D., D. Denyer, and P. Smart. (2003). Towards a methodology for developing
20
21 evidence-informed management knowledge by means of systematic review. British
rP
22 Journal of Management, 14(3): 207–222.doi:10.1111/1467-8551.00375.

23
24 Vaghefi, I., & Tulu, B. (2019). The continued use of mobile health apps: insights from a
ee
25
26 longitudinal study. JMIR mHealth and uHealth, 7(8), e12983.
27
28
Vassolo, R. S., Mac Cawley, A. F., Tortorella, G. L., Fogliatto, F. S., Tlapa, D., &
rR
29 Narayanamurthy, G. (2021). Hospital investment decisions in healthcare 4.0 technologies:

30
31 Scoping review and framework for exploring challenges, trends, and research directions.
ev
32
33 Journal of Medical Internet Research, 23(8), e27571.
34
Zhang, J., Mihai, C., Tüshaus, L., Scebba, G., Distler, O., & Karlen, W. (2021). Wound
iew
35
36 image quality from a mobile health tool for home-based chronic wound management with
37
38 real-time quality feedback: Randomized feasibility study, JMIR MHealth UHealth, 9(7),
39
40 e26149, doi: 10.2196/26149.
On
41
42
43
44
ly
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
Fo
17
18
19
rP
20
21
22
23
ee
24
25
26
rR
27
28
29
ev
30
31
32
iew
33
34
35
36
37
On
38
39
40
41
ly
42
43
44
45
46 Figure 1. Flowchart of the research methodology
47
48
49
50
51
52
53
54
55
56
57
58
59
1
2
3
4 Publications by Journal
5
6
Applied Ergonomics
7
8 International Journal of Production Research
9 Technological Forecasting and Social Change
10 Journal of Industrial Integration and Management
11 Production Planning and Control
12 Computers and Electrical Engineering
13 Enterprise Information Systems
14 IEEE Journal of Biomedical and Health Informatics
15 Measurement: Journal of the International Measurement...
16 Applied Clinical Informatics
Fo
17 Journal of Patient Experience
18
Journal
Research in Social and Administrative Pharmacy

19
Journal of Surgical Research
rP
20
Sensors (Switzerland)
21
Frontiers in Neurology
22
23 International Journal of Medical Informatics
ee
24 Journal of Allergy and Clinical Immunology: In Practice

25 Health, Risk and Society
26 JMIR Formative Research
rR
27 JMIR Diabetes
28 JMIR Human Factors
29 JMIR Cardio
ev
30 JMIR Dermatol
31 Journal of Medical Internet Research
32 JMIR mhealth and uhealth
iew
33
International Journal of Industrial Ergonomics
34
35 0 1 2 3 4 5 6 7
36 Count
37
On
38
39 Figure 2. Publications by journal
40
41
ly
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
1
2
3
4 JOURNALS BY YEAR OF PUBLICATIONS
5
6
NUMBER OF PUBLICATIONS
18
7
8
9
11
10
11
12
13
4
14
2
15
16
Fo
2016 2019 2020 2021
17
18 YEAR
19
rP
20
21
Figure 3. Articles by publication year
22
23
ee
24
25
26
rR
27 Percentage of Publications by Country

28
29 Spain
ev
30 Brazil
31 India
32 China
iew
33 Norway
34 Netherlands
35 Italy
36 Australia
37 Uganda
Switzerland
On
38
UK
39
Germany
40
Canada
41 USA
ly
42
43 0% 5% 10% 15% 20% 25% 30% 35%
44 Switzerlan Netherlan
USA Canada Germany UK Uganda Australia Italy Norway China India Brazil Spain
45 d ds
46 % 31% 9% 11% 3% 3% 3% 3% 9% 3% 3% 6% 3% 11% 3%
47
48 Figure 4. Articles by country of study
49
50
51
52
53
54
55
56
57
58
59
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
Fo
17
18
19
rP
20 Figure 5. Geographic research areas
21
22
23
ee
24
25
26 Percentage of Technologies Implemented in Literature
rR
27
28
Patient Portal 6%
29
ev
H4.0 (in general) 11%

30
Technology Implemented
Fog Computing 3%
31
Machine/Deep Learning 6%
32
iew
Augmented Reality 3%
33
Blockchain Technology 3%
34
VR tools 3%
35
36 Interactive Voice Response (IVR) 3%
37 IoT 9%
EHR 3%
On
38
39 Secure Messaging 6%
40 Remote Patient Monitoring 14%
41 mHealth Apps 23%
Biomedical/digital sensors 9%
ly
42
43 0% 5% 10% 15% 20% 25%
44
Percentage
45
46
47 Figure 6. H4.0 technologies discussed in the selected articles
48
49
50
51
52
53
54
55
56
57
58
59

CTQM

Uploaded by

Copyright:

Available Formats

CTQM

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

CTQM

Uploaded by

Copyright:

Available Formats

Total Quality Management & Business Excellence

Manuscript Type: Research Article

Industry 4.0, Healthcare 4.0, Digital health, Quality measures, Quality,

As a socio-technical system, the healthcare industry is at the dawn of a

referred to as Healthcare 4.0 (H4.0). This research aims to provide a

patient safety, patient experience/satisfaction, and clinical effectiveness

processing-actuation. Further, the outcomes indicated that H4.0 digital

patient safety, experience, and clinical effectiveness. Further, this

URL: https://mc.manuscriptcentral.com/ctqm Email: CTQM-peerreview@journals.tandf.co.uk

33 Narkhede et al. This research intends to present a systematic literature evaluation of

30 world, multi-site trial

38 implementation on hospitals’ performance

intervention for people with Parkinson's disease on (VR)

27 characterization of a wearable integrated AR-BCI Reality (AR)

30 wireless sensors for remote management of chronic

38 Proof-of-concept study Technology

Communication Meyer (2020)

27 mHealth Apps Bhatia et al. (2021)

30 Zhang et al. (2021)

38 Machine/Deep Learning Bhatti et al. (2019)

Damery et al. technology language) had more difficulties

30 (2020)  Smartphone ownership processes.

42  High transaction fees

examine their impact on quality measures such as patient safety, patient

URL: https://mc.manuscriptcentral.com/ctqm Email: CTQM-peerreview@journals.tandf.co.uk

22 prevention, early diagnosis of life-threatening diseases, and management of chronic conditions

29 access to medical services, diagnosis, and treatments.

URL: https://mc.manuscriptcentral.com/ctqm Email: CTQM-peerreview@journals.tandf.co.uk

URL: https://mc.manuscriptcentral.com/ctqm Email: CTQM-peerreview@journals.tandf.co.uk

22 Existing literature review studies on H4.0

URL: https://mc.manuscriptcentral.com/ctqm Email: CTQM-peerreview@journals.tandf.co.uk

URL: https://mc.manuscriptcentral.com/ctqm Email: CTQM-peerreview@journals.tandf.co.uk

29 steps in the following sections.

URL: https://mc.manuscriptcentral.com/ctqm Email: CTQM-peerreview@journals.tandf.co.uk

URL: https://mc.manuscriptcentral.com/ctqm Email: CTQM-peerreview@journals.tandf.co.uk

45 Reporting and Dissemination

URL: https://mc.manuscriptcentral.com/ctqm Email: CTQM-peerreview@journals.tandf.co.uk

41 <<<<<<<<<<Insert Figure 3 Here>>>>>>>>>>

URL: https://mc.manuscriptcentral.com/ctqm Email: CTQM-peerreview@journals.tandf.co.uk

41 and remote monitoring of processes, patients, materials, and equipment.

45 Remote patient technology can facilitate information monitoring. Blockchain creates an

URL: https://mc.manuscriptcentral.com/ctqm Email: CTQM-peerreview@journals.tandf.co.uk

41 that data is captured and processed efficiently (Kim et al., 2019).

URL: https://mc.manuscriptcentral.com/ctqm Email: CTQM-peerreview@journals.tandf.co.uk

URL: https://mc.manuscriptcentral.com/ctqm Email: CTQM-peerreview@journals.tandf.co.uk

45 and monitor distance patients’ health status.

URL: https://mc.manuscriptcentral.com/ctqm Email: CTQM-peerreview@journals.tandf.co.uk

22 affect H4.0 technologies implementation in healthcare organizations (Budhwani et al., 2021;

URL: https://mc.manuscriptcentral.com/ctqm Email: CTQM-peerreview@journals.tandf.co.uk

22 to work on it and fulfill the gap.

URL: https://mc.manuscriptcentral.com/ctqm Email: CTQM-peerreview@journals.tandf.co.uk

41 healthcare. In Proceedings of the 2018 ACM international conference on bioinformatics,

45 Ahsan, M. M., & Siddique, Z. (2022a). Industry 4.0 in healthcare: A systematic

URL: https://mc.manuscriptcentral.com/ctqm Email: CTQM-peerreview@journals.tandf.co.uk

19 J. Pharm., 602, 120554, doi: 10.1016/j.ijpharm.2021.120554.

22 metrological characterization of a wearable, integrated AR-BCI hands-free system for

45 systems, Enterp. Inf. Syst., 13(3), 329–351, doi: 10.1080/17517575.2018.1557256.

URL: https://mc.manuscriptcentral.com/ctqm Email: CTQM-peerreview@journals.tandf.co.uk

22 e22229, doi: 10.2196/22229.