5.13. Regulatory frameworksTechnological innovations are always ahead of public policies, ev-idence, and clinical practice.85 Policymakers struggle to keep up withthe pace of innovation.80 Regulatory frameworks on digital technologiesmust protect privacy and security. However, there is a lack of regionaland international WHO-approved frameworks for the integration of dig-ital technologies.85-86 Moreover, regulatory frameworks are importantin ensuring the quality and safety of digital technologies, devices, andapplications.85 Lack of regulatory frameworks delays the approval ofdigital innovations, thus affecting the adoption and utilization of smarthealthcare
Question
5.13. Regulatory frameworksTechnological innovations are always ahead of public policies, ev-idence, and clinical practice.85 Policymakers struggle to keep up withthe pace of innovation.80 Regulatory frameworks on digital technologiesmust protect privacy and security. However, there is a lack of regionaland international WHO-approved frameworks for the integration of dig-ital technologies.85-86 Moreover, regulatory frameworks are importantin ensuring the quality and safety of digital technologies, devices, andapplications.85 Lack of regulatory frameworks delays the approval ofdigital innovations, thus affecting the adoption and utilization of smarthealthcare
Solution
The above passage discusses the challenges faced by policymakers in keeping up with the rapid pace of technological innovations. It emphasizes the need for regulatory frameworks to ensure the privacy, security, quality, and safety of digital technologies. However, it also highlights the lack of such frameworks, especially those approved by the World Health Organization (WHO), for the integration of digital technologies. This lack of regulatory frameworks can delay the approval of digital innovations, which in turn affects their adoption and utilization in smart healthcare.
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Regulatory difficulties: Different countries have dif-ferent laws (i.e., laws related to privacy of sensitivehealthcare data). Clinical grade medical devices musthave clearance and permission from national regulatoryauthority before they are launched in the market. Health-care 5.0 devices provide new difficulties for legislatorsand regulatory authority as well [51].
Barriers and facilitators to utilizing digital health technologiesby healthcare professionalsIsrael Júnior Borges do Nascimento 1,2 , Hebatullah Abdulazeem 3 , Lenny Thinagaran Vasanthan 4 , Edson Zangiacomi Martinez 5 ,Miriane Lucindo Zucoloto 5 , Lasse Østengaard 6 , Natasha Azzopardi-Muscat 1 , Tomas Zapata 1 and David Novillo-Ortiz 1 ✉Digital technologies change the healthcare environment, with several studies suggesting barriers and facilitators to using digitalinterventions by healthcare professionals (HPs). We consolidated the evidence from existing systematic reviews mentioning barriersand facilitators for the use of digital health technologies by HP. Electronic searches were performed in five databases (CochraneDatabase of Systematic Reviews, Embase®, Epistemonikos, MEDLINE®, and Scopus) from inception to March 2023. We includedreviews that reported barriers or facilitators factors to use technology solutions among HP. We performed data abstraction,methodological assessment, and certainty of the evidence appraisal by at least two authors. Overall, we included 108 reviewsinvolving physicians, pharmacists, and nurses were included. High-quality evidence suggested that infrastructure and technicalbarriers (Relative Frequency Occurrence [RFO] 6.4% [95% CI 2.9–14.1]), psychological and personal issues (RFO 5.3% [95% CI2.2–12.7]), and concerns of increasing working hours or workload (RFO 3.9% [95% CI 1.5–10.1]) were common concerns reported byHPs. Likewise, high-quality evidence supports that training/educational programs, multisector incentives, and the perception oftechnology effectiveness facilitate the adoption of digital technologies by HPs (RFO 3.8% [95% CI 1.8–7.9]). Our findings showedthat infrastructure and technical issues, psychological barriers, and workload-related concerns are relevant barriers tocomprehensively and holistically adopting digital health technologies by HPs. Conversely, deploying training, evaluating HP’sperception of usefulness and willingness to use, and multi-stakeholders incentives are vital enablers to enhance the HP adoption ofdigital interventions.npj Digital Medicine (2023) 6:161 ; https://doi.org/10.1038/s41746-023-00899-4INTRODUCTIONRecent developments in health technology have positivelyaffected multiple and essential sectors of the economy, especiallythe healthcare sector, by providing solutions that guarantee theexchange of medical knowledge and information and establishlong-lasting health outcomes 1,2 . Digital health technologies, suchas wearables devices, computerized decision support systems, andtelemedicine improve the technical performance and satisfactionof healthcare employees, demonstrate potential to decrease directand indirect costs of medical services, and enhance the quality ofdelivered care3 . Worldwide, using digital solutions in practiceseems inevitable, with modality-specific prevalence (e.g., 50.8% fortelemedicine, 89.9% for electronic health records, and 91.9% forsocial media platforms) 4–6 . However, the prevalence of use mightbe even higher, as no previous study has collated and assessedthe overall prevalence of using digital health technologies byhealthcare providers. Likewise, several studies have suggestedthat ethnicity, race, geographic location, age, and medicalspecialty directly interfere in the adoption of technology use,evidencing the importance of understanding variables accountingfor the digital divide and disparity of access7–9 .Several barriers to healthcare’s overall quality, transparency, andefficiency naturally arise during or following the creation,implementation, and maintenance of digital health technologies.Therefore, during the design of any health-related project, it isessential to identify and quanti-qualitatively analyze its risks andfacilitators, enhancing the likelihood of obtaining favorableoutcomes and optimizing the chances of success. The efficientimplementation of digital technologies, characterized by properimplementation of a systematic management approach, includingstrategic planning, resource allocation, and control and evaluationprocesses, is fundamental to refining healthcare services, equip-ment, and technologies 10–12 . In reaction to these aforementionedelements, multiple efforts have strengthened healthcare systemsthrough employing DHTs for healthcare professionals andstakeholders from low-, middle-, and high-income countries. Forinstance, the World Health Organization (WHO) endorsed in the73rd World Health Assembly the institution of the Global Strategyon Digital Health 2020–2025, in which four guiding principles relyon the acknowledgment that the institutionalization of digitalhealth in a national system requires a decision and commitmentby countries, recognition that successful digital technologiesrequire an integrated strategy, promotion of the appropriate useof digital interventions for health, and recognition of the urgentneed to address the major impediments faced by least-developedcountries implementing digital health technologies 13 . Further-more, the Regional Digital Health Action Plan for the WHOEuropean Region 2023–2030 has a critical regional focus area onstrengthening digital literacy skills and capacity-building in thegeneral population, with particular attention to the healthworkforce, for the use of digital health services and diseaseprevention and management 14 . Due to these global actions
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