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Cited by 302Digitalization, Law, and RegulationArtificial Intelligence in Healthcare and EducationHealthcare Regulation

The DOI matches its Crossref record; 33 of the 33 references it cites were found in a registry or an index.

Global Regulatory Frameworks for the Use of Artificial Intelligence (AI) in the Healthcare Services Sector

Open access
Palaniappan, Kavitha, Lin, Elaine Yan Ting, Vogel, Silke·2024·Healthcare
DOI 10.3390/healthcare12050562PMC PMC10930608
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Abstract

The healthcare sector is faced with challenges due to a shrinking healthcare workforce and a rise in chronic diseases that are worsening with demographic and epidemiological shifts. Digital health interventions that include artificial intelligence (AI) are being identified as some of the potential solutions to these challenges. The ultimate aim of these AI systems is to improve the patient's health outcomes and satisfaction, the overall population's health, and the well-being of healthcare professionals. The applications of AI in healthcare services are vast and are expected to assist, automate, and augment several healthcare services. Like any other emerging innovation, AI in healthcare also comes with its own risks and requires regulatory controls. A review of the literature was undertaken to study the existing regulatory landscape for AI in the healthcare services sector in developed nations. In the global regulatory landscape, most of the regulations for AI revolve around Software as a Medical Device (SaMD) and are regulated under digital health products. However, it is necessary to note that the current regulations may not suffice as AI-based technologies are capable of working autonomously, adapting their algorithms, and improving their performance over time based on the new real-world data that they have encountered. Hence, a global regulatory convergence for AI in healthcare, similar to the voluntary AI code of conduct that is being developed by the US-EU Trade and Technology Council, would be beneficial to all nations, be it developing or developed.

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Figure 1 Applications of AI in healthcare services.
Figure 1 Applications of AI in healthcare services.CC BY · PubMed Central

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  1. Tsang, 2017, The Impact of Artificial Intelligence on Medical Innovation in the European Union and United States, Intellect. Prop. Technol. Law J., 29, 3

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Metadata

Authors
Palaniappan, K., Lin, E. Y. T., & Vogel, S.
Affiliations
National University of Singapore (SG)
Corresponding author
Palaniappan, Kavitha
ORCID
Venue
Healthcare
Publisher
MDPI AG
Published
2024-02-28
Volume
12
Issue
5
Pages
562
ISSN
2227-9032 (ISSN-L)
DOI
10.3390/healthcare12050562
PMC
PMC10930608
OpenAlex
W4392293571
Cited by
301
References
33
Citations by year
2026: 107 · 2025: 168 · 2024: 26
FWCI
91.59
Type
journal article
Language
en
Open access
Licence
Locations
  • Healthcare (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
Funders
Ministry of Health (MH 114:63/5)
Topics
  • Social Sciences › Law › Digitalization, Law, and Regulation
  • Health Sciences › Medicine › Health Informatics › Artificial Intelligence in Healthcare and Education
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Healthcare Regulation
Keywords
artificial intelligence in healthcare, AI regulation, regulatory framework, software as a medical device, digital health products, regulatory convergence, autonomous AI systems, health workforce shortage, chronic disease

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