Robots To The Rescue: Regulation Of Artificial Intelligence In Healthcare In Malaysia

Published date13 August 2021
Subject MatterConsumer Protection, Media, Telecoms, IT, Entertainment, Food, Drugs, Healthcare, Life Sciences, Technology, Advertising, Marketing & Branding, Biotechnology & Nanotechnology, Dodd-Frank, Consumer Protection Act, New Technology
Law FirmAzmi & Associates
AuthorMs Ili Syazwani Shairi


The application of artificial intelligence ("AI") technology in the healthcare industry has undoubtedly revolutionised clinical practice. There is great optimism that the AI application can provide substantial improvements in all areas of healthcare from automating daily drudgery and routine medical tasks to performing diagnostics and treating functions. The upsurge in the usage of AI and medical robots in healthcare settings has even prompted certain agencies to devise specific rules and guidelines to govern the technology. In April 2021, the European Union ("EU") put forth its "Proposal for a Regulation on a European approach for AI" with the intention of establishing human-centric AI rules and "the first ever legal framework on AI, which addresses the risks of AI and positions Europe to play a leading role globally."1 Subsequently, in June 2021, in an unprecedented move, the World Health Organization ("WHO") issued six guiding principles to be the basis for AI regulation and governance for its member countries.2 These developments, together with the eruption of the 21st century global pandemics such as Ebola and COVID-19, indicate that there are strong merits in discussing the ways in which AI-powered healthcare products and services are regulated in Malaysia, which this article seeks to explore.

Healthcare AI in the Pandemic Age

The application of AI in the healthcare scene is typically practised as a partnership between human and machine, each bringing their complementary strengths. In December 2019, BlueDot, a Canada-based digital-health company that uses an AI-driven algorithm to predict the spread of infectious diseases, notified its clients to the detection of unusual pneumonia cases in Wuhan, China. Several days later, the World Health Organisation (WHO) released their first public warnings about a virus that we now know as COVID-19. The global spread of the COVID-19 outbreak has since accelerated the usage of AI in healthcare settings,3 owing to the deadly nature of the virus, which necessitates faster diagnosis and treatments.

AI has also been utilised for drug research by analysing available data on COVID-19. This technology has been used in accelerating drug testing in real-time, beating the speed of standard testing by humans which takes longer time.4 Further, AI has also become a powerful tool for diagnostic test designs in this pandemic age. For instance, in mid-2020, Huawei Malaysia collaborated with the Malaysian Ministry of Health to contribute Huawei Cloud AI-assisted diagnosis solution to a COVID-19 hospital in Malaysia in order to provide faster COVID-19 diagnosis. AI has also played its role in developing vaccines and treatments at much faster rate than usual and has been proven to be helpful for clinical trials during the development of the vaccine.5

As regards the development of pharmaceuticals, clinical trials take sometimes more than a decade and cost billions of dollars. Speeding this up and making it more cost-effective would have massive effect on everyday medicine. For instance, Atomwise uses supercomputers that root out therapies from a database of molecular structures. The company launched a virtual search for existing medicines that could be redesigned to treat the Ebola virus. They found two drugs predicted by the company's AI technology which may significantly lessen Ebola infectivity. This analysis, which typically would have taken months or years, was completed in less than one day.6

The global AI-associated healthcare market size was valued at USD 6.7 billion in 2020 and is expected to expand at a compound annual growth rate of 41.8% from 2021 to 2028.7 As this trend seems promising, it is even more important now for all AI companies to demonstrate the efficacy of their method and the safety of AI with peer-reviewed research, whilst ensuring full compliance with the law.

WHO Guiding Principles on AI

Growing use of AI technology for healthcare purposes has prompted WHO to issue formal guiding principles for proper design and usage of AI in the healthcare industry. Twenty experts reportedly spent two years developing the guidance, which marks the issuance of the first ever consensus report on AI regulatory and governance in healthcare settings. Through a guidance document issued in June 2021, WHO outlines the following six guiding principles, with the aim of limiting the risks and maximising the opportunities intrinsic to the use of AI for health:8

  • Protecting human autonomy: In the context of health care, this means that humans should remain in control of health-care systems and medical decisions; privacy and confidentiality should be protected, and patients must give valid informed consent through appropriate legal frameworks for data protection. ("Principle 1")
  • Promoting human well-being and safety and the public interest: The designers of AI technologies should satisfy regulatory requirements for safety, accuracy and efficacy for well-defined use cases or indications. Measures of quality control in practice and quality improvement in the use of AI must be available. ("Principle 2")
  • Ensuring transparency, explainability, and intelligibility: Transparency requires that sufficient information be published or documented before the design or deployment of an AI technology. Such information must be easily accessible and facilitate meaningful public consultation and debate on how the technology is designed and how it should or should...

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