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2024-03-27
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Copyright (c) 2024 George Benneh Mensah, Maad M. Mijwil, Mostafa Abotaleb, Amr Badr, Ioannis Adamopoulos, Abdullah S. Arafat, Mohammad Hameed
This work is licensed under a Creative Commons Attribution 4.0 International License.
How to Cite
Role of Food and Drugs Authority Act, 1992 (PNDCL 305B) and Legislative Instrument (LI) in Regulating Artificial Intelligence Based Medical Devices, Apps, and Systems to Prevent Negligence
George Benneh Mensah
EGRC Ghana Limited, Accra, Ghana
https://orcid.org/0009-0006-6280-5738
Maad M. Mijwil
Computer Techniques Engineering Department, Baghdad College of Economic Sciences University, Baghdad, Iraq
https://orcid.org/0000-0002-2884-2504
Mostafa Abotaleb
Department of System Programming, South Ural State University, Chelyabinsk, Russia
https://orcid.org/0000-0002-3442-6865
Amr Badr
Faculty of Science, School of Science and Technology, University of New England, Armidale, NSW 2350, Australia
https://orcid.org/0000-0003-2260-2128
Ioannis Adamopoulos
Hellenic Republic, Region of Attica, Department of Environmental hygiene and Public Health and Sanitarian inspections, Greece
https://orcid.org/0000-0002-4942-7123
Abdullah S. Arafat
King Saud ben Abdulaziz University for Health Sciences, Saudi Arabia
https://orcid.org/0000-0002-9887-6718
Mohammad Hameed
Higher Technological Institute, The tenth of Ramadan, Egypt
https://orcid.org/0009-0005-6607-5245
DOI: https://doi.org/10.58496/BJIoT/2024/004
Keywords: Ghana FDA, Artificial Intelligence, Medical Devices, IoMT, Healthcare
Abstract
Objective: This analysis evaluates whether Ghana’s Food and Drugs Authority Act provides adequate statutory basis and policy tools for the medical regulatory authority to evaluate risks and oversee artificial intelligence (AI) based software devices, given complexities of AI technology.
Methods: Case examples of medical AI systems and international regulatory issues establish current challenges for regulators. Specific sections of the Act are analysed regarding definitions, requirements for safety and efficacy evidence, guidelines for changes to approved devices, and post-market powers.
Results and Conclusions: Current law does not provide explicit provisions to require transparency into AI systems’ decision-making or continuous monitoring of real-world performance. However added clauses on privacy and cybersecurity demonstrate a policy precedent for regulating complex technologies.
Recommendations: Updates should enable differentiated evaluation approach based on risk-tiers. Powers for inspecting algorithmic logic require expansion to address AI opacity.
Novelty and Significance: This represents the first analysis situating medical AI governance within Ghanaian statutes. Stress-testing decades old policy structures against emerging technology risks is both scientifically novel and significant for public health oversight.
