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South Africa’s new National Policy on Data and the Cloud is a significant step towards digital transformation. It emphasises the need for infrastructure development, regulatory frameworks, and skills enhancement to support a burgeoning digital economy. The policy outlines strategies for accelerating broadband connectivity, promoting cloud-first approaches for government services, and ensuring data security. Moreover, it aims to create a digital trust environment essential for fostering innovation and economic growth.
We tackle the most challenging areas of law governing health research, from developing a DTA template for South Africa to writing on-point academic articles. We aim to provide legal clarity on the laws governing health research on the African continent.
Our legal experts publish extensively on legal aspects affecting your health research project. Easily find what is most relevant to you by selecting keywords from the dropdown menu.
| Title | Journal | Year | Link | Key words |
|---|---|---|---|---|
| Who would own the HeLa cell line if the Henrietta Lacks case happened in present-day South Africa? | Journal of Law and the Biosciences | 2023 | Read | science and the law, ownership |
| Is benefit sharing with research participants lawful in South Africa? An unexplored question in the governance of genomics research | Journal of Law and the Biosciences | 2023 | Read | benefit-sharing, science and the law, health research |
| Towards a data transfer agreement for the South African research community: the empowerment approach | South African Journal of Bioethics and Law | 2023 | Read | DTA |
| Toward an open access genomics database of South Africans: Legal considerations | South African Journal of Science | 2023 | Read | genetics, health research, science and the law |
| Regulating human genomic research in Africa: why a human rights approach is a more promising conceptual framework than genomic sovereignty | Frontiers in Genetics | 2023 | Read | genetics, health research, science and the law |
| Promoting equality in the governance of heritable human genome editing through Ubuntu: Reflecting on a South African public engagement study | The American Journal of Bioethics | 2023 | Read | genetics, science and the law |
| Repurposing research data for commercial use: POPIA, a foil or a facilitator? | South African Journal of Science | 2023 | Read | health research, science and the law |
| Mapping the regulatory landscape of AI in healthcare in Africa | Frontiers in Pharmacology | 2023 | Read | AI, science and the law |
| An imbalanced approach to governance? An analysis of the WHO's position on human genome editing | Bioethics | 2023 | Read | genetics |
| Open science and human genetic data: recommendations on South Africa’s Draft National Open Science Policy | Frontiers in Genetics | 2023 | Read | genetics, science and the law |
| POPIA does indeed apply to health research: A response to Bronstein and Nyachowe | South African Medical Journal | 2023 | Read | data protection, health research, science and the law |
| The human genome as the common heritage of humanity | Frontiers in Genetics | 2023 | Read | genetics |
| Does data protection law in South Africa apply to pseudonymised data? | Frontiers in Pharmacology | 2023 | Read | data protection, pseudonymisation |
| Legal and ethical principles governing the use of artificial intelligence in radiology services in South Africa | Developing World Bioethics | 2023 | Read | AI, science and the law |
| Response to Brand et al.(2022)'Data sharing governance in sub-Saharan Africa during public health emergencies' | South African Journal of Science | 2023 | Read | cross-border data sharing, data governance |
| A golden opportunity for South Africa to legislate on human heritable genome editing | South African Journal of Bioethics and Law | 2023 | Read | genetics, science and the law |
| Liability for harm caused by AI in healthcare: an overview of the core legal concepts | Frontiers in Pharmacology | 2023 | Read | AI, science and the law |
| The wisdom of claiming ownership of human genomic data: a cautionary tale for research institutions | Developing World Bioethics | 2024 | Read | genetics, science and the law, ownership |
| The proposed Code of Conduct for Research in South Africa: despite good progress, unresolved issues remain | Humanities and Social Sciences Communications | 2024 | Read | health research |
| The Regulation of Health-Related Direct-to-Consumer Genetic Tests in South Africa by the Medicines and Related Substances Act | South African Law Journal | 2024 | Read | genetics, health research |
| Forcing a square into a circle: why South Africa’s draft revised material transfer agreement is not fit for purpose | Frontiers in Pharmacology | 2024 | Read | human biological material, health research |
| Cross-border data sharing for research in Africa: An analysis of the data protection and research ethics requirements in 12 jurisdictions | Research Square | 2024 | Read | data protection, cross-border data sharing |
| Benefit‐sharing with human participants in health research in South Africa: A call for clarity | Developing World Bioethics | 2024 | Read | health research, benefit-sharing |
| Data protection law: Lessons from Tanzania for South Africa? | South African Journal of Bioethics and Law | 2024 | Read | data protection |
| The anatomy of a data transfer agreement for health research | Frontiers in Pharmacology | 2024 | Read | DTA, health research |
| Children as participants in health research in South Africa: A response to Labuschaigne, Mahomed and Dhai | Developing World Bioethics | 2024 | Read | health research, children in health research |
| Enhancing data governance in collaborative research: Introducing SA DTA 1.1 | South African Journal of Bioethics and Law | 2024 | Read | data governance |
| Human in the loop requirement and AI healthcare applications in low-resource settings: A narrative review | South African Journal of Bioethics and Law | 2024 | Read | AI, science and the law |
| Defining and pursuing diversity in human genetic studies | Nature Genetics | 2024 | Read | genetics |
| Data governance in African health research: ELSI challenges and solutions | Frontiers in Pharmacology | 2024 | Read | data governance |
| Collective Property Rights in Human Biological Materials in Kenya | Journal of Conflict Management & Sustainable Development | 2022 | Read | science and the law, property rights, human biological material |
| How to interpret core concepts in POPIA. Recommendations on the draft Code of Conduct for Research | South African Journal of Science | 2023 | Read | consent, data protection, de-identification |
| Artificial intelligence in healthcare: Proposals for policy development in South Africa | South African Journal of Bioethics and Law | 2022 | Read | AI, science and the law |
| Toward an open access genomics database of South Africans: ethical considerations | Frontiers in Genetics | 2023 | Read | science and the law |
| First do no harm: legal principles regulating the future of artificial intelligence in health care in South Africa | Potchefstroom Electronic Law Journal | 2022 | Read | AI, science and the law |
| “Privacy by Design” in the EU General Data Protection Regulation: A new privacy standard or the emperor’s new clothes? | South African Law Journal | 2022 | Read | data protection, science and the law |
| Altering the human genome: mapping the genome editing regulatory system in South Africa | Potchefstroom Electronise Reg | 2021 | Read | science and the law |
| Human genome editing: how to prevent rogue actors | BMC Medical Ethics | 2020 | Read | science and the law |
| The lawful sharing of health research data | Information & Communication Technology Law | 2021 | Read | science and the law, data protection |
| The multidimensional legal nature of personal genomic sequence data: a South African perspective | Frontiers Genetics | 2022 | Read | intellectual property, science and the law |
| Decoding the EU Artificial Intelligence Act | American Society and International Law Insights | 2021 | Read | AI, science and the law |
| Software as Medical Devices (SaMDs): Critical rights issues regarding AI software-based health technologies in South Africa | Journal of South African Law / Tydskrif vir SuidAfrikaanse Reg | 2020 | Read | AI, science and the law |
| Biotech innovation in South Africa: Twenty years in review | Biotechnology Law Report | 2016 | Read | intellectual property, science and the law |
| Patenting decisions by South African biotechnology entrepreneurs | Biotechnology Law Report | 2016 | Read | intellectual property, science and the law |
| Stem cell research, morality, and law: an analysis of Brüstle v Greenpeace from a South African perspective | South African Journal of Human Rights | 2017 | Read | intellectual property, science and the law |
| CRISPR: Challenges to South African biotechnology law | South African Journal of Bioethics and Law | 2018 | Read | science and the law |
| An optimistic vision for biosciences in South Africa: A response to the ASSAf report on human genetics and genomics | South African Journal of Science | 2019 | Read | science and the law |
| Navigating uncharted waters: biobanks and informational privacy in South Africa | South African Journal of Human Rights | 2019 | Read | data protection, science and the law |
| Genomic research and privacy: A response to Staunton et al. | South African Medical Journal | 2020 | Read | data protection, science and the law |
| Informed consent in medical malpractice suits: An analysis of Beukes v Smith | South African Law Journal | 2020 | Read | informed consent |
| COVID-19 and quarantine orders: A practical approach | South African Medical Journal | 2020 | Read | pandemic preparedness, science and the law |
| South Africa’s new standard material transfer agreement: proposals for improvement and pointers for implementation | BMC Medical Ethics | 2020 | Read | data protection, human biological material, science and the law |
| One material transfer agreement to rule them all? A call for revising South Africa’s new standard material transfer agreement. | Humanities and Social Sciences Communications | 2021 | Read | data protection, human biological material, science and the law |
| Protecting personal information in research: Is a code of conduct the solution? | South African Journal of Science | 2021 | Read | data protection, human biological material, science and the law |
| Time for Cinderella to go to the ball: Reflections on the right to freedom of scientific research | South African Law Journal | 2021 | Read | science and the law |
| Why POPIA does not apply to DNA | South African Journal of Science | 2021 | Read | data protection, human biological material, science and the law |
| Exempting Health Research from the Consent Provisions of POPIA | Potchefstroom Electronic Law Journal | 2021 | Read | data protection, science and the law |
| AI inventorship: The right decision? | South African Journal of Science | 2021 | Read | AI, intellectual property, science and the law |
| The legal status of human biological material used for research | South African Law Journal | 2021 | Read | human biological material, science and the law |
| Public health emergency preparedness and response in South Africa: A review of recommendations for legal reform relating to data and biological sample sharing. | South African Journal of Bioethics and Law | 2021 | Read | data protection, human biological material, pandemic preparedness, science and the law |
| Why research institutions should indemnify researchers against POPIA civil liability | South African Journal of Science | 2022 | Read | data protection, science and the law |
| Research and the meaning of ‘public interest’ in POPIA | South African Journal of Science | 2022 | Read | data protection, science and the law |
| Clearing the CRISPR patent landscape: Towards a solution for South Africa | South African Law Journal | 2022 | Read | intellectual property, science and the law |
