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Intellectual Property Challenges in AI-based Digital Health Diagnostics: A Comprehensive Review
| International Journal of Computer Applications |
| Foundation of Computer Science (FCS), NY, USA |
| Volume 187 - Number 114 |
| Year of Publication: 2026 |
| Authors: Medha Sanketh, Sahana Markande, Kruthika N., Chitra B.T. |
10.5120/ijca4f889d5f5416
|
Medha Sanketh, Sahana Markande, Kruthika N., Chitra B.T. . Intellectual Property Challenges in AI-based Digital Health Diagnostics: A Comprehensive Review. International Journal of Computer Applications. 187, 114 ( Jun 2026), 1-8. DOI=10.5120/ijca4f889d5f5416
Abstract
Artificial intelligence (AI) is rapidly transforming digital healthcare, particularly in diagnostic systems such as radiology and clinical decision support. However, this progress has exposed significant gaps in existing intellectual property (IP) and regulatory frameworks, which were not designed for AI-driven innovation. This paper examines key challenges including inventorship, data ownership, algorithmic transparency, and regulatory fragmentation. A comparative analysis of global legal frameworks, such as the EU AI Act (2024), Council of Europe AI Convention (2024), and US FDA Software as a Medical Device (SaMD) guidelines is presented, along with selected judicial case studies that highlight evolving approaches to accountability in AI-assisted diagnostics. In addition, statistical trends from the past six years are analysed to demonstrate the rapid growth and adoption of AI in healthcare. The paper further explores future developments, including explainable AI and autonomous diagnostic systems, and emphasizes the need for harmonized global IP policies. It concludes that adaptive regulatory frameworks are essential to ensure both innovation and equitable access in AI-driven healthcare.
References
- S. Rai et al., “Evolving IP landscape for AI-driven innovations in the biomedical sector,” Frontiers in Artificial Intelligence, vol. 7, 2024.
- T. Minssen et al., “AI and IP in healthcare technologies,” in Research Handbook on Health, AI and the Law, 2024.
- B. Haibe – Kains et al., “Forecasting AI trends in health care: systematic patent analysis,” JMIR AI, 2024.
- P. Boor et al., “Current trend of AI patents in digital pathology,” Cancers, 2022.
- R. Nagam, “Diagnostic medical AI: futuristic prospects,” Frontiers in Artificial Intelligence, 2023.
- Congressional Research Service, “Artificial intelligence and patent law,” 2024.
- A. Sharma et al., “Data privacy in healthcare: AI era,” Indian Dermatology Online Journal, 2023.
- X. Wang et al., “Privacy protection in AI for healthcare: Chinese perspective,” Healthcare, 2022.
- I. Shams et al., “Balancing privacy and progress in AI healthcare,” Applied Sciences, vol. 14, 2024.
- P. Verma et al., “AI in safeguarding patient privacy,” PMC, 2025.
- J. Amann et al., “Ethical and legal considerations in healthcare AI,” PMC, 2025.
- J. L. Cross et al., “Bias in medical AI,” PLOS Digital Health, 2024.
- N. Norori et al., “Addressing bias in big data and AI for healthcare,” Patterns, 2021.
- S. Reddy et al., “Gaps in global regulatory frameworks for AI in healthcare,” MDPI, 2024.
- M. Mashar et al., “AI algorithms in healthcare: FDA regulation sufficient?,” JMIR AI, 2023.
- I. Masood et al., “Evolving regulatory paradigm of AI in MedTech,” npj Digital Medicine, 2024.
- D. Ueda et al., “Fairness of AI in healthcare,” npj Digital Medicine, 2024.
- World Intellectual Property Organization (WIPO), “Intellectual property and artificial intelligence,” WIPO, 2023.
- WIPO, “AI and intellectual property policy developments,” 2024.
- G. Kloppers et al., “Ethical challenges in AI-driven medical data management,” Discover Artificial Intelligence, 2025.
- Council of Europe, “Framework Convention on AI, Human Rights, Democracy and the Rule of Law,” 2024.
- European Commission, “Regulation (EU) 2024/1689 – Artificial Intelligence Act,” 2024.
- E. P. Vardas et al., “Medicine, healthcare and the AI Act,” European Heart Journal Digital Health, 2025.
- F. Busch et al., “Navigating the EU AI Act for healthcare,” npj Digital Medicine, 2024.
- EUR–Lex, “Council Decision (EU) 2024/2218,” 2024.
- U.S. CMS, “Policy guidance on AI in healthcare decisionmaking,” 2024.
- U.S. FDA, “Artificial Intelligence/Machine Learning (AI/ML)Enabled Medical Devices,” 2024.
- U.S. FDA, “Software as a Medical Device (SaMD): Clinical Evaluation,” 2023.
- Grand View Research, “Artificial intelligence in healthcare market size report, 2024 – 2030,” 2024.
- MarketsandMarkets, “AI in medical diagnostics market report,” 2024.
- Fact.MR, “AI diagnostics market outlook,” 2024.
- World Health Organization (WHO), “Ethics and governance of AI for health,” 2021.
- OECD, “Artificial intelligence in health: policy and governance,” 2023.
- European Commission, “Product Liability Directive (updated for AI systems),” 2024.
- UK National Health Service (NHS), “AI in healthcare funding and deployment report,” 2023.
- Nature Medicine Editorial, “Artificial intelligence in clinical practice,” Nature Medicine, 2023.
- Stanford University, “AI Index Report 2024,” Stanford HAI, 2024.
- McKinsey & Company, “The economic potential of AI in healthcare,” 2023.
- PMC, “AI-driven transformative applications in disease diagnosis,” 2025.
- European Commission, “Ethics guidelines for trustworthy AI,” 2021.
- IBM Research, “Explainable AI: Interpreting machine learning models,” 2023.
- PMC, “AI in healthcare: transforming the practice of medicine,” 2021.
- PMC, “AI in healthcare and medicine: therapeutic advances,” 2024.
- Nature Digital Medicine, “Explainable AI in clinical applications,” 2024.
- JMIR, “Future use of AI in diagnostic medicine,” 2025.
- World Economic Forum, “The future of AI in healthcare,” 2024.
- U.S. District Court, “Estate of Gene B. Lokken v. UnitedHealth Group, Inc.,” District of Minnesota, 2025.
- U.S. District Court, “Humana Inc. Medicare Advantage Coverage Litigation,” United States, 2024.
- U.S. District Court, “Overjet, Inc. v. VideaHealth, Inc.,” District of Massachusetts, 2024.
- Federal Court of Canada, “Haghshenas v. Canada (Citizenship and Immigration),” 2023.
- U.S. Court of Appeals for the Federal Circuit, “Thaler v. Vidal,” 2022.
- U.S. District Court for the District of Columbia, “Thaler v. Perlmutter,” 2023.
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