USA Law and Practice Contributed by: Nadia de la Houssaye, Andy Lee, Jason Loring and Graham Ryan, Jones Walker LLP
fication requirements when using health data for AI development. HIPAA provides two methods for de-identification: safe harbour, which requires the removal of specific identifiers; and expert deter - mination, which relies on statistical and scientific principles to minimise re-identification risk. • Re-identification risks: AI systems may create new re-identification risks through pattern recognition capabilities that can infer individual identities from seemingly anonymous data. Organisations must guard against re-identification risks when datasets are combined and implement ongoing monitoring for potential privacy breaches. • Synthetic data generation: Synthetic data genera - tion techniques can create realistic datasets for AI training while protecting individual privacy. These approaches use statistical methods or genAI to preserve important statistical properties while removing direct links to individual patients. • Technical safeguards: Strong technical safeguards must be implemented when using de-identified data for AI training – including access controls, encryption, audit logging and secure computing environments – and should address both intention - al and accidental re-identification risks throughout the AI development process. Patents remain one of the most effective tools for pro - tecting healthcare innovations. AI developers should consider the following when developing new systems and platforms. • Patentability of AI algorithms and software: Healthcare AI innovations are eligible for patent protection when they meet traditional patentabil - ity requirements of novelty, non-obviousness and utility, and satisfy subject matter eligibility require - ments under current patent law interpretations. However, abstract mathematical algorithms and natural phenomena often cannot be patented. • Medical method patents: AI-enabled diagnostic and treatment methods may qualify for patent pro - tection when they apply emerging AI technology 7. Intellectual Property Issues Regarding Healthcare AI 7.1 Patent Protection
to specific medical problems. These patents must demonstrate technical innovation beyond merely applying known AI techniques. • International patent strategies: Healthcare AI com - panies must often develop tailored, international patent strategies that address varying patent law requirements across different jurisdictions. Recent developments suggest increased scrutiny of AI-related patents. The Federal Circuit’s approach to software patentability under the Alice framework continues to evolve, with AI-specific considerations including whether the AI application provides a techni - cal improvement to computer functionality, the degree of human intervention in AI-generated inventions and potential heightened obviousness rejections when prior art includes AI tools. 7.2 Copyright and Trade Secrets Software code, user interfaces, and documentation may receive copyright protection as original works of authorship. However, copyright protection does not extend to underlying algorithms or mathematical con - cepts, limiting its scope for AI innovations. Additional issues to consider include: • training data copyright – when using third-party data for training purposes, developers should obtain appropriate licences for copyrighted medi - cal literature, imaging databases and other materi - als. • trade secret protection – trade secret protection may provide valuable intellectual property protec - tion for AI algorithms, training datasets and devel - opment methodologies that derive economic value from remaining confidential. 7.3 Ownership of AI Outputs When multiple parties contribute to the development, deployment and analysis of healthcare AI technology and its outputs, the following issues should be con - sidered. • Generated content ownership: Legal frameworks governing the ownership of AI-generated diag - nostic findings, treatment recommendations and other clinical outputs remain largely unsettled, as
136 CHAMBERS.COM
Powered by FlippingBook