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Artificial Intelligence & Technology

Singapore: HSA Releases AI Medical Software Consultation Findings

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In brief

On 13 February 2026, the Health Sciences Authority (HSA) published the findings of its public consultation on the proposed exemption from manufacturer’s licensing and product registration requirements for artificial intelligence software as a medical device (AI-SaMD) developed by selected public healthcare entities for use in public healthcare (AI‑SaMD sandbox).

The public consultation was held from 19 May 2025 to 19 June 2025, and the HSA announced that the feedback was generally supportive of the proposed AI-SaMD sandbox. The HSA also published a summary of the suggestions provided.

In more detail

As covered in our May 2025 alert, the HSA invited the public to provide feedback on the proposed AI-SaMD sandbox from 19 May 2025 to 19 June 2025.

The respondents generally expressed support for the proposal and provided constructive suggestions, which broadly fell into the following categories:

  1. Suggestions to strengthen controls within the sandbox, such as imposing additional International Organisation for Standardisation (ISO), International Electrotechnical Commission and cybersecurity requirements, and for the AI-SaMDs in the sandbox to eventually be registered with HSA
  2. Suggestions to expand the scope of the AI-SaMD sandbox to allow other healthcare professionals, apart from registered medical practitioners, to provide oversight over the development of these AI-SaMDs, and extending participation beyond the public healthcare sector, such as to private healthcare institutions and software developers

The HSA emphasised that the proposed sandbox is intended to ensure appropriate regulatory oversight, while at the same time fostering healthcare innovation. Therefore, the HSA has to consider the existing cybersecurity and data security safeguards that public healthcare entities have to comply with, as well as the prevailing requirements under the Health Products Act and the Healthcare Services Act.

Taking into account the above considerations, the HSA will undertake the following:

  • Scope the sandbox only to AI-SaMDs that pose lower potential patient risks, i.e., Class A and Class B AI‑SaMDs, which only aim to diagnose and/or drive clinical patient management for non-critical medical conditions (For more information on the risk classification of AI-SaMDs, see our previous alert.)
  • Require a clinician employed in a public healthcare institution, and holding the position of consultant or higher, to oversee the AI-SaMD’s design, validation and output, and to ensure that the AI-SaMD is manufactured under the supervision of a qualified medical practitioner
  • Require public healthcare developers to conduct yearly quality management system self‑attestations to confirm compliance with ISO 13485 standards
  • Require AI-SaMDs to be endorsed by the chair of the medical board or the CEO of the public healthcare institution for deployment, ensuring that senior leadership is aware of and accountable for the AI-SaMDs being deployed in their public healthcare institution or cluster
  • Require that the public healthcare institution or cluster notify the HSA of the AI-SaMDs before deploying them for use in patients
  • Require that deployers inform patients when AI-SaMDs developed under the proposed sandbox will be used in their medical care
  • Engage with public healthcare developers on the HSA product registration upon the wider deployment of the AI-SaMD across public healthcare

The HSA reiterated that the sandbox is an expansion of the exceptions within the Health Products Act, and the HSA will continue to uphold the key safeguards, such as post-market obligations and accountability, to ensure regulatory oversight and patient safety.

Key takeaways

The HSA has been embracing and encouraging the adoption and use of AI within the Singapore healthcare system, along with providing regulatory guidance to ensure patient safety. This AI-SaMD sandbox is one such measure that facilitates broader AI adoption and scaling up across the Singapore healthcare ecosystem, and the HSA has confirmed that it will be considering extending the scope to beyond public healthcare.

The HSA will closely monitor the outcomes of the sandbox to evaluate and determine the next steps, including the calibration of controls, and to create a comprehensive framework to support AI innovation while ensuring the safe and effective use of AI in healthcare.

Companies should continue to monitor how the HSA calibrates its controls toward AI-SaMDs in Singapore, as the outcomes of the sandbox may have knock-on effects on wider controls and guidance for AI-SaMDs.

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Author

Andy Leck is a distinguished senior legal practitioner in Intellectual Property and Technology, Media and Telecommunications (TMT) matters. He is the head of the Intellectual Property and Technology (IPTech) Practice Group in Singapore, and serves as the Asia Pacific head of Baker McKenzie's TMT Industry Group. Andy is widely recognized by reputable global industry and legal publications as a leader in his field. He was named on "The A-List: Singapore's Top 100 lawyers" by Asia Business Law Journal since 2018. Chambers Asia Pacific notes that Andy as "a well-known IP practitioner who is highlighted for his record of handling major trade mark litigation, as well as commercial exploitation of IP rights in the media and technology sectors. He's been in the industry for a long time and has always been held in high regard. He is known to be very fair and is someone you would like to be in the trenches with you during negotiations." Furthermore, Asian Legal Business acknowledges Andy as a leading practitioner in his field and notes that he “always gives good, quick advice, [is] client-focused and has strong technical knowledge for his areas of practice.” Under his leadership, the TMT team in Singapore is highly regarded for its expertise in “outsourcing, cloud computing and TMT IP-related mandates” and “data privacy, compliance, technology and telecoms regulations.” Andy was appointed by the Intellectual Property Office of Singapore (IPOS) as an IP Adjudicator to hear IP disputes between 2021 and 2023. He has been an appointed member of the Singapore Copyright Tribunal since May 2010 and a mediator with the WIPO Arbitration and Mediation Center, as well as the Singapore Mediation Centre.

Author

Ren Jun Lim is a principal with Baker McKenzie Wong & Leow. He represents local and international clients in both contentious and non-contentious intellectual property matters. He also advises on a full range of healthcare, as well as consumer goods-related legal and regulatory issues. Ren Jun co-leads Baker McKenzie Wong & Leow's Healthcare as well as Consumer Goods & Retail industry groups. He sits on the Law Society of Singapore IP Committee and on the Executive Committee of the Association of Information Security Professionals. He is also a member of the Vaccines Working Group, Singapore Association of Pharmaceutical Industries, a member of the International Trademark Association, as well as a member of the Regulatory Affairs Professionals Association. Ren Jun is ranked in the Silver tier for Individuals: Enforcement and Litigation and Individuals: Prosecution and Strategy, and a recommended lawyer for Individuals: Transactions by WTR 1000, 2020. He is also listed in Asia IP's Best 50 IP Expert, 2020, recognised as a Rising Star by Managing IP: IP Stars, 2019 and one of Singapore's 70 most influential lawyers aged 40 and under by Singapore Business Review, 2016. Ren Jun was acknowledged by WTR 1000 as a "trademark connoisseur who boasts supplementary knowledge of regulatory issues in the consumer products industry." He was also commended by clients for being "very responsive to enquiries and with a keen eye for detail, he is extremely hands-on. His meticulous and in-depth approach to strategising is key to the excellent outcomes we enjoy."

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