Sources and disclaimer
Primary instruments and the regulatory commentary current as of June 2026. Device and data rules in this space move fast, so re-verify before each new market entry.
Australia. TGA AI software guidance (Feb 2026); TGA AI-in-healthcare final report (2025); Therapeutic Goods Act 1989 and SaMD rules (2021). Privacy Act 1988 and APPs; Privacy and Other Legislation Amendment Act 2024.
EU. MDR 2017/745 (Rule 11); AI Act, Regulation 2024/1689; Digital Omnibus package (announced Nov 2025). GDPR (Articles 9, 28, 35, Chapter V).
UK. MHRA Software and AI as a Medical Device Change Programme; draft Medical Devices (Amendment) Regulations 2026 (11 May 2026). UK GDPR, Data Protection Act 2018, Data (Use and Access) Act 2025.
US. 21st Century Cures Act; FDA Clinical Decision Support Software final guidance (6 Jan 2026). HIPAA Privacy and Security Rules; CCPA/CPRA and newer state acts.
India. Medical Device Rules 2017; CDSCO Draft Guidance on Medical Device Software (21 Oct 2025); Telemedicine Practice Guidelines 2020. DPDP Act 2023 and DPDP Rules 2025 (notified 13 Nov 2025).
UAE. Federal Decree-Law 38 of 2024 and the Emirates Drug Establishment; DOH and DHA AI healthcare policies. Federal Decree-Law 45 of 2021 (PDPL); Federal Law 2 of 2019 (ICT in health).
This is general regulatory mapping, not legal advice. It is a reference overview and a starting point for clinic and clinician questions. Classification turns on the specific intended-purpose statements, copy, and contracts we put in front of a regulator, and the rules in every market here have moved within the past year. Before any pilot contract is signed, the per-agent Intended Purpose statements and the not a medical device position paper should be reviewed by a device-regulatory lawyer in the relevant market.