Technical Reference Group for Software as a Medical Device (SaMD) and Artificial Intelligence (AI) From Therapeutic Goods Administration (TGA) π¦πΊ Information on the role and membership of the Technical Reference Group for SaMD and AI. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on August 15, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Proposal for a COUNCIL DECISION on the signing, on behalf of the European Union, of the Council of Europe Framework Convention on Artificial Intelligence, Human Rights, Democracy and the Rule of Law From European Parliament πͺπΊ A proposal for the European Union to sign the Council of Europe Framework Convention on Artificial Intelligence, focusing on human rights, democracy, and the rule of law. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on June 26, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Software and artificial intelligence (AI) as a medical device From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD). Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on June 13, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Artificial Intelligence (AI) and medical device software From Therapeutic Goods Administration (TGA) π¦πΊ Information for software manufacturers when AI is considered a medical device, and how we regulate AI medical devices. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 9, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Impact of AI on the regulation of medical products From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ Implementing the Artificial Intelligence (AI) White Paper principles. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on April 30, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Commission Decision of 24Β January 2024 establishing the European Artificial Intelligence Office From European Parliament πͺπΊ Commission Decision establishing the European Artificial Intelligence Office. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on January 24, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Proposal for a COUNCIL REGULATION amending Regulation (EU) 2021/1173 as regards an EuroHPC initiative for start-ups to boost European leadership in trustworthy Artificial Intelligence From European Parliament πͺπΊ A proposal to amend a regulation for an EuroHPC initiative aimed at boosting European leadership in trustworthy AI through start-ups. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 24, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Guidance on the Review and Approval of Artificial Intelligence (AI)-based Medical Devices From Ministry of Food and Drug Safety (MFDS) π°π· This guidance applies to machine Learning-enabled medical devices, in which machine learning-based AI technology is applied to diagnose, manage, or predict diseases by analyzing medical data. They also apply to AI software configured using hardware. For example, clinical decision supporting (CDS)β¦ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 20, 2023 Other (Public Domain) 0 reuses 0 favorites
Software and AI as a Medical Device Change Programme From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ The Medicines and Healthcare products Regulatory Agency (MHRA) have embarked upon an ambitious programme of reform to ensure that medical device regulation is fit for purpose for software, including artificial intelligence (AI). Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on June 14, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Guidance for Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices (MDS β G010) From Saudi Food and Drug Authority (SFDA) πΈπ¦ This document provides guidance on AI/ML-enabled medical devices, offering insights for their development and implementation. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on January 3, 2023 Other (Public Domain) 0 reuses 0 favorites
Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on adapting non-contractual civil liability rules to artificial intelligence (AI Liability Directive) From European Parliament πͺπΊ Proposal for a directive on adapting non-contractual civil liability rules to artificial intelligence (AI Liability Directive). Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on September 28, 2022 Creative Commons Attribution 4.0 0 reuses 0 favorites
Recommendation for a COUNCIL DECISION authorising the opening of negotiations on behalf of the European Union for a Council of Europe convention on artificial intelligence, human rights, democracy and the rule of law From European Parliament πͺπΊ This document is a recommendation for the European Union to open negotiations on a Council of Europe convention on artificial intelligence and human rights. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 18, 2022 Creative Commons Attribution 4.0 0 reuses 0 favorites
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL LAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE (ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN UNION LEGISLATIVE ACTS From European Parliament πͺπΊ A proposal for a regulation on artificial intelligence, aiming to establish harmonized rules and amend existing legislative acts in the European Union. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 21, 2021 Creative Commons Attribution 4.0 0 reuses 0 favorites
The 6th Term Science Board (FY2022, FY2023) From Pharmaceuticals and Medical Devices Agency (PMDA) π―π΅ A document discussing the 6th Term Science Board for FY2022 and FY2023, focusing on Regulatory Science, The Science Board, and Standard Development. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 10, 2024 Other (Public Domain) 0 reuses 0 favorites
The 3rd Term Science Board (FY2016, FY2017) From Pharmaceuticals and Medical Devices Agency (PMDA) π―π΅ Explore the 3rd Term Science Board's work from FY2016 to FY2017, covering topics like Regulatory Science, The Science Board, and Standard Development. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Subcommittees From Pharmaceuticals and Medical Devices Agency (PMDA) π―π΅ This document discusses the role of subcommittees in areas such as Regulatory Science, The Science Board, and Standard Development. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 10, 2024 Other (Public Domain) 0 reuses 0 favorites