Guidance: Ambient voice technology-enabled products
Guidance on device qualification and classification of ambient voice technology-enabled products as medical devices in Great Britain.
UK MHRA · UK
Category
Digital Health & AI
Digital health sits across several regulatory regimes at once. Software with a medical purpose is a medical device under the MDR or IVDR, many AI-enabled devices are also high-risk systems under the EU AI Act, and reimbursement pathways such as Germany's DiGA add requirements of their own.
Regulation
Category
Type · Breadth
Date
MHRA clarifies regulatory status of ambient voice technologies used in the NHS
MHRA guidance clarifies how medical device law applies to ambient voice technology products in UK health and care settings.
UK MHRA · UKHDS Certification Framework v2.1: anticipated changes
Version 2.1 of the health data hosting certification framework, published October 2026, strengthens transparency requirements on third-country data transfers and foreign legislation submission.
ANS - French Digital Health Agency · FranceGuidance: Digital mental health technology: qualification and classification
Guidance to help manufacturers of digital mental health technologies determine regulatory qualification and appropriate device classification.
UK MHRA · UKThe enforcement framework of the AI Act
The European Commission's AI Office, national competent authorities, and the European Data Protection Supervisor share enforcement of the AI Act across different AI system categories.
EU AI Act Implementation · EU-wideAI Act enforcement and transparency requirements begin 2 August 2026
From 2 August 2026, AI Act enforcement begins and transparency rules require AI systems to disclose interaction with users and label AI-generated or altered content.
EU AI Act Implementation · EU-wideGuidance on qualification and classification of safety wristbands used in telecare services and recognition as medical devices
Guidance on how to qualify and classify safety wristbands used in telecare services as medical devices and their regulatory classification.
Poland URPL · PolandChanges to the questions and answers and guidance document on mobile technologies
Swissmedic updated its Q&A and guidance document on mobile technologies.
Swissmedic · SwitzerlandINFARMED guidance on digital health solutions as medical devices
INFARMED publishes guidance clarifying the regulatory framework for digital health solutions including software, mobile applications and AI-based solutions as medical devices.
Portugal INFARMED · PortugalAI talent, skills and literacy
Commission policy to increase AI experts and literacy among workers and the public; Article 4 AI Act obligations on providers and deployers entered into force February 2025, amended July 2026.
EU AI Act Implementation · EU-wideNational Commission into the Regulation of AI in Healthcare: research, engagement and call for evidence findings
Findings from the National Commission's call for evidence and research activities on AI regulation in healthcare.
UK MHRA · UKAEPD analysis of data quality, accuracy and minimisation in processing by AI systems
The Spanish Data Protection Authority examines GDPR compliance requirements for data quality, accuracy and minimisation in AI-based processing.
AEPD (Spanish Data Protection Agency) · SpainGuidance: Borderline products: medical devices and other products
MHRA guidance on how it determines whether a borderline product meets the definition of a medical device and whether device regulations apply.
UK MHRA · UKIberoamerican Network approves reference document on enhanced safeguards required for neurodata processing in non-health settings
The Iberoamerican Network of Data Protection Authorities has approved a reference document establishing enhanced safeguards for processing neurodata outside healthcare contexts.
AEPD (Spanish Data Protection Agency) · SpainNew impulse paper provides recommendations for cross-process digital transformation
Working group recommends criteria and priorities for digitising paper-based healthcare and care processes under the 'Gemeinsam Digital' strategy.
gematik (German Digital Health) · GermanyAI Act for Medical Devices
High-risk AI systems in medical devices must meet AI Act requirements on risk management, data governance, documentation, logging, transparency and oversight, with penalties up to €15M or 3% of global turnover.
EC AI Act & Regulation · EU-wideEuropean Health Data Space (EHDS) Regulation: overview
The EHDS is the EU's first sector-specific common data space, establishing a framework for health data access and use across member states.
European Health Data Space · EU-wideEuropean Health Data Space Regulation: entry into force
EHDS Regulation becomes law 20 days after publication in the EU Official Journal.
European Commission · EU-wideCommission guidelines on transparency obligations for providers and deployers of certain AI systems
Guidelines clarify AI Act transparency obligations for interactive AI systems and AI-generated content, effective 2 August 2026.
EU AI Act Implementation · EU-wideGuidance: Innovation Accelerator
MHRA establishes an Innovation Accelerator programme offering scientific expertise, regulatory guidance and enhanced advice to developers of innovative health products.
UK MHRA · UKCommission publishes Code of Practice on marking and labelling AI-generated content
Commission publishes a Code of Practice establishing requirements for marking and labelling of AI-generated content.
EC AI Act & Regulation · EU-wideContent of Human Factors Information in Medical Device Marketing Submissions; Guidance for Industry and FDA Staff
FDA guidance establishes a risk-based framework for human factors information required in device marketing submissions to CDRH.
US Federal Register - FDA Guidance Notices · United StatesLondon Region I MHRA Regulatory Sandbox: call for expressions of interest
MHRA invites expressions of interest from AI-enabled medical device manufacturers and NHS providers to participate in a regulatory sandbox.
UK MHRA · UKMHRA data requirements to support regulatory decision making
MHRA sets out data requirements and governance expectations for the UK Health Data Research Service to enable regulatory decision-making.
UK MHRA · UKFrequently Asked Questions on the European Health Data Space
News announcement 26 March 2026 Frequently Asked Questions on the European Health Data Space 1 min read
European Health Data Space · EU-wideFourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications
DEA and HHS extend telemedicine flexibilities for controlled-medication prescribing through December 31, 2026.
US Federal Register - DEA Telehealth Rules · United StatesArtificial intelligence in health: an ethical guide for responsible innovation
Actualités
ANS - French Digital Health Agency · FranceMyHealth@EU Patient Summaries and ePrescriptions Mandatory
Cross-border exchange of patient summaries and ePrescriptions becomes mandatory for all EU Member States.
European Commission · EU-wideMHRA seeks input on AI regulation at 'pivotal moment' for healthcare
UK MHRA National Commission is seeking evidence to shape regulation of AI in healthcare and support an AI-enabled NHS.
UK MHRA · UKRegulation of AI in Healthcare
MHRA seeks evidence on AI regulation in healthcare to inform the National Commission's recommendations.
UK MHRA · UKSégur du numérique en santé: regulatory framework for paramedical professionals and midwives published
Official publication of the decree establishing the Ségur du numérique en santé programme for paramedical professionals and midwives, setting the regulatory framework for software interoperability and secure health data exchange.
ANS - French Digital Health Agency · FranceNew Guide: 'How to' KIM for Care Facilities
gematik publishes guidance on implementing and using KIM (secure healthcare email) in care facilities, based on pilot experience in Hamburg region.
gematik (German Digital Health) · GermanyMSSanté deployment guide: supporting healthcare facilities towards generalised use of secure messaging
Guidance on implementing MSSanté secure messaging across healthcare facilities in France.
ANS - French Digital Health Agency · FranceUpdate - Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5
Version 5 of the EC manual on borderline and classification decisions under MDR and IVDR published.
EC Public Health · EU-wideCommission Implementing Regulation (EU) 2026/771 establishing the European Health Data Space Board
Implementing regulation establishing the governance structure and operational procedures for the European Health Data Space Board.
EUR-Lex Official Journal · EU-wideStandardisation of the AI Act
Harmonised standards will support implementation of the AI Act's high-risk AI system requirements and pre-market compliance obligations.
EC AI Act & Regulation · EU-wideEU AI Act: Prohibited AI Systems Ban under Article 5
Article 5 prohibitions on biometric categorization, social scoring, and emotion recognition in workplace and education settings enter into force.
European Commission · EU-wideMDCG 2025-6 – FAQ on Interplay between the Medical Devices Regulation, In vitro Diagnostic Medical Devices Regulation and the Artificial Intelligence Act
FAQ clarifying how MDR, IVDR and the AI Act interact in the regulation of AI-enabled medical devices and diagnostics.
EC Medical Devices · EU-wideFrance HDS Certification - New Standards Mandatory
Updated HDS certification standards for health data hosting providers are now mandatory; ANS enforcement penalties are operational.
ANS - French Digital Health Agency · FranceEHDS Primary Use Infrastructure Operational
MyHealth@EU infrastructure for primary use becomes mandatory; cross-border Patient Summaries and ePrescriptions/eDispensations exchange required; full EHR vendor compliance deadline March 2029.
European Health Data Space · EU-wideEHDS Full Implementation (Primary and Secondary Use)
EHDS infrastructure operational for patient care data exchange and research access; providers and EHR manufacturers must comply with interoperability requirements; fines up to €20M or 4% of turnover.
European Health Data Space · EU-wideAEMPS enables procedure for prior notification of in-house manufacture of in vitro diagnostic devices
AEMPS establishes a procedure for healthcare centres to submit prior notifications of in-house IVD manufacture pending the specific electronic application.
AEMPS (Spanish Medicine Agency) · SpainGeneral Principles on the use of Artificial Intelligence in the preparation of the JCA dossier
EC Public Health publishes general principles governing AI use in preparing Joint Clinical Assessment dossiers.
EC Public Health · EU-wideMHRA issues new guidance for people using mental health apps and technologies
MHRA publishes online resources to help the public and professionals understand safe, effective digital mental health technologies.
UK MHRA · UKGuidance: AI Airlock Phase 2 Cohort
Phase 2 of the Airlock programme will include seven additional AI-powered technologies for clinical documentation, cancer diagnostics, eye disease detection, and obesity treatment.
UK MHRA · UKGermany DiGA Performance Reporting Mandatory
DiGA manufacturers must implement continuous performance measurement (AbEM) and report to BfArM; up to 20% of reimbursement price becomes outcome-dependent.
BfArM DiGA Fast Track · GermanyGovernance and enforcement of the AI Act
The European AI Office and the national market surveillance authorities are responsible for
EU AI Act Implementation · EU-wideEDPB guidelines on anonymisation, web scraping for generative AI, and blockchain data processing
EDPB adopts final guidelines on anonymisation, web scraping for generative AI, and personal data processing through blockchain technologies.
EDPB (European Data Protection Board) · EU-wideCommission presents EU Action Plan on Cybersecurity and Artificial Intelligence
EU Action Plan addresses risks and opportunities of advanced AI models for cybersecurity, bringing together Member States, industry and EU organisations.
EU AI Act Implementation · EU-wideCommission seeks feedback on draft guidelines for classification of high-risk artificial intelligence systems
The Commission invites stakeholder input on draft guidelines for classifying high-risk AI systems under the AI Act.
EC AI Act & Regulation · EU-wide
Showing 50 of 137 tracked updates
— health-tech relevant only. Show all health policy
See all in the feed →