Digital health and artificial intelligence sit at the intersection of several regulatory regimes. Software that has a medical purpose is regulated as 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 further requirements. This page collects the updates HealthSignal tracks on the AI Act, Software as a Medical Device, clinical decision support, cybersecurity, and digital health reimbursement, drawn only from official public sources.
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 · FranceLeer más
AEPD (Spanish Data Protection Agency) · SpainGuidance on device qualification and classification of ambient voice technology-enabled products as medical devices in Great Britain.
UK MHRA · UKMHRA guidance clarifies how medical device law applies to ambient voice technology products in UK health and care settings.
UK MHRA · UKGuidance to help manufacturers of digital mental health technologies determine regulatory qualification and appropriate device classification.
UK MHRA · UKThe 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-wideFrom 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-wideGuidelines clarify AI Act transparency obligations for interactive AI systems and AI-generated content, effective 2 August 2026.
EU AI Act Implementation · EU-wideGuidance on how to qualify and classify safety wristbands used in telecare services as medical devices and their regulatory classification.
Poland URPL · PolandSwissmedic updated its Q&A and guidance document on mobile technologies.
Swissmedic · SwitzerlandINFARMED publishes guidance clarifying the regulatory framework for digital health solutions including software, mobile applications and AI-based solutions as medical devices.
Portugal INFARMED · PortugalCommission 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-wideFindings from the National Commission's call for evidence and research activities on AI regulation in healthcare.
UK MHRA · UKMHRA guidance on how it determines whether a borderline product meets the definition of a medical device and whether device regulations apply.
UK MHRA · UKThe 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) · SpainOfficial 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 · FranceWorking group recommends criteria and priorities for digitising paper-based healthcare and care processes under the 'Gemeinsam Digital' strategy.
gematik (German Digital Health) · GermanyHigh-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-wideThe 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-wideEHDS Regulation becomes law 20 days after publication in the EU Official Journal.
European Commission · EU-wideFAQ clarifying how MDR, IVDR and the AI Act interact in the regulation of AI-enabled medical devices and diagnostics.
EC Medical Devices · EU-wideAEMPS establishes a procedure for healthcare centres to submit prior notifications of in-house IVD manufacture pending the specific electronic application.
AEMPS (Spanish Medicine Agency) · SpainEC Public Health publishes general principles governing AI use in preparing Joint Clinical Assessment dossiers.
EC Public Health · EU-wideMHRA establishes an Innovation Accelerator programme offering scientific expertise, regulatory guidance and enhanced advice to developers of innovative health products.
UK MHRA · UKCommission publishes a Code of Practice establishing requirements for marking and labelling of AI-generated content.
EC AI Act & Regulation · EU-wideFDA guidance establishes a risk-based framework for human factors information required in device marketing submissions to CDRH.
US Federal Register - FDA Guidance Notices · United StatesMHRA invites expressions of interest from AI-enabled medical device manufacturers and NHS providers to participate in a regulatory sandbox.
UK MHRA · UKThe Commission invites stakeholder input on draft guidelines for classifying high-risk AI systems under the AI Act.
EC AI Act & Regulation · EU-wideMHRA sets out data requirements and governance expectations for the UK Health Data Research Service to enable regulatory decision-making.
UK MHRA · UKNews announcement 26 March 2026 Frequently Asked Questions on the European Health Data Space 1 min read
European Health Data Space · EU-wideDEA and HHS extend telemedicine flexibilities for controlled-medication prescribing through December 31, 2026.
US Federal Register - DEA Telehealth Rules · United StatesActualités
ANS - French Digital Health Agency · FranceCross-border exchange of patient summaries and ePrescriptions becomes mandatory for all EU Member States.
European Commission · EU-wideUK MHRA National Commission is seeking evidence to shape regulation of AI in healthcare and support an AI-enabled NHS.
UK MHRA · UKMHRA seeks evidence on AI regulation in healthcare to inform the National Commission's recommendations.
UK MHRA · UKgematik publishes guidance on implementing and using KIM (secure healthcare email) in care facilities, based on pilot experience in Hamburg region.
gematik (German Digital Health) · GermanyGuidance on implementing MSSanté secure messaging across healthcare facilities in France.
ANS - French Digital Health Agency · FranceVersion 5 of the EC manual on borderline and classification decisions under MDR and IVDR published.
EC Public Health · EU-wideHarmonised standards will support implementation of the AI Act's high-risk AI system requirements and pre-market compliance obligations.
EC AI Act & Regulation · EU-wideArticle 5 prohibitions on biometric categorization, social scoring, and emotion recognition in workplace and education settings enter into force.
European Commission · EU-wideUpdated HDS certification standards for health data hosting providers are now mandatory; ANS enforcement penalties are operational.
ANS - French Digital Health Agency · FranceEHDS 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-wideMyHealth@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-wideCompilation of Joint Clinical Assessment reports, procedural guidance on AI use in HTA dossiers, data transparency principles, and methodological FAQs for medical devices and IVDs.
EU HTA Regulation Implementation · EU-wideMHRA publishes online resources to help the public and professionals understand safe, effective digital mental health technologies.
UK MHRA · UKPhase 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 · UKDiGA manufacturers must implement continuous performance measurement (AbEM) and report to BfArM; up to 20% of reimbursement price becomes outcome-dependent.
BfArM DiGA Fast Track · GermanyThe European AI Office and the national market surveillance authorities are responsible for
EU AI Act Implementation · EU-wideEDPB adopts final guidelines on anonymisation, web scraping for generative AI, and personal data processing through blockchain technologies.
EDPB (European Data Protection Board) · EU-wideEU 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-wide