{ "schema": "aih-lab/regulator-export/v1", "fetched_at": "2026-05-27T16:27:19.241Z", "count": 27, "records": [ { "id": "1497549e-de6d-4b4c-8f87-59d96138003e", "slug": "demo-estroke-pathway", "title": "AI imaging triage for the acute stroke pathway", "product_name": "e-Stroke", "taxonomy_version": "2026.1", "family_number": 15, "family_name": "Emergency & Trauma", "deploying_organisation": "[demo] Oxford University Hospitals NHS FT", "deploying_country": "GB", "vendor_organisation": "[demo] Brainomix", "intended_use_statement": "Interprets acute stroke imaging to support rapid identification of large-vessel occlusion and treatment eligibility, accelerating thrombectomy referral.", "clinical_specialty": "emergency_medicine", "care_setting": "emergency", "autonomy_level": "informs_human", "is_gpai_based": false, "eu_ai_act_risk_tier": "high_risk", "eu_ai_act_high_risk_basis": "annex_i_medical_device", "is_medical_device": true, "eu_mdr_class": "class_iib", "ce_marking_status": "ce_marked", "fda_status": "510k_cleared", "iso_14971_risk_class": "medium", "gdpr_processing_basis": "public_interest", "gdpr_dpia_status": "completed", "data_identifiability": "pseudonymised", "human_oversight_model": "Stroke physician confirms every imaging interpretation before a treatment decision.", "explainability_method": "post_hoc", "nice_esf_tier": "tier_c_treat_diagnose_risk", "nice_evidence_category": "3", "headline_metric_name": "time_saved", "headline_metric_value": 60, "subgroup_performance_assessed": true, "known_bias_signals": null, "pipeline_stage": "scaled", "evidence_strength": "developing", "assurance_pack_criteria_version": "2026.1", "assurance_pack_result": "passed", "assurance_pack_issued_at": "2023-03-01T00:00:00+00:00", "assurance_pack_document_url": null, "replication_package_published_at": null, "technical_guide_url": null, "clinical_guide_url": null, "governance_template_url": null, "regulatory_checklist_url": null, "open_safety_signals": null }, { "id": "2068c46c-0502-42a8-b4a8-55bfb9f704d8", "slug": "extra-ich-volume", "title": "AI overlay for intracranial-haemorrhage volume measurement", "product_name": "e-ASPECTS", "taxonomy_version": "2026.1", "family_number": 15, "family_name": "Emergency & Trauma", "deploying_organisation": "[demo] Charité – Universitätsmedizin Berlin", "deploying_country": "DE", "vendor_organisation": "[demo] Brainomix", "intended_use_statement": "Segments and quantifies haemorrhage volume on serial non-contrast head CT to support neurosurgical decision-making and follow-up.", "clinical_specialty": "radiology", "care_setting": "hospital_inpatient", "autonomy_level": "informs_human", "is_gpai_based": false, "eu_ai_act_risk_tier": "high_risk", "eu_ai_act_high_risk_basis": "annex_i_medical_device", "is_medical_device": true, "eu_mdr_class": "class_iia", "ce_marking_status": "ce_marked", "fda_status": "510k_cleared", "iso_14971_risk_class": "medium", "gdpr_processing_basis": "public_interest", "gdpr_dpia_status": "completed", "data_identifiability": "pseudonymised", "human_oversight_model": "Neurosurgeon signs every volume measurement before it informs management.", "explainability_method": "post_hoc", "nice_esf_tier": "tier_c_treat_diagnose_risk", "nice_evidence_category": "3", "headline_metric_name": "sensitivity", "headline_metric_value": 0.94, "subgroup_performance_assessed": true, "known_bias_signals": null, "pipeline_stage": "maturing", "evidence_strength": "developing", "assurance_pack_criteria_version": null, "assurance_pack_result": null, "assurance_pack_issued_at": null, "assurance_pack_document_url": null, "replication_package_published_at": null, "technical_guide_url": null, "clinical_guide_url": null, "governance_template_url": null, "regulatory_checklist_url": null, "open_safety_signals": 1 }, { "id": "b8880ad9-4b78-440e-b9c0-b647d3d852fe", "slug": "demo-mia-breast-screening", "title": "AI second reader for breast cancer screening", "product_name": "Mia", "taxonomy_version": "2026.1", "family_number": 1, "family_name": "Diagnostic Imaging & Pathology", "deploying_organisation": "[demo] Oxford University Hospitals NHS FT", "deploying_country": "GB", "vendor_organisation": "[demo] Kheiron Medical Technologies", "intended_use_statement": "Acts as an independent second reader of screening mammograms to support the double-reading workflow and reduce reader workload without lowering cancer detection.", "clinical_specialty": "radiology", "care_setting": "hospital_outpatient", "autonomy_level": "informs_human", "is_gpai_based": false, "eu_ai_act_risk_tier": "high_risk", "eu_ai_act_high_risk_basis": "annex_i_medical_device", "is_medical_device": true, "eu_mdr_class": "class_iib", "ce_marking_status": "ce_marked", "fda_status": "not_submitted", "iso_14971_risk_class": "medium", "gdpr_processing_basis": "public_interest", "gdpr_dpia_status": "completed", "data_identifiability": "pseudonymised", "human_oversight_model": "Every flagged case is reviewed by a qualified radiologist before recall; AI never recalls a patient autonomously.", "explainability_method": "post_hoc", "nice_esf_tier": "tier_c_treat_diagnose_risk", "nice_evidence_category": "3", "headline_metric_name": "sensitivity", "headline_metric_value": 0.91, "subgroup_performance_assessed": true, "known_bias_signals": "Slightly lower sensitivity reported for dense breast tissue (BI-RADS density C/D); monitored as part of the validation review.", "pipeline_stage": "validated", "evidence_strength": "emerging", "assurance_pack_criteria_version": "2026.1", "assurance_pack_result": "passed", "assurance_pack_issued_at": "2024-02-01T00:00:00+00:00", "assurance_pack_document_url": null, "replication_package_published_at": null, "technical_guide_url": null, "clinical_guide_url": null, "governance_template_url": null, "regulatory_checklist_url": null, "open_safety_signals": null }, { "id": "d0cf37eb-62d7-49b5-bc34-44092a585839", "slug": "extra-camhs-triage", "title": "AI triage for child & adolescent mental health", "product_name": "Limbic Care", "taxonomy_version": "2026.1", "family_number": 7, "family_name": "Mental Health & Neurology", "deploying_organisation": "[demo] Karolinska University Hospital", "deploying_country": "SE", "vendor_organisation": "[demo] Limbic", "intended_use_statement": "Collects symptom information conversationally and routes the referral to the right CAMHS clinical team, escalating safety risks to a clinician in under five minutes.", "clinical_specialty": "psychiatry", "care_setting": "community", "autonomy_level": "human_in_the_loop", "is_gpai_based": true, "eu_ai_act_risk_tier": "limited_risk", "eu_ai_act_high_risk_basis": "not_applicable", "is_medical_device": false, "eu_mdr_class": "not_a_device", "ce_marking_status": "not_required", "fda_status": "not_applicable", "iso_14971_risk_class": "low", "gdpr_processing_basis": "consent", "gdpr_dpia_status": "completed", "data_identifiability": "pseudonymised", "human_oversight_model": "A clinician reviews every referral before the first appointment; risk responses raise an immediate human alert.", "explainability_method": "none", "nice_esf_tier": "tier_b_inform_monitor", "nice_evidence_category": "2", "headline_metric_name": "accuracy", "headline_metric_value": 0.88, "subgroup_performance_assessed": true, "known_bias_signals": "Reduced sensitivity for under-15s — flagged for additional validation.", "pipeline_stage": "maturing", "evidence_strength": "developing", "assurance_pack_criteria_version": null, "assurance_pack_result": null, "assurance_pack_issued_at": null, "assurance_pack_document_url": null, "replication_package_published_at": null, "technical_guide_url": null, "clinical_guide_url": null, "governance_template_url": null, "regulatory_checklist_url": null, "open_safety_signals": 1 }, { "id": "77cbd410-b631-413d-ada0-633855058691", "slug": "extra2-genomic-variant-interp", "title": "AI-assisted tumour-board genomic variant interpretation", "product_name": "Paige Insight", "taxonomy_version": "2026.1", "family_number": 6, "family_name": "Genomics & Precision Medicine", "deploying_organisation": "[demo] Karolinska University Hospital", "deploying_country": "SE", "vendor_organisation": "[demo] Paige AI", "intended_use_statement": "Synthesises somatic + germline variants from next-generation sequencing into a ranked, evidence-backed recommendation for the multidisciplinary tumour board.", "clinical_specialty": "oncology", "care_setting": "hospital_outpatient", "autonomy_level": "informs_human", "is_gpai_based": true, "eu_ai_act_risk_tier": "high_risk", "eu_ai_act_high_risk_basis": "annex_iii", "is_medical_device": false, "eu_mdr_class": "not_a_device", "ce_marking_status": "not_required", "fda_status": "not_applicable", "iso_14971_risk_class": "medium", "gdpr_processing_basis": "consent", "gdpr_dpia_status": "completed", "data_identifiability": "pseudonymised", "human_oversight_model": "Every recommendation is reviewed and approved by the tumour board before being acted on.", "explainability_method": "post_hoc", "nice_esf_tier": "tier_c_treat_diagnose_risk", "nice_evidence_category": "2", "headline_metric_name": "auc", "headline_metric_value": 0.86, "subgroup_performance_assessed": true, "known_bias_signals": "Genomic reference panels skew toward European ancestry; expansion underway.", "pipeline_stage": "maturing", "evidence_strength": "developing", "assurance_pack_criteria_version": null, "assurance_pack_result": null, "assurance_pack_issued_at": null, "assurance_pack_document_url": null, "replication_package_published_at": null, "technical_guide_url": null, "clinical_guide_url": null, "governance_template_url": null, "regulatory_checklist_url": null, "open_safety_signals": null }, { "id": "99c8295a-ab23-47ff-85ac-c93cdc6320e5", "slug": "demo-ambient-documentation", "title": "Ambient clinical documentation assistant", "product_name": "Nabla Copilot", "taxonomy_version": "2026.1", "family_number": 11, "family_name": "Administrative Automation", "deploying_organisation": "[demo] Erasmus MC", "deploying_country": "NL", "vendor_organisation": "[demo] Nabla", "intended_use_statement": "Transcribes the clinician–patient conversation and drafts a structured clinical note for the clinician to review, edit and sign.", "clinical_specialty": "general_practice", "care_setting": "hospital_outpatient", "autonomy_level": "human_in_the_loop", "is_gpai_based": true, "eu_ai_act_risk_tier": "limited_risk", "eu_ai_act_high_risk_basis": "not_applicable", "is_medical_device": false, "eu_mdr_class": "not_a_device", "ce_marking_status": "not_required", "fda_status": "not_applicable", "iso_14971_risk_class": "low", "gdpr_processing_basis": "consent", "gdpr_dpia_status": "completed", "data_identifiability": "pseudonymised", "human_oversight_model": "The clinician reviews, corrects and approves every generated note before it enters the record.", "explainability_method": "none", "nice_esf_tier": "tier_a_system_service", "nice_evidence_category": "1", "headline_metric_name": "time_saved", "headline_metric_value": 4.5, "subgroup_performance_assessed": false, "known_bias_signals": "Transcription accuracy lower for non-native and accented speech; multilingual evaluation in progress.", "pipeline_stage": "maturing", "evidence_strength": "developing", "assurance_pack_criteria_version": null, "assurance_pack_result": null, "assurance_pack_issued_at": null, "assurance_pack_document_url": null, "replication_package_published_at": null, "technical_guide_url": null, "clinical_guide_url": null, "governance_template_url": null, "regulatory_checklist_url": null, "open_safety_signals": null }, { "id": "c837e342-5eba-43e3-a933-96800907b0ac", "slug": "extra-scribe-diabetes", "title": "Ambient scribe for outpatient diabetes clinic", "product_name": "Nabla Copilot", "taxonomy_version": "2026.1", "family_number": 11, "family_name": "Administrative Automation", "deploying_organisation": "[demo] Oxford University Hospitals NHS FT", "deploying_country": "GB", "vendor_organisation": "[demo] Nabla", "intended_use_statement": "Transcribes the consultation, drafts the SOAP note and pre-populates the discharge letter for clinician review and signature.", "clinical_specialty": "endocrinology", "care_setting": "hospital_outpatient", "autonomy_level": "human_in_the_loop", "is_gpai_based": true, "eu_ai_act_risk_tier": "limited_risk", "eu_ai_act_high_risk_basis": "not_applicable", "is_medical_device": false, "eu_mdr_class": "not_a_device", "ce_marking_status": "not_required", "fda_status": "not_applicable", "iso_14971_risk_class": "low", "gdpr_processing_basis": "consent", "gdpr_dpia_status": "completed", "data_identifiability": "pseudonymised", "human_oversight_model": "Every generated note is reviewed, edited and signed by the consulting clinician before it enters the record.", "explainability_method": "none", "nice_esf_tier": "tier_a_system_service", "nice_evidence_category": "1", "headline_metric_name": "time_saved", "headline_metric_value": 6, "subgroup_performance_assessed": false, "known_bias_signals": "Lower transcription quality for strong regional accents; ongoing evaluation across UK regions.", "pipeline_stage": "maturing", "evidence_strength": "developing", "assurance_pack_criteria_version": null, "assurance_pack_result": null, "assurance_pack_issued_at": null, "assurance_pack_document_url": null, "replication_package_published_at": null, "technical_guide_url": null, "clinical_guide_url": null, "governance_template_url": null, "regulatory_checklist_url": null, "open_safety_signals": null }, { "id": "bb1037d5-a67d-4718-be0f-38f4100c4ee0", "slug": "demo-idx-dr-retinopathy", "title": "Autonomous diabetic retinopathy screening in primary care", "product_name": "IDx-DR", "taxonomy_version": "2026.1", "family_number": 1, "family_name": "Diagnostic Imaging & Pathology", "deploying_organisation": "[demo] Amsterdam UMC", "deploying_country": "NL", "vendor_organisation": "[demo] Digital Diagnostics", "intended_use_statement": "Provides an autonomous screening decision for more-than-mild diabetic retinopathy from retinal fundus images, referring positive cases to ophthalmology.", "clinical_specialty": "other", "care_setting": "primary_care", "autonomy_level": "autonomous", "is_gpai_based": false, "eu_ai_act_risk_tier": "high_risk", "eu_ai_act_high_risk_basis": "annex_i_medical_device", "is_medical_device": true, "eu_mdr_class": "class_iib", "ce_marking_status": "ce_marked", "fda_status": "de_novo", "iso_14971_risk_class": "medium", "gdpr_processing_basis": "consent", "gdpr_dpia_status": "completed", "data_identifiability": "pseudonymised", "human_oversight_model": "Autonomous diagnostic output; clinical governance defines escalation, and any ungradable image is referred to a human grader.", "explainability_method": "post_hoc", "nice_esf_tier": "tier_c_treat_diagnose_risk", "nice_evidence_category": "3", "headline_metric_name": "sensitivity", "headline_metric_value": 0.87, "subgroup_performance_assessed": true, "known_bias_signals": "Image quality and gradability vary with cataract prevalence; performance audited across age bands.", "pipeline_stage": "validated", "evidence_strength": "robust", "assurance_pack_criteria_version": "2026.1", "assurance_pack_result": "passed", "assurance_pack_issued_at": "2023-05-01T00:00:00+00:00", "assurance_pack_document_url": null, "replication_package_published_at": null, "technical_guide_url": null, "clinical_guide_url": null, "governance_template_url": null, "regulatory_checklist_url": null, "open_safety_signals": null }, { "id": "3568cffc-c06f-4b24-90e6-ec8fb48de489", "slug": "extra-cds-sepsis-bundle", "title": "CDS — sepsis bundle compliance prompts", "product_name": "BriefCase CDS", "taxonomy_version": "2026.1", "family_number": 2, "family_name": "Clinical Decision Support", "deploying_organisation": "[demo] Amsterdam UMC", "deploying_country": "NL", "vendor_organisation": "[demo] Aidoc", "intended_use_statement": "Prompts the clinical team to deliver each element of the sepsis-6 bundle within the recommended time window, surfacing the next missing step on the ward dashboard.", "clinical_specialty": "intensive_care", "care_setting": "hospital_inpatient", "autonomy_level": "informs_human", "is_gpai_based": false, "eu_ai_act_risk_tier": "high_risk", "eu_ai_act_high_risk_basis": "annex_iii", "is_medical_device": false, "eu_mdr_class": "not_a_device", "ce_marking_status": "not_required", "fda_status": "not_applicable", "iso_14971_risk_class": "medium", "gdpr_processing_basis": "public_interest", "gdpr_dpia_status": "completed", "data_identifiability": "pseudonymised", "human_oversight_model": "Senior nurse confirms each prompt; the AI never administers a treatment autonomously.", "explainability_method": "intrinsic", "nice_esf_tier": "tier_c_treat_diagnose_risk", "nice_evidence_category": "2", "headline_metric_name": "time_saved", "headline_metric_value": 18, "subgroup_performance_assessed": true, "known_bias_signals": "Night-shift compliance lower than day-shift; staffing pattern, not algorithm.", "pipeline_stage": "maturing", "evidence_strength": "developing", "assurance_pack_criteria_version": null, "assurance_pack_result": null, "assurance_pack_issued_at": null, "assurance_pack_document_url": null, "replication_package_published_at": null, "technical_guide_url": null, "clinical_guide_url": null, "governance_template_url": null, "regulatory_checklist_url": null, "open_safety_signals": 1 }, { "id": "33695ba5-acc0-4887-9e4e-43fdfa8e27f6", "slug": "demo-trial-recruitment-matching", "title": "Clinical trial recruitment matching", "product_name": null, "taxonomy_version": "2026.1", "family_number": 17, "family_name": "Research & Clinical Trials", "deploying_organisation": "[demo] Erasmus MC", "deploying_country": "NL", "vendor_organisation": "[demo] TU Delft — AIH Lab", "intended_use_statement": "Screens structured records and clinical notes against trial eligibility criteria to surface a ranked list of candidate patients for the research team.", "clinical_specialty": "oncology", "care_setting": "back_office", "autonomy_level": "informs_human", "is_gpai_based": true, "eu_ai_act_risk_tier": "minimal_risk", "eu_ai_act_high_risk_basis": "not_applicable", "is_medical_device": false, "eu_mdr_class": "not_a_device", "ce_marking_status": "not_required", "fda_status": "not_applicable", "iso_14971_risk_class": "low", "gdpr_processing_basis": "public_interest", "gdpr_dpia_status": "completed", "data_identifiability": "pseudonymised", "human_oversight_model": "The research team verifies eligibility and obtains consent; AI only prioritises candidates.", "explainability_method": "post_hoc", "nice_esf_tier": "tier_a_system_service", "nice_evidence_category": null, "headline_metric_name": "ppv", "headline_metric_value": 0.74, "subgroup_performance_assessed": false, "known_bias_signals": null, "pipeline_stage": "curated", "evidence_strength": "emerging", "assurance_pack_criteria_version": null, "assurance_pack_result": null, "assurance_pack_issued_at": null, "assurance_pack_document_url": null, "replication_package_published_at": null, "technical_guide_url": null, "clinical_guide_url": null, "governance_template_url": null, "regulatory_checklist_url": null, "open_safety_signals": null }, { "id": "51a963ba-0978-4163-aff9-fad7089c8734", "slug": "demo-deterioration-monitoring", "title": "Continuous deterioration monitoring on general wards", "product_name": null, "taxonomy_version": "2026.1", "family_number": 9, "family_name": "Patient Monitoring (ICU/Ward)", "deploying_organisation": "[demo] Rigshospitalet", "deploying_country": "DK", "vendor_organisation": null, "intended_use_statement": "Analyses continuous vital-sign streams to detect early physiological deterioration and reduce unrecognised clinical decline between observation rounds.", "clinical_specialty": "intensive_care", "care_setting": "hospital_inpatient", "autonomy_level": "informs_human", "is_gpai_based": false, "eu_ai_act_risk_tier": "not_assessed", "eu_ai_act_high_risk_basis": "not_applicable", "is_medical_device": false, "eu_mdr_class": "not_a_device", "ce_marking_status": "not_required", "fda_status": "not_applicable", "iso_14971_risk_class": "not_assessed", "gdpr_processing_basis": "public_interest", "gdpr_dpia_status": "pending", "data_identifiability": "pseudonymised", "human_oversight_model": "Nurse-facing alerts trigger a structured review; no automated intervention.", "explainability_method": "intrinsic", "nice_esf_tier": "tier_b_inform_monitor", "nice_evidence_category": null, "headline_metric_name": "sensitivity", "headline_metric_value": 0.82, "subgroup_performance_assessed": false, "known_bias_signals": null, "pipeline_stage": "curated", "evidence_strength": "emerging", "assurance_pack_criteria_version": null, "assurance_pack_result": null, "assurance_pack_issued_at": null, "assurance_pack_document_url": null, "replication_package_published_at": null, "technical_guide_url": null, "clinical_guide_url": null, "governance_template_url": null, "regulatory_checklist_url": null, "open_safety_signals": null }, { "id": "39e22083-46b3-4231-a72d-c41f0cb28594", "slug": "demo-paige-prostate", "title": "Digital pathology decision support for prostate cancer", "product_name": "Paige Prostate", "taxonomy_version": "2026.1", "family_number": 1, "family_name": "Diagnostic Imaging & Pathology", "deploying_organisation": "[demo] Karolinska University Hospital", "deploying_country": "SE", "vendor_organisation": "[demo] Paige AI", "intended_use_statement": "Highlights tissue regions on digitised prostate biopsy slides suspicious for cancer to support the reporting pathologist.", "clinical_specialty": "pathology", "care_setting": "hospital_outpatient", "autonomy_level": "informs_human", "is_gpai_based": false, "eu_ai_act_risk_tier": "high_risk", "eu_ai_act_high_risk_basis": "annex_i_medical_device", "is_medical_device": true, "eu_mdr_class": "class_iia", "ce_marking_status": "ce_marked", "fda_status": "de_novo", "iso_14971_risk_class": "not_assessed", "gdpr_processing_basis": "public_interest", "gdpr_dpia_status": "completed", "data_identifiability": "pseudonymised", "human_oversight_model": "Pathologist reviews every slide; AI output is an overlay, not a diagnosis.", "explainability_method": "post_hoc", "nice_esf_tier": "tier_c_treat_diagnose_risk", "nice_evidence_category": null, "headline_metric_name": "auc", "headline_metric_value": 0.97, "subgroup_performance_assessed": false, "known_bias_signals": null, "pipeline_stage": "curated", "evidence_strength": "emerging", "assurance_pack_criteria_version": null, "assurance_pack_result": null, "assurance_pack_issued_at": null, "assurance_pack_document_url": null, "replication_package_published_at": null, "technical_guide_url": null, "clinical_guide_url": null, "governance_template_url": null, "regulatory_checklist_url": null, "open_safety_signals": null }, { "id": "bb935df8-1850-4ad2-bcaf-e949fe557b73", "slug": "extra-ed-los-forecast", "title": "Emergency department length-of-stay forecast", "product_name": null, "taxonomy_version": "2026.1", "family_number": 10, "family_name": "Workflow & Operational Efficiency", "deploying_organisation": "[demo] Aarhus University Hospital", "deploying_country": "DK", "vendor_organisation": null, "intended_use_statement": "Predicts expected length of stay per patient at triage so the ED can adjust staffing and bed allocation in near-real time.", "clinical_specialty": "emergency_medicine", "care_setting": "emergency", "autonomy_level": "informs_human", "is_gpai_based": false, "eu_ai_act_risk_tier": "minimal_risk", "eu_ai_act_high_risk_basis": "not_applicable", "is_medical_device": false, "eu_mdr_class": "not_a_device", "ce_marking_status": "not_required", "fda_status": "not_applicable", "iso_14971_risk_class": "low", "gdpr_processing_basis": "legitimate_interest", "gdpr_dpia_status": "not_required", "data_identifiability": "pseudonymised", "human_oversight_model": "Operations team treats the forecast as one input; admission decisions remain clinical.", "explainability_method": "intrinsic", "nice_esf_tier": "tier_a_system_service", "nice_evidence_category": "1", "headline_metric_name": "auc", "headline_metric_value": 0.79, "subgroup_performance_assessed": false, "known_bias_signals": null, "pipeline_stage": "curated", "evidence_strength": "emerging", "assurance_pack_criteria_version": null, "assurance_pack_result": null, "assurance_pack_issued_at": null, "assurance_pack_document_url": null, "replication_package_published_at": null, "technical_guide_url": null, "clinical_guide_url": null, "governance_template_url": null, "regulatory_checklist_url": null, "open_safety_signals": null }, { "id": "2e0b8410-cd8f-43cd-8b8b-48d7c774adfb", "slug": "extra-hf-wearable", "title": "Heart-failure decompensation early warning from wearables", "product_name": null, "taxonomy_version": "2026.1", "family_number": 14, "family_name": "Population Health & Epidemiology", "deploying_organisation": "[demo] Erasmus MC", "deploying_country": "NL", "vendor_organisation": null, "intended_use_statement": "Combines wearable vital-sign trends and patient-reported symptoms to flag likely decompensation 3–7 days before clinical presentation, prompting community-nurse contact.", "clinical_specialty": "cardiology", "care_setting": "home", "autonomy_level": "informs_human", "is_gpai_based": false, "eu_ai_act_risk_tier": "high_risk", "eu_ai_act_high_risk_basis": "annex_iii", "is_medical_device": false, "eu_mdr_class": "not_a_device", "ce_marking_status": "not_required", "fda_status": "not_applicable", "iso_14971_risk_class": "medium", "gdpr_processing_basis": "public_interest", "gdpr_dpia_status": "completed", "data_identifiability": "pseudonymised", "human_oversight_model": "A community nurse contacts the patient on every amber alert; the AI never escalates to hospital without a human.", "explainability_method": "intrinsic", "nice_esf_tier": "tier_b_inform_monitor", "nice_evidence_category": "2", "headline_metric_name": "sensitivity", "headline_metric_value": 0.79, "subgroup_performance_assessed": true, "known_bias_signals": "Higher false-positive rate for atrial-fibrillation patients; under recalibration.", "pipeline_stage": "maturing", "evidence_strength": "developing", "assurance_pack_criteria_version": null, "assurance_pack_result": null, "assurance_pack_issued_at": null, "assurance_pack_document_url": null, "replication_package_published_at": null, "technical_guide_url": null, "clinical_guide_url": null, "governance_template_url": null, "regulatory_checklist_url": null, "open_safety_signals": 1 }, { "id": "210e6e60-3536-4161-b776-70b5f1ab3481", "slug": "extra2-discharge-readiness", "title": "Hospital discharge readiness & follow-up scheduling", "product_name": null, "taxonomy_version": "2026.1", "family_number": 12, "family_name": "Care Coordination & Pathways", "deploying_organisation": "[demo] Erasmus MC", "deploying_country": "NL", "vendor_organisation": null, "intended_use_statement": "Predicts discharge readiness from clinical and operational signals, drafts the discharge summary structure, and proposes a follow-up appointment slot for primary care.", "clinical_specialty": "general_practice", "care_setting": "hospital_inpatient", "autonomy_level": "human_in_the_loop", "is_gpai_based": true, "eu_ai_act_risk_tier": "minimal_risk", "eu_ai_act_high_risk_basis": "not_applicable", "is_medical_device": false, "eu_mdr_class": "not_a_device", "ce_marking_status": "not_required", "fda_status": "not_applicable", "iso_14971_risk_class": "low", "gdpr_processing_basis": "public_interest", "gdpr_dpia_status": "pending", "data_identifiability": "pseudonymised", "human_oversight_model": "Ward team approves every discharge decision and follow-up booking; the AI assembles drafts only.", "explainability_method": "intrinsic", "nice_esf_tier": "tier_a_system_service", "nice_evidence_category": "1", "headline_metric_name": "time_saved", "headline_metric_value": 24, "subgroup_performance_assessed": false, "known_bias_signals": null, "pipeline_stage": "maturing", "evidence_strength": "developing", "assurance_pack_criteria_version": null, "assurance_pack_result": null, "assurance_pack_issued_at": null, "assurance_pack_document_url": null, "replication_package_published_at": null, "technical_guide_url": null, "clinical_guide_url": null, "governance_template_url": null, "regulatory_checklist_url": null, "open_safety_signals": null }, { "id": "2624299a-fafb-49bf-93a7-c5a8297d84ff", "slug": "demo-aidoc-ich-triage", "title": "Intracranial haemorrhage triage on non-contrast head CT", "product_name": "BriefCase ICH", "taxonomy_version": "2026.1", "family_number": 1, "family_name": "Diagnostic Imaging & Pathology", "deploying_organisation": "[demo] Charité – Universitätsmedizin Berlin", "deploying_country": "DE", "vendor_organisation": "[demo] Aidoc", "intended_use_statement": "Flags head CT studies suspected of acute intracranial haemorrhage and re-prioritises them in the radiology worklist to shorten time-to-diagnosis.", "clinical_specialty": "radiology", "care_setting": "emergency", "autonomy_level": "informs_human", "is_gpai_based": false, "eu_ai_act_risk_tier": "high_risk", "eu_ai_act_high_risk_basis": "annex_i_medical_device", "is_medical_device": true, "eu_mdr_class": "class_iia", "ce_marking_status": "ce_marked", "fda_status": "510k_cleared", "iso_14971_risk_class": "medium", "gdpr_processing_basis": "public_interest", "gdpr_dpia_status": "completed", "data_identifiability": "pseudonymised", "human_oversight_model": "Worklist prioritisation only — the radiologist makes and signs every diagnostic report.", "explainability_method": "post_hoc", "nice_esf_tier": "tier_c_treat_diagnose_risk", "nice_evidence_category": "2", "headline_metric_name": "specificity", "headline_metric_value": 0.95, "subgroup_performance_assessed": true, "known_bias_signals": null, "pipeline_stage": "maturing", "evidence_strength": "developing", "assurance_pack_criteria_version": null, "assurance_pack_result": null, "assurance_pack_issued_at": null, "assurance_pack_document_url": null, "replication_package_published_at": null, "technical_guide_url": null, "clinical_guide_url": null, "governance_template_url": null, "regulatory_checklist_url": null, "open_safety_signals": null }, { "id": "d3a93371-cdff-4b0a-ac42-641dc914b7c4", "slug": "demo-viz-lvo-alerting", "title": "Large-vessel occlusion detection and care-team alerting", "product_name": "Viz LVO", "taxonomy_version": "2026.1", "family_number": 15, "family_name": "Emergency & Trauma", "deploying_organisation": "[demo] Hospital Clínic de Barcelona", "deploying_country": "ES", "vendor_organisation": "[demo] Viz.ai", "intended_use_statement": "Detects suspected large-vessel occlusion on CT-angiography and sends a synchronised mobile alert to the stroke care team to compress time-to-treatment.", "clinical_specialty": "emergency_medicine", "care_setting": "emergency", "autonomy_level": "informs_human", "is_gpai_based": false, "eu_ai_act_risk_tier": "high_risk", "eu_ai_act_high_risk_basis": "annex_i_medical_device", "is_medical_device": true, "eu_mdr_class": "class_iia", "ce_marking_status": "ce_marked", "fda_status": "510k_cleared", "iso_14971_risk_class": "medium", "gdpr_processing_basis": "public_interest", "gdpr_dpia_status": "pending", "data_identifiability": "pseudonymised", "human_oversight_model": "Notification only; diagnosis and treatment remain with the stroke team.", "explainability_method": "post_hoc", "nice_esf_tier": "tier_b_inform_monitor", "nice_evidence_category": "2", "headline_metric_name": "sensitivity", "headline_metric_value": 0.9, "subgroup_performance_assessed": false, "known_bias_signals": null, "pipeline_stage": "maturing", "evidence_strength": "emerging", "assurance_pack_criteria_version": null, "assurance_pack_result": null, "assurance_pack_issued_at": null, "assurance_pack_document_url": null, "replication_package_published_at": null, "technical_guide_url": null, "clinical_guide_url": null, "governance_template_url": null, "regulatory_checklist_url": null, "open_safety_signals": null }, { "id": "87b01b26-b0b8-4f3e-8470-f798bc2ba081", "slug": "demo-theatre-scheduling", "title": "Operating theatre scheduling optimisation", "product_name": null, "taxonomy_version": "2026.1", "family_number": 10, "family_name": "Workflow & Operational Efficiency", "deploying_organisation": "[demo] Karolinska University Hospital", "deploying_country": "SE", "vendor_organisation": null, "intended_use_statement": "Forecasts case durations and proposes an optimised theatre schedule to improve utilisation and reduce late starts and overruns.", "clinical_specialty": "operations_admin", "care_setting": "back_office", "autonomy_level": "human_in_the_loop", "is_gpai_based": false, "eu_ai_act_risk_tier": "minimal_risk", "eu_ai_act_high_risk_basis": "not_applicable", "is_medical_device": false, "eu_mdr_class": "not_a_device", "ce_marking_status": "not_required", "fda_status": "not_applicable", "iso_14971_risk_class": "low", "gdpr_processing_basis": "legitimate_interest", "gdpr_dpia_status": "not_required", "data_identifiability": "anonymised", "human_oversight_model": "Scheduling coordinators review and adjust the proposed plan before publishing.", "explainability_method": "intrinsic", "nice_esf_tier": "tier_a_system_service", "nice_evidence_category": "1", "headline_metric_name": "time_saved", "headline_metric_value": 12, "subgroup_performance_assessed": false, "known_bias_signals": null, "pipeline_stage": "maturing", "evidence_strength": "none", "assurance_pack_criteria_version": null, "assurance_pack_result": null, "assurance_pack_issued_at": null, "assurance_pack_document_url": null, "replication_package_published_at": null, "technical_guide_url": null, "clinical_guide_url": null, "governance_template_url": null, "regulatory_checklist_url": null, "open_safety_signals": null }, { "id": "c24acff5-59a0-4022-8a0d-955012c6cf4e", "slug": "extra2-or-instrument-forecast", "title": "Operating-theatre instrument inventory forecast", "product_name": null, "taxonomy_version": "2026.1", "family_number": 18, "family_name": "Supply Chain & Asset Management", "deploying_organisation": "[demo] Hospital Clínic de Barcelona", "deploying_country": "ES", "vendor_organisation": null, "intended_use_statement": "Forecasts daily surgical-instrument demand from the elective schedule and historical usage, prioritising sterilisation cycles and reorder windows.", "clinical_specialty": "operations_admin", "care_setting": "back_office", "autonomy_level": "informs_human", "is_gpai_based": false, "eu_ai_act_risk_tier": "minimal_risk", "eu_ai_act_high_risk_basis": "not_applicable", "is_medical_device": false, "eu_mdr_class": "not_a_device", "ce_marking_status": "not_required", "fda_status": "not_applicable", "iso_14971_risk_class": "low", "gdpr_processing_basis": "legitimate_interest", "gdpr_dpia_status": "not_required", "data_identifiability": "anonymised", "human_oversight_model": "Sterilisation lead reviews the daily plan before publishing.", "explainability_method": "intrinsic", "nice_esf_tier": "tier_a_system_service", "nice_evidence_category": "1", "headline_metric_name": "time_saved", "headline_metric_value": 8, "subgroup_performance_assessed": false, "known_bias_signals": null, "pipeline_stage": "curated", "evidence_strength": "emerging", "assurance_pack_criteria_version": null, "assurance_pack_result": null, "assurance_pack_issued_at": null, "assurance_pack_document_url": null, "replication_package_published_at": null, "technical_guide_url": null, "clinical_guide_url": null, "governance_template_url": null, "regulatory_checklist_url": null, "open_safety_signals": null }, { "id": "b362b019-ba36-44a1-bc02-ffd3f6fa5293", "slug": "extra-preop-risk", "title": "Pre-operative risk-stratification model for major surgery", "product_name": null, "taxonomy_version": "2026.1", "family_number": 4, "family_name": "Surgical Planning & Navigation", "deploying_organisation": "[demo] Hospital Clínic de Barcelona", "deploying_country": "ES", "vendor_organisation": null, "intended_use_statement": "Computes a 30-day mortality and morbidity risk score from pre-operative records to support anaesthetic optimisation and shared decision-making.", "clinical_specialty": "surgery", "care_setting": "hospital_outpatient", "autonomy_level": "informs_human", "is_gpai_based": false, "eu_ai_act_risk_tier": "high_risk", "eu_ai_act_high_risk_basis": "annex_iii", "is_medical_device": false, "eu_mdr_class": "not_a_device", "ce_marking_status": "not_required", "fda_status": "not_applicable", "iso_14971_risk_class": "medium", "gdpr_processing_basis": "public_interest", "gdpr_dpia_status": "completed", "data_identifiability": "pseudonymised", "human_oversight_model": "Anaesthetist reviews the risk band before booking; no autonomous decision.", "explainability_method": "post_hoc", "nice_esf_tier": "tier_c_treat_diagnose_risk", "nice_evidence_category": "3", "headline_metric_name": "auc", "headline_metric_value": 0.85, "subgroup_performance_assessed": true, "known_bias_signals": "Slight under-performance for patients with prior cancer; periodic recalibration scheduled.", "pipeline_stage": "validated", "evidence_strength": "robust", "assurance_pack_criteria_version": null, "assurance_pack_result": null, "assurance_pack_issued_at": null, "assurance_pack_document_url": null, "replication_package_published_at": null, "technical_guide_url": null, "clinical_guide_url": null, "governance_template_url": null, "regulatory_checklist_url": null, "open_safety_signals": null }, { "id": "2ca56cd8-af04-4b2d-8748-9b02fd63143d", "slug": "demo-prescribing-decision-support", "title": "Prescribing decision support — drug interaction alerts", "product_name": null, "taxonomy_version": "2026.1", "family_number": 5, "family_name": "Medication Safety & Optimisation", "deploying_organisation": "[demo] Aarhus University Hospital", "deploying_country": "DK", "vendor_organisation": null, "intended_use_statement": "Screens new prescriptions against the medication list and patient parameters to alert prescribers to clinically significant drug interactions.", "clinical_specialty": "pharmacy", "care_setting": "hospital_inpatient", "autonomy_level": "informs_human", "is_gpai_based": false, "eu_ai_act_risk_tier": "not_assessed", "eu_ai_act_high_risk_basis": "not_applicable", "is_medical_device": false, "eu_mdr_class": "not_a_device", "ce_marking_status": "not_required", "fda_status": "not_applicable", "iso_14971_risk_class": "not_assessed", "gdpr_processing_basis": "legal_obligation", "gdpr_dpia_status": "not_required", "data_identifiability": "pseudonymised", "human_oversight_model": "Interruptive alert at the point of prescribing; the prescriber accepts or overrides with a reason.", "explainability_method": "intrinsic", "nice_esf_tier": "tier_b_inform_monitor", "nice_evidence_category": null, "headline_metric_name": "ppv", "headline_metric_value": 0.68, "subgroup_performance_assessed": false, "known_bias_signals": "High override rate observed for low-severity alerts; tiering of alert severity under review to reduce fatigue.", "pipeline_stage": "curated", "evidence_strength": "none", "assurance_pack_criteria_version": null, "assurance_pack_result": null, "assurance_pack_issued_at": null, "assurance_pack_document_url": null, "replication_package_published_at": null, "technical_guide_url": null, "clinical_guide_url": null, "governance_template_url": null, "regulatory_checklist_url": null, "open_safety_signals": null }, { "id": "a330077b-1496-46ad-9eac-af5fe5a506ff", "slug": "demo-limbic-self-referral", "title": "Self-referral assistant for NHS Talking Therapies", "product_name": "Limbic Access", "taxonomy_version": "2026.1", "family_number": 7, "family_name": "Mental Health & Neurology", "deploying_organisation": "[demo] Oxford University Hospitals NHS FT", "deploying_country": "GB", "vendor_organisation": "[demo] Limbic", "intended_use_statement": "Supports patient self-referral by collecting clinical information conversationally and routing referrals, reducing administrative wait time.", "clinical_specialty": "psychiatry", "care_setting": "community", "autonomy_level": "human_in_the_loop", "is_gpai_based": true, "eu_ai_act_risk_tier": "limited_risk", "eu_ai_act_high_risk_basis": "not_applicable", "is_medical_device": false, "eu_mdr_class": "not_a_device", "ce_marking_status": "not_required", "fda_status": "not_applicable", "iso_14971_risk_class": "low", "gdpr_processing_basis": "consent", "gdpr_dpia_status": "completed", "data_identifiability": "pseudonymised", "human_oversight_model": "A clinician reviews every referral before assessment; risk responses trigger immediate human escalation.", "explainability_method": "none", "nice_esf_tier": "tier_b_inform_monitor", "nice_evidence_category": "2", "headline_metric_name": "accuracy", "headline_metric_value": 0.93, "subgroup_performance_assessed": true, "known_bias_signals": null, "pipeline_stage": "validated", "evidence_strength": "developing", "assurance_pack_criteria_version": "2026.1", "assurance_pack_result": "passed", "assurance_pack_issued_at": "2023-03-15T00:00:00+00:00", "assurance_pack_document_url": null, "replication_package_published_at": null, "technical_guide_url": null, "clinical_guide_url": null, "governance_template_url": null, "regulatory_checklist_url": null, "open_safety_signals": null }, { "id": "232c0a36-6390-4ae7-b11e-d7654bdd83f2", "slug": "demo-sepsis-early-warning", "title": "Sepsis early warning system — bedside deployment", "product_name": null, "taxonomy_version": "2026.1", "family_number": 3, "family_name": "Predictive Risk Stratification", "deploying_organisation": "[demo] Amsterdam UMC", "deploying_country": "NL", "vendor_organisation": null, "intended_use_statement": "Continuously estimates the risk of sepsis from vital signs and laboratory results, prompting earlier clinical review of deteriorating patients.", "clinical_specialty": "intensive_care", "care_setting": "hospital_inpatient", "autonomy_level": "informs_human", "is_gpai_based": false, "eu_ai_act_risk_tier": "high_risk", "eu_ai_act_high_risk_basis": "annex_iii", "is_medical_device": false, "eu_mdr_class": "not_a_device", "ce_marking_status": "not_required", "fda_status": "not_applicable", "iso_14971_risk_class": "medium", "gdpr_processing_basis": "public_interest", "gdpr_dpia_status": "completed", "data_identifiability": "pseudonymised", "human_oversight_model": "Generates a ward review prompt; the clinical team decides on escalation and the sepsis bundle.", "explainability_method": "intrinsic", "nice_esf_tier": "tier_c_treat_diagnose_risk", "nice_evidence_category": "2", "headline_metric_name": "auc", "headline_metric_value": 0.84, "subgroup_performance_assessed": true, "known_bias_signals": "Early thresholds produced more alerts for older patients; recalibrated during the pilot to balance alert burden.", "pipeline_stage": "maturing", "evidence_strength": "emerging", "assurance_pack_criteria_version": null, "assurance_pack_result": null, "assurance_pack_issued_at": null, "assurance_pack_document_url": null, "replication_package_published_at": null, "technical_guide_url": null, "clinical_guide_url": null, "governance_template_url": null, "regulatory_checklist_url": null, "open_safety_signals": 1 }, { "id": "fee8b653-de9b-4280-95a7-9b0794266d4f", "slug": "demo-symptom-assessment-triage", "title": "Symptom assessment for pre-admission triage", "product_name": "Ada", "taxonomy_version": "2026.1", "family_number": 13, "family_name": "Patient Engagement & Communication", "deploying_organisation": "[demo] Charité – Universitätsmedizin Berlin", "deploying_country": "DE", "vendor_organisation": "[demo] Ada Health", "intended_use_statement": "Guides patients through a structured symptom interview and recommends an appropriate level of care, signposting to the right service.", "clinical_specialty": "general_practice", "care_setting": "community", "autonomy_level": "informs_human", "is_gpai_based": true, "eu_ai_act_risk_tier": "limited_risk", "eu_ai_act_high_risk_basis": "not_applicable", "is_medical_device": false, "eu_mdr_class": "not_a_device", "ce_marking_status": "not_required", "fda_status": "not_applicable", "iso_14971_risk_class": "low", "gdpr_processing_basis": "consent", "gdpr_dpia_status": "completed", "data_identifiability": "anonymised", "human_oversight_model": "Advisory only; patients are clearly told they are interacting with AI and urgent presentations are escalated to human triage.", "explainability_method": "none", "nice_esf_tier": "tier_b_inform_monitor", "nice_evidence_category": null, "headline_metric_name": "accuracy", "headline_metric_value": 0.71, "subgroup_performance_assessed": false, "known_bias_signals": null, "pipeline_stage": "curated", "evidence_strength": "none", "assurance_pack_criteria_version": null, "assurance_pack_result": null, "assurance_pack_issued_at": null, "assurance_pack_document_url": null, "replication_package_published_at": null, "technical_guide_url": null, "clinical_guide_url": null, "governance_template_url": null, "regulatory_checklist_url": null, "open_safety_signals": null }, { "id": "9c2bfffc-06d6-40f2-9006-36387645afc1", "slug": "extra-trial-paeds-onc", "title": "Trial-matching for paediatric oncology", "product_name": null, "taxonomy_version": "2026.1", "family_number": 17, "family_name": "Research & Clinical Trials", "deploying_organisation": "[demo] Karolinska University Hospital", "deploying_country": "SE", "vendor_organisation": null, "intended_use_statement": "Cross-matches structured records, genomic markers and trial eligibility criteria to surface a prioritised list of candidate clinical trials per patient.", "clinical_specialty": "oncology", "care_setting": "back_office", "autonomy_level": "informs_human", "is_gpai_based": true, "eu_ai_act_risk_tier": "limited_risk", "eu_ai_act_high_risk_basis": "not_applicable", "is_medical_device": false, "eu_mdr_class": "not_a_device", "ce_marking_status": "not_required", "fda_status": "not_applicable", "iso_14971_risk_class": "low", "gdpr_processing_basis": "consent", "gdpr_dpia_status": "completed", "data_identifiability": "pseudonymised", "human_oversight_model": "Multidisciplinary tumour board reviews every match before approach.", "explainability_method": "post_hoc", "nice_esf_tier": "tier_a_system_service", "nice_evidence_category": null, "headline_metric_name": "ppv", "headline_metric_value": 0.71, "subgroup_performance_assessed": false, "known_bias_signals": "Coverage skewed toward Northern-European genetic backgrounds; cohort expansion under way.", "pipeline_stage": "curated", "evidence_strength": "emerging", "assurance_pack_criteria_version": null, "assurance_pack_result": null, "assurance_pack_issued_at": null, "assurance_pack_document_url": null, "replication_package_published_at": null, "technical_guide_url": null, "clinical_guide_url": null, "governance_template_url": null, "regulatory_checklist_url": null, "open_safety_signals": null }, { "id": "1d737093-45ae-4854-a3c6-90c2ad7cdaa4", "slug": "extra2-t2d-outcome", "title": "Type-2 diabetes long-term outcome predictor", "product_name": null, "taxonomy_version": "2026.1", "family_number": 8, "family_name": "Chronic Disease Management", "deploying_organisation": "[demo] Amsterdam UMC", "deploying_country": "NL", "vendor_organisation": null, "intended_use_statement": "Estimates 5-year risk of major diabetes-related complications (cardiovascular, renal, retinal) from longitudinal primary-care records to support care-plan intensification.", "clinical_specialty": "endocrinology", "care_setting": "primary_care", "autonomy_level": "informs_human", "is_gpai_based": false, "eu_ai_act_risk_tier": "high_risk", "eu_ai_act_high_risk_basis": "annex_iii", "is_medical_device": false, "eu_mdr_class": "not_a_device", "ce_marking_status": "not_required", "fda_status": "not_applicable", "iso_14971_risk_class": "medium", "gdpr_processing_basis": "public_interest", "gdpr_dpia_status": "completed", "data_identifiability": "pseudonymised", "human_oversight_model": "GP discusses and confirms care-plan changes with the patient; the AI never adjusts medication on its own.", "explainability_method": "intrinsic", "nice_esf_tier": "tier_c_treat_diagnose_risk", "nice_evidence_category": "3", "headline_metric_name": "auc", "headline_metric_value": 0.82, "subgroup_performance_assessed": true, "known_bias_signals": "Slightly lower discrimination in patients > 80; periodic recalibration scheduled.", "pipeline_stage": "validated", "evidence_strength": "robust", "assurance_pack_criteria_version": "draft-2026.1", "assurance_pack_result": "passed", "assurance_pack_issued_at": "2024-06-12T00:00:00+00:00", "assurance_pack_document_url": null, "replication_package_published_at": null, "technical_guide_url": null, "clinical_guide_url": null, "governance_template_url": null, "regulatory_checklist_url": null, "open_safety_signals": null }, { "id": "954be140-c3b5-4f7e-8551-8e0e4ed9c168", "slug": "extra2-poststroke-rehab", "title": "Wearable-guided post-stroke rehabilitation coach", "product_name": null, "taxonomy_version": "2026.1", "family_number": 16, "family_name": "Rehabilitation & Allied Health", "deploying_organisation": "[demo] Rigshospitalet", "deploying_country": "DK", "vendor_organisation": null, "intended_use_statement": "Uses wearable motion and HRV data plus a daily symptom check-in to recommend the next rehabilitation exercise and flag clinically-relevant deterioration to the physiotherapist.", "clinical_specialty": "rehabilitation", "care_setting": "home", "autonomy_level": "informs_human", "is_gpai_based": false, "eu_ai_act_risk_tier": "limited_risk", "eu_ai_act_high_risk_basis": "not_applicable", "is_medical_device": false, "eu_mdr_class": "not_a_device", "ce_marking_status": "not_required", "fda_status": "not_applicable", "iso_14971_risk_class": "low", "gdpr_processing_basis": "consent", "gdpr_dpia_status": "completed", "data_identifiability": "pseudonymised", "human_oversight_model": "Physiotherapist remains the lead clinician; AI suggestions are framed as options.", "explainability_method": "intrinsic", "nice_esf_tier": "tier_b_inform_monitor", "nice_evidence_category": "2", "headline_metric_name": "time_saved", "headline_metric_value": 12, "subgroup_performance_assessed": true, "known_bias_signals": null, "pipeline_stage": "maturing", "evidence_strength": "emerging", "assurance_pack_criteria_version": null, "assurance_pack_result": null, "assurance_pack_issued_at": null, "assurance_pack_document_url": null, "replication_package_published_at": null, "technical_guide_url": null, "clinical_guide_url": null, "governance_template_url": null, "regulatory_checklist_url": null, "open_safety_signals": null } ] }