# Skills tagged "Healthcare" 30 skills with this tag. URL: https://rakenne.app/skill-tags/healthcare/index.md - [Clinical Report Writing](https://rakenne.app/skills/clinical-reports/index.md) — Write comprehensive clinical reports including case reports (CARE guidelines), diagnostic reports (radiology, pathology, lab), clinical trial reports (ICH-E3, SAE, CSR), and patient documentation … - [Clinical Trial Protocol (ICH E6(R3) GCP)](https://rakenne.app/skills/ich-gcp-clinical-trial-protocol/index.md) — Draft and validate clinical trial protocols per ICH E6(R3) Good Clinical Practice and ICH E8(R1) General Considerations for Clinical Studies. Ensures the protocol contains all required elements for … - [CQC Statement of Purpose](https://rakenne.app/skills/cqc-statement-of-purpose/index.md) — Draft, update, and validate the legally required Statement of Purpose for CQC-registered healthcare providers in England. Maps service descriptions to the Five Key Questions (Safe, Effective, Caring, … - [DiGA Fast-Track](https://rakenne.app/skills/diga-fast-track/index.md) — Prepare and validate Fast-Track applications for listing Digital Health Applications (DiGA) in the BfArM directory per DiGAV. Cross-checks clinical study protocols against claimed Positive … - [Dossier AMM France — HAS / ANSM](https://rakenne.app/skills/maa-dossier-has-ansm/index.md) — Préparer et vérifier les dossiers d'Autorisation de mise sur le marché (AMM/MAA) pour le marché français. Contexte HAS et ANSM, structure CTD, cohérence des données d'essais cliniques (avec … - [eCTD Cross-Module Verifier](https://rakenne.app/skills/ectd-cross-module-verifier/index.md) — Verify consistency and data integrity of eCTD pharmaceutical dossiers. Cross-checks Module 2 (Summaries) against Module 5 (Clinical Study Reports) to ensure study references, p-values, N-counts, … - [FDA Submission Wizard](https://rakenne.app/skills/fda-submission-wizard/index.md) — Draft and validate FDA medical device submissions. Supports 510(k) Premarket Notifications (eSTAR format) with predicate comparison and substantial equivalence arguments, and PMA (Premarket Approval) … - [Health Canada & MDSAP](https://rakenne.app/skills/health-canada-mdsap/index.md) — Align QMS documentation to MDSAP and Health Canada expectations. Guides users to map procedures and records to MDSAP/ISO 13485, prepare for audits, and use the mdsap_audit_aligner skill when … - [HIPAA Security Risk Assessment (SRA)](https://rakenne.app/skills/hipaa-security-risk-assessment/index.md) — Draft and validate the Security Risk Assessment required by the HIPAA Security Rule (45 CFR §164.308(a)(1)). Defines scope and ePHI boundaries, inventories assets and Business Associate relationships, … - [HIQA Complaints Procedure](https://rakenne.app/skills/hiqa-complaints-procedure/index.md) — Draft or update a complaints procedure for healthcare services aligned with HIQA NSSBH and national complaints guidance. - [HIQA Consent Policy](https://rakenne.app/skills/hiqa-consent-policy/index.md) — Draft or update a consent policy for healthcare services aligned with HIQA NSSBH and Irish consent law. - [HIQA Healthcare Governance](https://rakenne.app/skills/hiqa-healthcare-governance/index.md) — Draft or update a governance and accountability framework for healthcare services aligned with HIQA NSSBH Theme 5. - [HIQA Incident Investigation Report](https://rakenne.app/skills/hiqa-incident-investigation-report/index.md) — Draft an incident investigation report for healthcare services aligned with HIQA NSSBH and learning from incidents. - [HIQA Incident Reporting Procedure](https://rakenne.app/skills/hiqa-incident-reporting-procedure/index.md) — Draft or update an incident reporting procedure for healthcare services aligned with HIQA NSSBH (internal reporting; for notifiable incidents use hiqa-notifiable-incidents-reporting). - [HIQA Notifiable Incidents Reporting](https://rakenne.app/skills/hiqa-notifiable-incidents-reporting/index.md) — Draft or update the process for reporting notifiable incidents to HIQA/Chief Inspector under the Patient Safety Act 2023. - [HIQA Open Disclosure Policy](https://rakenne.app/skills/hiqa-open-disclosure-policy/index.md) — Draft or update an open disclosure policy aligned with the Patient Safety Act 2023 and HIQA NSSBH. - [HIQA Quality Improvement Plan](https://rakenne.app/skills/hiqa-quality-improvement-plan/index.md) — Draft or update a quality improvement plan for healthcare services aligned with HIQA NSSBH. - [HIQA Risk Register](https://rakenne.app/skills/hiqa-risk-register/index.md) — Draft or update a risk register for healthcare services aligned with HIQA NSSBH (safe care, governance). - [HIQA Safeguarding Policy](https://rakenne.app/skills/hiqa-safeguarding-policy/index.md) — Draft or update a safeguarding policy for healthcare services aligned with HIQA NSSBH and national safeguarding guidance. - [HIQA Workforce Performance Management Policy](https://rakenne.app/skills/hiqa-workforce-performance-policy/index.md) — Draft or update a workforce performance management policy for healthcare services aligned with HIQA NSSBH Theme 6. - [HIQA Workforce Recruitment Policy](https://rakenne.app/skills/hiqa-workforce-recruitment-policy/index.md) — Draft or update a workforce recruitment policy for healthcare services aligned with HIQA NSSBH Theme 6. - [HIQA Workforce Supervision Policy](https://rakenne.app/skills/hiqa-workforce-supervision-policy/index.md) — Draft or update a workforce supervision policy for healthcare services aligned with HIQA NSSBH Theme 6. - [HIQA Workforce Training Policy](https://rakenne.app/skills/hiqa-workforce-training-policy/index.md) — Draft or update a workforce training policy for healthcare services aligned with HIQA NSSBH Theme 6. - [HITRUST CSF Assessment](https://rakenne.app/skills/hitrust-csf-assessment/index.md) — Draft HITRUST CSF Validated Assessment deliverables for e1, i1, or r2 certification: control requirement responses at all maturity levels, evidence artifacts, Corrective Action Plans, and the … - [Medical Council Professional Ethics](https://rakenne.app/skills/medical-council-professional-ethics/index.md) — Draft Informed Consent and Clinical Indemnity policies for private clinics in Ireland, aligned with the Irish Medical Council Guide to Professional Conduct and Ethics. Validate policies with the Guide … - [Monitoramento de Infecções (IRAS) e RAM](https://rakenne.app/skills/hospital-safety-reporter/index.md) — Padroniza relatórios mensais de infecção hospitalar e resistência microbiana para hospitais e clínicas, com foco em notificação de indicadores nacionais obrigatórios e detecção de discrepâncias … - [Pharmacy QMS (ApBetrO)](https://rakenne.app/skills/apbetro-pharmacy-qms/index.md) — Pflege und Erstellung des Qualitaetsmanagementsystems (QMS) fuer oeffentliche Apotheken gemaess Apothekenbetriebsordnung (ApBetrO). Erstellt QMS-Handbuecher, Hygieneplaeane nach RKI-Richtlinien, … - [PRD — Healthcare / Health Tech PM](https://rakenne.app/skills/prd-healthcare-pm/index.md) — Draft and validate PRDs for healthcare and health tech: clinical workflows, HIPAA/safety, consent, data handling. - [QMS CAPA Tracker](https://rakenne.app/skills/qms-capa-tracker/index.md) — Draft and validate CAPA (Corrective and Preventive Action) reports for medical device quality management systems. Standardizes root cause analysis using 5 Whys or Fishbone (Ishikawa) methods, enforces … - [USA Medical Power of Attorney](https://rakenne.app/skills/usa-medical-power-of-attorney/index.md) — Draft and validate a healthcare proxy or advance directive (medical POA and optional living will) in the USA. --- Back to [All Tags](https://rakenne.app/skill-tags/) | [Skill Library](https://rakenne.app/skills/)