Healthcare
Skill packages tagged with “Healthcare”
Clinical Report Writing
Write comprehensive clinical reports including case reports (CARE guidelines), diagnostic reports (radiology, pathology, lab), clinical trial reports (ICH-E3, SAE, CSR), and patient documentation (SOAP notes, H&P, discharge summaries). Includes regulatory compliance and validation tools.
Clinical Trial Protocol (ICH E6(R3) GCP)
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 ethics committee / IRB submission and regulatory filing (EMA, FDA IND, ANVISA).
CQC Statement of Purpose
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, Responsive, Well-led) and validates regulated activities against CQC registration categories. Covers care homes, GP practices, dental surgeries, domiciliary care, and hospitals.
DiGA Fast-Track
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 Versorgungseffekte and audits technical documentation for ISiK interoperability standards compliance.
Dossier AMM France — HAS / ANSM
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 maa_dossier_check).
eCTD Cross-Module Verifier
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, endpoints, and safety data are aligned before regulatory submission to FDA, EMA, or PMDA.
FDA Submission Wizard
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) dossiers with clinical and non-clinical data sections.
Health Canada & MDSAP
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 available.
HIPAA Security Risk Assessment (SRA)
Draft and validate the Security Risk Assessment required by the HIPAA Security Rule (45 CFR §164.308(a)(1)). Maps ePHI assets to threats, vulnerabilities, and safeguards across administrative, physical, and technical categories. Produces the SRA report and risk register aligned with HHS/OCR audit protocol.
HIQA Complaints Procedure
Draft or update a complaints procedure for healthcare services aligned with HIQA NSSBH and national complaints guidance.
HIQA Consent Policy
Draft or update a consent policy for healthcare services aligned with HIQA NSSBH and Irish consent law.
HIQA Healthcare Governance
Draft or update a governance and accountability framework for healthcare services aligned with HIQA NSSBH Theme 5.
HIQA Incident Investigation Report
Draft an incident investigation report for healthcare services aligned with HIQA NSSBH and learning from incidents.
HIQA Incident Reporting Procedure
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
Draft or update the process for reporting notifiable incidents to HIQA/Chief Inspector under the Patient Safety Act 2023.
HIQA Open Disclosure Policy
Draft or update an open disclosure policy aligned with the Patient Safety Act 2023 and HIQA NSSBH.
HIQA Quality Improvement Plan
Draft or update a quality improvement plan for healthcare services aligned with HIQA NSSBH.
HIQA Risk Register
Draft or update a risk register for healthcare services aligned with HIQA NSSBH (safe care, governance).
HIQA Safeguarding Policy
Draft or update a safeguarding policy for healthcare services aligned with HIQA NSSBH and national safeguarding guidance.
HIQA Workforce Performance Management Policy
Draft or update a workforce performance management policy for healthcare services aligned with HIQA NSSBH Theme 6.
HIQA Workforce Recruitment Policy
Draft or update a workforce recruitment policy for healthcare services aligned with HIQA NSSBH Theme 6.
HIQA Workforce Supervision Policy
Draft or update a workforce supervision policy for healthcare services aligned with HIQA NSSBH Theme 6.
HIQA Workforce Training Policy
Draft or update a workforce training policy for healthcare services aligned with HIQA NSSBH Theme 6.
HITRUST CSF Assessment
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 Validated Assessment Report.
Medical Council Professional Ethics
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 and check Open Disclosure protocols against the Patient Safety Act 2023.
Monitoramento de Infecções (IRAS) e RAM
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 estatísticas. Regulação: ANVISA, Notas Técnicas 02/2026 e 03/2026.
Pharmacy QMS (ApBetrO)
Pflege und Erstellung des Qualitaetsmanagementsystems (QMS) fuer oeffentliche Apotheken gemaess Apothekenbetriebsordnung (ApBetrO). Erstellt QMS-Handbuecher, Hygieneplaeane nach RKI-Richtlinien, Rezepturprotokolle nach DAB/Ph.Eur. und prueft die Compliance.
PRD — Healthcare / Health Tech PM
Draft and validate PRDs for healthcare and health tech: clinical workflows, HIPAA/safety, consent, data handling.
QMS CAPA Tracker
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 Effectiveness Check completeness, and validates CAPA structure against ISO 13485 and FDA 21 CFR Part 820 requirements.
USA Medical Power of Attorney
Draft and validate a healthcare proxy or advance directive (medical POA and optional living will) in the USA.