123건 · 관련도순
Addresses healthcare AI privacy at the intersection of HIPAA and the EU AI Act for clinical decision support systems. Covers training data PHI handling, model transparency and explainability, patient rights in algorithmic decisions, FDA/OCR regulatory coordination, and bias monitoring. Keywords: healthcare AI, HIPAA, AI Act, clinical decision support, PHI training data, model transparency.
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Addresses HIPAA compliance for mobile health (mHealth) applications, wearable devices, and remote patient monitoring. Covers OCR guidance on mobile device PHI, FDA-regulated mobile medical applications, FTC Health Breach Notification Rule for non-HIPAA apps, BYOD policies, and encryption requirements for ePHI on mobile platforms. Keywords: mHealth, mobile health, HIPAA mobile, wearable, remote monitoring, BYOD, mobile device management, app privacy.
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Think and work like an expert Mass Spectrometrist. Use when a task calls for Mass Spectrometrist judgment. Reasons from ion formation, m/z resolution and mass accuracy, fragmentation, and calibrated ion statistics through ESI/APCI/MALDI tuning, CID/HCD/ETD MS/MS, isotope-pattern formula assignment, and spectral libraries (NIST, mzCloud, GNPS) under FDA/ICH M10/MSI tiers, while treating matrix suppression, PEG/siloxane/keratin contamination, decoy-driven FDR inflation, and unassigned adducts as first-class failure modes.
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Think and work like an expert Genome Engineering (CRISPR) Scientist. Use when a task calls for Genome Engineering (CRISPR) Scientist judgment. Reasons from NHEJ/HDR/MMEJ competition and editor modality choice through CRISPick/CRISPResso2 guide design, LOCK/lssDNA and RNP HDR, base and prime editing (PE4/PE5, epegRNA), CAST-Seq/UDiTaS on-target SV assessment, clonal genotyping, and FDA/IBC-bound off-target and genome-integrity analytics.
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Think and work like an expert Clinical Pharmacologist. Use when a task calls for Clinical Pharmacologist judgment. Reasons from exposure–response, popPK (NONMEM), DDI (ICH M12), TDM/NTI windows, and renal/hepatic/allometric adjustment; aligns dose finding with ICH E4 and FDA clinical pharmacology labeling.
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Think and work like an expert Biomedical Engineer. Use when a task calls for Biomedical Engineer judgment. Reasons from ISO 14971 risk management, ISO 10993 biocompatibility matrices, ASTM F/ISO 14242 mechanical and wear testing, and FDA 510(k) substantial equivalence; treats stress shielding, UHMWPE osteolysis, F2129 corrosion artifacts, and predicate/material mismatches as first-class failure modes.
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Device-track catalyst analysis: 510(k), PMA, and De Novo decision events, CMS coverage and NTAP milestones, recalls and watch actions as risk signals, and post-market surveillance obligations — dated, verified, and sized per event for any medtech ticker or watchlist.
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Med-adapted recent-quarter review: last print financials, pipeline-milestone awareness, and FDA-event context — reads the quarter through the med lens (milestones moved, runway, regulatory updates) rather than generic financials alone.
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Med-adapted earnings preview: consensus estimates, historical surprises, guidance sensitivities, and the FDA-catalyst overlay (PDUFA/AdCom/trial readouts near the print) for biotech/pharma names.
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Med-sector overview across med.medicines_biotech and med.medical_devices with med trends, catalysts, FDA-decision context, and a cross-sector ripple map (quantified sign/magnitude per name). Use to frame any biotech/pharma/device analysis before diving into a single name.
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CDER-track catalyst analysis for medicines: PDUFA target dates, AdCom votes, sNDA/sBLA label expansions, biosimilar interchangeability and 180-day exclusivity, Orange Book state, and CRL remediation timelines — enumerated, verified, and sized per event for any biotech/pharma ticker or watchlist.
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Computes and interprets treatment effect measures (OR, RR, RD, HR, NNT) with calibrated confidence intervals (Wilson, Newcombe, Miettinen-Nurminen, MOVER, profile likelihood, Bender NNT) and reports marginal vs conditional estimands per FDA 2023 covariate adjustment guidance. Use when reporting treatment effects in confirmatory trials, comparing effect sizes across studies, or constructing forest plots.
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End-to-end clinical trial analysis workflow from CDISC SDTM/ADaM loading through ICH E9(R1) estimand-driven primary analysis to CONSORT 2025 regulatory-compliant reporting. Covers data preparation, FDA 2023 marginal vs conditional logistic regression, categorical tests with Boschloo, modern HTE/subgroup methods, missing-data sensitivity (MMRM, reference-based MI, Permutt tipping point), graphical multiplicity (Bretz-Maurer), survival analysis (Cox/RMST/competing risks) when applicable, and Table 1. Use when performing a complete analysis of clinical trial data.
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Patterns for designing and analyzing clinical trials, including survival analysis, endpoint selection, sample size calculation, interim analyses, and regulatory considerations. Covers FDA/EMA guidelines and modern adaptive designs. Use when ", " mentioned.
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Use this skill to create fillable Word forms (.docx) with real Content Controls (SDT) + legacy FormField checkboxes + MERGEFIELD mail-merge placeholders + document protection. Trigger on: 'fillable form', 'form fields', 'content controls', 'SDT', 'word form', 'fill in', 'only editable fields', 'protect document', 'onboarding form', 'HR intake', 'survey template', 'contract / SOW template', 'mail-merge template', 'compliance checklist', 'medical intake questionnaire'. Output is a single .docx where specific fields are editable and the rest is locked. This skill is INDEPENDENT, not a scene layer on docx — payload is `<w:sdt>` + `<w:ffData>` + `<w:fldChar>` + `documentProtection`, none of which docx base skill covers. Do NOT trigger for regular reports, letters, memos, academic papers, pitch decks, or any document with no user-fillable fields — route those to officecli-docx or its scene layers.
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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, H&P, discharge summaries). Full support with templates, regulatory compliance (HIPAA, FDA, ICH-GCP), and validation tools.
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Codified expertise for quality control, non-conformance investigation, root cause analysis, corrective action, and supplier quality management in regulated manufacturing. Informed by quality engineers with 15+ years experience across FDA, IATF 16949, and AS9100 environments. Includes NCR lifecycle management, CAPA systems, SPC interpretation, and audit methodology. Use when investigating non-conformances, performing root cause analysis, managing CAPAs, interpreting SPC data, or handling supplier quality issues.
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Evaluates regulatory decision impact with approval probability, timeline analysis, and outcome scenario modeling for event-driven positions. Use when analyzing regulatory events, evaluating FDA/FCC/DOJ decisions, or modeling regulatory outcomes.
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Guide the team through writing a change-impact record for IEC 62304 / FDA / ISO 26262 ASIL C+ projects. Surfaces the affected REQ/DES/TEST/CODE artefacts and captures human-attested verification approach.
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Audit a pharmaceutical regulatory submission system -- evaluate eCTD backbone assembly and XML validation, CTD module completeness (Modules 1-5), FDA ESG and EMA CESP gateway integration, document authoring and publishing workflows, ICH M4/M8/E3 guideline compliance.
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Computes sample size and power for clinical trials including continuous, binary, and time-to-event endpoints; superiority, non-inferiority, and equivalence designs; FDA 2016 non-inferiority margin selection with M1/M2 framework; Schoenfeld 1981 and Lakatos 1988 for survival; Schuirmann TOST and 80-125% bioequivalence; minimum clinically important difference (MCID) vs δ distinction. Use when justifying trial size in protocol or SAP per CONSORT 2025 item 16a.
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Computes and interprets treatment effect measures (OR, RR, RD, HR, NNT) with calibrated confidence intervals (Wilson, Newcombe, Miettinen-Nurminen, MOVER, profile likelihood, Bender NNT) and reports marginal vs conditional estimands per FDA 2023 covariate adjustment guidance. Use when reporting treatment effects in confirmatory trials, comparing effect sizes across studies, or constructing forest plots.
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Performs logistic regression for clinical trial outcomes (binary, ordinal, multinomial) with marginal-vs-conditional estimand reporting per FDA 2023 covariate adjustment guidance, g-computation/standardisation for marginal effects, modified Poisson for RR, Brant test for proportional odds, Firth penalty for separation, and Hauck-Donner detection. Use when modeling binary or ordinal endpoints in confirmatory or exploratory clinical trials.
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Calls microsatellite instability from WES/WGS/targeted-panel with MSIsensor, MSIsensor-pro, MSIsensor-ct (panel-aware), mSINGS, and MANTIS for FDA pembrolizumab MSI-H pan-tumor / Lynch syndrome / dMMR ICI biomarker. Use when stratifying ICI eligibility (Le 2015), pairing MSI with TMB-H (Sha 2020 / Salem 2018), screening Lynch syndrome (universal IHC + MSI), or distinguishing MSI-H tumors from POLE-exo hypermutator with overlapping signatures.
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